PHARMOCRACY II

How Corrupt Deals and Misguided Medical Regulations are Bankrupting America and What To Do About It

by William Faloon- Co Founder of the Life Extension Foundation (c) 2017

Preface

Healthcare is bankrupting the United States. Medical costs have escalated to a level that indi-viduals, businesses, and debt-laden governments can no longer afford to pay.ere is a real-world solution.Congress can create legislation that will allow free-mar-ket forces to drive down sick-care costs, better enable dis-ease prevention, and rapidly perfect curative therapies.is book provides factual documentation on how bro-ken the US healthcare system is today. It is over 300 pages long because there are at least that many reasons why health-care costs far more than it should.Until now, no one has identified and amalgamated the plethora of illogical regulations that directly cause health-care to be so overpriced.While this book attacks FDA corruption and ineptitude, Congress is the body of government that provides the FDA with enabling laws that ultimately result in needless human suffering and death—while the nation descends into financial ruination.

Pharmocracy II2•Implementing free-market approaches can spare Medicare and Medicaid from insolvency, while significantly improv-ing the health and productivity of the American public.Pharmocracy II provides an irrefutable and rational basis to remove the suffocating compulsory aspect of healthcare regulation and allow free-market forces to compete against government-sanctioned medicine.is book documents how the free market can provide superior healthcare at far lower prices while better pro-tecting consumers.Disregard of the obvious problems revealed in this book will condemn the United States to a downward economic spiral with little improvement in healthy human longevity. — William Faloon

Introduction

A fierce debate is  raging as to who will pay for this nation’s skyrocketing “sick-care” costs.Private companies have scaled back sharply on the healthcare coverage they used to provide.1,2 Employees now pay an increasing percentage of their medical insurance pre-miums, along with higher deductibles, co-pays, and no-pays (i.e., exclusions). Many businesses provide their employees with no health coverage.Based on the median income in the United States, the typical family cannot come close to paying the staggering cost of healthcare themselves.It seems rather odd, but since neither the private busi-ness sector nor individuals can afford today’s sick-care costs, the burden is increasingly being borne by the sector least able to pay, i.e., heavily indebted local, state, and fed-eral governments.Even those covered by government insurance (such as municipal employees and Medicare recipients) are facing higher medical insurance premiums.

The federal government is already saddled with a huge unfunded Medicare liability. No one has figured out where the money will come from to cover these future healthcare costs. To put Medicare alone into context, in year 2015, the unfunded liability stood at $27 trillion to $43.5 trillion, depending on which federal agency projection you look at. 3 Yet total federal tax revenue taken in annually (which includes Medicare premiums) is only around $3.2 trillion. 4 President Obama stated in 2010 that we are approaching a point where government will have to spend more money on Medicare than on every other federal program combined!5,6 In the ensuing seven years, however, nothing has been done by any politician to address the massive unfunded healthcare liability the United States (and other nations) must contend with. The Medicare unfunded liability does not count the escalating costs of Medicaid (sick-care coverage for the poor) that are shared by federal and state governments. Medicaid is funded with current tax revenue and newly issued debt, but its spiraling growth has created a new multi-trillion dollar unfunded liability, and no one knows where the money will come from to pay it. 7 Bernard Madoff was sentenced to 150 years in prison because he took investors’ money and diverted it to other purposes. The federal government forced Americans to pay Medicare premiums their entire lives. Instead of those premiums being placed in a reserve fund for future use, they were squandered on whatever was most politically expedient at the time, which included overpaying—with tax dollars—those with the right political connections. While Madoff will spend the rest of his life incarcerated, no one talks about bringing civil or criminal charges against those responsible for what may be the largest Ponzi scheme in the history of the human race: Medicare, with its >$27 trillion of unfunded liabilities. Like the federal government, many local and state governments have also operated a Ponzi scheme of unfunded pension and healthcare liabilities they cannot pay. 8 State and local governments long ago promised their employees free or heavily subsidized healthcare for life. Skyrocketing sick-care costs, combined with increases in human longevity, have made it impossible for these promised healthcare benefits to be fulfilled under today’s over-regulated environment that causes medicine to exponentially cost more than it should. Since the federal government is mathematically insolvent, it seems ludicrous to assume that exorbitant sickcare costs can be resolved by any level of government. While politicians point fingers over who should pay America’s medical bills, please remember that there is a real-world solution. Healthcare in the United States is so tightly regulated that it in many ways resembles the inefficiencies of Maoist China, where the economy suffocated for decades due to erratic and illogical governmental decrees. As China lifted its regulatory stranglehold, prosperity flourished. It’s time for US leaders to follow China’s example and stop over-regulating medicine!

WE HAVE BEEN DECEIVED BY BIG PHARMA

Americans have paid outlandish prices for prescription drugs, believing that pharmaceutical profits would fund research leading to medical breakthroughs. The problem is that very few real-world discoveries have manifested. One can point to some treatments that prolong 6 • Pharmocracy II patient survival, but these are offset by lethal side effects inflicted by fraudulently approved therapies. 9–11 The fact is that few real cures have occurred, despite Americans spending more healthcare dollars than anyone else. 

Examples of cures are antibiotics and vaccines that eradicated diseases. These were developed long before today’s regulatory stranglehold ended these kinds of breakthrough innovations. 

Since the first Pharmocracy was written, several pharmaceuticals have been developed that “cure” most cases of hepatitis C. While these drugs represent a major biomedical advance, their outrageous price (such as $1,000 per pill for the drug Solvaldi®) is beyond rational affordability. 

Major strides have been made against chronic myeloid leukemia, but once again, drug prices exceeding $100,000 per year for the lifetime of each patient has led oncology groups to state that these costs are “unsustainable.” 12,13 

Unregulated medicine continues to make considerable strides. The majority of the population, however, does not know about these approaches. Vested financial interests have spent billions to ensure that the media, politicians, and bureaucrats continue suppressing more effective and less expensive ways to prevent and treat degenerative illnesses. 

Americans have been deceived by those who associate regulations with beneficial outcomes. As it relates to medical progress, relatively little has occurred for the lethal diseases impacting aging Americans. The abysmal track record of conventional medicine is a direct reflection of the “regulatory burden” that stifles development of novel and less expensive therapies. 14 

Few Americans understand that the underlying purpose of any given regulation is to provide a government-protected advantage to the group favoring that regulation. It’s not about Introduction • 7 how a regulation will protect the public, but instead a matter of how can it “financially benefit a special interest.” 15 

An oft-cited example is a petition the drug maker Wyeth filed with the FDA asking that a natural human form of estrogen called estriol be banned. 16 The female hormone drugs Wyeth sold (Premarin® and PremPro®) had been shown to produce side effects. 17–26 Instead of spending research dollars to come up with safer forms of estrogen (such as combining natural estrogens with indole-3-carbinol and natural progesterone),27–33 it was much cheaper to persuade political hacks at the FDA to outlaw the competition (i.e., bioidentical estriol hormone compounds). 34 Pharmaceutical companies have spent enormous amounts of money persuading the FDA to reclassify nutrients like pyridoxamine into prescription drugs so they can monopolize them for their own economic benefit. 35 Pyridoxamine is a form of vitamin B6 that reduces the formation of advance glycation end products. 36 It was sold as a dietary supplement for years before the FDA mandated it be removed (in 2009) because a pharmaceutical company wanted to have pyridoxamine approved as a “drug” to treat kidney disease. 

Interestingly, as this book was being updated in 2017, the pyridoxamine “drug” remains bogged down in the expensive and cumbersome “approval” process. That means no American can derive its potential life-saving benefit at any price. 

The FDA took away what was a low-cost dietary supplement to benefit a drug company. This provided one company with a monopoly to investigate and possibly market this non-patented version of vitamin B6 (pyridoxamine). The company owning the monopoly (courtesy of the FDA) now struggles to cover the enormous costs of having it “approved” by the same federal agency. 37 8 • Pharmocracy II 

If it were not for aggressive letter-writing campaigns by consumers to Congress, most dietary supplements would now be expensive prescription drugs, or not available at all.

FDA—FAILURE, DECEPTION, ABUSE

In 2010, I finished a 498-page book called FDA: Failure, Deception, Abuse, which exposed how over-regulation has destroyed citizens’ health and this nation’s finances. One year later, I put together the first Pharmocracy book to expose more atrocities committed by out-of-control politicians and bureaucrats against our health and pocketbooks. 

This book, Pharmocracy II, provides startling updates to a medical cost crisis that is exploding out of control. 

The magnitude of the artificially inflated drug costs are beyond obscene. As I was finalizing this book, the media was focusing on a generic drug used to save the lives of children who suffer acute allergic food allergies. 

The name of the drug is EpiPen®, and its cost has risen 550% since year 2007. 38 There is nothing unique about the active ingredient (epinephrine) in this injectable that parents carry to save their child’s life. The maker nonetheless enjoys a virtual monopoly based on effective lobbying, aggressive legal defense against competitors, and the high costs of getting the FDA to approve competing versions of the identical drug. 

The retail price for a pack of two EpiGen® pens is $608 (up from $94 in 2007). 39 Many parents cannot afford this outlandish price and risk their children slowly suffocating to death if an acute allergic reaction occurs. 

In case you’re wondering what it costs to make this drug, experts are quoted as stating the epinephrine put into a similar auto injector can be made for $3–$7. 40 With sterile Introduction • 9 quality control, this drug could be profitably sold for less than $100—if it were not for the power Congress bestows on the FDA to pick and choose who gets to make it. 

 

In response to media backlash, the maker of the EpiPen® promised to make a generic version that costs only $300… which is still as much as one hundred times more than what it costs to make. 41 The $300 price for a drug that may be needed multiple times each year is still unaffordable by many parents whose deductibles are over $4,000 each year.

 

A few months after the EpiPen® disclosures, a drug used by migraine suffers shot up to $728 for nine tablets.42 The active ingredients in this drug, called Treximet®, are generics (sumatriptan and naproxen) that long ago came off patent. If purchased separately, these same two drugs would cost consumers around $19. By combining them, the pharmaceutical company can reap in huge profits from taxpayer-funded programs like Medicare and Medicaid.

To provide an idea of how much profit there is with Treximet®, the company offers to sell it directly to hardship cases for only $20 as opposed to the $728 price that many consumers are faced with at the pharmacy counter. The company still makes a profit based on cost of product on $20 direct sales.

In this Orwellian tragedy, the annual cost of “regulated” drugs can amount to thousands of dollars whereas the same drugs in a “free market” environment would plummet considerably.

WHY CONGRESS DOES NOT ACT

Imagine a member of Congress introducing a bill repealing this kind of FDA-protected monopoly.

The pharmaceutical industry would spend whatever amount of money needed to keep this law from being enacted, and would heavily finance whoever ran against this member of Congress in the next election.

In other words, it would be political suicide to attempt to allow unregulated drugs to be sold, even though deregulation would go a long way to solving today’s healthcare cost crisis. That’s why consumers have to band together to demand Congress ignore pharmaceutical lobbyists and introduce emergency legislation that repeal today’s absurd over-regulation of medicine.

The title of this book is Pharmocracy II, but I contemplated the original title as Regulation Breeds Corruption. The reason I considered that title is that egregious pharmaceutical company profits are protected by regulations. These vested interests will go to any corrupt length to ensure these regulations are perpetuated, no matter how inane they are.

The word “corruption” is often interpreted as meaning something illegal. The word corruption, however, can be defined as immoral behavior, an example of which is the exploitation of a position of power for personal gain. When it comes to campaign contributions, lobbying, and offering congressional staff generous employment after they retire, these are not overtly illegal acts.46 They routinely happen, which means this kind of devastating corruption has been institutionalized and must now be eliminated.

HOW REGULATED COSTS ADD UP 

Institutionalized corruption artificially inflates the cost of virtually every healthcare service. 

When one considers there are thousands of medicalrelated products and services that are artificially inflated by senseless regulations, it becomes clear that radical change is required to avoid an economic meltdown. 

In dealing with runaway healthcare costs, a solution is to make certain drugs like statins available without the necessity of a doctor’s visit. There are now companies that employ physicians to review blood tests over the phone and prescribe certain medications, but the FDA and state licensing boards are a constant threat to their existence.47 

Corrupt regulations ensure that efficiencies that would slash healthcare costs never see the light of day.

SIMPLE SOLUTION TO AVERT ECONOMIC RUINATION

The Life Extension Foundation® initiated a petition drive back in the 1980s to allow individual Americans to “opt out” of the FDA’s regulatory umbrella. Our rationale was that this would provide consumers with more advanced treatments at lower prices.

Hundreds of enlightened Life Extension Foundation® members petitioned the FDA demanding liberation from its regulatory stranglehold. The public, Congress, and the media were apathetic at that time.

The FDA was far from lethargic. They responded to our petition analogous to an angry hornet’s nest (and how dictators respond to dissidents). The notion that we dared challenge the FDA’s absolute authority resulted in years of legal battles where the FDA did everything in its power to try to destroy the Life Extension Foundation® (and put me in jail).

Fast-forward to today. The political climate has changed. The healthcare cost crisis we long ago predicted has evolved into a harsh reality no one can ignore. It is mathematically impossible to solve it by forcing one group to pay regulated medicine’s corruptly inflated costs. The only salvation is the free-market reforms that the Life Extension Foundation ® long ago drafted.

Our proposal is quite simple. Change the laws to allow good-manufacturing practice-certified (GMP) manufacturing facilities to produce generic prescription drugs that do not undergo the excessive regulatory hurdles that force consumers to pay egregiously inflated prices.

To alert consumers when they are getting a generic that is not as heavily regulated as it is currently, the law would mandate that the label of these less-regulated generic drugs clearly state:

This is not an FDA-approved manufactured generic drug and may be ineffective and potentially dangerous. This drug is not manufactured under the same standards required for an FDA-approved generic drug. Purchase this drug at your own risk.

By allowing the sale of these less costly generics, consumers will have a choice as to which companies they choose to trust.

Equally important among our proposals is one that allows consumers to be told about the off-label benefits of prescription drugs. An example is the extensive body of evidence that metformin may help prevent—not simply treat—type 2 diabetes,49,50 and that metformin may also prevent and help treat certain cancers.

A concern critics raise about this free-market solution is safety. Who will protect consumers from poorly made generic drugs, they ask? 

First of all, the manufacturers of these drugs would be subject to the same regulation as GMP-certified over-thecounter drug and dietary supplement makers. FDA inspectors will visit facilities, take sample products, and assay them to ensure the potency of active ingredients, dissolution, etc. Manufacturers that fail to make products that meet the label’s claims would face civil and criminal penalties. 

Secondly, there is no incentive not to provide the full potency of active ingredients in these less-regulated generic drugs. The price of the active ingredient makes up such a small percentage of the overall cost that a manufacturer would be idiotic to scrimp on potency.63 

Companies that foolishly make inferior generics will be viciously exposed by the media, along with the FDA, consumer protection groups, and even prescribing physicians who will be suspicious if a drug is not working as it is supposed to. (Just imagine how easy it would be to spot a bogus generic statin that did not reduce cholesterol?)

Companies producing inferior products will be quickly driven from the marketplace as consumers who choose to purchase these lower-cost generics will seek out laborato-ries that have reputations for making flawless products..

Substandard companies would not only be castigated in the public’s eye, but also face civil litigation from custom-ers who bought the defective generics.. When one considers that GMP-certified manufacturing plants can cost hundreds of millions of dollars to set up, a company would guarantee itself future insolvency if it failed to produce generic drugs that met minimum standards..

PHARMACEUTICAL COMPANY PROPAGANDA

No matter how many facts show that free-market generic drugs will be safe, there are alarmists who believe that even if one person might suffer a serious adverse event because of a lower-cost generic drug, the law should not be amended to allow the sale of these less-regulated products..

What few understand is that enabling lower-cost drugs to be sold might reduce the number of poorly made drugs.. The reason is that prescription drug counterfeiting remains a major issue..64 Drugs are counterfeited because they are so expensive.. In the free-market environment we espouse, a month’s supply of a popular cholesterol-lowering drug like simvastatin would sell for less than $3..00.. It is difficult to imagine anyone profiting by counterfeiting it.. So amend-ing the law to enable these super-low-cost drugs to be sold might reduce the counterfeiting that exists right now..

Another reason these less-regulated generics will do far more good than harm is that people who need them to live will be able to afford them.. The media has reported on heart-wrenching stories of destitute people who are unable to pay for their prescription drugs.. They either do without, or take a less-than-optimal dose.. The availability of these free-market generics will enable virtually anyone to be able to afford their medications out of pocket..

EXAMPLE OF SUCCESSFUL REVOLT AGAINST FDA

A few years ago, news broke that the FDA had granted an exclusive monopoly to a company to sell a non-patented progesterone drug that prevents premature births..65

Healthy women naturally secrete huge amounts of proges-terone during pregnancy, which helps maintain their uterine lining.. To protect against premature births and miscarriages in women who don’t secrete enough progesterone, doctors have for decades prescribed progesterone medications that were made by state-licensed compounding pharmacies.. The cost per injection was around $20..

By granting orphan drug status to one company (KV Phar-maceutical), FDA rules banned all other forms of proges-terone for this indication.. The immediate impact was that the cost per injection of this progesterone drug was set to skyrocket to $1,500—or as much as $30,000 for a full-term pregnancy..66

An uprising over this price gouging forced the FDA to back down and state it “does not intend to take enforce-ment action against pharmacies that compound hydroxy-progesterone caproate..”67

What the FDA is saying is that while it has the discre-tion to arrest compounding pharmacists for making this drug, it does not “intend to” do so..68 After the FDA made this announcement, KV Pharmaceutical reduced the price to $690, which was still more than 34 times its previous free-market price.. As of this writing, the cost of KV’s pro-gesterone drug is $779 per injection..69

It is unclear how private insurance and Medicaid will determine whether to pay $779 per injection for the ver-sion the FDA law says is the only one that can be legally sold, or continue paying for the much lower-cost com-pounded version..

Women who are denied access to this drug because of this regulatory quagmire face increased risks they will deliver pre-term babies.. In these cases, the costs for inten-sive neonatal care can run into the hundreds of thousands of dollars per prematurely born baby, a price often borne by Medicaid or private insurance..

No country on earth can afford this kind of institution-alized corruption in which the chosen few pharmaceutical companies favored by the FDA reap extortionist profits as the nation collapses into a financial abyss..

This rare instance in which public backlash forced the FDA to back away from protecting a drug company’s obscene profit reveals that citizens have the power to save this coun-try from financial Armageddon..

FIGHT BACK AGAINST INSTITUTIONAL CORRUPTION

The United States of America faces a healthcare cost cri-sis that will render Medicare, Medicaid, and many private insurance plans insolvent.. The shocking details about this country’s inability to fund medical costs are no lon-ger confined to my column in the Life Extension Magazine®.. You are reading about them virtually every day in the mainstream media..

When terrorists attacked the United States in 2001, there were patriotic Americans who enlisted in the armed services.. Many lost their limbs, their vision, and their lives..

No one has to engage in physical combat to save this coun-try from the institutionalized inefficiencies and corruption that plague today’s disease care system.. All you have to do is enter STOPFDA..org into your computer’s web browser.. This will then automatically send a copy of these introduc-tory chapters and a special letter to the President, your Rep-resentative, and two Senators..

It is that simple to take affirmative action to help save our country from the insolvency so many other countries chronically suffer with..

I sincerely hope that after reading this book, not one reader will fail to petition the federal government by log-ging on to www..STOPFDA..org..

We must unite and demand that Congress tear down the barriers of medical over-regulation that are destroying this nation’s financial future..

MAGNITUDE OF IMPENDING HEALTHCARE COST CRISIS

In 2009, Medicare’s unfunded liability was pegged at $37 trillion..70 What that meant is that for the government to meet its future obligations, it should have had $37 trillion in a trust fund earning interest.. But politicians constantly manipulate the numbers..

As this book was being written, there are four different “official” estimates of what Medicare’s unfunded liabili-ties are, ranging from a low of $27..9 trillion to a high of $43..5 trillion..71,72 Private government watchdog groups have pegged Medicare’s true unfunded liability at over $100 trillion..73,74

The reason for these wild fluctuations is that in any given year, government officials can create “assumptions” out of thin air, like assuming doctors will take 21% pay cuts.. Congress has not enacted these mandatory pay cuts, but bureaucrats sometimes pretend they have so that Medi-care’s true unfunded liability is understated..75

Despite these accounting gimmicks, a government report released in 2016 states that Medicare’s hospital fund will go bankrupt in 2024, which is five years sooner than Medi-care’s trustees estimated the prior year..76

Be it $24 trillion or $100 trillion, the government does not have the money to pay its future Medicare obligations.. Government also has no idea where the money will come from to cover unfunded liabilities for Medicaid, Veterans, and federal, state, and local employee sick-care plans it is on the hook for..

This book provides real-world solutions to spare the United States from healthcare cost-induced insolvency..

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43. The Latest in Atrocious Supreme Court Decisions—Only 2 Justices Stand Up for Your Rights . . . Available at: http://articles . mercola..com/sites/articles/archive/2011/03/22/betrayal-of-consumers-by-us-supreme-court-gives-total-liability-shield-to-big-pharma..aspx.. Accessed November 15, 2016..
 
44. Why Drug Prices Are Out Of Control, Or Money Well Spent By Big Pharma.. Available at: http://www..truth-out.. org/opinion/item/21294-Why-Drug-Prices-Are-Out-Of-Control-Or-Money-Well-Spent-By-Big-Pharma.. Accessed December 12, 2016..
 
45. “60 Minutes” Exposes the Horrific Moral Bankruptcy of Big Pharma’s Cancer Drug Giants Like Novartis & Sanofi.. Available at: http://www..feelguide..com/2014/10/06/60-minutes-exposes-the-horrific-moral-bankruptcy-of-big-pharmas-cancer-drug-giants-like-novartis-sanofi/.. Accessed November 15, 2016..
 
46. 90% of Prescriptions Exposed As A Scam, Massive Corruption Uncovered Between Doctors & Big Pharma.. Available at: http://www..feelguide..com/2014/01/12/90-of-prescriptions-exposed-as-a-scam-massive-corruption-uncovered-between-doctors-big-pharma/.. Accessed December 12, 2016..
 
47. Online pharmacies step up efforts to reach your patients.. Available at: http://www..acpinternist..org/archives/1999/11/ epharm..htm.. Accessed November 16, 2016..
 
48. The FDA versus the Life Extension Foundation.. Available at: http://www..benbest..com/polecon/fdalef..html.. Accessed November 16, 2016..
 
49. Zinman B, Harris SB, Neuman J, et al.. Low-dose combination therapy with rosiglitazone and metformin to prevent type 2 diabetes mellitus (CANOE trial): a double-blind randomized controlled study.. Lancet.. 2010 Jul 10;376(9735):103–11..
 
50. Charles MA, Eschwege E.. Prevention of type 2 diabetes: Role of metformin.. Drugs. 1999 58 Suppl..1:71–3..
 
51. Libby G, Donnelly LA, Donnan PT, Alessi DR, Morris AD, Evans JM.. New users of metformin are at low risk of inci-dent cancer: a cohort study among people with type 2 diabe-tes.. Diabetes Care.. 2009 Sep;32(9):1620–5..
 
52. Rattan R, Giri S, Hartmann L, Shridhar V.. Metformin atten-uates ovarian cancer cell growth in an AMP-kinase dispens-able manner.. J Cell Mol Med.. 2011 Jan;15(1):166–78..
 
53. Liu B, Fan Z, Edgerton SM, et al.. Metformin induces unique biological and molecular responses in triple negative breast cancer cells.. Cell Cycle.. 2009 Jul 1;8(13):2031–40..
 
54. Anisimov VN, Egormin PA, Piskunova TS, et al.. Metformin extends life span of HER-2/neu transgenic mice and in com-bination with melatonin inhibits growth of transplantable tumors in vivo.. Cell Cycle.. 2010 Jan 1;9(1):188–97..
 
55. Alimova IN, Liu B, Fan Z, et al.. Metformin inhibits breast cancer cell growth, colony formation and induces cell cycle arrest in vitro.. Cell Cycle.. 2009 Mar 15;8(6):909–15..
 
56. Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR.. Long-term metformin use is associated with decreased risk of breast cancer.. Diabetes Care.. 2010 Jun;33(6):1304–8..
 
 
57. Yurekli BS, Karaca B, Cetinkalp S, Uslu R.. Is it the time for metformin to take place in adjuvant treatment of Her-2 positive breast cancer? Teaching new tricks to old dogs.. Med Hypotheses.. 2009 Oct;73(4):606–7..
 
58. Stanosz S.. An attempt at conservative treatment in selected cases of type I endometrial carcinoma (stage I a/G1) in young women.. Eur J Gynaecol Oncol.. 2009 30(4):365–9..
 
59. Ben Sahra I, Laurent K, Giuliano S, et al.. Targeting cancer cell metabolism: the combination of metformin and 2-deox-yglucose induces p53-dependent apoptosis in prostate can-cer cells.. Cancer Res.. 2010 Mar 15;70(6):2465–75..
 
60. Wang LW, Li ZS, Zou DW, Jin ZD, Gao J, Xu GM.. Metformin induces apoptosis of pancreatic cancer cells.. World J Gastro-enterol.. 2008 Dec 21;14(47):7192–8..
 
61. Algire C, Amrein L, Zakikhani M, Panasci L, Pollak M.. Met-formin blocks the stimulative effect of a high-energy diet on colon carcinoma growth in vivo and is associated with reduced expression of fatty acid synthase.. Endocr Relat Can-cer.. 2010 Jun;17(2):351–60..
 
62. Memmott RM, Mercado JR, Maier CR, Kawabata S, Fox SD, Dennis PA.. Metformin prevents tobacco carcinogenin-duced lung tumorigenesis.. Cancer Prev Res (Phila Pa).. 2010 Sep;3(9):1066–76..
 
63. Faloon W.. Consumer rape.. Life Extension Magazine®.. 2002 Apr;8(4)..
 
64. Growing problem of fake drugs hurting patients, compa-nies.. Available at: http://usatoday30..usatoday..com/money/ industries/health/2010-09-12-asia-counterfeit-drugs_N.. htm.. Accessed November 17, 2016..
 
65. Available at: http://www..fda..gov/NewsEvents/Newsroom/ PressAnnouncements/ucm242234..htm.. Accessed November 17, 2016..
 
66. Available at: http://www..nbcnews..com/id/41994697/ns/ health-pregnancy/t/premature-labor-drug-spikes/.. Accessed November 17, 2016..
 
67. Available at: http://www..fda..gov/NewsEvents/Newsroom/ PressAnnouncements/ucm249025..htm.. Accessed Novem-ber 18, 2016..
 
68. Drug maker lowers price of Makena pregnancy drug to $690 per dose. . Available at: http://articles. .latimes. .com/2011/ apr/01/news/la-pn-makena-price-cut-fda-20110401.. Accessed November 21, 2016..
 
69. Available at: https://www..drugs..com/price-guide/makena.. Accessed November 23, 2016..
 
70. The 81% Tax Increase.. Available at: http://www..forbes.. com/2009/05/14/taxes-social-security-opinions-colum-nists-medicare..html.. Accessed November 22, 2016..
 
71. 2015 Medicare/Social Security Trustees’ Report Analysis.. Available at: http://www..finance..senate..gov/imo/media/ doc/2015%20Trustees%20Report%20SS%20Medicare..pdf..
 
72. The 2016 Trustees Report: Yet Another Warning to Con-
 
gress and the President.. Available at: http://www..heritage.. org/research/reports/2016/07/the-2016-trustees-report-yet-another-warning-to-congress-and-the-president#_ftn14.. Accessed December 13, 2016..
 
73. Treasury Data Reveals Federal Shortfall of $614,000 per U. .S. . Household. . Available at: Available at: http://www.. intellectualtakeout..org/blog/treasury-data-reveals-federal-shortfall-614000-us-household.. Accessed November 22, 2016..
 
74. You Think The Deficit Is Bad? Federal Unfunded Liabilities Exceed $127 Trillion.. Available at: http://www.. forbes..com/sites/realspin/2014/01/17/you-think-the-deficit-is-bad-federal-unfunded-liabilities-exceed-127-trillion/#64c026bc10d3.. Accessed December 13, 2016..
 
 
75. Senate passes SGR deal, averting 21% Medicare pay cut for doctors.. Available at: https://www..advisory..com/daily-briefing/2015/04/15/sgr-reform-passes.. Accessed Decem-ber 13, 2016..
 
76. Congressional Research Service: Medicare: Insolvency Pro-
 
jections October 5, 2016.. Available at: https://fas..org/sgp/ crs/misc/RS20946..pdf.. Accessed December 13, 2016..

 

SEPTEMBER 2013
Horrific Conditions
inside Drug Factories

 

Ive never understood why people traffic heroin or cocaine when higher profit margins are available manufacturing prescription drugs.. In my early days I assumed that with their enormous price markups, at least minimum quality-control standards would exist at drug makers.. How unin-formed I was! As history has taught us, pharmaceutical companies don’t care about their customer’s health.. It’s not a part of their business model whether their drugs heal

 

or harm.. Their overriding concern is to make money.. Dietary supplement companies do not enjoy the gargan-

tuan profit margins of regulated drug makers.. Yet never have I seen such reckless disregard for consumer protec-tion as has been exposed in the field of prescription drug manufacturing..

 

The FDA pretends to protect the public against contami-nated drugs.. The sordid facts reveal an agency incapable

 

 

  • 85

 

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of acting in a rational manner, and when the FDA does something “after the fact,” they often create worse prob-lems.. Such is the case of a company that made contami-nated injectable drugs that sickened 745 Americans with 58 associated deaths at the time of this writing..1 The FDA identified problems with this manufacturer as early as 2002, but dropped the ball into a state pharmacy board’s lap that failed to act.. FDA again identified dangerous problems in 2006, but once more failed to take actions other than send a “warning letter..” The FDA now says it needs more power and money to do its job.. What the FDA does not want the public to know is that the reason this shady manufacturer was able to take over such a significant part of the market is that FDA actions caused other companies to stop mak-ing certain injectable drugs..

 

The media was initially confused by this tragedy and blamed it on lack of regulatory authority.. In this article, you’ll see past this charade as you’ll read how a drug factory pretended to be a compounding pharmacy.. Particularly appalling is the FDA’s inability to recognize that making as many as 17,000 vials of a drug all at once under filthy conditions was a far cry from custom-making one drug at a time per individual pre-scription in a sterile environment.. The contamination prob-lem, however, is not isolated to one bad drug maker.. It turns out that these kinds of safety violations were routine at drug factories that the FDA had certified as being safe..

 

US DRUG FACTORIES IN “TERRIBLE SHAPE”

 

Here’s how the New York Times described conditions inside

 

FDA-registered drug factories:

 

Weevils floating in vials of heparin.. Morphine car-tridges containing up to twice the labeled dose.. Manufacturing plants with rusty tools, mold in

 

Horrific Conditions inside Drug Factories •  87

 

 

production areas and—in one memorable case— a barrel of urine..2

 

The New York Times emphasized that these were not reports about the injectable drug maker that was linked to 745 cases of infection and 58 American deaths..1 These quality lapses were found at large drug companies whose names are familiar to many Americans..2

 

When these problems were discovered, the FDA sent out “warnings” to these companies.. Instead of fixing the prob-lems, many of these drug makers decided it was cheaper to simply discontinue making the drug(s).. The result was severe shortages of the drugs cited by the FDA..2 This opened up the market for disreputable companies to make these same drugs, who did so under the same kind of abysmal condi-tions the FDA found at large drug factories.. The FDA would like to take credit for stopping these problems, but in cer-tain cases, it was people working at the drug factories that came forward to complain about unsanitary manufacturing conditions, or people dying from contaminated drugs, that prompted FDA action.. The sad fact is that some drug com-panies are so greedy they will not stop their highly profit-able assembly lines to perform even the most rudimentary sterilizing procedures..

 

CONTAMINATED INJECTABLE DRUGS

 

Fungal meningitis causes inflammation of the lining of the brain and spinal cord that results in dreadful sickness and sometimes death..3 A drug factory made large quanti-ties of a steroid (methylprednisone) that was injected into the joints and spines of aging humans in chronic pain.. It provided temporary relief.. The problem was this drug was contaminated with a black fungus that infected those who were injected with it..4 Since injectable drugs bypass the

 

88   •  Pharmocracy II

 

 

natural barriers afforded by an intact digestive/immune system, they have to be manufactured and maintained in a sterile environment to avoid killing patients.. FDA inspec-tions in 2002 and 2006 revealed injectable drugs being made under substandard (non-sterile) conditions at a drug factory.. It was not until hundreds fell ill and scores died that the FDA took meaningful action..5,6

 

HOW THE FDA BUNGLED THE INVESTIGATION

 

The name of the company that made the fungus-laced inject-able drug is New England Compounding Center (NECC)..4,5 It pretended to be a compounding pharmacy, but instead func-tioned as a drug factory.. The FDA claims that it lacks ade-quate regulatory authority over compounding pharmacies, but FDA’s inspection of NECC in the year 2002 revealed prob-lems with sterility and other issues..7 That same year, the FDA informed the Massachusetts State Board of Pharmacy of an adverse reaction to methylprednisone, which is the same drug that in 2012 caused the fungal-meningitis outbreak..8

 

Had the FDA done their job back in 2002, they would have forced NECC to register as a drug manufacturer and subjected NECC to stricter regulatory oversight, although that may still not have prevented the problems since FDA-registered drug makers were later found to have similar unsanitary facilities..9 The FDA and Massachusetts state pharmacy board’s most blatant failure, however, was to uncover horrific conditions inside NECC and take no prac-tical steps to enforce safety compliance or shut down NECC before tragedy struck..10

 

GOOD MANUFACTURING PRACTICES OVERLOOKED

 

 

According to Massachusetts state regulators, the NECC drug factory failed to sterilize injectable drugs, something that is

 

Horrific Conditions inside Drug Factories •  89

 

 

mandatory for a substance that is going to be injected into the body..11 The regulators said that NECC didn’t keep man-ufacturing equipment clean, operated a leaky boiler near the “clean room” where injectable drugs were packaged, and shipped products before receiving test results showing the products were sterile, which violates good manufactur-ing guidelines..12,13 In addition, NECC did not test the man-ufacturing equipment used to sterilize injectable drugs on a timely basis according to regulators..13 The result of these multitudes of quality lapses were injectable vials that con-tained black matter inside, which turned out to be the fun-gus that has been linked to 58 deaths so far..1,10

 

FDA INSPECTS AFTER CATASTROPHE

 

After hundreds had fallen ill from fungal meningitis, the FDA conducted a thorough inspection of NECC’s drug fac-tory..14 The FDA’s report cited greenish-yellowish discolor-ation on sterilization equipment and non-sterile raw ingre-dients.. The FDA found that 25% of supposedly sterile vials were contaminated with greenish-black foreign matter and that 100% of these vials sent for analysis contained fun-gus..14 The FDA noted that NECC was unable to provide doc-umentation that its steam autoclave devices were capable of achieving product sterility, a critical factor when making injectable drugs..10,13 In fact, FDA inspectors found green-ish-yellow discoloration inside the one cleaning autoclave and a tarnished discoloration inside another..13,15 NECC turned off its air conditioning in “clean rooms” from 8:00 pm to 5:30 am, which is improper because failing to keep clean rooms at low temperature and low humidity provides a fertile environment for fungal growth..14,15

 

Particularly troubling in the FDA report was documen-tation that NECC had found microbial contamination,

 

90   •  Pharmocracy II

 

 

but did not enact cleanliness procedures to neutralize this lethal threat..14 Furthermore, “clean rooms” used to make injectable drugs had been identified by NECC’s own staff as detecting bacteria and molds, but the FDA could find no evidence that the company acted to fix these lethal prob-lems..14 The FDA’s belated inspection of NECC did nothing to prevent the suffering and death of hundreds of victims who contracted fungal infections from contaminated vials of methylprednisone injected into their spines and joints..10

 

FDA: FAILURE, DECEPTION AND ABUSE

 

My book titled FDA: Failure, Deception and Abuse was pub-lished in early 2010, but no one in Congress listened, and scores of Americans are dead because of the FDA’s egregious

 

ineptitude in the NECC fiasco.

 

 

CONGRESS CITES FDA FAILURE

 

The House and Senate held several hearings in November 2012 on the NECC tragedy.. Congress wanted to know why the FDA didn’t do more to prevent the production and sale of these tainted steroids.. As anticipated, the FDA claimed that it didn’t have enough authority to regulate pharmacies that compound drugs.. FDA Commissioner (Margaret Hamburg, MD) warned that if Congress didn’t strengthen legislation, another similar tragedy is inevitable.. Dr.. Hamburg stated before the House committee, 16–18 “If we fail to act, this type of incident will happen again.. It is a matter of when, not if..”

 

What Dr.. Hamburg may not have expected was documen-tation that the FDA and the Massachusetts pharmacy board both repeatedly visited NECC and found problems, but the strongest action the FDA took was the issuance of a warning letter in 2006.. In response to Dr.. Hamburg claiming the FDA

 

Horrific Conditions inside Drug Factories •  91

 

 

needed more “authority,” one Representative responded, “We’re just not buying it, doctor.. .. .. .. You lack the authority to do anything, yet you send a letter like this?” (In reference to FDA 2006 Warning Letter).. This warning letter documented numerous violations of existing rules the FDA found in 2006, yet the FDA failed to take action until citizens started dying..

 

House members repeatedly berated regulators who failed to prevent the fungal meningitis outbreak, stating the FDA and Massachusetts state regulators both knew as far back as 2002 that there were problems at the pharmacy, which dis-tributed more than 17,000 doses from contaminated lots of steroids.. Dr.. Hamburg was lambasted by House Committee members who stated:

 

This is a complete and utter failure on the part of your agency.

 

This is one of the worst public health disasters ever caused by a contaminated drug in this country..

 

After a tragedy like this the first question we all ask is “Could this have been prevented?” After an examination of documents produced by the Massachusetts Board of Pharmacy and the US Food and Drug Administration, the answer here appears to be, “Yes..”18

 

Other House members came to Dr.. Hamburg’s defense, arguing that a solution needed to be found instead of seek-ing to “prosecute the Food and Drug Administration.

 

SENATE HARSHLY CRITICIZES THE FDA

 

The day after the November 2012 House hearing, where the FDA asked for more authority, a bi-partisan staff of the Senate Health, Education, Labor, and Pensions Commit-tee issued a report detailing how federal and state regula-

 

92   •  Pharmocracy II

 

 

tors knew nearly a decade before of serious safety concerns with the pharmacy (NECC) tied to hundreds of meningi-tis cases, but failed to act decisively.. The report concluded that “bureaucratic inertia appears to be what allowed a bad actor to repeatedly risk public health..”19,20 While acknowl-edging the lack of clarity in what the FDA’s role should be in regulating compounding pharmacies, the Senate cited plenty of evidence that the FDA should have taken action against NECC, which clearly was functioning as a drug fac-tory.. The Senate investigators wrote, “Both federal and state regulators were well aware that NECC and its own-ers posed a risk to the public health” and “repeatedly failed to demonstrate that the company could safely compound sterile products..”19 The Senate report uncovered an inter-nal FDA memo in 2003 that concluded there was “poten-tial for serious public health consequences if NECC’s com-pounding practices, in particular those relating to specific sterile products, are not improved..”19 The Senate confirmed that methylprednisolone produced by NECC “had previ-ously been a suspected cause of at least two cases with bac-terial meningitis-like symptoms” in 2002, leading to an FDA inspection . . . with no meaningful action taken..19

 

Most Senators expressed skepticism the FDA could effec-tively use widened authority under any new law, one stat-ing “the FDA has failed to use its existing authority .. .. ..” with another stating, “This has been going on since 2002.. .. .. .. It took all this time, and nobody did anything..”20 Regretta-bly, some Senators still believe that giving the FDA more tax dollars will solve these issues of bureaucratic incom-petence and mismanagement.. At the Senate hearing, FDA Commissioner Margaret A.. Hamburg conceded:

 

Perhaps we should have been more aggressive, (referring to the FDA’s failure to inspect NECC and

 

Horrific Conditions inside Drug Factories •  93

 

 

follow up on the 2006 warning letter).. There was a lot of debate within the agency about whether to proceed..20

 

Senators repeatedly questioned the FDA’s sending NECC a warning letter in 2006 and a letter in 2008 saying that it planned to inspect, but not following through until after the fungal meningitis outbreak occurred in late 2012..19,21

 

CBS NEWS ENABLES FDA TO TEMPORARILY DECEIVE PUBLIC

 

On March 10, 2013, CBS News’ 60 Minutes aired an emo-tional broadcast about the NECC tragedy that included interviewing victims who suffered horrific illnesses, along with family members of those who died..22 60 Minutes accu-rately told this story about NECC-contaminated drugs that caused 58 deaths and over 700 serious illnesses..1 What 60 Minutes omitted was the fact that the FDA knew about this disaster-waiting-to-happen, but failed to stop it until Americans started dying in 2012.. FDA officials were given free rein on 60 Minutes to blame this catastrophe on a lack of regulatory authority.. As you’re learning here, the fault instead lies with bureaucratic ineptitude at the hands of the FDA and the state pharmacy board that permitted these lethal deviations in good manufacturing practices to occur..

 

Instead of blaming the FDA for ignoring this lethal prob-lem, CBS News let FDA officials blame Congress for not giv-ing the FDA more regulatory power.. What the FDA does not want the public to know is that the reason this shady manu-facturer was able to take over such a significant part of the market is that FDA actions caused other companies to stop making certain injectable drugs.. CBS News overlooked the House and Senate investigations that documented FDA’s egregious failings in the NECC matter..

 

94   •  Pharmocracy II

 

 

 

FDA SAYS IT LACKS AUTHORITY . . .

 

But the FDA does have the authority. And it did in 2006, when the FDA inspected and sent a warning letter in effect telling NECC to stop manufacturing certain drugs or face legal action.19 In 2006, the warning came because NECC (pretending to be a compounding pharmacy) was found, among other things,

 

to have failed to verify if supposedly sterile drugs met safety standards.19

 

Move forward to 2012 and NECC was not only still operat-ing, but was selling tainted drugs manufactured under hor-rifically unsanitary conditions.19 Where was the FDA? Why did they wait for Americans to die before doing their job?

 

 

CONGRESS STRIKES BACK AT THE FDA

 

On April 16, 2013, the FDA was subpoenaed to appear before Congress to account for why more wasn’t done to protect the public against contaminated drugs made at NECC..13,23 Congress wanted the FDA Commissioner to explain why she was not more forthcoming about the FDA failures during the House and Senate hearings held in November 2012..

 

According to the House Committee report on the NECC debacle:

 

„ The investigation revealed what FDA Commissioner Margaret Hamburg did not disclose during the Novem-ber 2012 hearing: FDA received a litany of complaints about NECC and its sister company, Ameridose, right up until the 2012 outbreak..13

 

„ These complaints were related to the safety and potency of NECC and Ameridose products, issues that the FDA failed to routinely, if ever, inform the state about..13

 

Horrific Conditions inside Drug Factories •  95

 

 

„ After reviewing more than 27,000 documents, we found a dramatically different picture than the one painted by the FDA during our initial hearing in November.. We now know that doctors, patients, pro-viders, and whistleblowers tried to warn FDA for years that NECC and Ameridose were operating as manu-facturers and marketing their products nationwide without patient prescriptions..13

 

„ The FDA was also warned about sterility and safety issues with the companies’ products.. Rather than do its job and protect the patients who were taking NECC and Ameridose drugs, FDA chose not to act..13

 

The box below contains highlights from the House Com-mittee report showing that FDA failures contributed to the NECC disaster and how the FDA tried to cover up their own ineptitudes..

 

HIGHLIGHTS FROM HOUSE COMMITTEE REPORT

 

ON FDA’S COVER-UP AND FAILINGS

 

On April 16, 2013, the House Committee on Energy and Over-sight issued a report titled:23

 

FDA’S OVERSIGHT OF NECC AND AMERIDOSE:

 

A HISTORY OF MISSED OPPORTUNITIES?

 

Here are some highlights from the Committee’s report:

 

Since the (November 2012) hearing, the Committee has pressed FDA to produce all of its documents relating to NECC and Ameridose in order to obtain a full picture of FDA’s inspectional history, oversight, and decision-making with respect to these firms. Only after being threatened with the possibility of a subpoena in a February 1, 2013, letter to Commis-sioner Hamburg, did FDA finally complete its pro-duction on March 21, 2013.

 

96   •  Pharmocracy II

 

 

 

After reviewing these documents, Majority Commit-tee staff believes there is a strong basis for Members to pursue answers from FDA on whether this trag-edy was preventable had the agency taken action under its existing authorities to address the steady stream of complaints it had received about NECC and its sister company, Ameridose, since issuing a Warning Letter to NECC in December 2006.

 

One of FDA’s fundamental reasons for existence is to protect the public health by assuring the safety of our nation’s drug supply. With respect to NECC and Ameridose, documents produced to the Com-mittee raise serious questions about whether FDA repeatedly failed in its core mission.

 

The agency’s inaction in the face of years of com-plaints and red flags associated with the safety of both companies’ products and underlying prac-tices had a tragic ending.*

 

*This entire document can be accessed at: www.lef.org/necc.

 

 

WHAT CONGRESS OVERLOOKED

 

What was not discussed in Congressional hearings was the FDA’s history of abusing and misusing whatever author-ity Congress gave it.. For example, when the FDA first dis-covered problems at NECC (in 2002), it chose to direct its resources to prosecuting a man named Jay Kimball, who sold a drug (liquid deprenyl) that harmed no one.. Jay Kim-ball remains in prison..24 In 2006, while the FDA did not think it needed to stop NECC’s lethal manufacturing prac-tices, it somehow found the time to censor claims by cherry growers that cited scientific studies on their website show-ing cherries conferred health benefits..25

 

Horrific Conditions inside Drug Factories •  97

 

 

What few understand is how the FDA has historically abused its authority in a discriminatory manner.. The new “authority” the FDA is seeking would enable the agency to pick out small, well-run pharmaceutical firms and regulate them out of business using minor technical arguments that have no bearing on safety..

 

GLAXO PAYS $750 MILLION FINE FOR QUALITY LAPSES

 

GlaxoSmithKline is the world’s 4th largest drug maker, with annual sales of nearly $46 billion and profits of almost $9 billion..26 In July 2002, the FDA sent a warning letter about quality problems uncovered at one of Glaxo’s subsidiary manufacturers.. The egregious problems, however, were not corrected despite additional FDA inspections that contin-ued to turn up severe problems, including failure to safe-guard against microbial contamination..27 The FDA initiated a seizure action in 2005 to remove adulterated and improp-erly made drugs..28 Horrendous problems persisted, how-ever, until the Justice Department filed a criminal com-plaint against GlaxoSmithKline and stopped what could have been a human catastrophe..29 In October 2010, GlaxoS-mithKline agreed to plead guilty and pay a $750 million fine to resolve criminal and civil liability regarding the manufac-turing deficiencies..29

 

GLAXO’S DEFECTIVE DRUGS

 

The defective drugs, manufactured between 2001 and 2005, were Kytril, Bactroban, Paxil CR, and Avandamet..29 Kytril is a sterile injectable anti-nausea medication used by can-cer patients receiving chemotherapy or radiation.. Bactro-ban is a topical anti-infection ointment used to treat skin infections.. Paxil CR is the controlled-release formulation of the popular anti-depressant drug Paxil, and Avandamet

 

98   •  Pharmocracy II

 

 

is a combination of Avandia and metformin.. Avandia has since essentially disappeared from the market because of increased heart attack risks, though an FDA advisory panel recently recommended it be allowed to be prescribed to cer-tain diabetic patients..30 Years after FDA approval, Glaxo sent out a black box warning about increased suicide risks in users of Paxil..31 With the realization that cardiovascular dis-ease is the leading cause of death among diabetics, and sui-cide a huge risk in depressed patients, the notion that the FDA approved drugs with these kinds of side effects borders on absurdity..32,33 These lethal side effect issues, however, are irrelevant to the manufacturing lapses that occurred..

 

According to an employee who filed a lawsuit against Glaxo over these uncorrected defects, the water system was contaminated, the air system allowed for cross-contamina-tion between products, the warehouse was so overcrowded that rented vans were used for storage, the plant could not ensure the sterility of intravenous drugs, and pills of differ-ing strengths were sometimes mixed in the same bottles..34 Although FDA inspectors had spotted some problems, most were missed..

 

Glaxo paid the $750 million fine and admitted that its subsidiary failed to ensure that Kytril and Bactroban fin-ished products were free of contamination from microor-ganisms.. It also admitted that its manufacturing process caused Paxil CR two-layer tablets to split, which the com-pany itself called a “critical defect,” because potential dis-tribution of tablets would not have any therapeutic effect and no controlled release mechanism..35 Glaxo admitted that Avandamet tablets did not always have the proper mix of active ingredients and, as a result, potentially con-tained too much or too little of the ingredient with the therapeutic effect..29

 

Horrific Conditions inside Drug Factories •  99

 

 

POTENTIAL LETHAL IMPACT OF GLAXO’S ABHORRENT LACK OF QUALITY CONTROL

 

One can only imagine the problems that would occur if a depressed individual took a powerful anti-diabetic drug like Avandia, which could inflict acute hypoglycemia.. A former employee identified nine instances where the wrong pills were sold, including Avandia® mixed in packages of over-the-counter antacids like Tagamet®..36 For chemo-therapy patients who are immune-compromised, they could have easily succumbed to an infection without their oncologists ever suspecting it was linked to the anti-nau-sea drug Kytril, which was not tested to ensure it was free of microbial contamination..

 

NO JAIL TIME FOR GLAXO EXECUTIVES

 

Glaxo denies that any patients were ever harmed by the adulterated drugs they distributed in the United States and also denied that these kinds of problems occurred at its other drug factories.. No one from Glaxo faced criminal charges.. I again remind readers that Jay Kimball, who sold a clean product that harmed no one, remains in federal prison.. One difference is that Jay Kimball had no money for an attorney and had to represent himself in court (or render himself insolvent defending against FDA’s prejudi-cial accusations).. Pharmaceutical behemoths like Glaxo, on the other hand, spend virtually unlimited money on lobbyists and lawyers and have not faced personal crimi-nal liability for the misdeeds they allowed..

 

REPUTATION IN LIEU OF REGULATION

 

 

One reason why horrific quality issues occur at pharmaceuti-cal companies is that few consumers know who makes their prescription drugs.. When your doctor writes a prescription,

 

100   •  Pharmocracy II

 

 

you take it to your pharmacy and usually get a brown-col-ored bottle with pills inside.. Seldom is the manufacturer’s name stated on the bottle.. Drug companies can thus run their manufacturing facilities with reckless abandon with lit-tle reputational risk.. Dietary supplement companies, on the other hand, prominently state their name on the labels of their products.. In a more sensibly regulated environment, better-operated pharmaceutical companies would prosper as their reputation for quality control became known.. Unfor-tunately, today’s Orwellian regulatory structure has cre-ated utter chaos, with retail pharmacies not knowing which generic manufacturer is going to make which generic drug at any given time..

 

Since we established the Life Extension Pharmacy® six years ago, we have learned how dangerous the prescription drug marketplace has become, with counterfeiting, short-ages, and quality problems more rampant than reported by the media.. We would prefer that pharmaceutical com-panies place a higher value on their reputation and instill better quality standards.. Instead, regulatory burdens are so cumbersome that quality control takes a back seat to pleasing bureaucrats who wield unbridled power, but lack the competency to recognize catastrophic problems as occurred with the contaminated steroids made by NECC..

 

HOW MUCH MORE FDA FAILURE WILL AMERICANS TOLERATE?

 

In 1906, a book called The Jungle was published that described appalling conditions inside America’s meat pack-ing industry.. The revelations in this book resulted in the establishment of federal laws that mandated standards of strength, purity, and quality of foods and drugs.. Condi-tions inside some of America’s drug factories are eerily sim-

 

Horrific Conditions inside Drug Factories •  101

 

 

ilar to those described in The Jungle, yet the FDA has been around for more than 100 years! How much longer is the public expected to wait before the FDA effectively spends its $4 billion annual budget on real consumer protection, as opposed to threatening walnut and cherry growers for claiming health benefits of their foods?

 

No matter how many times the FDA fails to protect con-sumers against contaminated drugs, there are no calls for meaningful reform.. Instead of recognizing FDA ineptitude, cries ring out to give the FDA more money and power .. .. .. as Americans perish from contaminated drugs the FDA had the authority to stop!

 

NO FREE MARKET!

 

What the public doesn’t yet understand is that contaminated drugs are the result of draconian regulations that limit free-market competition. By restricting drug making to only those controlled by incompetent bureaucrats, the inevitable result will be shortages, poor quality, and high prices.. As I write this article, one of the challenges in dealing with the NECC catastrophe is that there may be new shortages of injectable drugs because there are not enough drug factories in the US to meet patient demand.. Shortages create opportunities for unsavory companies to dump even greater amounts of over-priced and contaminated drugs into the bodies of unsuspect-ing victims.. This kind of problem would not continue in a free market, but ever-increasing regulations are exacerbating the problems of drug shortages, deadly manufacturing prac-tices, and obscenely high prices..

 

102   •  Pharmocracy II

 

 

References

 

  1. Available at: http://www..cdc..gov/hai/outbreaks/meningitis-map-large..html.. Accessed June 25, 2013..

 

  1. Available at: https://www..nytimes..com/2012/10/18/business/ drug-makers-stalled-in-a-cycle-of-quality-lapses-and-shortages..html?pagewanted=all.. Accessed June 13, 2013..

 

  1. Available at: http://www..cdc..gov/meningitis/fungal..html.. Accessed June 20, 2013..

 

  1. Available at: http://www. .nejm. .org/doi/full/10. .1056/ NEJMra1212617?query=featured_meningitis.. Accessed June 13, 2013..

 

  1. Available at: http://www..upi..com/Health_News/2012/11/13/ Meningitis -pharmacy -had – many – violations/UPI – 28381352863651/.. Accessed June 13, 2013..

 

  1. Available at: http://www..washingtonpost..com/national/health-science/previous-fungal-meningitis-outbreak-a-decade-ago-resulted-in-no-oversight-changes/2012/11/05/8417d84e-1fa8-11e2-9cd5-b55c38388962_story..html.. Accessed June 13, 2013..

 

  1. Available at: http://finance..yahoo..com/news/fda-seeks-more-authority-amid-meningitis-outbreak-225136817–finance.. html.. Accessed June 13, 2013..

 

  1. Available at: http://www. .reuters. .com/article/2012/10/23/ us-usa-health-meningitis-congress-idUSBRE89M00820121023.. Accessed June 20, 2013..

 

  1. Available at: http://www.nytimes .com/2012/10/18/business/ drug-makers-stalled-in-a-cycle-of-quality-lapses-and-shortages..html?pagewanted=all.. Accessed June 13, 2013..

 

  1. Available at: http://online..wsj..com/article/SB10001424052 970203406404578075092760806164..html.. Accessed June 13, 2013..

 

  1. Available at: http://www. .mass. .gov/eohhs/docs/dph/ quality/boards/necc/necc-preliminary-report-10-23-2012.. pdf.. Accessed June 27, 2013..

 

Horrific Conditions inside Drug Factories •  103

 

 

  1. Available at: http://foodpoisoningbulletin..com/2012/necc-methylprednisolone-acetate-linked-to-meningitis-outbreak-evidence-drug-made-under-insanitary-conditions/.. Accessed June 20, 2013..

 

  1. Available at: http://energycommerce..house..gov/press-release/ committee-report-meningitis-outbreak-chronicles-fdas-missed-opportunities-to-protect-public-health.. Accessed June 21, 2013..

 

  1. Available at: http://www. .fda. .gov/downloads/AboutFDA/ CentersOffices/ OfficeofGlobalRegulatoryOperationsandPolicy/ ORA/ORAElectronicReadingRoom/UCM325980..pdf.. Accessed June 13, 2013..

 

  1. Available at: http://www..nytimes..com/2012/10/27/health/fda-finds-unsanitary-conditions-at-new-england-compounding-center..html?pagewanted=all.. Accessed June 14, 2013..

 

  1. Available at: http://www..reuters..com/article/2012/11/14/ us-usa-health-meningitis-widow-idUSBRE8AD13020121114.. Accessed June 14, 2013..

 

  1. Available at: http://www..nytimes..com/2012/11/15/health/ fda-asking-for-more-control-over-drug-compounding.. html?_r=0.. Accessed June 14, 2013..

 

  1. Available at: http://www..nbcnews..com/health/pharmacy-owner-refuses-testify-about-fungal-outbreak-1C7055774?f ranchiseSlug=healthmain.. Accessed June 14, 2013..

 

  1. Available at: http://www. .help. .senate. .gov/imo/media/ doc/11_15_ 12%20HELP%20Staff%20Report%20on%20 Meningitis%20Outbreak..pdf.. Accessed June 14, 2013..

 

  1. Available at: http://stream..wsj..com/story/latest-headlines/ SS-2-63399/SS-2-102550/.. Accessed June 14, 2013..

 

  1. Available at: http://www.fda .gov/ICECI/EnforcementActions/ WarningLetters/2006/ucm076196..htm.. Accessed June 14, 2013..

 

104   •  Pharmocracy II

 

 

  1. Available at: http://www..cbsnews..com/8301-18560_162-57573175/meningitis-whistleblower-on-60-minutes/.. Accessed June 14, 2013..

 

  1. Available at: http://energycommerce. .house. .gov/sites/ republicans..energycommerce..house..gov/files/analysis/ 20130416Meningitis..pdf.. Accessed June 17, 2013..

 

  1. Available at: http://www..lef..org/magazine/mag2004/aug2004_ report_prisons_03..htm?source=search&key= Jay%20Kimball.. Accessed June 17, 2013..

 

  1. Available at: http://usatoday30. .usatoday. .com/news/ health/2006-03-19-cherry-warnings_x..htm?csp=34.. Accessed June 17, 2013..

 

  1. Available at: http://www..forbes..com/lists/2010/18/global-2000-10_The-Global-2000_Sales_2..html.. Accessed June 21, 2013..

 

  1. Available at: http://www. fda.. gov/downloads/iceci/. enforcementactions/enforcementstory/enforcement storyarchive/ucm091066..pdf.. Accessed June 17, 2013..

 

  1. Available at: http://www..fda..gov/NewsEvents/Newsroom/ PressAnnouncements/2005/ucm108418. .htm. . Accessed June 17, 2013..

 

  1. Available at: http://www..justice..gov/opa/pr/2010/October/ 10-civ-1205..html.. Accessed June 17, 2013..

 

  1. Available at: http://www..findavandiahelp..com/avandia_ fda.. Accessed June 17, 2013..

 

  1. Available at: http://www..justice..gov/opa/pr/2012/July/12-civ-842..html.. Accessed June 18, 2013..

 

  1. Available at: http://www. .world-heart-federation. .org/ cardiovascular-health/cardiovascular-disease-risk-factors/ diabetes/.. Accessed June 15, 2013..

 

  1. Available at: http://www..webmd..com/depression/guide/ depression-recognizing-signs-of-suicide.. Accessed June 18, 2013..

 

Horrific Conditions inside Drug Factories •  105

 

 

  1. Available at: http://www.nytimes .com/2010/10/27/business/ 27drug..html?pagewanted=all.. Accessed June 18, 2013..

 

  1. Available at: http://chiefofficers..net/888333888/cms/index.. php/news/industries/health_care _pharma/pharmaceuticals /health_gsk_pays_usd750_million_fine_and_penalties_in_ usa.. Accessed June 15, 2013..

 

  1. Available at: http://www..cbsnews..com/8301-18560_162-7195247..html.. Accessed June 18, 2013..

NOVEMBER 2012

 

Metformin Makes

Headline News

 

Metformin is the firstline drug of choice in the treat-

ment of type II diabetes.. It was first approved in Europe in 1958..1 Americans had to wait until 1994 to legally obtain metformin..1 The holdup in approv-

 

ing metformin goes beyond the FDA.. It is an indictment of a political/legal system that will forever cause needless suf-fering and death unless substantively changed..

 

When Life Extension® informed Americans about drugs like metformin in the 1980s, the FDA did everything in its power to incarcerate me and shut down our Foundation..2 FDA propaganda at the time was that consumers needed to be “protected” against “unproven” therapies.. As his-tory has since proven, the result of the FDA’s embargo has been unparalleled human carnage.. So called “consumer protection” translated into ailing Americans being denied access to therapies that the FDA now claims are essential to saving lives..

 

 

  • 107

 

108   •  Pharmocracy II

 

 

Today’s major problem is not drugs available in other countries that Americans can’t access.. Instead, it is a politi-cal/legal system that suffocates medical innovation.. Head-line news stories earlier this year touted the anti-cancer effects of metformin, data that Foundation members were alerted to long ago..3 The problem is that it is illegal for metformin manufacturers to promote this drug to can-cer patients or oncologists.. It’s also illegal to promote met-formin to healthy people who want to reduce their risk of cancer, diabetes, vascular occlusion, and obesity.. This fatal departure from reality continues unabated, as our dysfunc-tional political/legal system denies information about met-formin that could spare countless numbers of lives..

 

Type II diabetics suffer sharply higher rates of cancer4–7 and vascular disease..8–11 The anti-diabetic drug metformin has been shown in numerous scientific studies to slash the risk of cancer12–24 and lower markers of vascular disease..25–28 Metformin was shown to reduce blood sugar levels in the 1920s..28 One reason it fell off the radar screen is that insu-lin quickly became popular because it produced an imme-diate glucose-lowering effect.. What doctors back then did not realize is that while insulin saved the lives of type I dia-betics (who produce little or no insulin), those with type II diabetes often produce too much insulin as their pancreas tries to offset multiple metabolic imbalances..

 

One of the metabolic imbalances of type II diabetes is the excess formation of glucose in the liver.. To ensure that blood glucose never drops too low, the liver manufactures glucose in a process called gluconeogenesis.. In type II dia-betes, despite an elevated blood glucose level, the liver inap-propriately continues to pump out glucose.. This inappro-priate outburst of glucose from the liver in type II diabetes patients is a classic hallmark of the disease.. In fact, scientific

 

Metformin Makes Headline News               •  109

 

 

data that measures glucose output by the liver shows that the typical type II diabetic produces three times more glu-cose in their liver than non-diabetics..29 And, as previously reported in this publication, even most non-diabetics pro-duce too much glucose in their liver as they age..

 

Scientific data shows that metformin reduces glucose production and the rate of gluconeogenesis by anywhere from 24% to 36%, respectively, thus reducing blood glu-cose levels while lowering the amount of insulin that is chronically secreted..29 Metformin also enhances insulin sensitivity, thus enabling cells to remove more glucose from the bloodstream, which further lowers glucose and insulin levels..30–33 In a recent study conducted by a team of researchers in Italy, 500 mg three times a day of metfor-min reduced insulin levels by 25%..

 

EXCESS INSULIN IS A “DEATH HORMONE”

 

In response to continuous over-production of glucose by the liver, the pancreas secretes huge amounts of insulin to sup-press it.. This excess amount of insulin damages blood vessel walls34–36 and promotes tumor growth..37–41 For a type II dia-betic who is over-producing insulin, the use of insulin injec-tions provides a relatively brief respite from high blood glu-cose levels—with horrific long-term consequences.. Drug companies today are heavily promoting convenient insulin injection devices to physicians and suggesting that many of them have forgotten about insulin’s proven glucose-lower-ing effects.. The harsh reality is that for most type II diabet-ics, excess insulin represents a “death hormone” that causes weight gain,42–44 cancer,45–47 and vascular disease..48–51

 

It was not only the discovery of insulin that delayed rec-ognition of metformin.. Drugs known as sulfonylureas pro-mote the insulin release from the pancreas.. Sulfonylureas

 

110   •  Pharmocracy II

 

 

were liberally prescribed for decades and are another ill-conceived way of temporarily suppressing blood glucose at the expense of systemic metabolic havoc.. Like insulin, sul-fonylurea drugs induce weight gain, which is the opposite effect one is seeking when treating most type II diabetics.. All sulfonylureas carry an FDA-mandated warning about increased risk of cardiovascular death..

 

In one study lasting more than 10 years, patients who primarily received metformin had a 39% reduction in the risk of heart attack and a 36% reduction of death from any cause..52 The same study showed that metformin did not cause weight gain in overweight patients, while patients prescribed sulfonylureas gained more than 7 pounds, and those using insulin injections gained over 10 pounds..53 For the multi-decade period Americans were denied access to metformin, doctors felt they had little choice but to pre-scribe sulfonylurea drugs and insulin injections.. The need-less suffering and death endured by diabetics during this “dark age” of American medicine is incalculable..

 

WHY AMERICAN DOCTORS WERE AFRAID OF METFORMIN

 

For decades, the American medical establishment labored under an egregious misconception about the safety of met-formin.. The reason was that drugs in the same class of met-formin (biguanides) can cause a potentially fatal condi-tion called lactic acidosis, where the body becomes overly acidic in the presence of excess lactic acid.. While other bigu-anide drugs were withdrawn because of lactic acidosis risk, it turned out that metformin did not induce this same side effect in healthier people..54 As long as one has sufficient kid-ney, liver, cardiac, and pulmonary function, any excess lac-tic acid caused by metformin is safely removed by the kid-neys..55–57 It turned out that only patients with severe kidney,

 

Metformin Makes Headline News               •  111

 

 

liver, pulmonary, or cardiac impairment had to avoid met-formin because of lactic acidosis concerns, and even these worries were overblown..

 

I’ll never forget what a brilliant medical doctor personally told me after a large study came out that dispelled the myth connecting metformin with lactic acidosis.. This doctor knew how effective metformin was, but was terrified of creating lactic acidosis in any of his patients.. He told me something to the effect of, “If this study showing lactic acidosis is not a risk for metformin users is true, then the multi-decade oversight that caused doctors to fear metformin represents one of the great blunders in medical history..”

 

The regrettable fact is that doctors in the United States were taught to avoid drugs in the class of metformin, even though metformin itself was being safely used throughout the world.. If only the medical establishment in the United States had looked across the border as close as Canada, they would have seen metformin being liberally prescribed with nowhere near the incidences of lactic acidosis they feared..

 

In the early years, when I was taking metformin for anti-aging purposes, most doctors warned me about lactic aci-dosis risk.. I always asked where in the scientific literature does it show a healthy person is at risk for lactic acidosis when taking metformin? They could never cite a reference, so I continued taking my metformin..

 

ANALYSIS SHOWS METFORMIN DOES NOT CAUSE LACTIC ACIDOSIS

 

A Cochrane Systematic Review of over 300 trials evalu-ated the incidence of lactic acidosis among patients pre-scribed metformin vs.. non-metformin anti-diabetes medi-cations.. Of 100,000 people, the incidence of lactic acidosis was 4..3 cases in the metformin group and 5..4 cases in the

 

112   •  Pharmocracy II

 

 

non-metformin group.. The authors concluded that met-formin is not associated with an increased risk for lactic acidosis..58

 

HOW METFORMIN FUNCTIONS

 

Metformin reduces blood glucose levels primarily by sup-pressing glucose formation in the liver (hepatic gluconeo-genesis)..59 More importantly, it activates an enzyme called AMPK (AMP-activated protein kinase) that plays an impor-tant role in insulin signaling, systemic energy balance, and the metabolism of glucose and fats..60 Activation of AMPK is one mechanism that may explain why diabetics prescribed metformin have sharply lower cancer rates.. For instance, in a controlled study at MD Anderson Cancer Center, the risk of pancreatic cancer was 62% lower in diabetics who had taken metformin compared to those who had never taken it..61 Diabetics suffer sharply higher incidences of pancreatic cancer than non-diabetics..61

 

YOUR NUTRIENTS “MAY” WORK AS WELL AS METFORMIN

 

Virtually every Life Extension® member takes curcumin on a daily basis.. Curcumin activates the same AMPK enzyme at a rate that may be higher than metformin.. Curcumin also increases insulin sensitivity while reducing expression of glucose-producing genes..80 Coffee rich in chlorogenic acid or green coffee extract supplements have demonstrated a profound reduction in gluconeogenesis—with a corre-sponding decrease in post-meal glucose elevations..81–83 We know that suppression of gluconeogenesis, enhanced insulin sensitivity, and activation of AMPK are some of the mechanisms behind metformin’s broad-spectrum ben-efits.. It is not possible at this time, however, to know for sure if aging humans can derive identical benefits from

 

Metformin Makes Headline News               •  113

 

 

nutrients like curcumin and chlorogenic acid as are pro-vided by metformin.. With my understanding of the bene-ficial mechanisms of curcumin and chlorogenic acid, I per-sonally take these nutrients plus a high dose (850 mg) of metformin two to three times a day..

 

HOW METFORMIN MAY INCREASE HEART ATTACK RISK

 

Metformin reduces triglycerides,62–64 glucose, 32,65,66 insu-lin,67–69 and hemoglobin A1C (a marker of long-term glucose control)..32,70 These blood markers are all proven heart attack risk factors.. Yet not all studies show met-formin reduces heart attack incidence.. One study found that when metformin was added to a group of non-over-weight patients taking sulfonylurea drugs, there was a significant increase in overall mortality..71 This suggests that metformin should not be combined with sulfonyl-ureas.. Furthermore, not all studies show that metformin reduces cardiovascular risk or improves overall survival in type II diabetic patients.. There are several reasons to explain these discrepancies..

 

Metformin is known to cause vitamin B12 deficiency which translates into higher levels of artery-clogging homo-cysteine..72–74 The tiny amount of vitamin B12 and other B-vitamins found in commercial supplements is not always sufficient to offset this problem.. Those who take metformin should ensure they are taking higher doses of B-vitamins (at least 300 mcg of vitamin B12) and check their homo-cysteine levels to make sure it stays in the safer ranges..75 One study showed that the addition of 5,000 mcg of folic acid to patients taking metformin reduced their homocys-teine from 15..1 µmol/L to 12..1 µmol/L.. Optimal homocys-teine levels are probably under 8 µmol/L, but any reduction is helpful.. Sadly, most diabetics prescribed metformin don’t

 

114   •  Pharmocracy II

 

 

check their homocysteine levels and don’t take enough B-vitamins to prevent a deficiency..

Some studies show that metformin reduces free testos-terone and total testosterone levels in men..77 Testosterone is especially important in male diabetics as it significantly enhances insulin sensitivity..78 Life Extension® has previ-ously published clinical data showing the critical impor-tance of diabetic men to maintain youthful testosterone levels in order to improve glucose utilization..79

 

The greatest challenge in evaluating clinical data on met-formin is that it is often prescribed to debilitated patients who have undergone severe arterial attack for many decades.. These diabetic patients are at significant risk of cardiovascu-lar disease from a number of underlying causes.. They need to take aggressive steps to correct all independent risk fac-tors for vascular disease, something that is never done in clinical studies..

 

POLITICIANS OVERLOOK MOST IMPORTANT ISSUE

 

Billions of dollars are being spent on campaign ads by politi-cians.. Most of the issues raised will not directly affect you in a meaningful way.. Overlooked is a problem that will affect every one of us—the suffocating impact of antiquated leg-islation on medical progress.. Once you or a family member is diagnosed with a disease like pancreatic cancer, campaign ads become background clutter.. Your only concern is finding a therapy that offers some hope of survival..

 

The best our current archaic system offers for pancreatic cancer is a drug called gemcitabine.. Compared to another chemo drug, gemcitabine increased average survival by a meager 36 days, which conventional doctors described as a “significant improvement..”91 A team of researchers was able to improve on gemcitabine by using instead a toxic

 

Metformin Makes Headline News               •  115

 

 

combination of chemotherapy drugs (called FOLFIRINOX).. Compared to the gemcitabine group, patients able to tol-erate the debilitating side effects of FOLFIRINOX lived

 

  • .3 months longer than the gemcitabine group, but suf-fered greater toxicity..92,93

 

The fact that pancreatic cancer still quickly kills virtu-ally everyone who contracts it is a stark example of how today’s regulatory system stifles innovation.. Unregulated environments have produced technologies like hand-held computers that perform miraculously and are affordable to mostly everyone.. Life Extension® for years has pro-vided hard-core scientific documentation about the anti-cancer properties of metformin.. Yet unless the current political/legal stranglehold over medical innovation is lifted, the only cancer patients likely to benefit from met-formin will be Foundation members who insist their doc-tors prescribe it.. Recall that metformin was discovered

 

  • years ago, yet conventional doctors are still failing to use it in the prevention and treatment of a host of age-related disorders..

 

SHOULD YOU ASK YOUR DOCTOR ABOUT METFORMIN?

 

Metformin is a synthetic compound available in low cost generic form.. Some members tell me their health insur-ance plans cover almost 100% of the cost.. Even out of pocket, metformin is remarkably inexpensive.. The chal-lenge some members find is persuading their doctors to pre-scribe metformin if they are not diabetic.. You may recall the many articles we have published showing that any elevation of fasting glucose above 85 mg/dL increases one’s risk for contracting classic diabetic complications like heart attack and stroke..84–90 Therefore, those whose glu-cose levels exceed 85 mg/dL should consider metformin

 

116   •  Pharmocracy II

 

 

for its glucose-lowering properties alone, though chloro-genic acid-standardized coffee extracts may accomplish a similar effect..

 

No one should take metformin without having a com-plete battery of blood tests to show their doctor that it is not contraindicated because of disorders like kidney fail-ure.. Those with low blood sugar (hypoglycemia) may not be able to use metformin.. A suggested starting dose of metformin is 250 mg before a large meal.. The dose may be increased after a week to 250 mg before three meals a day.. After a month, you may consider increasing to 500 mg before meals and eventually go up to 850 mg before meals, which is the upper limit dose.. If you notice a slight reduction in appetite, use it to cut back on your calorie intake and hopefully shed some fat pounds.. By stabiliz-ing blood sugar and insulin levels, metformin can help reduce food cravings..

 

THE POLITICAL/LEGAL SYSTEM MUST BE CHANGED

 

Human clinical research has long been oppressed in the United States by a variety of laws that conspire to deny med-ical progress.. The few new therapies that are approved are mediocre, expensive, and often laden with side effects.. The current system represents the worst of all worlds when it comes to the kind of scientific advances that aging people need to significantly extend their healthy life spans..

 

Your support of Life Extension® enables us to continue our relentless campaign to tear down the strangleholds erected by public and private institutions.. The 37-year delay in approving metformin provides a real-world example of how broken our political/legal systems are when it comes to finding cures for degenerative disease and the aging process itself..

 

Metformin Makes Headline News               •  117

 

 

WHAT YOU CAN DO TO STOP NEEDLESS SUFFERING AND DEATH

 

Scientists have identified novel ways of treating cancer and other illnesses, but too little of this new technology is being used in clinical practice.. When new discoveries are made, drug companies spend years seeking a patent, and then more years carrying it through the cumbersome bureaucratic approval process.. A major reason so many cancer patients die today is an antiquated regulatory sys-tem that causes effective therapies to be delayed (or sup-pressed altogether)..

 

This system must be changed, if the 1,500 American cancer patients who perish each day are to have a realistic chance of being saved.. Our long-standing proposal has been to change the law so that anyone can opt out of the FDA’s umbrella of “protection..” This approach will allow companies to sell drugs that have demonstrated safety and a reasonable likelihood of effectiveness, which are clearly labeled “Not Approved by the FDA..” Patients who wish can still use only FDA-approved drugs, while those willing to take a risk, in consultation with their doctors, will be allowed to try drugs shown to be safe that are still not approved..

 

We believe that this initiative will result in a renaissance in the practice of medicine similar to the computer tech-nology revolution of the past four decades.. In this environ-ment, many lethal diseases will succumb to cures that are less expensive than is presently the case.. And greater com-petition will help eliminate the healthcare cost crisis that exists today.. Seriously ill people, in consultation with their doctors, should be able to make up their own minds about what drugs they are willing to try..

 

This is the time when political leaders will at least listen to their constituent’s concerns.. I encourage each of you to

 

118   •  Pharmocracy II

 

 

log on to our legislative action website at www..lef..org/lac to easily email your Representative and two Senators a let-ter demanding they enact legislation that will enable those with serious illness to obtain therapies far enough along in the clinical trials process to be deemed safe, but not yet approved by the FDA..

 

TAKE ACTION NOW!

 

Tell Congress to Change the Law!

 

There are millions of cancer patients alive right now who face possible or probable death in the next twelve months.. If you add their family members and friends, there are tens of millions of Americans who should be outraged by an outdated regulatory system that bans access to potentially life-saving therapies..

 

The FDA continues to suppress innovative therapies because the public has failed to demand that our elected officials rein in the FDA’s arbitrary authority.. The first step in changing today’s outmoded system is for those who understand the magnitude of this problem to communicate the urgent need for change to Congress.. Those concerned about this serious issue should log on to www..lef..org/lac to insist that their Representative and two Senators help enact legislation that will enable cancer patients to obtain therapies far enough along in the clinical trials process to be deemed safe, but not yet approved by the FDA..

 

Take Action Now!

 

Those without computer access can photocopy the letter below and mail it to their Representative at The US House of Representatives, Washington, DC, 20515 and two Sen-ators at The US Senate, Washington, DC, 20510.. We also ask that you phone your Congressional members at 1-202-

 

Metformin Makes Headline News               •  119

 

 

224-3121 to let them know how disgusted you are that doctors and patients are not allowed to choose drugs that may be effective against an often fatal disease..

 

The Honorable:

 

I am writing to ask that you sponsor or co-sponsor legislation to enable cancer patients (and those with other serious diseases) to purchase medica-tions while they are pending final approval by the FDA.. This approach will allow companies to sell novel drugs with a label clearly stating that they are “Not Approved by the FDA..”

 

Consumers who wish to rely on the FDA can limit their choices to fully approved drugs only, while those willing to take a risk (in consultation with their doctors) will be allowed to try what they choose.. (Companies that make fraudulent claims for products can be prosecuted under the laws that exist today..)

 

This initiative can result in a renaissance in the practice of medicine, similar to the computer tech-nology revolution that has occurred over the past three decades.. In this environment free of regu-latory burden, many inexpensive cures will very likely be found for lethal diseases.. And greater competition will help eliminate the healthcare cost crisis that exists today..

 

I am tired of reading about medical breakthroughs, only to be told that I will have to wait years before the therapy might become available.. As 1,500 Americans die of cancer each day, I con-sider the introduction and passage of such a law an extremely high priority..

 

120   •  Pharmocracy II

 

 

Seriously ill people have the fundamental right to make up their own minds about what drugs they are allowed to try, in consultation with their phy-sicians.. Please let me know that you will sponsor or co-sponsor such legislation, which will provide us with quicker access to drugs that the FDA has found safe and potentially effective, but have not yet received final approval..

 

Sincerely,

 

Name:

 

Address:

 

City:

 

 

References

 

  1. Available at: http://onlinelibrary..wiley..com/doi/10..1111/ j..1464-5491..2011..03469..x/pdf.. Accessed August 2, 2012..

 

  1. Available at: http://www..lef..org/magazine/mag96/sept96_ freedom..html.. Accessed May 11, 2012..

 

  1. Available at: http://www.cnn.com/2012/04/05/health/diabetes-drug-fights-cancer/.. Accessed May 11, 2012..

 

  1. Castillo JJ, Mull N, Reagan JL, Nemr S, Mitri J. Increased inci – dence of non-Hodgkin lymphoma, leukemia, and myeloma in patients with diabetes mellitus type 2: a meta-analysis of observational studies.. Blood.. 2012 May 24;119(21):4845–50..

 

  1. Vigneri P, Frasca F, Sciacca L, Pandini G, Vigneri R.. Diabetes and cancer.. Endocr Relat Cancer.. 2009 Dec;16(4):1103–23..
  2. Michels KB, Solomon CG, Hu FB, et al.. Type II diabetes and subsequent incidence of breast cancer in the Nurses’ Health Study.. Diabetes Care.. 2003 Jun;26(6):1752–8..

 

  1. Aschebrook-Kilfoy B, Sabra MM, Brenner A, et al.. Diabetes and thyroid cancer risk in the National Institutes of Health-AARP Diet and Health Study.. Thyroid.. 2011 Sep;21(9):957–63..

 

Metformin Makes Headline News               •  121

 

 

  1. Haffner SM, Miettinen H.. Insulin resistance implications for type II diabetes mellitus and coronary heart disease.. Am J Med.. 1997 Aug;103(2):152–62..

 

  1. Mazzone T, Chait A, Plutzky J.. Cardiovascular disease risk in type 2 diabetes mellitus: insights from mechanistic stud-ies.. Lancet.. 2008 May 24;371(9626):1800–9..

 

  1. Alexander CM, Landsman PB, Teutsch SM, Haffner SM.. Third National Health and Nutrition Examination Survey (NHANES III); National Cholesterol Education Program (NCEP).. NCEP-defined metabolic syndrome, diabetes, and prevalence of cor-onary heart disease among NHANES III participants age 50 years and older.. Diabetes.. 2003 May;52(5): 1210–4..

 

  1. Schurgin S, Rich S, Mazzone T.. Increased prevalence of sig-nificant coronary artery calcification in patients with diabe-tes.. Diabetes Care.. 2001 Feb;24(2):335–8..

 

  1. Libby G, Donnelly LA, Donnan PT, Alessi DR, Morris AD, Evans JM.. New users of metformin are at low risk of inci-dent cancer: a cohort study among people with type 2 diabe-tes.. Diabetes Care.. 2009 Sep;32(9):1620–5..

 

  1. Romero IL, McCormick A, McEwen KA, et al.. Relationship of type II diabetes and metformin use to ovarian cancer pro-gression, survival, and chemosensitivity.. Obstet Gynecol.. 2012 Jan;119(1):61–7..

 

  1. Li D, Yeung SC, Hassan MM, Konopleva M, Abbruzzese JL.. Antidiabetic therapies affect risk of pancreatic cancer.. Gas-troenterology.. 2009 Aug;137(2):482–8..

 

  1. Wang LW, Li ZS, Zou DW, Jin ZD, Gao J, Xu GM.. Metformin induces apoptosis of pancreatic cancer cells.. World J Gastro-enterol.. 2008 Dec 21;14(47):7192–8..

 

  1. Wright JL, Stanford JL.. Metformin use and prostate cancer in Caucasian men: results from a population-based case-con-trol study.. Cancer Causes Control.. 2009 Nov;20(9):1617–22..

 

122   •  Pharmocracy II

 

 

  1. Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR.. Long-term metformin use is associated with decreased risk of breast cancer.. Diabetes Care.. 2010 Jun;33(6):1304–8..

 

  1. Cantrell LA, Zhou C, Mendivil A, Malloy KM, Gehrig PA, Bae-Jump VL.. Metformin is a potent inhibitor of endometrial can-cer cell proliferation—implications for a novel treatment strat-egy.. Gynecol Oncol.. 2010 Jan;116(1):92–8..

 

  1. Hirsch HA, Iliopoulos D, Tsichlis PN, Struhl K.. Metformin selectively targets cancer stem cells, and acts together with chemotherapy to block tumor growth and prolong remis-sion.. Cancer Res.. 2009 Oct 1;69(19):7507–11..

 

  1. Anisimov VN, Egormin PA, Piskunova TS, et al.. Metformin extends life span of HER-2/neu transgenic mice and in com-bination with melatonin inhibits growth of transplantable tumors in vivo.. Cell Cycle.. 2010 Jan 1;9(1):188–97..

 

  1. Evans JM, Donnelly LA, Emslie-Smith AM, Alessi DR, Morris AD.. Metformin and reduced risk of cancer in diabetic patients.. BMJ.. 2005 Jun 4;330(7503):1304–5..

 

  1. Hosono K, Endo H, Takahashi H, et al.. Metformin suppresses colorectal aberrant crypt foci in a short-term clinical trial.. Cancer Prev Res (Phila).. 2010 Sep;3(9):1077–83..

 

  1. Onitilo AA, Engel JM, Glurich I, Stankowski RV, Williams GM, Doi SA.. Diabetes and cancer II: role of diabetes medi-cations and influence of shared risk factors.. Cancer Causes Control.. 2012 Jul;23(7):991–1008.. Epub 2012 Apr 25..

 

  1. Memmott RM, Mercado JR, Maier CR, Kawabata S, Fox SD, Dennis PA.. Metformin prevents tobacco carcinogen-induced lung tumorigenesis.. Cancer Prev Res (Phila).. 2010 Sep;3(9):1066–76..

 

  1. Nagi DK, Yudkin JS.. Effects of metformin on insulin resis-tance, risk factors for cardiovascular disease, and plasmino-gen activator inhibitor in NIDDM subjects.. A study of two ethnic groups.. Diabetes Care.. 1993 16(4):621–29..

 

Metformin Makes Headline News               •  123

 

 

  1. Evans JM, Ogston SA, Emslie-Smith A, Morris AD.. Risk of mortality and adverse cardiovascular outcomes in type 2 dia-betes: a comparison of patients treated with sulfonylureas and metformin.. Diabetologia.. 2006 May;49(5):930–6..

 

  1. Brame L, Verma S, Anderson T, Lteif A, Mather K.. Insulin resistance as a therapeutic target for improved endothelial function: metformin.. Curr Drug Targets Cardiovasc Haematol Disord.. 2004 Mar;4(1):53–63..

 

  1. Available at: http://www..idb..hr/diabetologia/10no3-2..pdf.. Accessed August 2, 2012..

 

  1. Hundal RS, Krssak M, Dufour S, et al.. Mechanism by which metformin reduces glucose production in type 2 diabetes.. Diabetes.. 2000 Dec;49(12):2063–9..

 

  1. Moon RJ.. The addition of metformin in type 1 diabetes improves insulin sensitivity, diabetic control, body compo-sition and patient well-being.. Diabetes Obes Metab.. 2007 Jan;9(1):143–5..

 

  1. Wong AK, Symon R, Alzadjali MA, et al.. The effect of metfor-min on insulin resistance and exercise parameters in patients with heart failure.. Eur J Heart Fail. 2012 Jun 27.. [Epub ahead of print]

 

  1. Boyda HN, Procyshyn RM, Tse L, et al.. Differential effects of 3 classes of antidiabetic drugs on olanzapine-induced glu-cose dysregulation and insulin resistance in female rats.. J Psychiatry Neurosci. 2012 May 28;37(4):110140.. doi: 10..1503/ .110140.. [Epub ahead of print]

 

  1. Campagnoli C, Pasanisi P, Abbà C, et al.. Effect of different doses of metformin on serum testosterone and insulin in non-diabetic women with breast cancer: a randomized study.. Clin Breast Cancer.. 2012 Jun;12(3):175–82..

 

  1. Cersosimo E, DeFronzo RA.. Insulin resistance and endothe-lial dysfunction: the road map to cardiovascular diseases.. Diabetes Metab Res Rev.. 2006 Nov-Dec;22(6):423–36..

 

124   •  Pharmocracy II

 

 

  1. Eschwège E.. The dysmetabolic syndrome, insulin resistance and increased cardiovascular (CV) morbidity and mortality in type 2 diabetes: aetiological factors in the development of CV complications.. Diabetes Metab.. 2003 Sep;29(4 Pt 2):6S19–27..

 

  1. Osei K.. Insulin resistance and systemic hypertension.. Am J Cardiol.. 1999 Jul 8;84(1A):33J-36J..

 

  1. Tran TT, Medline A, Bruce WR.. Insulin promotion of colon tumors in rats. Cancer Epidemiol Biomarkers Prev.. 1996 Dec;5(12):1013–5..

 

  1. Parekh N, Lin Y, Hayes RB, Albu JB, Lu-Yao GL.. Longitudinal associations of blood markers of insulin and glucose metab-olism and cancer mortality in the T hird National Health and Nutrition Examination Survey.. Cancer Causes Control.. 2010 Apr;21(4):631–42..

 

  1. Otani T, Iwasaki M, Sasazuki S, Inoue M, Tsugane S; Japan Public Health Center-based Prospective Study Group. . Plasma C-peptide, insulin-like growth factor-I, insulin-like growth factor binding proteins and risk of colorectal can-cer in a nested case-control study: the Japan public health center-based prospective study.. Int J Cancer.. 2007 May 1;120(9):2007–12..

 

  1. Ma J, Li H, Giovannucci E, et al.. Prediagnostic body-mass index, plasma C-peptide concentration, and prostate cancer-specific mortality in men with prostate cancer: a long-term survival analysis.. Lancet Oncol.. 2008 Nov;9(11):1039–47..

 

  1. Hirose K, Toyama T, Iwata H, Takezaki T, Hamajima N, Tajima K.. Insulin, insulin-like growth factor-I and breast cancer risk in Japanese women.. Asian Pac J Cancer Prev.. 2003 Jul-Sep;4(3):239–46..

 

  1. Sigal RJ, El-Hashimy M, Martin BC, Soeldner JS, Krolewski AS, Warram JH.. Acute postchallenge hyperinsulinemia predicts weight gain: a prospective study.. Diabetes.. 1997 Jun;46(6):1025–9..

 

Metformin Makes Headline News               •  125

 

 

  1. Russell-Jones D, Khan R.. Insulin-associated weight gain in diabetes—causes, effects and coping strategies.. Diabetes Obes Metab.. 2007 Nov;9(6):799–812..

 

  1. Johnson MS, Figueroa-Colon R, Huang TT, Dwyer JH, Goran MI.. Longitudinal changes in body fat in African-American and caucasian children: influence of fasting insulin and insulin sensitivity.. J Clin Endocrinol Metab.. 2001 Jul;86(7):3182–7..

 

  1. Bowker SL, Majumdar SR, Veugelers P, Johnson JA.. Increased cancer-related mortality for patients with type 2 diabe-tes who use sulfonylureas or insulin.. Diabetes Care 2006 Feb;29(2):254–8..

 

  1. Kaaks R.. Plasma insulin, IGF-I and breast cancer.. Gynecol Obstet Fertil.. 2001 Mar;29(3):185–91..

 

  1. Nilsen TI, Vatten LJ.. Prospective study of colorectal cancer risk and physical activity, diabetes, blood glucose and BMI: exploring the hyperinsulinaemia hypothesis.. Br J Cancer.. 2001 Feb 2;84(3): 417–22..

 

  1. Hegele RA.. Premature atherosclerosis associated with monogenic insulin resistance. . Circulation. . 2001 May 8;103(18):2225–9..

 

  1. Chu N, Spiegelman D, Hotamisligil GS, Rifai N, Stampler M, Rimm EB.. Plasma insulin, leptin, and soluble TNF receptors levels in relation to obesity-related atherogenic and throm-bogenic cardiovascular disease risk factors among men.. Ath-erosclerosis.. 2001 Aug;157(2):495–503..

 

  1. Lichtenstein MJ, Yarnell JW, Elwood PC, et al.. Sex hor-mones, insulin, lipids, and prevalent ischemic heart disease.. Am J Epidemiol.. 1987 Oct;126(4):647–57..

 

  1. Dekker JM, Girman C, Rhodes T, et al.. Metabolic syndrome and 10-year cardio-vascular disease risk in the Hoorn Study.. Circulation.. 2005 Aug 2;112(5):666–73..

 

  1. Available at: http://www. .nejm. .org/doi/full/10. .1056/ NEJMoa0806470#t=article.. Accessed July 11, 2012..

 

126   •  Pharmocracy II

 

 

  1. Available at: http://www..bmj..com/content/310/6972/83.. full.. Accessed July 11, 2012..

 

  1. Available at: http://www..medscape..com/viewarticle/714920.. Accessed July 11, 2012..

 

  1. Klow NE, Draganov B, Os I.. Metformin and contrast media-increased risk of lactic acidosis.. Tidsskr Nor Laegeforen.. 2001 Jun 10;121(15):1829..

 

  1. Brown JB, Pedula K, Barzilay J, Herson MK, Latare P.. Lac-tic acidosis rates in typeII diabetes.. Diabetes Care.. 1998 Oct;21(10):1659–63..

 

  1. Misbin RI.. The phantom of lactic acidosis due to metformin in patients with diabetes.. Diabetes Care.. 2004 Jul;27(7): 1791–3..
  2. Salpeter S, Greyber E, Pasternak G, Salpeter E.. Risk of fatal and nonfatal lactic acidosis with metformin use in type 2 diabetes mellitus.. Cochrane Database Syst Rev.. 2010 Apr 14;(4):CD002967..

 

  1. Kirpichnikov D, McFarlane SI, Sowers JR.. Metformin: an update.. Ann Intern Med.. 2002 137(1):25–33..

 

  1. Towler MC, Hardie DG.. AMP-activated protein kinase in metabolic control and insulin signaling.. Circ Res.. 2007 100(3):328–41..

 

  1. Li D, Yeung SC, Hassan MM, Konopleva M, Abbruzzese JL.. Antidiabetic therapies affect risk of pancreatic cancer.. Gas-troenterology.. 2009 Aug;137(2):482–8..

 

  1. Emral R, Köseoğlulari O, Tonyukuk V, Uysal AR, Kamel N, Corapçioğlu D.. The effect of short-term glycemic regulation with gliclazide and metformin on postprandial lipemia.. Exp Clin Endocrinol Diabetes.. 2005 Feb;113(2):80–4..

 

  1. Mughal MA, Jan M, Maheri WM, Memon MY, Ali M.. The effect of metformin on glycemic control, serum lipids and lipoproteins in diet alone and sulfonylurea-treated type 2 diabetic patients with sub-optimal metabolic control.. J Pak Med Assoc.. 2000 Nov;50(11):381–6..

 

Metformin Makes Headline News               •  127

 

 

  1. Lund SS, Tarnow L, Frandsen M, et al.. Impact of metfor-min versus the prandial insulin secretagogue, repaglinide, on fasting and postprandial glucose and lipid responses in non-obese patients with type 2 diabetes.. Eur J Endocrinol.. 2008 Jan;158(1):35–46..

 

  1. Hundal RS, Krssak M, Dufour S, et al.. Mechanism by which metformin reduces glucose production in type 2 diabetes.. Diabetes.. 2000 Dec;49(12):2063–9..

 

  1. Bjørnholt JV, Erikssen G, Aaser E, et al.. Fasting blood glu-cose: an underestimated risk factor for cardiovascular death.. Results from a 22-year follow-up of healthy nondiabetic men.. Diabetes Care.. 1999 Jan;22(1):45–9..

 

  1. Goodwin PJ, Pritchard KI, Ennis M, Clemons M, Graham M, Fantus IG.. Insulin-lowering effects of metformin in women with early breast cancer.. Clin Breast Cancer.. 2008 Dec;8(6):501–5..

 

  1. Velazquez EM, Mendosa S, Hamer T, Sosa F, Glucck CJ.. Metformin therapy in women with polycystic ovary syn-drome reduces hyperinsulinemia, insulin resistance, hyper-androgenemia, and systolic blood pressure, while facilitat-ing menstrual regularity and pregnancy.. Metabolism.. 1994 May;43(5):647–54..

 

  1. MB Davidson, AL Peters.. An overview of metformin in the treatment of type 2 diabetes mellitus.. Am J Med.. 1997Jan;102(1):99–110..

 

  1. Avilés-Santa L, Sinding J, Raskin P.. Effects of metformin in patients with poorly controlled, insulin-treated type 2 dia-betes mellitus.. A randomized, double-blind, placebo-con-trolled trial.. Ann Intern Med.. 1999 Aug 3;131(3):182–8..

 

  1. Olsson J, Lindberg G, Gottsäter M, et al.. Increased mortal-ity in Type II diabetic patients using sulphonylurea and met-formin in combination: a population-based observational study.. Diabetologia.. 2000 May;43(5):558–60..

 

128   •  Pharmocracy II

 

 

  1. Mazokopakis EE, Starakis IK.. Recommendations for diag-nosis and management of metformin-induced vitamin B12 (Cbl)deficiency.. Diabetes Res Clin Pract.. 2012 Jul 7.. [Epub ahead of print]

 

  1. Carlsen SM, Følling I, Grill V, Bjerve KS, Schneede J, Refsum H.. Metformin increases total serum homocysteine levels in non-diabetic male patients with coronary heart disease.. Scand J Clin Lab Invest.. 1997 Oct;57(6):521–7..

 

  1. de Jager J, Kooy A, Lehert P, et al.. Long term treatment with metformin in patients with type 2 diabetes and risk of vita-min B-12 deficiency: randomised placebo controlled trial.. 2010 May 20;340:c2181.. doi: 10..1136/bmj..c2181..

 

  1. Langan RC, Zawistoski KJ.. Update on vitamin B12 defi-ciency.. Am Fam Physician. 2011 Jun 15;83(12):1425–30..

 

  1. Aghamohammadi V, Gargari BP, Aliasgharzadeh A.. Effect of folic acid supplementation on homocysteine, serum total anti-oxidant capacity, and malondialdehyde in patients with type 2 diabetes mellitus.. J Am Coll Nutr.. 2011 Jun;30(3):210–5..

 

  1. Ozata M, Oktenli C, Bingol N, Ozdemir IC.. The effects of metformin and diet on plasma testosterone and leptin lev-els in obese men.. Obes Res.. 2001 Nov;9(11):662–7..

 

  1. Grossmann M, Thomas MC, Panagiotopoulos S, et al.. Low testosterone levels are common and associated with insu-lin resistance in men with diabetes.. J Clin Endocrinol Metab.. 2008 May;93(5): 1834–40..

 

  1. Available at:http://www..lef..org/magazine/mag2007/jul2007_ report_diabetes_01..htm.. Accessed July 9, 2012..

 

  1. Kim T, Davis J, Zhang AJ, He X, Mathews ST.. Curcumin acti-vates AMPK and suppresses gluconeogenic gene expression in hepatoma cells.. Biochem Biophys Res Commun.. 2009 Oct 16;388(2):377–82..

 

  1. Henry-Vitrac C, Ibarra A, Roller M, Merillon JM, Vitrac X.. Contribution of chlorogenic acids to the inhibition of human

 

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hepatic glucose-6-phosphatase activity in vitro by Svetol, a standardized decaffeinated green coffee extract.. J Agric Food Chem.. 2010 Apr 14;58(7):4141–4..

 

  1. Andrade-Cetto A, Vazquez RC.. Gluconeogenesis inhibition and phytochemical composition of two Cecropia species.. J Ethnopharmacol.. 2010 Jul 6;130(1):93–7..

 

  1. Nagendran MV.. Effect of Green Coffee Bean Extract (GCE), High in Chlorogenic Acids, on Glucose Metabolism.. Poster presentation number: 45-LB-P.. Obesity 2011, the 29th Annual Scientific Meeting of the Obesity Society.. Orlando, Florida.. October 1–5, 2011..

 

  1. Available at: http://www..lef..org/magazine/mag2012/feb2012_ Doctors-Overlook-Leading-Cause-Premature-Death_01..htm.. Accessed July 11,2012..

 

  1. Available at: http://www..lef..org/magazine/mag2012/feb2012_ Suppress-Deadly-After-Meal-Blood-Sugar-Surges_01..htm.. Accessed July 11, 2012..

 

  1. Available at: http://www..lef..org/magazine/mag2011/ss2011_ Are-We-All-Pre-Diabetic_01..htm.. Accessed July 11, 2012..

 

  1. Available at: http://www..lef..org/magazine/mag2011/ss2011_ Effective-Approaches-to-Blunt-Blood-Sugar-Surges_01..htm.. Accessed July 11, 2012..

 

  1. Available at: http://www..lef..org/magazine/mag2011/jan2011_ Glucose-The-Silent-Killer_01..htm.. Accessed July 11, 2012..
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  1. Burris HA III, Moore MJ, Andersen J, et al.. Improvements in survival and clinical benefit with gemcitabine as first-line therapy for patients with advanced pancreas cancer: a ran-domized trial.. J Clin Oncol.. 1997 Jun;15(6):2403–13..

 

130   •  Pharmocracy II

 

 

  1. Conroy T, Desseigne F, Ychou M, et al.. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer.. N Engl J Med.. 2011 May 12;364(19):1817–25..

 

  1. Lowery MA, O’Reilly EM.. Genomics and pharmacogenom-ics of pancreatic adenocarcinoma.. Pharmacogenomics J.. 2012 Feb;12(1):1–9..

Big Pharma: Putting Profits above Patients

 

 

Large pharmaceutical companies today wield enormous power.. These giants of the medical industry spend vast sums on research and development of new drugs and reap hun-dreds of billions of dollars in sales.. Besides research outlays, Big Pharma funds a portion of the FDA budget, spends bil-lions in lobbying Congress, and provides more campaign con-tributions than any other industry..* Does Big Pharma oper-ate in the best interest of consumers and patients? If not, where is the watchdog to safeguard patients when health is threatened by harmful drugs? Who stands up for practitio-ners or innovators who develop competing treatments? In this set of articles, William Faloon provides a glimpse of the ruthless disregard for its own end users ruling the pharma-ceutical industry..

MARCH 2016

 

New England Journal of Medicine Exposes Generic Price Scandal

 

 

 

 

 

No one has fought against high drug prices longer or harder than Life Extension®..1–20 The penalty for exposing healthcare corruption is endless govern-mental investigations aimed at destroying our organiza-

 

tion.. The tide may be turning in our favor..

 

The New England Journal of Medicine published a report that uncovered a drug price scandal that we’ve sought to expose for the past four decades..21 CBS News turned this consumer swindle into a headline report that graphically depicted the devastating impact that skyrocketing generic drug prices are having..22 The next day, I gave an impromptu speech at an Alzheimer’s seminar where I asked the audi-ence to join me in amending the law to prohibit the FDA from granting monopoly status to generic drug makers..

 

 

  • 133

 

134   •  Pharmocracy II

 

 

Virtually everyone in the audience said they would person-ally take the time to protest high drug prices at local con-gressional offices..

 

Two months later, 60 Minutes featured an in-depth report on today’s broken sick-care system.. A quote from this 60 Minutes broadcast relating to the Affordable Care Act stated that it is the product of an “ .. .. .. orgy of lobbying and backroom deals in which just about everyone with a stake in the $3-trillion-a-year health industry came out ahead—except the taxpayers..” 23 The 60 Minutes report went on to state there is “no way in the world that we’re gonna be able to pay for it..” Investigative journalists have since corroborated how high drug prices are causing American consumers to become serfs of the pharmaceu-tical industry..

 

Today’s medical system provides mediocre efficacy at prohibitive prices.. When you read news stories about municipal, corporate, or personal bankruptcies, the high cost of healthcare is a consistent underlying factor.. Mis-guided politicians believe that government subsidies, mandates, and giveaways can resolve high sick-care costs.. Even a cursory glance at the extravagant prices of new medications exposes the falsity of this charade.. When a single new drug can cost $100,000, and protocols are being developed that combine several drugs priced in this range, how can any form of “cost-sharing” be expected to work? It has become mathematically impossible for these outlandish sick-care costs to become “affordable” via gov-ernment edict..

 

For example, a bottle of the prescription drug Valcyte® contains 60 tablets.. The price for this bottle of Valcyte® is around $4,200.. This works out to approximately $70 per tablet.. My cost for a four-month course of this medication is

 

New England Journal of Medicine Exposes Generic Price Scandal    •  135

 

 

over $16,000.. Some people are spending over $50,000 a year for this drug to stay alive—and this is often just one of many medications they need.. Before I describe a simple solution to this epidemic problem, I want to enlighten you to a growing scam in the prescription generic drug arena that finally is generating mainstream media coverage..

 

GENERIC DRUG PRICE GOUGING

 

Generic Drug

Price Increase

Percent Price

 

per Pill

Increase

 

 

 

 

 

 

Doxycycline

6.3 cents to $3.36

5,300%

 

(antibiotic)

 

 

 

 

 

 

 

Captopril

1.4 cents to 39.9

2,850%

 

(antihypertensive)

cents

 

 

 

 

 

 

Clomipramine

22 cents to $8.32

3,780%

 

(antidepressant)

 

 

 

 

 

 

 

 

MAGNITUDE OF THE FRAUD

 

Price gouging on a growing number of generic drugs has grown beyond verbal description.. In the box you see above are examples of price increases occurring in the generic drug marketplace reported on by the New England Journal of Medicine..21 These kinds of price increases are not unique.. They reflect a growing swath of generic drugs that cost virtually nothing to manufacture, but they are spiking to stratospheric consumer price levels..

 

The New England Journal of Medicine gave an example of a generic drug (albendazole) that costs less than one dollar per daily dose overseas, but has risen to $119 per typical daily dose in the United States ($3,570 per month).. This is a 2,010% increase from what this same generic drug cost

 

136   •  Pharmocracy II

 

 

in 2010.. Medicaid spending on this one drug alone (alben-dazole) spiked from $100,000 in 2008 to $7..5 million in 2013—a 75-fold increase!21

 

WE’RE ALL BEING DEFRAUDED

 

Whether or not you need a generic drug whose price has exponentially increased, you are paying through higher health insurance premiums, higher deductibles, and higher co-pays, as well as limitations on what physician you may use and what services that doctor may perform.. A generic drug that I use called tretinoin costs $1,100 per month.. My health insurance covers $850, and I have to pick up the bal-ance of $250 per month.. This drug (tretinoin) was approved in 1995 and long ago lost patent protection, yet it is costing me $13,200 per year.. I say me because I pay this extortion-ist price via my insurance premiums along with the many “exclusions” that cause me to pay out-of-pocket for what health insurance used to cover.. What may shock you most is what the active ingredient of this drug costs.. Consumers are paying over $1,100 for this bottle of tretinoin.. Yet the active ingredient for the entire bottle costs a mere 80 cents.. Even including encapsulation and quality control, that’s a markup of about 400 times over the cost to make this off-patent drug..

 

As we reported in the September 2014 edition of Life Extension Magazine®, collusion among drug makers is causing generics to be priced beyond rational affordability..

 

The cover headline of the September 2014 issue was titled “How to Turn 8 Pennies Into $600..” This was based on an article where I reveal that an antiviral cream (acyclo-vir) that long ago lost patent protection was being sold to pharmacies for 7,500% over the active ingredient cost.. The active ingredient (acyclovir) costs only 8 pennies, yet phar-

 

New England Journal of Medicine Exposes Generic Price Scandal    •  137

 

 

macies are paying a generic maker $600 for this drug and selling it to consumers for around $700..

 

The media has just started reporting on the magni-tude of generic drug price gouging.. These kinds of price markups are unsustainable.. They are part of the reason why healthcare has become unaffordable whether or not you have so-called “insurance..” An increasing number of experts are coming to this realization, including editors of the New England Journal of Medicine and other publi-cations.. We are all being defrauded by this unconsciona-ble price gouging made possible by overregulation of pre-scription drugs..

 

I USED TO OWN A PHARMACY

 

I established a retail pharmacy (Life Extension Phar-macy®) in an attempt to slash the high cost of generic drugs.. I was able to witness some of the manipulation going on behind the scenes that results in consumer prices for gener-ics spiraling upward.. Our pharmacists never knew what the price of a generic drug would be from day to day.. Some drug companies “stop making” certain generics altogether, which usually results in a massive price spike from the remain-ing maker(s).. This happens because competition has all but disappeared..

 

One reason I set up the Life Extension Pharmacy® in 2008 was to slash the prices of generic drugs to our mem-bers.. Back then, pharmacies were selling generic drugs at out-of-pocket prices that were higher than what average people could afford.. My goal of slashing consumer pre-scription drug costs was short-lived, as generic makers raised prices so high that even co-pays on certain drugs remained unaffordable, even though the cost to make most generics is virtually nothing..

 

138   •  Pharmocracy II

 

 

 

THE POLITICIANS ARE CLUELESS

 

There has been more criticism leveled against the Afford-able Care Act than perhaps any other piece of enacted leg-islation. Sound-bite-speaking political candidates constantly state that if elected they will “abolish it.” The problem is none has the faintest clue what to replace it with. The reason they can’t even pretend to have a solution is that none under-

 

stands what’s behind the healthcare cost crisis.

 

Do you think any politician today knows that there are generic drugs being sold for over $1,000 a month whose active ingredient costs only 80 cents?The politicians don’t know this and it’s hard to expect they would.

 

It is up to the citizenry to enlighten Congress and demand that the Food, Drug, and Cosmetic Act be amended so that free-market forces can quickly resolve this generic price-gouging scandal.

 

 

WHY THIS CONCERNS LIFE EXTENSION®

 

New readers may wonder why an organization like Life Extension®, which is best known for pioneering lifesaving nutrients like coenzyme Q10, is making a big deal about generic drug price gouging.. One reason is that Life Exten-sion® does far more than formulate advanced dietary sup-plements.. Our Disease Prevention and Treatment protocols contain recommendations for people to ask their doctors about trying off-label drugs in order to achieve a better clinical outcome.. Our track record of recommending off-label drugs like metformin and cimetidine to better treat disease is unparalleled..24 Insurance companies, however, often refuse to pay for the off-label prescribed drugs we recommend..

 

If this price gouging does not stop, it will render off-label use of these drugs meaningless as consumers will not be able

 

New England Journal of Medicine Exposes Generic Price Scandal    •  139

 

 

to afford the generic drug’s high cost.. So in addition to spar-ing this nation’s sick-care system from economic collapse, we at Life Extension® need to ensure that affordable generic medications are available when the need arises for them..

 

A FREE-MARKET SOLUTION

 

The solution to this problem of rip-off drug pricing is to amend the Food, Drug, and Cosmetic Act to allow more competition in the generic marketplace.. If enacted, generic prices will plummet to levels so low you won’t even worry about what percentage your insurance company pays.. When generic drugs drop this much, it will push down many pat-ented pharmaceutical prices because generic substitutes often work as well as newer branded drugs..

 

Against us are pharmaceutical lobbyists who will do vir-tually anything to protect their lucrative monopoly against free-market competition.. On our side are 330 million Amer-ican consumers, most of whom cannot afford to fall ill even if they have health insurance.. That’s because the deduct-ibles, co-pays, and exclusions result in enormous out-of-pocket expenses that are today’s leading cause of personal bankruptcies.. My question is how many of you want to take political action to stop this price gouging?

 

WE’VE FOUGHT THE DRUG CARTELS SINCE THE 1980S

 

Life Extension® learned about the rip-off prices Americans were paying for their medications in the 1980s.. We launched a relentless campaign to educate the public and Congress about the high prices Americans were forced to pay com-pared to what identical medications cost in Europe and other countries.. When digging through a box of old papers, I ran across one of the many newspaper ads our supporters paid for to expose the corrupt prices and drug approval delays

 

140   •  Pharmocracy II

 

 

that were killing American citizens.. We’ve reproduced one of those ads from the year 1991 on the facing page..

You can see the date on this newspaper ad is October 11, 1991.. On November 7, 1991, we were in handcuffs, stand-ing before a federal judge, with the FDA insisting that we be denied bond because we represented a danger to the pub-lic (for informing Americans that lower-priced medications could be obtained almost anywhere else in the world).. For-tunately, an avalanche of letters from our supporters to the judge helped persuade him to grant us bond ($1 million).. The multiple charges the FDA tried to use to indict us were even-tually dismissed by the Department of Justice in 1995–1996.. If it were not for our supporters standing up to the FDA’s attempts to incarcerate us, there would be no Life Exten-sion® organization today, and supplements like coenzyme Q10 would likely be available only via expensive prescription..

 

Americans today routinely obtain lower-priced medica-tions from Canada because they can access offshore pharma-cies via the Internet.. This was not the case in the 1980s–1990s .. Back then, the FDA viciously fought anyone who dared to inform Americans where they could purchase less expen-sive medications..

 

LEGISLATION URGENTLY NEEDED!

 

Fighting the FDA’s ban on personal use importations of med-ications was only one battle we spearheaded.. The other dealt with the FDA’s attempts to turn many dietary supplements into prescription drugs.. When we initiated action to combat FDA’s attempts to ban dietary supplements, a huge percent-age of our supporters rallied to stop this from happening..

 

The result was passage of a bill (Dietary Supplement Health and Education Act-1994) that protected supplements and substantially lowered consumer prices..

 

New England Journal of Medicine Exposes Generic Price Scandal    •  141

 

 

MIAMI HERALD NEWSPAPER AD OUR SUPPORTERS PAID FOR TWENTY-SIX YEARS AGO—FRIDAY, OCTOBER 11, 1991

 

WHY DO PRESCRIPTION DRUGS COST SO MUCH?

 

In the 1980s prescription drug prices went up to three times faster than inflation!

 

Medical costs are rising so fast now that pharmaceutical companies schedule four new price increases every year!

If you pay for your medical insurance, then you know your premiums skyrocket every year. Employees are now being asked to subsidize their medical insurance plans because the costs have exceeded their employer’s ability to pay.

If you cannot afford medical insurance and get sick, you may not be able to get any medical care.

 

THE FDA IS THE REASON MEDICATIONS ARE SO COSTLY

 

Because of bureaucratic “red tape,” it now costs pharmaceutical companies an average of 231 million dollars to develop one new patent medicine and get it “approved.”

 

This FDA mandated high-cost of “approval” forces pharmaceutical companies to charge the outrageous prices you pay for prescription drugs.

In Europe, where approval requirements are more reasonable, the exact same medicine costs far less money.

The Parkinson’s disease medication Eldepryl can be purchased in Europe for as little as 25 cents a tablet. In the United States, the cost is over $2.00 a tablet.

Not only do Americans pay as much as eight-times more for their medication, but they often have to wait 10 to 20 years longer than Europeans to gain access to new drugs. Eldepryl was available in Europe in the 1970s, but it was not “approved” by the FDA until 1989. That meant millions of Parkinson’s patients had to suffer and die even though an effective treatment was already available.

 

THIS IS A NATIONAL EMERGENCY!

 

Americans are suffering and dying from diseases that already have effective treatments. The FDA is illegally blocking your access to these safe and effective medical drugs.

 

When and if the FDA finally “approved” new therapies, they cost so much that there is now a healthcare cost emergency in the United States.

 

SPEAK UP—BEFORE AN ILLNESS BANKRUPTS YOU

 

Only the Life Extension Foundation dares to challenge the FDA’s incompetent and corrupt prescription drug approval process.

The Life Extension Foundation will send you free information about highly effective medicines not approved by the FDA, but legally available to Americans. There are now thousands of useful medical therapies available in Europe and other parts of the world that the FDA is keeping from you.

 

We will also send you postcards to send to members of Congress which call for an investigation into the illegal and unconstitutional activities the FDA routinely commits against the American people. Call us at:

 

1-800-841-LIFE

 

or write:

 

THE LIFE EXTENSION FOUNDATION

 

PO BOX 229120

 

HOLLYWOOD, FL 33022


 

(This ad is paid for by contributions from Americans who cherish their constitutional right to freedom of choice in healthcare matters)

 

142   •  Pharmocracy II

 

 

For those who think it’s not worth the effort to let your voice be heard, consider the consequences of failing to take action.. Seniors may have to return to the work force to afford their medications.. Those working full time may have to find additional part-time work to pay the high premi-ums and many out-of-pocket expenses no longer covered by medical insurance.. This problem can be partially resolved if free-market competition is allowed in the generic drug mar-ketplace.. If we can persuade Congress to amend the Food, Drug, and Cosmetic Act, the price of many generic drugs will plummet more than 90%..

 

We at Life Extension® are organizing a grassroots cam-paign to overwhelm the lobbyists that currently domi-nate Congress and the federal agencies that are adversely impacting our health and longevity.. A website has been set up for those who want to enlist as activists to combat the atrocities perpetrated against the citizenry by our politi-cians and unelected/unaccountable bureaucrats.. To enroll in this campaign to tear down high drug prices, log on to: LifeExtension..com/consumer..

 

 

FEEBLE SUGGESTIONS FROM THE

 

AMERICAN MEDICAL ASSOCIATION

 

In recognition of the generic drug pricing scandal, the Jour-nal of the American Medical Association (JAMA) published an editorial on November 24, 2015, titled “Options to Promote Competitive Generics Markets in the United States.” Of inter-est was the citing of a statistic showing that 86% of all pre-scriptions written are for generic drugs. The editorial goes on to describe the problem of generic drug shortages as one

 

reason why prices have seen such colossal increases.

 

Some of the solutions proposed in this JAMA editorial resem-ble Soviet-era attempts to regulate their economy that all

 

New England Journal of Medicine Exposes Generic Price Scandal    •  143

 

 

 

proved disastrous. The JAMA authors make it appear impossi-ble to predict competitive pressures in the generic drug arena. Their solution is for the federal government to enact new laws to protect generic manufacturers against the uncertainties of the marketplace, such as limiting the number of makers who could produce the same generic drug.

 

When I read this I thought, are educated people really this stupid? Every day in the private sector, projections are made for future inventory needs, often for products that have razor-thin margins. Yet when you walk into a grocery store, the shelves are consistently well-stocked, and shortages almost never occur. How do all these private-sector companies manage this with-out federal protection against overly optimistic projections?

 

Completely overlooked by the JAMA authors is the fact that when a free market is allowed to determine supply and demand, there are no shortages, and consumer prices usu-ally go down over time (inflation-adjusted).There is no secret to making ample quantities of quality generic drugs. Yet con-sumers are being blatantly lied to as to why their costs for generic drugs are surging.

 

WE ARE MORE THAN A SUPPLEMENT SUPPLIER . . .

 

I know many of you view us as a trusted maker of innova-tive dietary supplements.. The reality is that your support helps fund a variety of programs that challenge conven-tional dogma relating to human longevity and consumer justice.. To reiterate what I said at the beginning of this edi-torial, no one has fought longer or harder against extor-tionist drug prices than Life Extension®.. We have battled pharmaceutical interests for decades and won concessions in Congress and the courts that no one would have ever believed possible..

 

You’re finally seeing news media revelations about the price gouging we predicted would inevitably happen

 

144   •  Pharmocracy II

 

 

back in the 1980s.. The sad fact is that none of our politi-cians have the basic knowledge needed to rein in today’s runaway healthcare costs.. We at Life Extension®, on the other hand, have a 36-year track record of involvement in all ends of the pharmaceutical arena.. We know the only impediment to slashing generic drug costs is citizen apa-thy that allows the FDA to continue enforcing a defacto monopoly that benefits the entrenched pharmaceutical establishment..

 

To enlist as an activist to combat high drug prices log on to: LifeExtension..com/consumer..

 

References

 

  1. Available at: http://www.lifeextension.com/Magazine/2014/4/ Unsustainable-Cancer-Drug-Prices/Page-01. . Accessed November 30, 2015..

 

  1. Available at: http://www.lifeextension.com/Magazine/2014/9/ How-To-Turn-8-Pennies-Into-$600/Page-01. . Accessed November 30, 2015..

 

  1. Available at: http://www.lifeextension.com/Magazine/2012/4/ Lethal-Shortages/Page-01.. Accessed November 30, 2015..

 

  1. Available at: http://www..lifeextension..com/Magazine/2011/3/ No-Real-Healthcare-Cost-Crisis/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2009/9/ Why-American-Healthcare-is-Headed-for-Collapse/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2009/8/ The-Generic-Drug-Rip-Off/Page-02.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2009/3/ FDA-Ending-the-Atrocities/Page-01.. Accessed November 30, 2015..

 

New England Journal of Medicine Exposes Generic Price Scandal    •  145

 

 

  1. Availableat:http://www.lifeextension.com/Magazine/2007/8/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2007/4/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2005/3/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2004/4/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Available at: http://www.lifeextension.com/Magazine/2002/10/ awsi/Page-01.. Accessed November 30, 2015..
  2. Availableat:http://www.lifeextension.com/Magazine/2002/4/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2000/2/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2000/7/ cover_story/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2000/8/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2000/9/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Availableat:http://www.lifeextension.com/Magazine/2000/7/ cover_story/Page-02.. Accessed November 30, 2015..

 

  1. Available at: http://www.lifeextension.com/Magazine/1999/6/ awsi/Page-01.. Accessed November 30, 2015..

 

  1. Available at: http://www.lifeextension.com/Magazine/1998/12/ awsi/Page-01.. Accessed November 30, 2015..
  2. Alpern JD, Stauffer WM, Kesselheim AS.. High-cost generic drugs—implications for patients and policymakers.. N Engl J 2014;371(20):1859–62..

 

  1. Available at: http://www..cbsnews..com/news/generic-drug-prices-skyrocketing/.. Accessed November 30, 2015..

 

  1. Available at: http://www..cbsnews..com/news/obamacare-60-minutes/.. Accessed November 30, 2015..

 

146   •  Pharmocracy II

 

 

  1. Available at: http://www. .lifeextension. .com/about/lef-scientific-achievements-in-health-and-longevity_01.. Accessed November 30, 2015..

APRIL 2014

 

“Unsustainable” Cancer Drug Prices

 

 

 

 

 

Over 100 oncologists are protesting the outlandish prices charged for cancer drugs and how these inflated costs are economically “unsustainable.1

 

Their exposé was published in a prestigious medical journal and received headline news coverage last year..1,2 The more than 100 oncologists who authored this report noted that of twelve cancer drugs approved in 2012, eleven were priced above $100,000 per year..1 Before relating the details, I ask readers to fathom who can afford $100,000 a year for one drug? This does not include hospital costs, physician fees, or other medications cancer patients typically require.. Private insurance premiums are soaring in response to skyrocketing medical costs, along with governmental meddling.. Federal healthcare programs face insolvency even without this kind of price gouging..

 

The oncologists protesting these high prices are experts in chronic myeloid leukemia, a bone marrow cancer that is responding unusually well to new cancer drugs.. The

 

 

  • 147

 

148   •  Pharmocracy II

 

 

dilemma these doctors disclose is that patients are sur-viving longer than expected .. .. .. in some cases indefi-nitely .. .. .. as long as they continue to receive their expen-sive drugs..1,3 These doctors conclude that the prices of these drugs “are too high, unsustainable, may compro-mise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems..”1 These revelations from inside the cancer establishment will not surprise Life Extension’s members, who long ago learned how regulatory strangle-holds over drug development inflict harsh economic pain.. Chronic Myelogenous Leukemia (also known as Chronic Myeloid Leukemia or CML) is a cancer of the blood and bone marrow..4 It’s one of four main kinds of leukemia.. It is characterized by the increased and unregulated growth of predominantly myeloid cells in the bone marrow and the accumulation of these cells in the blood..4 Treatment enhancements have been significant for this type of leuke-mia.. In the 1960s, five-year overall survival rates were only 3–5%..5 Five-year survival rates today are over 90% in those with chronic phase disease..5,6 CML is one of the few can-cers where meaningful treatment progress has occurred..6

 

COST PER MONTH OF ADDED LIFE

 

The more than 100 oncologists protesting the high prices are impressed with the anti-leukemic properties of these drugs.. They note how some patients appear able to survive with chronic myeloid leukemia indefinitely .. .. .. as long as they have access to the expensive medication(s)..1 The con-cern they raise is how individuals and/or society can ever afford the high prices, and why pharmaceutical companies need to charge so much after they earn back the costs of development..

 

“Unsustainable” Cancer Drug Prices         •  149

 

 

Unlike patients with metastasized solid tumors (colon, lung, pancreatic), patients with chronic myeloid leukemia (CML) now live close to normal life spans, as long as they receive the appropriate drugs and adhere to treatment.. In these patients, their CML condition has become different from cancers that sadly kill many patients within a year or two.. The CML form of leukemia is now more similar to chronic disorders like diabetes and hypertension, where daily therapy is required to produce the benefit of long-term survival..1 The problem is that patients stricken with CML are becoming the “financial victims” of the treatment success, having to pay outlandishly high prices forever to stay alive..

 

HOW HIGH?

 

Three drugs approved by the FDA in 2012 to treat leukemia are priced at the following astronomical levels:7

 

Ponatinib                                              $138,000

 

Bosutinib                                               $118,000

 

Bosutinib

Over $100,000

 

Older anti-leukemia drugs like imatinib (Gleevec®) were ini-tially priced at nearly $30,000 a year when released in 2001.. By 2012, the pharmaceutical company making Gleevec® increased the price to $92,000 a year..8

 

The annual costs for these anti-leukemia drugs are beyond the financial abilities of private industry, government, and 99% of individuals in the United States.. One reason why these drugs in particular are a problem is that each leuke-mia patient may need to use one or a combination of these medications for decades.. The economic unreality of all this is why more than 100 oncologists grouped together to alert the world that the high prices for these cancer drugs are “unsustainable..”1


150   •  Pharmocracy II

 

 

DEVELOPMENT COSTS LONG AGO PAID FOR

 

Pharmaceutical companies pretend they need to charge high prices to justify their expensive development costs.. The more than 100 oncologists carefully examined this argu-ment and found it to be unjustified.. Gleevec®, for instance, quickly covered its research and development costs with its $30,000/year initial annual price.. As it was approved for other indications, total revenue soared and it became a financial windfall for its maker (Novartis).. Despite pleas by patients and advocates to lower the price of Gleevec®, it sells for more than three times its original price..1,8 Who can afford to pay $92,000 a year for one drug?

 

COLLUSIVE BEHAVIOR AND HIGH PRICES

 

The drugs working so well against CML are in a class known as “tyrosine-kinase inhibitors..”1 There are now five tyro-sine-kinase inhibiting drugs approved to treat CML, yet all five have annual price ranges of $92,000 to $138,000 in the United States.. This is twice the price compared to Europe, where government health programs bargain for lower drug prices..1 As the more than 100 oncologists noted in their published report, the price in South Korea for these same tyrosine-kinase inhibitors ranges from $21,000 to $28,000..1 That’s perhaps because the Koreans developed their own tyrosine-kinase inhibitor that sells for an annual price of only $21,500, thus forcing pharmaceutical companies to lower their price sharply downward compared to the United States and even Europe..

 

The more than 100 oncologists who authored the pub-lished report protesting the high prices state:

 

A new branch of economics, called game theory, details how collusive behavior can tacitly main-tain high prices over extended periods of time,

 

“Unsustainable” Cancer Drug Prices         •  151

 

 

despite competitive markets, thus representing a form of collective monopoly..1

 

We at Life Extension® have alleged for decades that drug companies function like cartels in stomping out competi-tion while maintaining monopolistic-like pricing.. They do this in many ways that are quite open, such as filing lawsuits to delay the introduction of lower cost generics, and/or fil-ing petitions with the FDA asking the agency to disallow a competitor’s lower cost and sometimes superior product..9

 

It is interesting to note that some of the cancer-protec-tive effects of nutrients like curcumin have been partially attributed to its tyrosine-kinase inhibiting properties.. While curcumin has not yet been proven to be as specific as the drugs described in this article, a search on PubMed using the terms “curcumin and leukemia” reveals multiple mechanisms by which low-cost curcumin may prevent and treat a wide range of cancers..10

 

WHAT DO DRUGS REALLY COST TO DEVELOP?

 

There is a debate as to how much it really “costs” a pharma-ceutical company to bring a new cancer drug to market.. The sum of $1..3–1..7 billion37 is often cited, though some inde-pendent experts put it as low as $60–90 million..38 What-ever the real number, be assured it includes costs of devel-opment of the new drug that won FDA approval, all other drugs that failed, and ancillary expenses such as the cost of conducting the clinical trials, bonuses, salaries, infrastruc-tures, royalties, advertising, and all kinds of perks to the doctors who prescribe the drugs..

 

As to how much a new drug really costs to develop, once a company sells about a billion dollars of a medication, most of the rest is profit.. It’s incredulous to claim that new can-cer drugs are priced over $100,000 a year because they cost

 

152   •  Pharmocracy II

 

 

so much to develop.. As you’ll read later, much of the initial discovery costs are funded by non-profit entities involved in basic research.. After the first two years of a successful drug launch, the “costs” of development are usually more than paid back..

 

HOW DRUG COMPANIES FLEECE THE PUBLIC

 

Before the federal government started picking up the tab for cancer drugs, there was at least an affordability fac-tor that constrained how much pharmaceutical companies could charge.. This changed in response to intensive lobby-ing by pharmaceutical interests that enabled passage of laws such as the Medicare Modernization Act of 2003. This Act resulted in the federal government paying full retail price for cancer drugs and prohibited the federal government from negotiating a lower price..39 Even before the Medicare Mod-ernization Act, the federal government was paying retail prices for cancer drugs under existing Medicare and Med-icaid programs.. Passage of the Affordable Care Act of 2010 will enable pharmaceutical companies to gouge virtually the entire American market with their outlandish prices..40

 

Consumers pay for these inflated drug prices in the form of higher private insurance premiums, higher deductibles, higher co-pays, and higher taxes.. Medicare’s date with insolvency will be hastened as it pays out tens of billions of excess dollars into pharmaceutical company coffers.. Those who have employer-funded health insurance are paying a greater portion of their medical insurance premium, while healthcare inflation remains a major factor behind corpo-rate and municipal bankruptcies..

 

I don’t view it as a coincidence that since the passage of the Medicare Modernization Act, cancer drugs the federal government pays for (like Gleevec®) have spiraled upwards

 

“Unsustainable” Cancer Drug Prices         •  153

 

 

in price.. This Act was written and enacted into law under intensive pressure from pharmaceutical lobbyists.. We at Life Extension® vehemently opposed the Medicare Mod-ernization Act that enabled pharmaceutical companies to charge full retail price for drugs paid for by federal tax/ debt dollars.. The obscene profits earned by a relatively small number of pharmaceutical companies provide them with virtually unlimited resources to influence Congress, the FDA, academia, the media, medical journals, and pre-scribing physicians in ways that go against the welfare of the American public..

 

HOW GLEEVEC® WAS DISCOVERED

 

Gleevec® was approved by the FDA in 2001, but the history of its discovery dates back to 1960, when scientists from the University of Pennsylvania School of Medicine and Insti-tute for Cancer Research identified a genetic mutation in patients with CML (chronic myeloid leukemia)..48 The dis-covery meant that for the first time ever, scientists had dis-covered a genetic abnormality linked to a specific kind of cancer.. This finding set off an explosion of research into the genetic causes of cancer.. The next significant advance took place 13 years later through the work of researchers at the University of Chicago who found that the missing section of DNA that characterized CML had shifted to another chro-mosome, a phenomenon known as “trans-location..”49

 

In the 1980s, researchers from the National Cancer Insti-tute and Erasmus University identified the principal chro-mosomal cause of CML..50 Later, in 1990, researchers at UCLA found this defective chromosome produced a protein that enhances tyrosine kinase activity, which changes the cell’s normal genetic instructions and enables aberrant cell growth and division..50


154   •  Pharmocracy II

 

 

With the discovery that a single enzyme could cause the development of CML, researchers were given a rare oppor-tunity.. The genetic target was clear, and the development of a drug that could inhibit the protein that enhanced tyro-sine kinase could proceed rationally.. Work began in the early 1990s on the discovery of tyrosine kinase inhibitors by researchers at Novartis, who collaborated with scien-tists from the Howard Hughes Medical Institute and other research centers..50–53

 

The first Phase I study began in 1998..53,54 The results of these preliminary studies showed that over 98% of CML patients who took the drug were responding..54 Most patients experienced a significant reduction in the number of white blood cells and a reduction or disappearance in the number of cells containing the cancer-triggering chromosome.. Word of the drug’s effectiveness spread rapidly in the CML com-munity, and tremendous pressure was applied for Novar-tis to make more Gleevec® available so more patients could participate in the clinical trials.. As more Gleevec® was made available, thousands of CML patients had their death sen-tence lifted.. The FDA approved Gleevec® in 2001, ten weeks after Novartis submitted the application..55

 

This brief historical description shows how drug discov-ery is often initiated by non-profit research centers and then much later brought to fruition by commercial pharma-ceutical companies.. Some of the scientists involved in the early development of Gleevec® are part of the more than 100 oncologists who authored the report that seeks to lower the price of these tyrosine kinase inhibiting cancer drugs (such as Gleevec®).. While commercial companies play a vital role in drug development, it is so often research funded by non-profit entities that identifies a breakthrough “target” for which to develop a drug..

 

“Unsustainable” Cancer Drug Prices         •  155

 

 

NOVARTIS ACCUSED OF PAYING ILLEGAL KICKBACKS TO DOCTORS

 

Two of the five overpriced anti-leukemic drugs identified by oncologists are Gleevec® (imatinib) and Tasigna® (nilotinib), both made by Swiss pharmaceutical behemoth Novartis®..41 US prosecutors have brought civil-fraud charges against Novartis® for allegedly paying kickbacks to physicians to prescribe their diabetes and anti-hypertension drugs..42 Novartis claims the money was paid to doctors to speak at education programs around the United States.. The charges against Novartis allege speaking fees, lavish dinners, and vacations illegally provided to doctors totaling nearly $65 million..42 This money of course is all included in the “cost” of drug development..

 

HOW MUCH THE DOCTORS WERE PAID

 

The lawsuit alleges that the doctors (speakers) were usually paid $750–$1,500 per program, with some earning as much as $3,000 to talk at fancy restaurants, or in one case, on a fishing boat in Florida..42 The government’s lawsuit further alleges that one doctor was paid $3,750 for speaking to the same four doctors about a Novartis drug five times in a nine-month period..43 In another allegation, a doctor was paid $500 to speak at an expensive Manhattan restaurant dinner attended by his friends.. Many of these so-called “speaking engagements” occurred with less than three doctors attend-ing, or in some cases, no doctor attending, in which case I suppose, Novartis paid the doctor to speak to himself at a fancy dinner paid for by Novartis..

 

The government’s lawsuit describes dinners where the price per person attending ranged from $672 to over $1,000..42 I feel somewhat out of place here, but I have never been to a dinner where each guest ran up a tab like

 

156   •  Pharmocracy II

 

 

this for food and beverages.. The lawsuit alleges that few slides were ever shown at these speaking engagements.. “Instead, Novartis simply wined and dined the doctors at high-end restaurants with astronomical costs..”43 Not all the restaurants where Novartis paid doctors to speak and covered the meals were high-end.. Some were sports bars (such as Hooters) with so many blaring TV screens (and no private room) that it would have been impossible to make a scientific presentation..42

 

NOT THE FIRST TIME FOR NOVARTIS

 

This is not the first time Novartis has been accused of pay-ing doctors kickbacks to prescribe drugs that are often over-priced compared to generics, and therefore defraud govern-ment programs like Medicare and Medicaid..44,45 In 2010, the same unit of Novartis pled guilty to misdemeanor violations and paid $422..5 million to settle civil and criminal charges that it illegally marketed certain pharmaceutical products and paid doctors kickbacks to prescribe it..44 Novartis denies the charges that it illegally paid kickbacks to doctors in the current civil-fraud lawsuit..45

 

OUTLANDISH COST OF CANCER DRUGS

 

Pharmaceutical companies know that Medicare, Medicaid, and many insurance companies pay unlimited amounts of money for their drugs. What few consumers realize is that

 

they are bearing the cost of these over-priced drugs in the form of higher insurance premiums, higher deductibles, higher co-pays, more exclusions, higher taxes, and higher interest costs on the national debt as government programs pay these outlandish prices. Pharmaceutical companies price gouge the public by charging the obscene prices you see on the following two pages:

 

“Unsustainable” Cancer Drug Prices         •  157

 

 

 

 

 

 

 

 

Brand Name

Generic Name

Type of Cancer

Cost of Drugs

 

 

 

 

 

 

 

 

Avastin ®

(bevacizumab)

Breast Cancer

$100,00011, $55,000

 

 

Colon

(2004)12, $85,000 (2011)13

 

 

 

 

 

Avastin ®

(bevacizumab)

Brain Cancer

$43,00014

 

 

 

 

that recurred

 

 

 

Iclusig ®

(ponatinib)

Chronic Myeloid

$138,00015

 

 

 

 

Leukemia (CML)

 

 

 

Bosulif ®

(bosutinib)

Chronic Myeloid

$118,00015

 

 

 

 

Leukemia (CML)

 

 

 

Gleevec ®

(imatinib)

Chronic Myeloid

$30,000 (2001)

 

 

Leukemia (CML)

$92,000 (2012)15

 

 

 

 

 

Erbitux ®

(cetuximab)

Colon Cancer,

$80,00016

 

 

 

 

Lung Cancer

 

 

 

Cometriq ®

(cabozantinib)

Thyroid Cancer

$99,00017

 

 

 

 

 

 

 

 

Erivedge ®

(vismodegib®)

Skin Cancer

$75,00018

 

 

 

 

 

 

 

 

Herceptin ®

(trastuzumab)

Breast Cancer

$70,00019

 

 

 

 

 

 

 

 

Camptosar ®

(irinotecan)

Stage IV Colon

$44,08720

 

 

 

 

Cancer

 

 

 

Eloxatin ®

(oxaliplatin)

Stage IV Colon

$60,17920

 

 

 

 

Cancer

 

 

 

Synribo ®

 

Chronic Myeloid

$28,000 for induction

 

 

(omacetaxine)

and $14,000 for a

 

 

Leukemia (CML)

 

 

 

 

maintenance course15

 

 

 

 

 

 

 

 

Kadcyla ®

(ado-

Breast Cancer

$94,00021

 

 

 

trastuzumabemtansine )

 

 

 

 

Nexavar ®

(sorafenib)

Liver Cancer

$80,00022

 

 

Kidney Cancer

$96,00022

 

 

 

 

 

Perjeta ®

 

 

$106,20023 (based on

 

 

(pertuzumab)

Breast Cancer

18-month course of

 

 

 

 

 

treatment)

 

 

 

 

 

 

 

 

Provenge ®

(sipuleucel-T)

Prostate Cancer

$93,00024

 

 

 

 

 

 

 

 

 

 

Kidney Cancer,

Up to $3,925 per dose,

 

 

Proleukin ®

 

$109,900 per course

 

 

(aldesleukin)

Metastatic

based on 28 doses,

 

 

 

 

Melanoma

$549,500 per year based

 

 

 

 

 

on 5 courses25,26

 

 

 

 

 

 

 

 

158   •  Pharmocracy II

 

 

 

 

 

 

 

 

 

Brand Name

Generic Name

Type of Cancer

Cost of Drugs

 

 

 

 

 

 

 

 

Sutent ®

 

Kidney,

 

 

 

(sunitinib malate)

pancreatic and

$48,72027

 

 

 

 

GI Cancer

 

 

 

 

 

 

 

 

 

Tarceva ®

 

Non-Small Cell

 

 

 

(erlotinib)

Lung Cancer

$31,00028

 

 

 

 

$31,00028

 

 

 

 

 

 

 

 

 

Xalkori ®

(crizotinib)

Non-Small Cell

$115,00029

 

 

 

 

Lung Cancer

 

 

 

Xgeva ®

(denosumab)

Metastasis to

$6,60030

 

 

 

 

Bones

 

 

 

 

 

prostate Cancer

 

 

 

Xtandi ®

(enzalutamide)

(metastatic

$59,60031

 

 

 

 

castration-

 

 

 

 

 

resistant-mCrpC)

 

 

 

 

 

 

 

 

 

Votrient ®

(pazopanib)

Kidney Cancer

$93,00032 (based on

 

 

Sarcomas33 (2012)

800 mg per day)

 

 

 

 

 

Yervoy ®

 

 

about $116,00034 (about

 

 

(ipilimumab)

Melanoma

$29,000 per infusion,

 

 

 

 

 

4 needed)

 

 

 

 

 

 

 

 

Zelboraf ®

(vemurafenib)

Metastatic

$112,80035 (2012)

 

 

Melanoma

$60,00029 (2011)

 

 

 

 

 

Zytiga ®

 

Prostate Cancer

 

 

 

(abiraterone)

(castration-

$60,00036

 

 

 

 

resistant-CrpC)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A BROKEN SYSTEM!

 

The magnitude of pharmaceutical company malfeasance is incomprehensible to the lay public.. Consumers know healthcare costs are rising, yet cures for most killer diseases remain elusive.. New cancer drugs that add only a few ago-nizing months of survival are laden with such severe side effects that many patients reject them altogether.. Some can-cer patients say no to these over-priced drugs to spare their families insolvency.. Pharmaceutical companies today seek to gain FDA approval of patented drugs that may tempo-

 

“Unsustainable” Cancer Drug Prices         •  159

 

 

rarily shrink tumor volume, but don’t always meaningfully improve patient survival.. The leukemia drugs described in this article are the exception when it comes to long-term efficacy and relative safety..5,6

 

Richard Nixon declared war on cancer in 1971..46 Hun-dreds of billions of dollars of federal funds have been spent on research.. Cancer patients survive longer today, but miss-ing are the miracle cures envisioned 43 years ago.. Long-term side effects from radiation or chemotherapy cause deaths from stroke, heart failure, or immune impairment.. These cancer therapy-induced deaths are not “counted” in the can-cer statistics, thus enabling the cancer establishment to pre-tend they are making more progress than they really are..47

 

OUR “DIFFERENT” APPROACH TO CANCER TREATMENT

 

We at Life Extension® fund clinical cancer research aimed at discovering if protocols that involve dozens of drugs, nutri-ents, and other therapies can produce long-term complete responses, i..e.. cures.. We have spent millions of dollars test-ing a wide array of “other” companies’ therapies in unique combinations to see if we can attain remissions or complete responses.. Our clinical successes in some cases are unprec-edented, yet we don’t own the intellectual property (i..e.. the drugs) that enables these successes to occur.. Instead, we publish the results of our research in books like Disease Pre-vention and Treatment, on our website, or disseminate to our members through our health advisory staff..

 

We never use placebos in cancer patients as we believe this to be genocide.. All cancer patients who enter our clin-ical trials receive therapies that are intended to cure (or mitigate) their underlying malignancy.. Life Extension® does not believe any human being should be treated as an experimental lab animal.. Your support of our cancer

 

160   •  Pharmocracy II

 

 

research initiatives is made possible through your mem-bership dues, contributions, and supplement purchases..

 

References

 

  1. Experts in Chronic Myeloid Leukemia.. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsus-tainable prices of cancer drugs: from the perspective of a large group of CML experts.. Blood.. 2013 May 30;121(22):4439–42..

 

  1. Available at: http://money..cnn..com/2013/04/25/news/ economy/cancer-drug-cost/.. Accessed May 21, 2013..

 

  1. Gambacorti-Passerini C, Antolini L, Mahon FX, et al.. Mul-ticenter independent assessment of outcomes in chronic myeloid leukemia patients treated with imatinib.. J Natl Cancer Inst.. 2011 Apr 6;103(7):553–61..

 

  1. Available at: http://www. cancer.. org/cancer/leukemia.-chronicmyeloidcml/detailedguide/leukemia-chronic-myeloid-myelogenous-what-is-c-m-l.. Accessed June 17, 2013..

 

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  1. Available at: http://www..pslweb..org/liberationnews/news/ oncologists-protest-cancer-drugs-cost..html.. Accessed June 17, 2013..

 

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“Unsustainable” Cancer Drug Prices         •  161

 

 

  1. Available at: http://www..bankrate..com/finance/insurance/ insuring-costs-cancer-1..aspx.. Accessed June 7, 2013..

 

  1. Available at: http://www..drugs..com/newdrugs/fda-approves-avastin-combination-chemotherapy-first-line-most-common-type-lung-cancer-1140..html.. Accessed June 18, 2013..

 

  1. Available at: http://news..yahoo..com/avastin-fails-studies-brain-tumor-patients-133937951..html.. Accessed June 7, 2013..
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  1. Available at: http://www..bloomberg..com/apps/news?pid=n ewsarchive&sid=a477Nm93JYxM.. Accessed June 7, 2013..

 

  1. Available at: http://seekingalpha..com/article/1487722-exelixis-and-cabozantinib-asco-2013-highlights.. Accessed June 7, 2013..

 

  1. Available at: http://prescriptions. .blogs. .nytimes. .com/ 2012/01/30/f-d-a-approves-drug-for-an-advanced-skin-cancer/.. Accessed June 7, 2013..

 

  1. Available at: http://www. .medicalnewstoday. .com/ articles/250912..php.. Accessed June 19, 2013..

 

  1. Mullins CD, Hsiao FY, Onukwugha E, Pandya NB, Hanna N.. Comparative and cost-effectiveness of oxaliplatin-based or irinotecan-based regimens compared with 5-fluoroura-cil/leucovorin alone among US elderly stage IV colon cancer patients.. Cancer.. 2012 Jun 15;118(12):3173–81..

 

  1. Available at: http://www..nytimes..com/2013/02/23/business/ fda-approves-breast-cancer-drug..html?_r=0.. Accessed June 7, 2013..

 

  1. Available at: http://www..forbes..com/sites/matthewherper/ 2012/03/19/how-to-charge-1-6-million-for-a-new-drug-and-get-away-with-it/.. Accessed June 7, 2013..

 

  1. Availableat:http://www.nytimes .com/2012/06/09/business/ genentech-wins-approval-for-new-breast-cancer-drug.. html?_r=0.. Accessed June 7, 2013..

 

162   •  Pharmocracy II

 

 

  1. Available at: http://seekingalpha. .com/article/1413381-bracing-for-dendreon-q1-2013-earnings-all-eyes-on-provenge.. Accessed June 7, 2013..

 

  1. Available at: http://dailymed..nlm..nih..gov/dailymed/lookup.. cfm?setid=a588140c-f9ed-4a9b-a9a6-bf3daafd8a5a.. Accessed January 21, 2014..

 

  1. Available at: http://www..goodrx..com/proleukin/what-is.. Accessed January 21, 2014..

 

  1. Available at: http://www..bloomberg..com/apps/news?pid=ne wsarchive&sid=aER..9zj2HmSk.. Accessed June 7, 2013..

 

  1. Available at: http://www..nytimes..com/2005/07/12/business/ worldbusiness/12iht-drugs..html?_r=0.. Accessed June 7, 2013..
  2. Available at: http://www..forbes..com/sites/matthewherper/ 2011/08/26/pfizer-wins-approval-for-xalkori-lung-cancer-drug-that-heralds-age-of-expensive-personalized-medicines/.. Accessed June 7, 2013..

 

  1. Available at: http://prescriptions. .blogs. .nytimes. .com/ 2010/11/18/f-d-a-approves-a-bone-drug-for-cancer-patients/.. Accessed June 7, 2013..

 

  1. Available at: http://www. .nytimes. .com/2012/09/01/ business/fda-approves-prostate-cancer-drug..html.. Accessed June 7, 2013..

 

  1. Available at: http://cashcard. .lc. .healthtrans. .com/Pages/ PharmacyLocator..aspx?host=default.. Accessed June 7, 2013..

 

  1. Available at: http://www..fda..gov/NewsEvents/Newsroom/ PressAnnouncements/ucm302065..htm.. Accessed June 7, 2013..

 

  1. Available at: http://www..pharmacytimes..com/publications/ health-system-edition/2012/November2012/Formulary-Drug-Review-Ipilimumab-Yervoy.. Accessed June 7, 2013..

 

  1. Available at: http://www. .webmd. .com/melanoma-skin-cancer/news/20120222/zelboraf-may-double-survival-for-some-melanoma-patients.. Accessed June 7, 2013..

 

“Unsustainable” Cancer Drug Prices         •  163

 

 

  1. Available at: http://www..nytimes..com/2011/06/28/health/ 28prostate..html.. Accessed June 7, 2013..

 

  1. Collier R.. Drug development cost estimates hard to swallow.. CMAJ.. 2009 Feb 3;180(3):279–80..

 

  1. Light D, Lexchin J.. Pharmaceutical research and development: what do we get for all that money? 2012 344:4348..
  2. Available at: http://www. .gpo. .gov/fdsys/pkg/PLAW-108publ173/html/PLAW-108publ173..htm.. Accessed May 21, 2013..

 

  1. Available at: http://www. .gpo. .gov/fdsys/pkg/PLAW-111publ148/html/PLAW-111publ148..htm.. Accessed May 21, 2013..

 

  1. Available at: http://www..bloomberg..com/news/2012-10-25/ novartis-cannibalizes-gleevec-to-boost-new-cancer-drug.. html.. Accessed January 21, 2014..

 

  1. Available at: http://online..wsj..com/news/articles/SB1000 1424127887324474004578447053898340538.. Accessed January 27, 2014..

 

  1. Available at: http://www..tampabay..com/news/courts/lawsuit-pharmaceutical-company-gave-kickbacks-to-florida-doctors/2119133.. Accessed January 21, 2014..

 

  1. Available at: http://www. justice.. gov/opa/pr/2010/. September/10-civ-1102..html.. Accessed January 22, 2014..

 

  1. Available at: http://www..reuters..com/article/2013/04/23/ us-novartis-fraud-lawsuit-idUSBRE93M1C920130423.. Accessed January 22, 2014..

 

  1. Available at: http://dtp. .nci. .nih. .gov/timeline/noflash/ milestones/m4_nixon..htm.. Accessed January 22, 2014..

 

  1. Available at: http://www..cancer..net/survivorship/long-term-side-effects-cancer-treatment.. Accessed January 22, 2014..

 

  1. Nowell PC, Hungerford DA. A minute chromosome in human chronic granulocytic leukaemia.. Science.. 1960 132:164–172..

 

164   •  Pharmocracy II

 

 

  1. Rowley D.. A new consistent chromosomal abnormality in chronic myelogenous leukaemia identified by quinacrine flu-orescence and Giemsa staining.. Nature.. 1973 243:290–293..

 

  1. Available at: http://asheducationbook..hematologylibrary.. org/content/2008/1/418..full.. Accessed January 22, 2014..

 

  1. Available at: http://www..hhmi..org/news/five-year-study-shows-gleevecs-potency-against-chronic-myeloid-leukemia.. Accessed January 22, 2014..

 

  1. Druker BJ, Tamura S, Buchdunger E, et al.. Effects of a selec-tive inhibitor of the Abl tyrosine kinase on the growth of Bcr-Abl positive cells.. Nat Med. 1996 May;2(5):561–6..

 

  1. Available at: http://www..cancer..gov/researchandfunding/ extramural/cancercenters/accomplishments/gleevec.. Accessed May 21, 2013..

 

  1. Available at: http://bloodjournal..hematologylibrary..org/ content/105/7/2640..full.. Accessed May 21, 2013..

 

  1. Available at: http://www. .innovation. .org/index..cfm/ StoriesofInnovation/InnovatorStories/The_Story_of_ Gleevec.. Accessed January 22, 2014..

OCTOBER 2012

 

Legal Murder

 

 

 

 

 

No one knows exactly how many Americans were killed by Vioxx®.. According to Dr.. David Graham, the hero who defied his corrupt FDA superiors,

 

Vioxx® caused 88,000 to 139,000 excess cases of heart attack and stroke..1,2 This carnage occurred as Merck (the maker of Vioxx®) worked closely with high-level FDA officials to sup-press data showing the lethal dangers of this once-popu-lar arthritis drug..3,4 According to a review published in the Archives of Internal Medicine, Merck held back initial data showing Vioxx® caused an increase in heart attack and stroke risk..5 It took three more years of patients needlessly dying before Vioxx® was pulled off the market.. The FDA never mandated Vioxx® be banned.. As lawsuits started pil-ing up, Merck made a business decision to withdraw Vioxx® worldwide, while denying there was a safety issue..6

 

MERCK PLEADS GUILTY TO CRIMINAL CHARGES

 

After a seven-year Justice Department investigation, Merck pled guilty to a criminal misdemeanor that it illegally

 

 

  • 165

 

166   •  Pharmocracy II

 

 

promoted Vioxx® and deceived the government about the drug’s safety..7 Merck paid the federal government a $950 million fine.. It has also paid over $4 billion in compen-sation to victims (or their family members) for the side effects Vioxx® caused, along with punitive damages for covering up the lethal dangers..7 Before it was withdrawn, Merck racked up $11 billion in Vioxx® sales..8 So with the criminal fine paid to the government and the money paid out so far to victims, Merck appears to be billions of dollars ahead financially by knowingly selling a drug that killed tens of thousands of human beings!

 

EGREGIOUS COVER-UP

 

Four years before Vioxx® was withdrawn, the results from a large clinical trial were published comparing patients using naproxen or Vioxx®.. The findings showed a 500% increased risk of heart attack in Vioxx® users compared to those taking naproxen..9 This trial was designed, per-formed, and paid for by the drug industry.. The findings from this trial should have resulted in the FDA withdraw-ing approval of Vioxx®.. Instead, the drug industry (work-ing in cahoots with the FDA) came up with a ridicu-lous upside-down analysis of the data.. They concluded that Vioxx® did not cause a 500% increase in heart attacks, but instead that naproxen resulted in a 500% decrease in heart attack incidence..10

 

Dr.. David Graham is the senior epidemiologist in the FDA’s Office of Drug Safety.. Dr.. Graham knew that naproxen did not reduce heart attack risk by 500%.. When Dr.. Graham saw how data from this study was being manipulated to cover up Vioxx’s lethal dangers, he broke rank with corrupt FDA officials.. Dr.. Graham’s battle to expose the lethal dangers of Vioxx® almost got him fired from the FDA..

 

Legal Murder      •  167

 

 

GOVERNMENT DOESN’T CARE ABOUT VICTIMS

 

As most of you know, the intentional killing of a human is a felony, often punishable by life in prison (or worse).. In the Justice Department’s settlement with Merck, there is no discussion of murder.. Instead, Merck agreed to plead guilty to FDA “regulatory” violations involving its promo-tion of Vioxx® to rheumatoid arthritis patients when it was approved only to treat osteoarthritis.. Merck also pled guilty to misleading Medicaid officials about the safety of Vioxx®..11 Dr.. David Graham estimates that Vioxx® directly killed more Americans than died during the entire Vietnam War..9 Yet nowhere in the criminal settlement agreement does Merck have to admit to “intentionally killing people..”

 

It appears that the Justice Department is not concerned by the human body count.. The settlement only requires that Merck admit they failed to comply with FDA and Med-icaid regulations..12 Interestingly, there are published stud-ies showing that Vioxx® was effective against rheumatoid arthritis, but such data is irrelevant since the FDA had not “approved” Vioxx® for this indication..11 Our govern-ment was more concerned about “regulatory violations” than accurately assessing scientific facts about Vioxx® in the treatment of rheumatoid arthritis.. The rationale you’ll read next for Merck not being charged with felony murder demonstrates the insidious influence pharmaceutical behe-moths exert over the federal government..13

 

WHY PHARMACEUTICAL COMPANIES AREN’T CRIMINALLY PROSECUTED

 

Medicare and Medicaid pay out such a large portion of this nation’s healthcare costs that pharmaceutical com-panies must maintain access to these government spigots to remain in business.. If a drug company is convicted of

 

168   •  Pharmocracy II

 

 

“serious healthcare fraud,” they are automatically excluded from receiving federal payouts.. To protect the financial interests of large pharmaceutical companies, the federal government works out specials deals that enable them to avoid accountability for their illicit actions.. In recent years, our government has allowed pharmaceutical companies to escape felony fraud charges, or allows a shell company-subsidiary to take the blame for the parent company’s mis-deeds.. This is analogous to you committing a murder, but persuading a terminal cancer patient to take the blame for it, and prosecutors then letting you off the hook..

Vioxx® is in a class of drugs known as COX-II inhibitors.. Another drug in this class approved by the FDA was Bex-tra made by pharmaceutical behemoth Pfizer.. Bextra was also withdrawn because of increased risks of heart attacks, strokes, and deaths in patients prescribed it.14–16 As we reported in 2010, Pfizer was allowed to use a subsidiary shell com-pany to plead guilty to a criminal charge that it fraudulently sold Bextra..17 The fraud was based on Pfizer promoting Bextra’s use in higher doses to relieve acute surgical pain, something the drug was never approved for..18 Using a sub-sidiary to plead guilty to the Bextra charges enabled Pfizer to continue receiving lucrative Medicare/Medicaid reim-bursement on its other drugs.. By allowing the Vioxx® atroci-ties to be settled on misdemeanor charges instead of felony counts, Merck will continue receiving billions of dollars of annual payments from Medicare/Medicaid..

 

BEXTRA’S FATAL SIDE EFFECTS OVERLOOKED BY FDA

 

In an analysis presented at the American Heart Associa-tion, Bextra was shown to more than double the risk of heart attack or stroke.. The lead author of this study com-mented that, This is a time bomb waiting to go off..”19


Legal Murder      •  169

 

 

Pfizer paid a settlement to the federal government of $1..195 billion for the fraudulent marketing of Bextra..20 The record financial payout was not because Bextra injured and killed arthritis patients.. The fine was to settle gov-ernment claims that Pfizer illegally promoted the sale of Bextra for uses and dosages that the FDA specifically declined to approve.. Just as with Vioxx®, the government bases its Bextra fine on regulatory violations instead of the fact that human beings were killed!

 

NO EQUAL JUSTICE

 

The slap-on-the-wrist settlements of the Vioxx® and Bextra charges represent an egregious evasion of laws that are sup-posed to prohibit companies engaged in “serious healthcare fraud” from receiving tax dollars.. Of course none of the indi-vidual perpetrators at drug companies that caused these hor-rific numbers of deaths ever have to worry about jail time..

 

If a supplement company owner knowingly sold a prod-uct that caused even one death, he would likely face decades in prison.. As you’ll read in another article in this section, a man named Jay Kimball sold a drug (liquid deprenyl) that harmed no one, but he is still serving out a 13-year prison sentence.. The wrongful prosecution of Jay Kimball repre-sents one of the worst miscarriages of justice in the history of the American jurisprudence.. In comparing Jay Kimball’s case to the real crimes of Merck and Pfizer, the FDA did not even attempt to show that Jay’s liquid deprenyl harmed any-one.. The FDA merely cited “regulatory violations” involving his improper export of his liquid deprenyl to other coun-tries.. The result is 13 years in jail for Jay Kimball and finan-cial ruination for his family..21

 

Merck and Pfizer knowingly sold drugs (Vioxx® and Bex-tra) that killed tens of thousands of Americans, yet they

 

170   •  Pharmocracy II

 

 

continue receiving billions of Medicare/Medicaid dollars each year, with no one facing jail time, while their execu-tives lead lavish lifestyles..

 

COVERING UP OF VIOXXS LETHAL DANGERS

 

By April 2001, Merck had compiled internal data from two large human trials showing a staggering three-fold increase in total mortality (deaths) in patients using Vioxx®.22 In articles

 

that reported the results of these trials, analyses and statisti-cal tests of the mortality data were obscured. Even the study author’s conclusion regarding safety of Vioxx® was absurdly stated as the drug being “well tolerated.23

 

Data submitted to the FDA was manipulated to understate the higher numbers of deaths in Vioxx® users. For example, if heart attack or stroke deaths occurred more than 14 days after Vioxx® was discontinued, it was often omitted. Just imag-ine how many heart attack and stroke victims stopped tak-ing Vioxx® because arthritis was no longer their major medi-cal concern. Paralyzed stroke patients, for instance, have little need for Vioxx®, yet many of these stroke victims die more than 14 days after discontinuing Vioxx®.

 

After the VIGOR study was published showing a 500% increase in myocardial infarction (heart attack) in Vioxx® users,24 Merck directed its sales force to provide physicians with a distorted picture of the relevant scientific evidence. For instance, Merck sent a bulletin to its Vioxx® sales force of more than 3,000 representatives that ordered:

 

DO NOT INITIATE DISCUSSIONS ON THE FDA

 

ARTHRITIS ADVISORY COMMITTEE . . . OR THE

 

RESULTS OF THE . . . VIGOR STUDY.25

 

The Merck bulletin further advised that if a physician inquired about the VIGOR study, the sales representative should indicate that the study showed a gastrointestinal benefit and then say, “I cannot discuss the study with you.”25


Legal Murder      •  171

 

 

 

Merck further instructed its sales reps to show those doc-tors who asked whether Vioxx® caused myocardial infarction a pamphlet called “The Cardiovascular Card.” This pamphlet, prepared by Merck’s marketing department, indicated that Vioxx® was associated with 1/8 the mortality from cardio-vascular causes of that found with other anti-inflammatory drugs. The Cardiovascular Card, however, provided a mis-leading picture of the evidence on Vioxx®. The card did not include any data from the VIGOR study that showed a 500% increase in heart attack risk. Instead, it presented a pooled analysis of preapproval studies, in most of which low doses of Vioxx® were used for a short time. None of these studies were designed to assess cardiovascular safety, and none included a proper determination of cardiovascular events. In fact, FDA experts had publicly expressed “serious concerns” to the FDA’s advisory committee about using the preapproval stud-ies as evidence of Vioxx’s cardiovascular safety.

 

The cover-up of the lethal dangers of Vioxx® spanned a period of years, all the while tens of thousands of innocent victims worldwide perished needlessly. Merck continues to deny there is any safety problem with Vioxx®.

 

 

MERCK CONTROLS TIMING OF ANNOUNCEMENT OF GUILTY PLEA

 

Even for a company as huge as Merck, pleading guilty to criminal misdemeanors is embarrassing.. While the credi-bility of pharmaceutical companies has sunk to an all-time low, they still pretend to care about the public’s health.. Merck’s guilty plea was announced the day before Thanks-giving (2011), which is one of the busiest travel days of the year and a time when the fewest people are paying atten-tion to the news.. Talk about absolute power: Merck avoids felony charges, jail time for executives, and embarrass-ing publicity, all while keeping billions of surplus dollars

 

172   •  Pharmocracy II

 

 

on Vioxx® sales.. Jay Kimball, on the other hand, remains incarcerated and his family left indigent..

 

WE WARNED MEMBERS ABOUT DANGERS OF COX-2 INHIBITING DRUGS

 

While Merck was bombarding the public with television commercials claiming that one little pill a day of Vioxx® took away arthritis pain, Life Extension® warned its mem-bers about the lethal dangers of Vioxx® and other drugs that inhibit only the COX-2 enzyme.. We knew that Vioxx’s mechanism of action would result in sharply higher rates of coronary artery blockage and ischemic stroke.. So did scientists who evaluated Vioxx® before the FDA approved it.. Despite the criminal guilty plea, the $950 million set-tlement, and its withdrawal of Vioxx® worldwide, Merck still denies any wrongdoing on the part of its higher level executives or the company itself..

 

MORE GUILTY PLEAS BY BIG PHARMA

 

As we were finalizing this article, GlaxoSmithKline had reached the largest illegal drug settlement to date, agree-ing to pay $3 billion and plead guilty to criminal charges that included the drugs Avandia and Paxil.26 Avandia is a drug used to treat type II diabetes. Vascular disease is the leading cause of mortality in diabetic patients.27,28 In a study of 227,571 patients, those receiving Avandia were 27% more likely to suffer strokes, 25% more likely to develop heart failure, and 14% more likely to die compared to those taking another anti-diabetic drug called Actos.29,30 Avandia increased the very diseases that dia-betic patients are most vulnerable to—and Glaxo covered up

 

these deadly side effects!31

 

Paxil is a drug prescribed to treat depression. After years of cover-up, Glaxo sent a letter to physicians admitting that the risk of suicidal behavior was 6.7 times higher in study

 

Legal Murder      •  173

 

 

 

subjects taking Paxil compared to placebo. Suicide risk is high in depressed individuals, yet Glaxo covered up suicidal risks as it promoted the so-called “benefits” of Paxil in treat-ing depression.32 Glaxo’s guilty plea to criminal charges was announced two days before July 4, 2012, another busy travel time when few Americans are reading the news.

 

Two weeks after Glaxo’s record settlement, Johnson and Johnson agreed to pay $2.2 billion for its illegal marketing of the drug Risperdal to demented elderly patients.33 Risperdal is approved mainly to treat schizophrenia, but is associated with a number of deadly side effects including high blood sugar, irreg-ular pulse, and blood pressure irregularities.34 The most trou-bling side effect of Risperdal is impairment of judgment and thinking, which is the last thing a demented patient needs.34

 

In each of these cases, pharmaceutical companies were pro-moting drugs that worsened the diseases they were intend-ing to treat. We don’t yet know how their guilty pleas will be manipulated so they don’t lose out on lucrative Medicare/ Medicaid reimbursement.

 

 

References

 

  1. Available at: http://www..consumersunion..org/pub/core_ health_care/001651..html.. Accessed April 12, 2012..

 

  1. Available at: http://www..finance..senate..gov/imo/media/ doc/111804dgtest..pdf.. Accessed April 12, 2012..

 

  1. Available at: http://www..marshall-attorneys..com/Press/ 2004_11_01_WSJ..htm.. Accessed April 12, 2012..

 

  1. Horton R.. Vioxx, the implosion of Merck, and aftershocks at the FDA.. 2004 Dec 4–10;364(9450):1995–6..

 

  1. Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM.. Pooled analysis of rofecoxib placebo-controlled clinical trial data: lessons for postmarket pharmaceutical safety sur-veillance.. Arch Intern Med.. 2009 Nov 23;169(21):1976–85..

 

174   •  Pharmocracy II

 

 

  1. Available at: http://hcrenewal..blogspot..com/2011/12/merck-admits-little-while-settling..html.. Accessed January 18, 2012..

 

  1. Available at: http://wprsam..com/news/articles/2011/nov/22/ merck-to-pay-nearly-1-billion-to-settle-us-charges/.. Accessed April 12, 2012..

 

  1. Available at: http://www..examiner..com/health-in-los-angeles/ vioxx-settlement-hits-merck-for-950-million. . Accessed January 20, 2012..

 

  1. Available at: http://www..naturalnews..com/011401..html.. Accessed January 25, 2012..

 

  1. Available at: http://fl1..findlaw..com/news..findlaw..com/hdocs/ docs/vioxx/111804singh..pdf.. Accessed February 25, 2012..
  2. Available at: http://www..businessweek..com/news/2011-12-05/merck-to-plead-guilty-pay-950-million-in-u-s-vioxx-probe..html.. Accessed January 27, 2012..

 

  1. Available at: http://www..bloomberg..com/news/2011-11-22/ merck-agrees-to-pay-950-million-to-settle-u-s-government-s-vioxx-probe..html.. Accessed February 8, 2012..

 

  1. Available at: http://www..medscape..com/viewarticle/538025.. Accessed February 15, 2012..

 

  1. Available at: http://www..medicinenet..com/script/main/ art..asp?articlekey=46601.. Accessed February 15, 2012..

 

  1. Roumie CL, Mitchel EF Jr, Kaltenbach L, Arbogast PG, Gideon P, Griffin MR.. Nonaspirin NSAIDs, cyclooxygenase 2 inhibi-tors, and the risk for stroke.. Stroke.. 2008 Jul;39(7):2037–45..

 

  1. Roumie CL, Choma NN, Kaltenbach L, Mitchel EF Jr, Arbo-gast PG, Griffin MR.. Non-aspirin NSAIDs, cyclooxygenase-2 inhibitors and risk for cardiovascular events-stroke, acute myocardial infarction, and death from coronary heart dis-ease.. Pharmacoepidemiol Drug Saf. 2009 Nov;18(11):1053–63.

 

  1. Available at http://www..lef..org/magazine/mag2011/jun2011_ Obscene-Profits-Over-Human-Life_01..htm.. Accessed March 8, 2012..

 

Legal Murder      •  175

 

 

  1. Available at: http://www. .doj. .state. .wi. .us/absolutenm/ templates/template_share..aspx?articleid=837&zoneid=4.. Accessed April 12, 2012..

 

  1. Available at: http://www..medscape..com/viewarticle/538008.. Accessed February 22, 2012..

 

  1. A v a i l a b l e a t : h t t p : / / w w w . . h h.s . g o v / n e w s / press/2009pres/09/20090902a..html.. Accessed February 22, 2012..

 

  1. Available at: http://www..proliberty..com/observer/20001201.. htm.. Accessed April 12, 2012..

 

  1. Available at: http://www..cbsnews..com/stories/2008/04/15/ health/webmd/main4018030..shtml.. Accessed February 23, 2012..

 

  1. Available at: http://www. .bloomberg. .com/apps/news? pid=newsarchive&sid=a5z ..VogSbbXo&refer=home.. Accessed February 24, 2012..

 

  1. Bombardier C, Laine L, Reicin A, et al.. VIGOR Study Group.. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis.. VIGOR Study Group.. N Engl J Med.. 2000 Nov 23;343(21):1520–8, 2 p following 1528..

 

  1. Available at: http://www. .nejm. .org/doi/full/10. .1056/ NEJMp058136.. Accessed February 24, 2012..

 

  1. Available at: http://www..nytimes..com/2012/07/03/business/ glaxosmithkline-agrees-to-pay-3-billion-in-fraud-settlement.. html?_r=1&pagewanted=all.. Accessed July 25, 2012..

 

  1. Available at: http://www. .world-heart-federation. .org/ cardiovascular-health/cardiovascular-disease-risk-factors/ diabetes/.. Accessed July 25, 2012..

 

  1. Haffner SM, Lehto S, Rönnemaa T, Pyörälä K, Laakso M.. Mor-tality from coronary heart disease in subjects with type 2 dia-betes and in nondiabetic subjects with and without prior myo-cardial infarction.. N Engl J Med.. 1998 Jul 23;339(4):229–34..

 

176   •  Pharmocracy II

 

 

  1. Available at: http://www. .cbsnews. .com/2100-204_162-6627074..html.. Accessed July 25, 2012..

 

  1. Graham DJ, Ouellet-Hellstrom R, MaCurdy TE, et al.. Risk of acute myocardial infarction, stroke, heart failure, and death in elderly Medicare patients treated with rosiglitazone or pioglitazone.. JAMA.. 2010 Jul 28;304(4):411–8..

 

  1. Available at: http://www. .drugwatch. .com/2012/07/03/ glaxosmithkline-pays-3-billion-for-illegal-drug-marketing/.. Accessed July 25, 2012..

 

  1. Available at: http://us..gsk..com/docs-pdf/media-news/Paxil-CR-and-Paxil-Adult-Suicide..pdf.. Accessed July 25, 2012..

 

  1. Available at: http://abcnews..go..com/Business/wireStory/ report-jj-pay-22b-risperdal-settlement-16815635.. Accessed July 25, 2012..

 

  1. Available at: http://www..pdrhealth..com/drugs/risperdal.. Accessed July 25, 2012..

OCTOBER 2012

 

A Tragic Miscarriage of Justice: We Must Convince the President to Release Jay Kimball

 

 

 

 

 

Back in the year 2004, we dedicated an issue of Life Exten-sion Magazine® to the growing threat of wrongful pros-ecutions that were not based on real “crimes..” These prosecutions are instead instigated to serve private business interests, sometimes by pharmaceutical companies that pay “investigators” to find ways to destroy their small competi-tors.. With their enormous political influence, drug compa-nies use these private investigations to persuade the fed-eral government to arrest smaller competitors.. The result is that innovative companies offering superior medications at lower prices are destroyed.. Pharmaceutical companies financially flourish, while consumers and the healthcare system of the United States collapses under the weight of

 

this relentless corruption..

 

 

  • 177

 

178   •  Pharmocracy II

 

 

The most egregious example of prosecutorial misconduct occurred in 2000, when a man named Jay Kimball was sen-tenced to 13 years in jail for exporting a lower cost liquid deprenyl that may have been superior to the deprenyl tab-lets being sold for obscenely high prices in the US.. The com-pany making the deprenyl tablets launched a massive “pri-vate” investigation against Jay Kimball, and then turned their report over to the FDA and Justice Department.. Con-trary to the 100,000 Americans who die each year from Big Pharma’s fraudulently approved drugs, nothing in the pri-vate report suggested anyone was harmed by Jay’s prod-ucts.. Jay was nonetheless arrested on technical violations of pharmaceutical “export” laws and punished with such a draconian sentence that he may not leave prison alive..

 

DEPRENYL MAY BE AN ANTI-AGING DRUG

 

Deprenyl is a drug the FDA approved to treat early-stage Par-kinson’s disease.. It had long before been used throughout Europe.. Deprenyl enhances and prolongs the anti-Parkin-son effects of standard drugs like L-dopa.. Deprenyl has also demonstrated intriguing anti-aging properties..1–4 According to one study, rats treated with relatively low doses of depre-nyl lived up to 38% longer than the control group..1

 

In humans prior to age 45, dopamine levels remain fairly stable.. After that, dopamine in the human brain decreases by about 13% each decade.. When the dopamine content in the brain reaches about 30% of normal, Parkinson’s symp-toms may be present..5 When levels reach 10% of normal, death ensues..5 This has led to the hypothesis that if we live long enough, we will all develop Parkinson’s symptoms due to dopamine depletion in our brains..1

 

Monoamineoxidase B (MAO-B) is an enzyme in the brain that degrades neurotransmitters like dopamine.. As

 

A Tragic Miscarriage of Justice   •  179

 

 

humans age, MAO-B levels increase and degrade precious dopamine and other neurotransmitters.. Deprenyl is a selec-tive inhibitor of MAO-B..6 As little as 5 mg twice a week of deprenyl is all aging humans may need to maintain their dopamine at youthful levels..5 Not only may depre-nyl help prevent degenerative brain diseases, but it can also improve the quality of life, as evidenced by increased “mounting frequency” in old male rats treated with deprenyl compared to untreated controls..5,7–10 Dopamine is a primary “feel good” neurotransmitter that progres-sively depletes after age 45 in humans..5 Restoring dopa-mine levels using low-dose deprenyl (5 mg twice a week) may help aging humans regain some of their youthful sense of well-being..

 

JAY KIMBALL’S LIQUID DEPRENYL

 

Deprenyl is now a generic, but when the patent was in force, it sold for a lot of money.. Because of the inefficient regulatory environment that limits free-market competi-tion, generic deprenyl costs about the same now as when it was covered under a patent.. Jay Kimball had developed a purified liquid deprenyl that he claimed was superior to the outlandishly priced tablets the FDA had approved for Parkinson’s patients..11

 

Jay first started selling his liquid deprenyl over-the-coun-ter in the United States.. When the FDA ordered him to stop, he capitulated, as his small company lacked the resources to take on the FDA (and Big Pharma) in court.. Jay continued, however, to export his liquid deprenyl to other countries..12 You might ask, what is wrong with exporting medicines to other countries? It turns out that unless the FDA first approves the export, even sending a medication to other countries is “illegal..”

 

180   •  Pharmocracy II

 

 

PHARMACEUTICAL COMPANY DESTROYS JAY KIMBALL

 

The pharmaceutical company that sold deprenyl tablets became outraged when Americans who wanted Jay’s pur-portedly superior liquid deprenyl began ordering it from other countries.. That is when Jay got into big trouble.. The company making deprenyl tablets did not like the low-priced competition, so it ran to the FDA demanding that Jay Kimball be stopped.. The FDA did not move fast enough to suit the drug company, so it hired a private detective agency to conduct a criminal investigation independent of the government.. The private detectives did a superb job of documenting that Jay was indeed shipping depre-nyl to other countries.. This file was turned over to the FDA, which used the information supplied by the private investigators to raid Jay Kimball’s premises and eventu-ally indict him on numerous criminal counts.. There were no victims of Jay Kimball’s actions, just violations of FDA “export” regulations..

 

What happened after Jay was indicted is so unprec-edented that few attorneys believe the story until they read it.. Just from watching TV, most Americans are aware that defendants are entitled to an attorney and that if they cannot afford one, an attorney will be appointed and paid for by the government.. In fact, the government is often quite generous in providing a free attorney for violent street criminals.. If you murder someone, the gov-ernment will sometimes pay an expert criminal defense attorney huge fees so that the “incompetent counsel” argument cannot be used to overturn a death-penalty sentence.. Jay did not kill or injure anyone, but he was denied an attorney for his trial.. Jay’s problem was that he was not indigent, as are most street criminals.. Jay had some money to feed his wife and then 13-year-old

 

A Tragic Miscarriage of Justice   •  181

 

 

son and to provide housing for them.. The federal govern-ment demanded that Jay liquidate all of his assets to pay for an attorney, or else represent himself in court.. That would have meant that his wife and son would have to live on the street..

 

The federal prosecutors offered him a relatively lenient sentence if he pleaded guilty, but Jay defiantly stated that he had not harmed anyone and did not believe he did any-thing wrong.. Jay was told that if he did not plead guilty, he faced up to 3 years in prison if convicted.. Jay pleaded for an attorney, but since he was not flat broke, the gov-ernment would not pay for one.. Jay thus had to represent himself in court against the federal prosecutors, the FDA, and the drug company’s private detectives.. Having never practiced law, Jay did an abysmal job of defending himself and managed to get the judge to despise him in the pro-cess.. After the jury found Jay guilty, the judge sentenced him to an astounding 13 years in jail, citing Jay’s conduct in trial as a reason to add 10 years to what had been a maxi-mum three-year imprisonment..

 

HEALTH FREEDOM ACTIVISTS TRY TO HELP

 

When news spread that Jay Kimball was sentenced to 13 years in jail for FDA violations that had harmed no one, the health freedom community was outraged.. Jay was denied the basic right to have an attorney represent him, and then was sentenced to 10 years beyond the maximum sentence he was told he would face prior to trial.. Federal rules mandate that defendants be told their maximum prison sentence exposure in order to determine whether a guilty plea is appropriate.. While Jay had no legal resources to fight with during his trial, donations poured in after his conviction.. An appeal was filed seeking to overturn the

 

182   •  Pharmocracy II

 

 

10 additional years the judge had arbitrarily and unjustly imposed on him.. Despite the best efforts of one of the nation’s leading criminal defense firms, the appeal was denied (as most are nowadays)..

 

Jay made it clear to the judge that he was a political dis-sident and did not recognize the FDA’s authority over him.. Jay had become the embodiment of a “political prisoner..” As is the case in all police-state countries, this meant he would be sent to the harshest jails the Bureau of Prisons could find.. He endured filthy county jails in the beginning and then was sent to one of the worst jails (in Belle Glade, FL), where third-world-like squalor breeds infectious dis-eases among prisoners.. Jay contracted traumatic injuries at the hands of guards and infectious diseases that almost killed him.. Medical treatment was repeatedly denied..

 

When the government identifies a political dissident, the punishment often greatly exceeds that of a common street criminal.. After all, a dissident dares challenge the very authority of the government itself.. An example of this bar-baric behavior was Saddam Hussein, who jailed those who committed street crimes but summarily executed those sus-pected of questioning his absolute authority.. The same was true of Adolf Hitler’s death camps.. Eleven million people were murdered in the Nazi death camps.. Six million of those were Jews, with the remainder consisting of unpopular eth-nic groups, gypsies, homosexuals, those with physical or mental disabilities, and political dissidents..

 

Update (2106)

 

Jay Kimball was released from federal prison in June of 2015 after serving the entirety of his sentence.. During the time of his incarceration, both his wife and daughter died from breast cancer..

 

A Tragic Miscarriage of Justice   •  183

 

 

CHALLENGES WE HAVE CONFRONTED

 

It has taken us years to get to this point where we can effec-tively rally health freedom activists to petition the President of the United States to release Jay Kimball.. Jay has not made it easy as he has up till now refused to allow us to petition for commutation of sentence.. Jay instead relentlessly filed appeals showing in meticulous detail the wrongful nature of his conviction and the illegality of the 13-year sentence..

 

While imprisoned, Jay’s wife developed serious health problems.. Jay made a monumental mistake of escaping prison in an attempt to save his wife’s life.. After Jay devel-oped his own health problems and checked into a hospi-tal using his Medicare account number, he was re-arrested (but not prosecuted for escape).. His wife and daughter died afterwards from metastatic breast cancer.. His son has not been able to shake off the depression inflicted when his father was taken away at a young age (13 years)..

 

The carnage inflicted on Jay Kimball and his family by this miscarriage of justice defies words.. When I first wrote about the plight of Jay Kimball in 2004, some members wrote and assumed I was trying to liberate him because he was a “friend” of mine.. That is a categorically false assumption.. Jay Kimball has been victimized by an out-of-control criminal justice system to serve the finan-cial wishes of a pharmaceutical company.. I am not the kind of person who can sit back and watch the govern-ment horrifically trample an individual’s rights and do nothing about it..

 

184   •  Pharmocracy II

 

 

References

 

  1. Knoll J.. Antiaging compounds: (-)deprenyl (selegeline) and (-)1-(benzofuran-2-yl)-2-propylaminopentane, [(-)BPAP], a selective highly potent enhancer of the impulse propaga-tion mediated release of catecholamin.. CNS Drug Rev. 2001 Fall;7(3):317–45..

 

  1. Dalló J, Köles L.. Longevity treatment with (-)deprenyl in female rats: effect on copulatory activity and lifespan.. Acta Physiol Hung.. 1996;84(3):277–8..

 

  1. Kitani K, Kanai S, Carrillo MC, Ivy GO.. (-)Deprenyl increases the life span as well as activities of superoxide dismutase and catalase but not of glutathione peroxidase in selective brain regions in Fischer rats.. Ann N Y Acad Sci.. 1994 Jun 30;717:60–71..

 

  1. Freisleben HJ, Lehr F, Fuchs J.. Lifespan of immunosuppressed NMRI-mice is increased by deprenyl.. J Neural Transm Suppl.. 1994; 41:231–6..

 

  1. Knoll J.. (-)Deprenyl-medication: A strategy to modulate the age-related decline of the striatal dopaminergic system.. J Am Geriatr Soc. August 1992;40(8): 839–47..

 

  1. Magyar K, Knoll J.. Selective inhibition of the “B form” of monoamine oxidase. . Pol J Pharmacol Pharm. . 1977 May-Jun;29(3):233–46..

 

  1. Available at: http://www..lmreview..com/articles/view/ an-interview-with-joseph-knoll-md/.. Accessed February 8, 2012..

 

  1. Knoll J, Dallo J, Yen TT.. Striatal dopamine, sexual activity and lifespan.. Longevity of rats treated with (-)deprenyl.. Life 1989;45(6):525–31..

 

  1. Gelowitz DL, Richardson JS, Wishart TB, et al.. Chronic L-deprenyl or L-amphetamine: equal cognitive enhancement, unequal MAO inhibition.. Pharmacol Biochem Behav.. 1994 Jan;47(1):41–5..

 

A Tragic Miscarriage of Justice   •  185

 

 

  1. Brandeis R, Sapir M, Kapon Y, et al.. Improvement of cogni-tive function by MAO-B inhibitor L-deprenyl in aged rats.. 1: Pharmacol Biochem Behav.. 1991 Jun;39(2):297–304..

 

  1. Available at: http://proliberty..com/observer/20021102.. htm.. Accessed February 22, 2012..

 

  1. Available at: http://www..iahf..com/free_jay/20001127..html.. Accessed February 24, 2012..

Healthcare Crisis:

 

Can the System Survive?

 

 

Healthcare has become a major political and economic issue as medical costs have skyrocketed over the past sev-eral decades.. “Managed Care” has taken decisions away from doctors and placed them in the hands of insurance companies closely allied with government officials.. Private insurers reap profits while government-subsidized plans strain the already overburdened federal and state coffers.. Meanwhile, bureaucratic obstacles combine with over-regulated access to treatments with the ultimate result of increased suffering and preventable deaths.. What can consumers do? William Faloon points out some of the worst failures in the current system and urges citizens to reach out to their representatives in Congress and demand much-needed reform..

AUGUST 2014

 

Collapsing within Itself

 

 

 

 

 

Do you remember when your employer paid 100% of health insurance premiums for you and your fam-ily? This free health insurance was widely available

 

in the 1980s and usually covered every medical expense.. Back in those days, you did not read about healthcare costs bankrupting individuals, municipalities, corporations, and potentially the federal government.. In the 1980s, we at Life Extension® were a lone voice warning of economic tur-moil unless medicine was radically deregulated.. The govern-ment’s response to our free-market approach was multiple seizures of products and relentless attempts to jail us.. This was done at the behest of those in the mainstream who did not want their government-protected profit machine interfered with..

 

Move forward 30 years, and exorbitant healthcare costs dominate the financial news.. Politicians are desper-ately trying to figure a way out of a crisis their predeces-sors created.. You may wonder why no one has come up with a real-world solution.. Omitted from the debate are

 

 

  • 189

 

190   •  Pharmocracy II

 

 

the monopolistic pricing powers that regulations bestow to healthcare providers.. These regulations (restrictions) preclude innovative competitors from entering the mar-ket, while creating mounds of burdensome bureaucracy.. Consumers pay for these regulations in the form of high prices, shortages, long waits, side effects, and inferior care..

 

Inherent inefficiencies within the former Soviet Union led to it collapsing within itself.. These same ineptitudes exist with government-regulated medicine in the United States.. As we have exposed for 34 consecutive years, the cost of providing quality healthcare is a fraction of what is charged to individuals, insurance companies, and gov-ernment programs by industries protected by authoritar-ian edict.. Our solution is quite simple.. Tear down the reg-ulatory barriers that cause medical costs to be so grossly inflated, and what appears to be a permanent healthcare cost crisis will disappear into the history books..

 

The media does some accurate reporting about outland-ish medical prices, but the public quickly forgets the story.. So we did some searching to see how many articles expos-ing medical-related price gouging we could find.. The num-ber was astronomical.. When one looks at the magnitude of medical price gouging, and how widespread it is, the reason that healthcare is today’s leading political issue becomes brutally apparent.. The underlying causes of this financial catastrophe are antiquated regulatory barriers that impede the introduction of more cost-effective ways of delivering better medical care to consumers.. These senseless regula-tory barriers enable hyperinflated prices since those offer-ing superior medicine at lower prices are not allowed in.. What Life Extension® predicted in the 1980s is happening before your eyes.. Healthcare costs are spiraling beyond the affordability of the private and public sectors combined..

 

Collapsing within Itself    •  191

 

 

MARKUPS BEYOND COMPREHENSION

 

A woman named Jeanne Pinder experienced medical price gouging first hand and uncovered numbers that even startled me..1 What caused her to be curious was an anesthesia bill for $6,000 from one hospital that was three-times higher than the anesthesia bill from another hospital in the same time-frame.. She then questioned why an anti-nausea drug (ondan-setron) was billed by the hospital at $1,419.. Jeanne found that the price of ondansetron from a local drug supplier was only $2..49.. This indicated the hospital had marked up the price of this one drug by 569 times! Jeanne then did some meticulous research to find out what various insurance plans would pay for ondansetron.. For the same drug Jeanne was billed $1,419, the following insurance programs would pay:

 

Veterans Administration

$15.76

 

 

Michigan Blue Cross Blue Shield

$17.60

 

 

Medicare

$24.36

 

 

 

The hospital charged $1,419 for a drug that cost less than $3 to buy.. Jeanne’s investigation provides a real-world exam-ple of why healthcare costs have exploded beyond any real-world ability to afford..

 

Next time you’re told more money has to come out of your paycheck or pension to cover increased medical insurance premiums, or your private insurance rates go up, under-stand this is a facade designed to enrich the chosen few in the entrenched medical establishment.. It has no basis in economic reality..

 

NEW YORK TIMES EXPOSES EGREGIOUS MARKUPS


 

The New York Times published an article last year titled “How to Charge $546 for Six Liters of Saltwater..”2 This inves-tigative report looked at what the manufacturer’s price was

 

192   •  Pharmocracy II

 

 

for saline IV solution and what hospitals billed to patients or their insurance carrier.. It turned out that some of the patients’ bills included markups of 100 to 200 times over the manufacturer’s price, not counting separate charges for the administration of the IV solution..

 

How did the New York Times find out the saline cost? Man-ufacturers are required to report such prices annually to the federal government, which bases Medicare payments on the average national price plus 6%.. The limit Medicare would pay for one liter bag of normal saline was $1..07 last year.. Yet a bill from a New York hospital charged a private insur-ance company $91 for a bag of saline that cost the hospital just 86 cents.. What consumers forget is that private insur-ance companies hike insurance premiums based on these inflated drug charges..

 

CORRUPT LOBBYING CAUSES ASTHMA DRUG PRICE TO SOAR

 

When an off-patent asthma drug went back on-patent, its price soared from $15 to $100..3 The name of this old-line drug is albuterol, and it is one of the most common asthma medications used.. The way this off-patent asthma drug got back on-patent provides a startling look into the insidious lobbying schemes behind today’s inflated drug prices..3,4

 

In order for albuterol to be readily inhaled into the bron-chi, it requires a propellant.. The propellant in all albuterol drugs was CFC (chlorofluorocarbon).. CFC is the ozone-depleting agent that used to spew out of air conditioners, refrigerators, aerosol sprays, and many kinds of industrial equipment.. CFC was banned from virtually all uses, but it was still permitted to be used in the small amounts con-tained in drugs like asthma inhalers until late last year..5 Pharmaceutical companies that lost patents on medications

 

Collapsing within Itself    •  193

 

 

that used CFC wanted to regain a monopoly on this lucra-tive market.. So they went to the extreme length of contrib-uting $520,000 to a supposed environmental protection group to lobby the FDA to remove CFC from all drugs.. This consortium also aggressively developed patented combina-tions of albuterol and other inhalants with new propellants that won FDA approval..6

 

This nefarious lobbying effort paid off.. In 2005, the FDA approved an outright ban on many CFC-based inhalers starting in 2009..7 Subsequent bans took effect on other CFC drugs..7,8 Bear in mind that the consortium behind this lob-bying scheme consisted of the same companies selling CFC-propelled drugs.. They were effectively lobbying the FDA to ban their own drugs so they could monopolize the market with the new propellant versions they were patenting..6 CFC was the most effective medical propellant and according to some scientists, when compared to global CFC emissions, the tiny quantity used in inhalers posed no significant nega-tive impact on the ozone layer..6 The payoff for this deceptive lobbying campaign was a 6-fold increase in the price that could be charged for the new patented albuterol that was inferior to the previous CFC version in delivering the drug to suffocating asthmatics..8

 

Schemes like this to rip off consumers are not excep-tions.. They are customary business practices of compa-nies that routinely deceive the courts, Congress, and the FDA to deny generic competitors access to the market and stomp out the introduction of new medical products that could save lives and lower healthcare costs.. Do you see why there is no real healthcare cost crisis? There is instead a crooked marketplace dominated by lobbyists who use the government’s regulatory barriers to gouge the public with monopolistic prices..

 

194   •  Pharmocracy II

 

 

ANALOGIZING THIS TO GAS PRICES

 

Just imagine if Exxon® wanted to monopolize the gasoline market and patented a less-efficient way of refining crude oil into gasoline.. Then imagine Exxon® funds a fake environ-mental group to lobby the EPA (Environmental Protection Agency) to ban currently used refining methods.. Exxon® would then monopolize the market with its patented refin-ing method and be able to increase the retail price of gasoline from $3 a gallon to let’s say $18—the same 6-fold increase that occurred with albuterol.. This would force consumers to spend over $300 to fill their tank.. Since most people cannot afford a $300 gas tank fill, Exxon® would need to emulate pharmaceutical companies and persuade the government to use tax dollars to subsidize their artificially inflated prices.. This would force the government to set up a special web-site to determine which Americans were eligible for gasoline subsidies based on individual income levels..

 

Do you see what a mess this would create? There is no way that government could afford to subsidize these artifi-cially inflated gas prices, nor could companies do so for their employees or unions for their members.. Yet this is exactly what is happening with conventional medical costs.. Prices are being corruptly inflated, and all Congress does is bicker as to who is going to pay it.. The harsh fact is that no one can afford to keep paying for something that is corruptly priced far beyond its free-market value.. The fallout from this occurs before our eyes with the pending insolvencies of Medicare, Medicaid, municipal health plans, along with large swaths of the American economic landscape, including the post office..

 

THIS CATASTROPHE IS AVOIDABLE


 

Medical care is not a luxury.. It becomes a necessity when one falls ill.. Medical care is so essential that hundreds of

 

Collapsing within Itself    •  195

 

 

different state and federal government programs have been created to regulate and pay for it.. Yet many of these govern-ment programs encourage fraud and force inefficiencies.. The end result has become price gouging so severe that medical care has become unaffordable to society as a whole.. By way of example, the average annual cost per household for health-care is around $20,000..9 The average household, however, does not earn enough to part with $20,000, so no tax and redistribution system is ever going to work in the long run..

 

Common sense deregulation, on the other hand, would force vast improvements in healthcare while dramatically lowering costs.. Compare this to the electronic indus-try, which has seen exponential technological enhance-ments, but constantly plummeting prices.. If these kinds of advances had ever been translated to the medical arena, cures for virtually every degenerative disease would likely have already occurred..

 

FALLACY OF AFFORDABLE CARE ACT

 

Proponents of government-subsidized healthcare fail to realize the inflationary impact it has on healthcare prices..10–12 When the Medicare Modernization and Prescription Drug Act of 2003 was passed, it gave pharmaceutical companies free rein to charge the federal government full retail price on prescription drugs covered by the Act..13 It should be no surprise that the Medicare Modernization and Prescription Drug Act of 2003 was written and pushed into law by phar-maceutical lobbyists..

 

The Affordable Care Act passed in 2010 is deceptively named.. Premiums and co-pays for typical people are high, while annual deductibles are exorbitant..14–16 My private health insurance premium in 1982 was only $780 per year and paid full expenses for any hospital facility I chose in the

 

196   •  Pharmocracy II

 

 

United States.. My deductible was virtually non-existent.. The Affordable Care Act restricts where policy holders can get treatment, which can be a problem when a superior therapy is located outside one’s community hospital network.. Under the current so-called “Affordable” Care Act, young people today are paying around $3,000 a year in premiums for basic health insurance and are faced with annual deductibles of over $5,000!17,18 A significant percentage of the population does not have $5,000–$6,000 to cover their annual deduct-ible, meaning the government-mandated insurance premi-ums they pay are often of little real-world value..

 

The more accurately defined “Unaffordable Care Act” has spawned fierce debate.. When you see politicians attacking each other over how to best fund soaring sick-care costs, remember that there is no real-world solution as long as the government grants monopolistic pricing power to con-ventional medicine.. High medical prices would plummet in a deregulated environment, and the need for an “afford-able” care act might become obsolete..

 

WHAT YOU CAN DO

 

The public is slowly recognizing the disconnection between medical costs and the inflated prices consumers are forced to bear.. Media stories exposing over-priced healthcare are seen one day but often forgotten the next.. Politicians act oblivious to medical price gouging and can’t stop arguing about where the money should come from to fund bloated healthcare costs.. If Congress just investigated why Ameri-can medicine is so expensive, they might understand the need to remove archaic regulatory barriers that underlie the problem..

 

Three years ago, my book Pharmocracy was published for the purpose of exposing the flaws in the current regulatory

 

Collapsing within Itself    •  197

 

 

system that cause healthcare to be so overpriced.. I want to encourage members to not waver in this battle and to send a hard copy of Pharmocracy II to their Representative and/ or two Senators.. Rather than sit back and watch our nation financially flounder, contact your legislators and demand reform now..

 

References

 

  1. Available at: http://clearhealthcosts..com/blog/2010/11/ the-1481-drug-markup/.. Accessed March 10, 2014..

 

  1. Available at: http://www..nytimes..com/2013/08/27/health/ exploring-salines-secret-costs..html?_r=0.. Accessed March 10, 2014..

 

  1. Available at: http://www..nytimes..com/2013/10/13/us/the-soaring-cost-of-a-simple-breath..html.. Accessed March 10, 2014..

 

  1. Available at: http://www. .gpo. .gov/fdsys/pkg/CHRG-111hhrg50066/html/CHRG-111hhrg50066..htm.. Accessed March 10, 2014..

 

  1. Available at: http://www..fda..gov/newsevents/newsroom/ pressannouncements/ucm371901..htm.. Accessed March 11, 2014..

 

  1. Available at: http://www..motherjones..com/environment/ 2011/07/cost-increase-asthma-inhalers-expensive.. Accessed March 11, 2014..

 

  1. Available at: http://www..motherjones..com/kevin-drum/ 2013/10/heres-why-your-asthma-inhaler-costs-so-damn-much.. Accessed March 11, 2014..

 

  1. Available at: http://www..fda..gov/Drugs/ResourcesForYou/ Consumers/QuestionsAnswers/ucm077808..htm.. Accessed March 11, 2014..

 

  1. Available at http://www..money..cnn..com/2012/03/29/pf/ healthcare-costs/.. Accessed March 11, 2014..

 

198   •  Pharmocracy II

 

 

  1. Available at: http://bastiat. .mises. .org/2013/12/how-government-regulations-made-healthcare-so-expensive.. Accessed June 2, 2014..

 

  1. Available at: http://www..safehaven..com/article/32015/the-effect-of-the-affordable-care-act-on-medical-care-inflation.. Accessed June 2, 2014..

 

  1. Available at:http://www..galen..org/topics/ten-obamacare-predictions-for-2014/.. Accessed June 2, 2014..

 

  1. Available at: http://abcnews. .go. .com/Nightline/story? id=128998.. Accessed June 2, 2014..

 

  1. Available at: http://www..humanevents..com/2014/03/19/ obamacare-sticker-shock-get-ready-for-your-jacked-up-premiums-to-double-or-even-triple.. Accessed June 2, 2014..

 

  1. Available at: http://www..cbsnews..com/news/obamacare-deductibles-deliver-hefty-sticker-shock.. Accessed June 2, 2014..

 

  1. Available at: http://www. healthpocket.. com/healthcare.-research/infostat/2014-obamacare-deductible-out-of-pocket-costs.. Accessed June 2, 2014..

 

  1. Available at: http://www. healthpocket.. com/healthcare.-research/infostat/2014-obamacare-deductible-out-of-pocket-costs.. Accessed June 2, 2014..

 

  1. Available at: http://www..forbes..com/sites/jeffreydorfman/ 2013/10/31/the-high-costs-of-obamacare-hit-home-for-the-middle-class.. Accessed June 2, 2014..

 

  1. Available at: http://www..bloomberg..com/news/2013-11-15/ obamacare-deductibles-26-higher-make-cheap-rates-a-risk.. html.. Accessed June 2, 2014..

DECEMBER 2012

 

Former FDA

Commissioner Admits Risk

of Bureaucratic Delay

 

Ted Kennedy was diagnosed with a brain tumor in May

2008.. He received the best conventional treatment at Duke University Medical Center, which enabled him to survive until August 2009—a total of 15 months..

I’ll never forget being told when I was age 14 about a young girl who was dying of a brain tumor.. I asked a lot of igno-rant questions as to why doctors could not cure it, but no one had any logical answers.. That was back in 1968, yet a person stricken today with the most common brain tumor (glioblastoma multiforme) will only live a few miserable months longer than in the past..1 Over the years, the media has announced the discovery of promising cancer thera-pies, but most never make it to the clinical testing stage..

 

We at Life Extension® have been harshly critical of the FDA’s drug approval process, arguing that medical inno-vation has been suffocated by high costs and bureaucratic

 

 

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200   •  Pharmocracy II

 

 

uncertainties.. An increasing number of respected individ-uals are agreeing that delaying lifesaving therapies can no longer be tolerated, including former FDA Commissioner Andrew von Eschenbach.. Dr.. von Eschenbach is a former director of the National Cancer Institute and served as FDA Commissioner from 2005 to 2009.. He authored an editorial published in the Wall Street Journal that was critical of the FDA’s ability to evaluate and approve new life-saving thera-pies..2 The editorial opened by Dr.. von Eschenbach stating:

 

We stand on the cusp of a revolution in healthcare.. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer’s and cancer.. What’s missing .. .. .. is a modernized Food and Drug Administration that can rapidly and efficiently bring new discoveries to patients..2

 

Dr.. von Eschenbach cited current FDA Commissioner Margaret Hamburg’s concession before Congress that, “The FDA is relying on 20th century regulatory science to evaluate 21st century medical products..”3 The most com-pelling arguments Dr.. von Eschenbach made for mean-ingful reform were:

 

The FDA should approve drugs based on safety and leave efficacy testing for post-market studies.. Con-gress can ensure that the FDA serves as a bridge— not a barrier—to cutting-edge technologies..2

 

Said differently, once a potentially effective therapy has been cleared for safety, it should be made immediately avail-able to human beings who will otherwise suffer and die.. Brain tumor patients, for example, don’t have years to wait for FDA-mandated efficacy studies.. They need rapid access to new therapies that offer some hope of saving their lives..

 

Former FDA Commissioner Admits Risk of Bureaucratic Delay •  201

 

 

  1. VON ESCHENBACH DISCUSSES REGENERATIVE MEDICINE

 

Dr.. von Eschenbach wrote:

 

Breakthrough technologies deserve a breakthrough in the way the FDA evaluates them.. Take regener-ative medicine.. If a company can grow cells that repair the retina in a lab, patients who’ve been blinded by macular degeneration shouldn’t have to wait years while the FDA asks the company to complete laborious clinical trials proving efficacy.. Instead, after proof of concept and safety test-ing, the product could be approved for marketing with every eligible patient entered in a registry so the company and the FDA can establish effi-cacy through post-market studies..4

 

This common sense approach has been advocated by Life Extension® for more than 30 years.. It’s refreshing to see a former FDA Commissioner concur..

 

BRIDGING THE FDA’S “DEATH VALLEY”

 

Newly diagnosed cancer patients are usually given several treatment choices, all laden with guaranteed side effects with no promise of a cure or even a significant remission.. For most types of cancer, progress has been excruciatingly slow, even though there are more scientific studies being published about cancer now than at any time in human history.. The term “death valley” is increasingly being used to describe the gap that separates what is discovered in the scientific setting from what actually makes it into patients’ bodies.. The sad fact is there are so many bureau-cratic roadblocks that potentially effective therapies aren’t making it out of the laboratory setting.. The high costs of conducting human efficacy trials deny smaller companies

 

202   •  Pharmocracy II

 

 

equal opportunity to bring what may be superior medica-tions to market.. Dr.. von Eschenbach’s proposal to allow new therapies on the market as soon as safety is estab-lished would liberate many promising therapies currently trapped in the FDA’s oppressive quagmire..

 

WHO DOES NOT WANT FASTER APPROVAL?

 

There are those who financially benefit by maintaining the current system that requires enormous capital expendi-tures and many years of delay before new therapies are approved.. Large pharmaceutical companies enjoy a quasi-monopoly on the development of new drugs because vir-tually no one else can afford the gargantuan costs of FDA approval.. When small companies make a medical discov-ery, pharmaceutical giants often buy out the technology because smaller companies lack the resources to afford cur-rently mandated efficacy studies..

 

There’s also the issue of the enormous profitability on existing therapies.. Just look at the melanoma drug called Yervoy made by Bristol Myers Squib.. It costs $120,000 for this treatment that only extends survival in advanced mel-anoma patients an average of 108 days..5 It is in the eco-nomic interests of Bristol Myers Squib that no other mela-noma therapy be approved for the next 20 years so they can collect $120,000 from every melanoma patient who is not cured in the early stage.. Pharmaceutical giants stand to earn enormous profits as long as it costs so much to comply with FDA efficacy requirements that competition from superior therapies is stifled..

 

WHERE WE DON’T AGREE WITH DR. VON ESCHENBACH


 

There is a misconception in the mainstream that if the FDA were given more resources, that it could properly do its job..

 

Former FDA Commissioner Admits Risk of Bureaucratic Delay •  203

 

 

This fallacy was exposed in a report the FDA commissioned wherein it revealed that the FDA had systemic internal flaws that could not be corrected by the mere input of more money..6 While Dr.. von Eschenbach emphasizes the need to modernize the FDA “from the bottom up” to include a “comprehensive external review of the agency’s regulatory processes,”7 the track record of federal agencies improv-ing themselves is abysmal, especially with powerful spe-cial interests like pharmaceutical companies vehemently opposing any change..

 

WHY “EFFICACY” IS SOMETIMES MORE IMPORTANT THAN “SAFETY”

 

The public rightfully fears the risks posed by unsafe drugs, and we at Life Extension® have written many exposés on dangerous medicines the FDA should never have approved.. Yet the reality is that even the worst side-effect-prone drugs only affect a minority of patients.. When it comes to treating terminal diseases like Alzheimer’s and certain cancers, effi-cacy becomes paramount to safety because these patients will die unless an experimental therapy happens to work for them.. So restricting promising therapies to only those with proven safety will continue to condemn certain Americans to guaranteed death, which is why some patients need even earlier access to experimental treatments than what Dr.. von Eschenbach proposes..

 

THE FDA HAS LONG DELAYED LIFE-SAVING DRUGS

 

The current and former Commissioners of the FDA state that the FDA is incapable of approving 21st century tech-nologies in a timely fashion.. What they may not know is that the FDA delayed approval of life-saving therapies for much of the 20th century.. A chilling example is that of propranolol,

 

204   •  Pharmocracy II

 

 

a beta-blocker that saves the lives of tens of thousands of Americans each year.. Propranolol was used in Europe many years before the FDA approved it in the US..8,9 If you mul-tiply the number of lives that could have been saved each year if US patients had gained access to propranolol—times the multi-year delay—the total number exceeds 30,000 Americans who needlessly died because of the FDA’s delay in approving this ONE drug..9

 

The anti-diabetic drug metformin was approved in Eng-land in 1958, but the FDA did not get around to allowing it in the United States until 1994..10 Metformin is now the first-line treatment for early-stage diabetes..11–13 The num-ber of type II diabetics who perished needlessly because they did not have access to metformin is incalculable..

 

The anti-viral drug ribavirin was used throughout the world in the early 1980s, but FDA did not approve it for use in America until 1998..14–18 Ribavirin increases the efficacy of interferon in treating hepatitis C.. It is a broad-spectrum drug that can eradicate a wide range of lethal viruses, yet Americans died while ribavirin was sold over-the-counter in some countries..

 

Since the early 1960s, when Congress granted the agency authoritarian new powers, the FDA has functioned as a roadblock that denies Americans access to improved medi-cal therapies.. The timeline from when a drug demonstrates safety and the inordinate number of years it takes to gain regulatory approval speaks for itself..

 

LETHAL CONSEQUENCES OF DENIAL

 

Politicians are debating a lot of topics right now, but the most important problem facing Americans is not being discussed.. Once you or a loved one is diagnosed with a serious disease, all other issues become largely irrelevant.. Your only concern

 

Former FDA Commissioner Admits Risk of Bureaucratic Delay •  205

 

 

is whether there is a non-toxic cure available.. That’s why it’s imperative that free-market reforms are enacted that place the FDA in an advisory role that allows rapid medical prog-ress unimpeded by central government bureaucrats..

 

In response to Dr.. von Eschenbach’s editorial, a num-ber of doctors responded with complimentary letters, but emphasized that even more deregulation of FDA authori-tarian control is needed to bring about cures for today’s killer diseases..19 Some of these letters exposed how dys-function and unpredictability at the FDA is precluding vital early-stage scientific research..

 

The sad fact is that most of the American public remains in a state of denial about the lethal consequences of today’s antiquated regulatory structure.. This denial turns into harsh reality when one is diagnosed with an illness for which there is no current cure.. We at Life Extension® continue our relentless campaign to alert policy makers and the public about the urgent need to accelerate the introduction of new therapies.. This can only happen if the major roadblock (i..e.., the FDA) is relegated to an advisory role, away from its cur-rent dictatorial role.. Unlike any other issue, failure to affect meaningful FDA reform will result in millions of Americans needlessly suffering and dying every single year.. This is no longer just the opinion of health freedom fighters like me, but also the current and former Commissioners of the FDA!

 

AS THIS ARTICLE WAS GOING TO PRESS . . .

 

A White House advisory body on September 25, 2012, unveiled a plan to increase the number of new prescrip-tion drugs that go on the market each year by more quickly approving drugs to treat high-risk patients.. The President’s Council of Advisors on Science and Technology urged the FDA to expand its use of faster drug approvals to a wider

 

206   •  Pharmocracy II

 

 

range of diseases.. The council suggested the FDA could begin to approve drugs that may help only a narrow and high-risk patient population, such as people who are mor-bidly obese, under what the council called “special medical use” approvals.. While it is encouraging to see the White House agree with our long-standing position about the lethal consequences of drug delays, these kinds of changes are inadequate to address the cumbersome bureaucracy that impedes scientific discoveries from reaching the clinical setting where they are desperately needed by terminally ill humans..

 

References

 

  1. Henriksson R, Asklund T, Poulsen HS.. Impact of therapy on quality of life, neurocognitive function and their correlates in glioblastoma multiforme: a review.. J Neurooncol.. 2011 Sep;104(3):639–46.. Epub 2011 Apr 6..

 

  1. Available at: http://online..wsj..com/article/SB1000142405 2970203646004577215403399350874..html.. Accessed on July 16, 2012..

 

  1. Available at: http://www..fda..gov/downloads/AboutFDA/ Repor tsManualsForms/Repor ts/BudgetRepor ts/ UCM244196..pdf.. Accessed April 4, 2012..

 

  1. Available at: http://www..policymed..com/2012/04/former-fda-commissioner-calls-for-updated-systems-and-more-education-for-fda..html.. Accessed April 10, 2012..

 

  1. Available at: http://www. .nytimes. .com/2011/03/26/ business/26drug..html?_r=1.. Accessed April 10, 2012..

 

  1. Available at: http://www..fda..gov/ohrms/dockets/AC/07/ briefing/2007-4329b_02_01_FDA%20Report%20on%20 Science%20and%20Technology..pdf.. Accessed April 10, 2012..

 

  1. Available at: http://eyewiretoday..com/view..asp?20120214-wsj_the_fda_should_approve_drugs_based_on_safety_and_

 

Former FDA Commissioner Admits Risk of Bureaucratic Delay •  207

 

 

leave_efficacy_testing_for_post-market_studies.. Accessed July 16, 2012..

 

  1. Available at: http://www.fdareview.org/harm.shtml. Accessed April 12, 2012..

 

  1. Available at: http://www..isil..org/resources/lit/death-regulation.. html.. Accessed April 12, 2012..

 

  1. Available at: http://onlinelibrary..wiley..com/doi/10..1111/ j..1464-5491..2011..03469..x/pdf.. Accessed April 12, 2012..

 

  1. Bennett WL, Maruthur NM, Singh S, et al.. Comparative effec-tiveness and safety of medications for type 2 diabetes: an update including new drugs and 2-drug combinations.. Ann Intern Med.. 2011 May 3;154(9):602–13.. Epub 2011 Mar 14..

 

  1. Available at: http://care..diabetesjournals..org/content/32/ Supplement_1/S13..full.. Accessed April 13, 2012..

 

  1. Available at: http://www..ncbi..nlm..nih..gov/books/NBK55754/.. Accessed July 16, 2012..
  2. Knight V, McClung HW, Wilson SZ, Waters BK, Quarles JM, Cameron RW, Greggs SE, Zerwas JM, Couch RB.. Ribavirin small-particle aerosol treatment of influenza.. Lancet.. 1981 Oct 31;2(8253):945–9..

 

  1. Davis GL, Balart LA, Schiff ER, et al.. Treatment of chronic hepatitis C with recombinant interferon alfa.. A multicenter randomized, controlled trial.. Hepatitis Interventional Ther-apy Group.. N Engl J Med.. 1989 Nov 30;321(22):1501–6..

 

  1. Reichard O, Norkrans G, Frydén A, Braconier JH, Sönner-borg A, Weiland O.. Randomised, double-blind, placebo-con-trolled trial of interferon alpha-2b with and without ribavi-rin for chronic hepatitis C.. The Swedish Study Group.. Lancet.. 1998 Jan 10;351(9096):83–7..

 

  1. de Lédinghen V, Trimoulet P, Winnock M, et al; French Mul-ticenter Study Group.. Daily or three times per week inter-feron alpha-2b in combination with ribavirin or interferon alone for the treatment of patients with chronic hepatitis

 

208   •  Pharmocracy II

 

 

C not responding to previous interferon alone.. J Hepatol..

 

2002 Jun;36(6):819–26..

 

  1. Ali S, Nazir G, Khan SA, Iram S, Fatima F.. Comparative ther-apeutic response to pegylated interferon plus ribavirin ver-sus interferon alpha-2b in chronic hepatitis C patients.. J Ayub Med Coll Abbottabad.. 2010 Oct-Dec;22(4):127–30..

 

  1. Available at: http://online..wsj..com/article/SB10001424052 970204792404577229641193886650..html.. Accessed July 16, 2012..

OCTOBER 2011

 

How Regulation of Medicine Is Bankrupting the United States and What Congress Can Do to Stop It

 

 

 

EVEN COMPOUNDED TESTOSTERONE COSTS TOO MUCH

 

FDA regulations prohibit compounding pharmacies from making production-scale batches of popular drugs.. Each compounded drug must be individually formulated by a licensed pharmacist.. The result is that the labor involved in making a compounded drug comprises more than what the active ingredient costs.. But there are

 

additional regulations that add even greater costs.. Consumers require a prescription to buy compounded tes-

tosterone just like they do with FDA-approved testosterone.. While competent physician supervision can enhance the safety and efficacy of a testosterone replacement program, the frank reality is that the majority of prescriptions for drugs like AndroGel® are not prescribed by physicians who

 

 

  • 209

 

210   •  Pharmocracy II

 

 

understand how to optimally manage hormone replace-ment in men.. Seldom are estrogen levels monitored to pro-tect against estrogen overload that can occur when too much testosterone converts (aromatizes) into estrogen in an aging man’s body..41,42 An advantage with compounded testoster-one is that if a physician knows how to write a prescription for it, they often have received training on follow-up moni-toring.. Compounded testosterone cream can be obtained for less than $30 a month, compared to the $348/month price for AndroGel®.. Either form can contain the same amount of bioidentical testosterone.. Compounded testosterone cream is 91% less expensive than FDA-protected drugs, yet com-pounded testosterone is still twice as expensive as it needs to be because of governmental over-regulation..

 

In dealing with runaway healthcare costs, a solution is to make drugs like testosterone available to men over age 40 without the need of a doctor’s visit.. There have been compa-nies that have physicians review blood tests over the phone and prescribe testosterone, but FDA and state licensing boards have shut many of these down..43 Corrupt regulations ensure that efficiencies that would slash healthcare cost (at the expense of pharmaceutical profits) are outlawed..

 

SIMPLE SOLUTION TO AVERT ECONOMIC RUINATION

 

Life Extension® initiated a petition drive back in the 1980s to allow individual Americans to “opt-out” of the FDA’s reg-ulatory umbrella.. Our rationale was that this would pro-vide consumers with more advanced treatments at lower prices.. Hundreds of our enlightened members petitioned, requesting liberation from the FDA stranglehold.. The pub-lic, Congress, and media were apathetic at that time.. The FDA was far from lethargic.. They responded to our peti-tion in a way that resembled an angry hornet’s nest when

 

How Regulation of Medicine Is Bankrupting the United States   •  211

 

 

disturbed (or how some dictators respond to street protes-tors).. The notion that we dared challenge the FDA’s abso-lute authority resulted in years of legal battles in which the FDA did everything in its power to destroy us..44

Move forward to today, and the political climate has turned around.. The healthcare cost crisis we long ago predicted has evolved into a harsh reality no one can ignore.. It is mathe-matically impossible to solve it by forcing one group to pay regulated medicine’s inflated costs.. The only salvation is the free-market reforms we long ago drafted.. Our proposal is quite simple.. Amend the law to allow good manufactur-ing practice (GMP) certified facilities to produce generic prescription drugs that do not undergo the excessive reg-ulatory hurdles that force consumers to pay egregiously inflated prices.. To alert consumers when they are getting a generic whose manufacturing is not as heavily regulated as it is currently, the law would mandate that the label of these less-regulated generic drugs clearly states:

 

This is not an FDA-approved manufactured generic drug and may be ineffective and potentially dan-gerous.. This drug is NOT manufactured under the same standards required for an FDA-approved generic drug.. Purchase this drug at your own risk..

 

By allowing the sale of these less costly generics, con-sumers will have a choice as to what companies they choose to trust..

 

Equally important in our proposals is allowing consum-ers to be told about the off-label benefits of prescription drugs, such as the extensive body of evidence that met-formin may help prevent type 2 diabetes45,46 (and not just treat it) and that metformin may also prevent and help treat certain cancers..47–54


212   •  Pharmocracy II

 

 

  • concern critics raise regarding this free-market solu-tion is safety.. Who will protect consumers from poorly made generic drugs, they ask? First of all, there will be the same regulation of these drugs as there is with GMP-certified sup-plement makers.. FDA inspectors will visit facilities, take sam-ple products, and assay to ensure potency of active ingredi-ent and dissolution.. Laboratories that fail to make products that meet label claims would face civil and criminal penalties from the government.. Secondly, there is no incentive not to provide the full potency of active ingredient in these less regulated generic drugs.. The price of the active ingredients makes up such a small percentage of the overall cost that a manufacturer would be idiotic to scrimp on potency..55

 

Companies that foolishly make inferior generics will be viciously exposed by the media, along with the FDA, con-sumer protection groups, and even prescribing physicians, who will be suspicious if a drug is not working as it is sup-posed to.. Companies producing inferior products will be quickly driven from the marketplace as consumers who choose to purchase these lower-cost generics will seek out laboratories that have reputations for making flawless prod-ucts.. Substandard companies would not only be castigated in the public’s eye, but face civil litigation from customers who bought the defective generics.. When one considers that GMP-certified manufacturing plants can cost hundreds of millions to set up, a company would guarantee itself future insolvency if it failed to produce generic drugs that met minimum standards..

 

PHARMACEUTICAL COMPANY PROPAGANDA


 

No matter how many facts show that free-market generic drugs can be made safe, there are alarmists who believe that even if one person suffers a serious adverse event because

 

How Regulation of Medicine Is Bankrupting the United States   •  213

 

 

of a lower-cost generic drug, then the law should not be amended to allow the sale of these less regulated products.. What few understand is that enabling lower-cost drugs to be sold might reduce the number of poorly made drugs.. The reason is that prescription drug counterfeiting is a major issue today..56 Drugs are counterfeited because they are so expensive.. Yet in the free-market environment we espouse,

 

  • month’s supply of a popular cholesterol-lowering drug like simvastatin would sell for only $3. It is difficult to imag-ine anyone profiting by counterfeiting it.. So amending the law to enable these super low-cost drugs to be sold might reduce the counterfeiting that exists right now..

 

Another reason these less regulated generics will do far more good than harm is that people who need them to live will be able to afford them.. The media has reported on heart-wrenching stories of destitute people who are unable to pay for their prescription drugs.. They either do without or take a less-than-optimal dose.. The availability of these free-mar-ket generics will enable virtually anyone to be able to afford their medications..

 

Those who think generic drugs are safe today should be aware of isolated instances when improperly made active ingredients make it into prescription drugs sold in US phar-macies.. These defective ingredients often emanate from FDA-approved manufacturers in China and India.. The FDA gives false assurances that these government-approved laboratories are safe.. The reality is that the FDA can only inspect each Chinese drug-making factory at best only once every 13 years.57 So the protection consumers think they have today is a facade.. I would feel more comfortable buying generics from a company that had its own inspec-tors in offshore manufacturing facilities as opposed to relying on meaningless FDA rhetoric..

 

214   •  Pharmocracy II

 

 

AS THIS ARTICLE WAS BEING FINALIZED . . .

 

As this article was being finalized, news broke that the FDA had just granted an exclusive monopoly to a company to sell a non-patented progesterone drug that prevents premature births..58 Healthy women naturally secrete huge amounts of progesterone during pregnancy that helps maintain their uterine lining.. To protect against premature births and mis-carriages in women at risk, enlightened doctors have for decades prescribed progesterone medications that were made by state-licensed compounding pharmacies.. The cost per injection was around $20.. By granting orphan drug sta-tus to one company (KV Pharmaceutical), FDA rules banned all other forms of progesterone for this indication.. The immediate impact was that the cost per injection skyrock-eted to $1,500—or as much as $30,000 for a full-term preg-nancy..59 An uprising over this price gouging forced the FDA to back down and state it “does not intend to take enforce-ment action against pharmacies that compound hydroxy-progesterone caproate..”

 

What the FDA is saying is that while it has the discre-tion to arrest compounding pharmacists for making this drug, it does not “intend to” do so.. After the FDA made this announcement, KV Pharmaceutical reduced the price to $690 per injection—which is still more than 34 times its previous free-market price.. It is unclear how private insur-ance and Medicaid will determine whether to pay $690 per injection for the version FDA rules state is the only one that can be legally sold or continue paying for the much lower-cost compounded version..

 

Women who are denied access to this drug because of the regulatory quagmire face increased risks they will deliver pre-term babies.. In these cases, the costs for inten-sive neonatology care can run into the hundreds of thou-

 

How Regulation of Medicine Is Bankrupting the United States   •  215

 

 

sands of dollars per premature-born baby, a price often borne by Medicaid or private insurance.. No country on earth can afford this kind of institutionalized corruption, where the chosen few pharmaceutical companies favored by the FDA reap extortionist profits as the nation collapses into a financial abyss.. This rare instance in which public backlash forced the FDA to back away from protecting a pharmaceutical company’s obscene profit reveals that citi-zens have the power the save this country from financial Armageddon..

 

FIGHT BACK AGAINST THIS INSTITUTIONAL CORRUPTION

 

The United States of America faces a healthcare cost cri-sis that will render Medicare, Medicaid, and many private insurance plans insolvent.. The shocking details about this country’s inability to fund future medical costs are no lon-ger confined to the pages of Life Extension Magazine®. You are reading about them virtually every day in the main-stream media..60,61

 

When terrorists attacked the United States in 2001, there were patriotic Americans who enlisted in the armed ser-vices.. Many lost their limbs, their vision, and their lives.. No one has to engage in physical combat to save this country from the institutionalized inefficiencies and corruption that plague today’s disease-care system..

 

This book provides irrefutable logic to reform today’s broken healthcare system.. We believe if enough citizens send Pharmocracy II to Congress, that our leaders will be forced to recognize the obvious free-market solutions to today’s broken healthcare system.. To order copies of Phar-mocracy II today call 1-800-544-4440.


216   •  Pharmocracy II

 

 

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How Regulation of Medicine Is Bankrupting the United States   •  217

 

 

  1. Available at: http://www. .heritage. .org/research/reports/ 2005/10/the-economic-and-fiscal-effects-of-financing-medicares-unfunded-liabilities.. Accessed March 24, 2011..

 

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  1. Available at: http://www. .pcrm. .org/newsletter/aug10/ diabetes_drugs..html.. Accessed March 24, 2011..

 

  1. Ranpura V, Hapani S, Wu S.. Treatment-related mortality with bevacizumab in cancer patients: a meta-analysis. . JAMA.. 2011 Feb 2;305(5):487–94..

 

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  1. Available at: http://www..progressiveradionetwork..com/ health-headlines/2010/7/16/special-report-pharmaceutical-profit-big-government-and-bias..html.. Accessed March 24, 2011..

 

  1. Available at: http://www..anh-usa..org/access-to-estriol-2/.. Accessed March 24, 2011..

 

  1. Available at: http://iacprx. .convio. .net/site/DocServer/ Wyeth_Campaign_Fact_Sheet_0408..pdf?docID=3881&JSer vSessionIdr004=ibxg9a4i53..app214b.. Accessed July 15, 2011..

 

  1. Rossouw JE, Anderson GL, Prentice RL, et al. Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative random-ized controlled trial.. JAMA.. 2002 Jul 17;288(3):321–33..

 

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  1. Slatore CG, Chien JW, Au DH, Satia JA, White E.. Lung cancer and hormone replacement therapy: association in the vitamins and lifestyle study.. J Clin Oncol.. 2010 Mar 20;28(9):1540–6..

 

  1. Cushman M, Kuller LH, Prentice R, et al.. Estrogen plus pro-gestin and risk of venous thrombosis.. JAMA.. 2004 Oct 6;292(13):1573–80..

 

  1. Beral V.. Breast cancer and hormone-replacement therapy in the Million Women Study.. Lancet.. 2003 Aug 9;362(9382):419–27..
  2. Anderson GL, Judd HL, Kaunitz AM, et al.. Effects of estro-gen plus progestin on gynecologic cancers and associated diagnostic procedures: the Women’s Health Initiative ran-domized trial.. JAMA.. 2003 Oct 1;290(13):1739–48..

 

  1. Manson JE, Hsia J, Johnson KC, et al.. Estrogen plus pro-gestin and the risk of coronary heart disease.. N Engl J Med.. 2003 Aug 7;349(6):523–34..

 

  1. Shumaker SA, Legault C, Rapp SR, et al.. Estrogen plus proges-tin and the incidence of dementia and mild cognitive impair-ment in postmenopausal women: the Women’s Health Ini-tiative Memory Study: a randomized controlled trial.. JAMA.. 2003 May 28;289(20):2651–62..

 

  1. Chen CL, Weiss NS, Newcomb P, Barlow W, White E.. Hor-mone replacement therapy in relation to breast cancer.. JAMA.. 2002 Feb 13;287(6):734–41..

 

  1. Nakamura Y, Yogosawa S, Izutani Y, Watanabe H, Otsuji E, Sakai T.. A combination of indol-3-carbinol and genistein synergistically induces apoptosis in human colon cancer HT-29 cells by inhibiting Akt phosphorylation and progres-sion of autophagy.. Mol Cancer.. 2009 Nov 12;8:100..

 

  1. Katdare M, Osborne MP, Telang NT.. Inhibition of aberrant proliferation and induction of apoptosis in pre-neoplastic human mammary epithelial cells by natural phytochemi-cals.. Oncol Rep.. 1998 Mar-Apr; 5(2):311–5..

 

How Regulation of Medicine Is Bankrupting the United States   •  219

 

 

  1. Available at: http://www..appliedhealth..com/index..php? option=com_content&view=article&id=107071&Ite mid=205.. Accessed March 25, 2011..

 

  1. Available at: http://www..anh-usa..org/bioidentical-estriol-still-under-threat/.. Accessed March 25, 2011..

 

  1. Faloon W.. FDA seeks to ban pyridoxamine.. Life Extension Magazine®.. 2009 Jul;15(7):7–12..

 

  1. Available at: http://www..fda..gov/NewsEvents/Newsroom/ PressAnnouncements/2008/ucm116832. .htm. . Accessed March 25, 2011..

 

  1. Available at: http://articles. .mercola. .com/sites/articles/ archive/2011/03/22/betrayal-of-consumers-by-us-supreme-court-gives-total-liability-shield-to-big-pharma..aspx.. Accessed March 25, 2011..

 

  1. Available at: http://www. .pharmalot. .com/2007/04/60_ minutes_beats_up_big_pharma/.. Accessed March 25, 2011..

 

  1. Faloon W.. Startling low testosterone levels in male Life Extension members.. Life Extension Magazine®.. 2010 June; 16(6);7–12..

 

  1. Vermeulen A, Kaufman JM, Goemaere S, van Pottelberg I.. Estradiol in elderly men.. Aging Male.. 2002 Jun;5(2):98–102..

 

  1. Cohen PG.. Aromatase, adiposity, aging and disease.. The hypogonadal-metabolic-atherogenic-disease and aging con-nection.. Med Hypotheses.. 2001 Jun;56(6):702–8..

 

  1. Availableat:http://www.acpinternist .org/archives/1999/11/ epharm..htm.. Accessed March 25, 2011..

 

  1. Kent S.. Crime report: Victory over the FDA.. Life Extension Magazine®.. 1996 Sept..

 

  1. Zinman B, Harris SB, Neuman J, et al.. Low-dose combination therapy with rosiglitazone and metformin to prevent type 2 diabetes mellitus (CANOE trial): a double-blind randomised controlled study.. Lancet.. 2010 Jul 10;376(9735):103–11..

 

220   •  Pharmocracy II

 

 

  1. Charles MA, Eschwege E.. Prevention of type 2 diabetes: Role of Metformin.. Drugs.. 1999;58 Suppl..1:71–3; discus-sion 75–82..

 

  1. Libby G, Donnelly LA, Donnan PT, Alessi DR, Morris AD, Evans JM.. New users of metformin are at low risk of inci-dent cancer: a cohort study among people with type 2 diabe-tes.. Diabetes Care.. 2009 Sep;32(9):1620–5..

 

  1. Bodmer M, Meier C, Krahenbuhl S, Jick SS, Meier CR.. Long-term metformin use is associated with decreased risk of breast cancer.. Diabetes Care.. 2010 Jun;33(6):1304–8..

 

  1. Ben Sahra I, Laurent K, Giuliano S, et al.. Targeting cancer cell metabolism: the combination of metformin and 2-deox-yglucose induces p53-dependent apoptosis in prostate can-cer cells.. Cancer Res.. 2010 Mar 15;70(6):2465–75..

 

  1. Rattan R, Giri S, Hartmann L, Shridhar V.. Metformin atten-uates ovarian cancer cell growth in an AMP-kinase dispens-able manner.. J Cell Mol Med.. 2011 Jan;15(1):166–78..

 

  1. Wang LW, Li ZS, Zou DW, Jin ZD, Gao J, Xu GM.. Metformin induces apoptosis of pancreatic cancer cells.. World J Gastro-enterol.. 2008 Dec 21;14(47):7192–8..

 

  1. Memmott RM, Mercado JR, Maier CR, Kawabata S, Fox SD, Dennis PA.. Metformin prevents tobacco carcinogen-induced lung tumorigenesis.. Cancer Prev Res (Phila Pa).. 2010 Sep;3(9):1066–76..

 

  1. Algire C, Amrein L, Zakikhani M, Panasci L, Pollak M.. Met-formin blocks the stimulative effect of a high-energy diet on colon carcinoma growth in vivo and is associated with reduced expression of fatty acid synthase.. Endocr Relat Cancer.. 2010 Jun;17(2):351–60..

 

  1. Stanosz S.. An attempt at conservative treatment in selected cases of type I endometrial carcinoma (stage I a/G1) in young women.. Eur J Gynaecol Oncol.. 2009;30(4):365–9..
  2. Faloon W.. Consumer rape.. Life Extension Magazine®.. 2002 Apr..

 

How Regulation of Medicine Is Bankrupting the United States   •  221

 

 

  1. Available at: http://www..cmpi..org/in-the-news/in-the-news/ growing-problem-of-fake-drugs-hurting-patients-companies/.. Accessed March 25, 2011..

 

  1. Bate R.. Beware the Risks of Generic Drugs.. Wall Street Journal.. July 6, 2011..

 

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Cancer: Is the “Standard of Care” the Best Treatment? Be Informed!

 

 

Cancer rates have either stabilized or increased, depend-ing on the form of cancer, so that cancer is likely to become the leading cause of death in a few years.. “Treatment” of cancer has become a gargantuan industry unto itself with cancer centers and cancer wings a must-have component of major hospitals.. Billions of dollars are spent on can-cer research, but no “cure” has been found, and it appears that only treatment offering billions of dollars of poten-tial profit are welcome.. William Faloon explores the lim-itations of the current mainstream approach to cancer treatment and provides compelling evidence of some cut-ting-edge “unsanctioned” therapies that Life Extension Foundation® has pioneered.. Anyone facing a cancer diag-noses should have this valuable information..

OCTOBER 2014

 

Assembly Line Medicine

 

 

 

 

 

People fear cancer more than any other disease—and for good reason.. Upon diagnosis, a patient is often given several treatment choices.. None guarantees a cure, but all tend to inflict pain, immobility, mutilation, debilitation, risk of secondary complications (like stroke), and risk of secondary cancers (like leukemia).. Enlightened individuals face a particular degree of anxiety.. They’ve heard about less toxic treatments that may be more effec-tive.. They often worry they are missing out on a curative therapy because of constraints placed on physicians by today’s bureaucratic medical system that fosters ineffi-

 

ciency and mediocrity..

 

We at Life Extension® have long been aware of serious gaps that exist between what is discovered by cancer research-ers and what is delivered to patients in the clinical oncol-ogy setting.. When advanced cancer patients send us their medical records, we almost always identify treatment omis-sions that could have markedly improved odds of remission, improved survival, and even offered a cure.. One example is a drug called cimetidine.. It functions via several mecha-nisms to inhibit metastasis and improves survival in colon

 

 

  • 225

 

226   •  Pharmocracy II

 

 

cancer patients..1–8 In 2002, results from a clinical trial on patients with an aggressive form of colon cancer were pub-lished in the British Journal of Cancer.. Compared to controls, 10-year survival improved by a remarkable 2..7-fold in the group receiving cimetidine..4 Life Extension® has been rec-ommending cimetidine since 1985 for certain types of can-cer.. Not once have we had a cancer patient approach us who had been prescribed this nontoxic drug by their oncologist..

 

An oncologist is a physician who specializes in the diagno-sis, evaluation, and treatment of those afflicted with cancer.. Cancer patients rely on their oncologist to utilize the best therapies to meet their individual needs.. Regrettably, “man-aged care” has diluted the quality of care provided by many oncologists.. In a stunning new development, a health insur-ance company is offering oncologists $350/month for each patient that is put on the company’s recommended regimen..9 This will enable the insurance company to control treatment-related expenses of cancer patients, who will be afforded less individualized, creative, and comprehensive care..

 

Within 24 hours of you reading this article, 1,500 Ameri-cans will perish from cancer..10 There will be no sensational media accounts of these travesties, just more statistics to confirm the grim failure of mainstream medicine to find cures for this epidemic killer.. We at Life Extension® have never ignored the threat that cancer poses to healthy lon-gevity.. Yet many people today are in a state of denial, as if this insidious disease only afflicts others.. The news media redundantly covers details of traumatic deaths such as air-line crashes and terrorist attacks.. My reaction to these headline news stories is that the number of victims pales in comparison to the estimated 585,000 Americans that die from cancer every year..11 As I wrote in a 2004 article titled “Are You Afraid of Terrorists?” over 2..4 million Americans

 

Assembly Line Medicine •  227

 

 

die each year mostly from age-related disease.. Yet one ter-rorist attack dominates media coverage..12 So here we are 10 years later, and terrorists have killed less than 100 peo-ple in the United States.. The death toll from cancer in that same time period is around 5..8 million.. One could argue from a mathematical standpoint that violent death threats could be disregarded and resources instead poured into more efficient cancer research.. My personal views don’t directly relate to what you are about to read, but may help you understand how committed we are to eradicating can-cer in the same way that smallpox was last century..

 

THE BASICS ABOUT CANCER TREATMENT

 

There are some basic rules about cancer that everyone should know.. When it comes to achieving a “cure,” the best oppor-tunity exists at the time of first treatment.. Once tumor cells have been exposed to initial therapies, or one’s immune system has been compromised by surgical trauma, a malig-nancy can proliferate out of control and resist secondary therapeutic attempts..13–20 The best shot for a cure thus involves an individualized, multipronged plan of action to:

 

„ Eradicate the primary tumor;

 

„ Decrease fuels that feed metastatic growth;

 

„ Turn off stimuli that encourage cancer stem cell proliferation;

 

„ Block the escape routes used by residual cancer cells..

 

Some people erroneously believe they must try to eradi-cate their tumor immediately.. A more intelligent approach is to take the time needed to:

 

„ Ensure that the stage or extent of the tumor is within the boundaries of any ablative therapy (such as sur-gery or radiation);

 

228   •  Pharmocracy II

 

 

„ Investigate every mechanism an individual’s cancer will use to ensure its survival;

 

„ Then introduce agents into the treatment protocol to circumvent each of these tumor survival factors..

 

What I’m conveying here is that newly diagnosed cancer patients should take advantage of the relatively vulnera-ble nature of their “treatment-naïve” tumor to implement a plan that addresses a wide range of escape routes that tumor cells utilize upon exposure to radiation, chemother-apy, hormone blockade, and even surgery..21–25

 

IMMUNE STATUS SHOULD BE ASSESSED IN ALL CANCER PATIENTS

 

Once a tumor is established, it is difficult for the immune sys-tem to eradicate it.26–29 That’s why mainstream oncologists pay little attention to the immune status of their newly diagnosed patients.. In other words, since bolstering immune function alone won’t cure cancer, oncologists mistakenly think it is not of major importance.. Newly diagnosed patients often pres-ent with poor immune status even before immune-damaging chemotherapy, radiation, and/or surgery are initiated..30–33

 

Optimizing immune function prior to initiation of can-cer treatment can be a critical component of comprehen-sive therapy with curative intent..12,34–37 This involves in-depth immune profile blood testing and when indicated, precise administration of expensive drugs like interleu-kin2,12,38–46 filgrastim (Neupogen®),47,48pegfilgrastim (Neu-lasta®),49–58 and/or sargramostim (Leukine®)..59–62 Health insurance companies are trying to reduce the cost of cancer care and would rather patients not know about the need to optimize immune function before, during, and after toxic therapies are administered..63 The high cost of implement-ing comprehensive immune support is causing insurance companies to refuse to pay for it..

 

Assembly Line Medicine •  229

 

 

A large health insurance company is offering oncologists $350/month per patient as a reward to channel treatment toward the insurance company’s “recommended regimen..” We believe this will result in cancer patients dying sooner and using up fewer resources in the process..8 Oncologists fol-lowing these cookbook protocols will be able to squeeze far more patients into their hurried schedules.. Under this new scheme whereby oncologists are paid $350/month for each patient placed on the “recommended regimen,” insurance companies benefit financially, while patients are largely con-fined to chemo drug protocols that provide relatively mini-mal survival improvement in treating metastatic disease..

 

IMPACT OF SURGERY ON IMMUNE FUNCTION

 

The first line of defense against malignancy is our natural killer cells (NK).. Young individuals have high levels of func-tional natural killer immune cells, but this declines with aging..64–72 Natural killer cells originate in the bone mar-row (like other immune cells) and go through a maturation process that enables them to participate in early control of microbial infections and cancers..73–76 In a study examining NK cell activity in women shortly after surgery for breast cancer, it was reported that low levels of NK cell activ-ity were associated with an increased risk of death from breast cancer..77 In fact, reduced NK cell activity was a bet-ter predictor of survival than the actual stage of the cancer itself.. In another study, colon cancer patients with reduced NK cell activity before surgery had a 350% increased risk of metastasis during the following 31 months..78

 

The likelihood of surgery-induced metastasis requires a cancer patient’s immune system to be highly active and vigilant in seeking out and destroying renegade tumor cells immediately before, during, and after surgery.. Numerous

 

230   •  Pharmocracy II

 

 

studies document that cancer surgery results in substan-tial reduction in NK cell activity..79–82 In one investigation, NK cell activity in women having surgery for breast cancer was reduced by over 50% on the first day after surgery..81 A group of researchers stated that, “We therefore believe that shortly after surgery, even transitory immune dysfunction might permit neoplasms [cancer] to enter the next stage of development and eventually form sizable metastases.80

 

We know cancer surgery reduces NK activity.. This means that NK cell activity becomes impaired when it is most needed to fight metastasis.. With that said, the preopera-tive and perioperative periods present a window of oppor-tunity to actively strengthen immune function by enhanc-ing NK cell activity.. Fortunately, validated interventions to enhance NK cell activity are available to the person under-going cancer surgery.. While there are nutrients that can boost NK function, many cancer patients would benefit enormously with individualized courses of drugs like inter-leukin-2 (IL-2) and Leukine®.. IL-2 directly promotes NK function,83–85 while Leukine® induces bone marrow pro-duction of macrophages..86–88 Since these drugs are expen-sive, insurance companies will often refuse to pay for them as they are not approved by the FDA for the creative inter-ventions that published studies show may be effective..

 

HOW OFF-LABEL DRUGS SAVE LIVES

 

In the world of conventional oncology, FDA-approved drugs are routinely and legally prescribed for “unapproved uses” to better treat the disease..89,90 This is often referred to as using drugs“offlabel..” A 2008 study found that eight out of 10 oncologists surveyed had used drugs off-label..91 Studies have reported that about half of the chemotherapy drugs pre-scribed are for conditions not listed on the FDA-approved

 

Assembly Line Medicine •  231

 

 

drug label..92 The National Cancer Institute has stated, “Fre-quently the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs..”92 Off-label drug use in many cases is the genesis of innova-tion.. It enables oncologists to use their training and experi-ence to design creative therapeutic protocols based on new scientific findings.. When favorable results are found, the protocol may be published in medical journals so that other oncologists can emulate the treatment successes..

 

The problem for health insurance companies is that can-cer drugs are outlandishly priced, sometimes costing over $100,000 each per patient..93–95 Insurance companies don’t want to bear the costs associated with creatively designed treatments.. They want to limit their expenses by confining oncologists to chemo drugs that provide relatively little sur-vival improvement in advanced-stage cancers..63 This helps explain why one insurance company is offering oncologists $350/month per patient to not prescribe drugs beyond the insurance company’s “recommended regimen..”96 Other health insurance companies are doing it differently by reim-bursing oncologists less money when they prescribe newer, more expensive cancer drugs..97

 

NOT ALL OFF-LABEL DRUGS ARE EXPENSIVE

 

Some of the most effective off-label drugs are afford-able out-of-pocket (without insurance company involve-ment).. The problem occurs when oncologists are being paid ($350/month) to only offer an insurance company’s “recommended regimen..” This creates a disincentive to uti-lize Herculean initiatives to ensure their patients receive every therapy that could optimize outcomes with the goal of inducing a complete remission; in other words, the com-plete disappearance of all manifestations of the cancer..

 

232   •  Pharmocracy II

 

 

From our review of the scientific literature spanning decades, many cancer patients would benefit by taking aspirin98–100 and the antidiabetic drug metformin..101–115 Aspirin of course is readily accessible, but cancer patients are unlikely to use it if their oncologist does not recommend it.. Metformin requires a prescription, and if the insurance company catches the oncol-ogist prescribing metformin, which is not part of the “recom-mended regimen,” the oncologist might lose the $350/month stipend for that patient.. Even the use of aspirin requires the oncologist’s involvement as chemo patients whose platelet count is reduced to fewer than 100 x 10E3/uL are at risk for hemorrhage..116–119 Under these circumstances, aspirin should be deferred until platelet counts are restored..

There are numerous off-label drugs effective against cer-tain cancers (such as COX-2 inhibitors, certain statins, hor-mone modulators, etc..) that require a prescription, yet we are rapidly regressing to a system where medical decision-making is dictated by insurance company cost mandates and not physician dedication and experience..

 

HOW POSITIVE RESPONSES TO

 

CANCER THERAPY ARE DEFINED

 

  • Partial remission (PR) indicates 50% or greater reduction in all measureable evidence of tumor dimensions and tumor markers.

 

  • Complete remission (CR) indicates a disappearance of all measureable indicators of tumor activity.

 

  • Cure indicates complete disappearance of all manifestations of disease activity that is sustained over years and insures a high probability that the disease will not return.

 

Cancer patients can derive survival benefits when adju-vant therapies are combined with conventional treatments.

 

Assembly Line Medicine •  233

 

 

THE INSURANCE COMPANY’S “RECOMMENDED REGIMEN”

 

The chemotherapy drugs that insurance companies want oncologists to prescribe represent the most commonly used drugs in the industry and can be viewed as aggressive “cook-book medicine approach” treatments.. Some of drugs listed, such as Adriamycin®, are being limited by several oncolo-gists at major medical institutions, such as M.. D.. Anderson, for use in adjuvant settings due to excessive toxicity..121–123 Progressive oncologists, with whom Life Extension® is work-ing, are using mitoxantrone instead of Adriamycin® in their elderly patients since it has the same survival rate as Adria-mycin®, but is less toxic to the heart..124–126

 

Oncologists will be paid $350/month per patient by one insurer to prescribe chemo drugs such as Adriamycin®, which was approved by the FDA in 1974.. Another insurer is offering higher reimbursement to the oncologist when lower-cost chemo drugs are used.. All these chemo drugs are considered standard of care by the National Compre-hensive Cancer Network, which is an alliance of 25 cancer centers in the United States, most of which are designated by the National Cancer Institute as comprehensive can-cer centers.. Health insurance companies reward practicing oncologists for following the standard published protocols that minimize creative approaches for cancer treatment..

 

Perhaps the greatest failing of the chemo drugs that insurers are paying oncologists to prescribe is that they seldom cure advanced-stage cancers.. Despite widespread availability of these chemo drugs, metastatic lung can-cer kills 98% of patients within five years..127 Metastatic colon cancer kills 94% within five years..128 Those afflicted with metastatic breast cancer fare better, but 78% still die within five years..129


234   •  Pharmocracy II

 

 

Clinical oncology practice clearly needs more innova-tion—yet health insurance companies are providing finan-cial incentives for physicians to prescribe chemo drugs that fail to cure advanced-stage patients.. This kind of backwards approach to treatment will stifle the discovery of break-throughs so desperately needed to spare the lives of more than 585,000 Americans who perish from cancer annually.. I’m purposely leaving the names of the insurance compa-nies out of this article because it is likely that other insur-ers will follow this pattern of scientific regression.. What we are witnessing is clinical oncology practice being driven backward by outlandish drug prices, along with the high cost of increased physician involvement when aggressive therapies are utilized.. Health insurance companies argue their “recommended regimens” will improve patient care.. We at Life Extension® disagree and advocate that more (not fewer) individualized, creative, and comprehensive treatment approaches could spare numerous lives..

 

THE PROBLEM WITH CYTOTOXIC

 

(CHEMOTHERAPY) DRUGS

 

When chemotherapy drugs were developed in the 1950s to 1970s, there was optimism that a pharmaceutical cure for cancer might soon be found. These chemo drugs

 

killed cancer cells in the petri dish and shrank tumors in can-cer patients. The side effects, however, were horrific, and survival improvements were negligible for most solid malig-nancies. Medical oncologists are now being offered $350/ month per patient to prescribe chemo drugs that, in some cases, were introduced before many of you reading this article were born. There are drugs in the insurance compa-ny’s “recommended regimen” that are new and considered cutting-edge, but provide average survival improvements often measuring less than one year.

 

Assembly Line Medicine •  235

 

 

 

In the May 21, 2014 edition of the Journal of the American Med-ical Association, a study was published showing that lung can-cer patients survived 1.1 years longer when aggressive genomic testing was done and drugs that specifically target an individ-ual tumor are added to standard chemo regimens.120 These newer drugs target what’s known as “oncogenic drivers,” which are genetic abnormalities critical for tumor development and maintenance. The survival improvement in response to these “targeted” therapies is certainly welcomed news, but a far cry from a cure. The side effects from these newer cancer drugs are similar to old-line chemo drugs, meaning the patients endure significant suffering in exchange for added time.

 

Our scientific understanding of molecular oncology has grown exponentially over the past 40 to 50 years, yet rela-tively little of this knowledge is being delivered to the can-cer patient. Clinical oncology practice, in fact, has progressed so slowly that many old-line chemo drugs are still considered first-line therapy at cancer institutions today, despite their failures to produce cures in the majority of advanced cases.

 

The problem is that consumers with health insurance may not have a choice. If their oncologist follows the insur-ers “recommended regimen,” they will be prescribed chemo drugs that have historically provided relatively minimal sur-vival improvement. These patients might better benefit from creative therapies that health insurance companies now balk at paying for.

 

On the right side column is a list of chemotherapy drugs that one insurance company wants most of its insured customers restricted to, along with the dates of each drug’s approval and how many years each of these drugs has been in use. Some of these drugs were approved more than 60 years ago. That does not mean they are not still useful against certain malignancies. The invariable question is whether certain patients who would benefit from more comprehensive and creative approaches will instead be prescribed these “standard-of-care” drugs because

 

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of the financial incentives being offered to oncologists. To receive their $350/month stipend per patient, oncologists have to stay with the insurance company’s “recommended regimen” for that patient. This financial incentive comes to $4,200 a year per patient treated following the insurer’s protocol!

 

Drug Name

Approval Date

Years In Use

 

 

 

 

 

Leucovorin

June 20, 1952

62

 

 

 

 

 

 

November 16, 1959

 

 

Cyclophosphamide

(Manufacturing

 

 

changes in 1976,1977,

55

 

(Cytoxan®)

1979,1984, 1987, 2000

 

Cytoxan®(lyophilized)

 

 

 

equivalent

 

 

 

 

 

 

Fluorouracil (5-FU)

April 25, 1962

52

 

 

 

 

 

DoxorubicinHCL

 

 

 

injectable

August 7, 1974

39

 

(Adriamycin®)

 

 

 

 

 

 

 

Cisplatin (Platinol®)

December 19, 1978

35

 

 

 

 

 

Carboplatin

March 3, 1989

25

 

(Paraplatin®)

 

 

 

 

 

 

 

 

December 29, 1992

 

 

Paclitaxel (Taxol®)

(Manufacturing change

21

 

or addition 1993, 1994,

 

 

 

 

1997, 1998, 2001)

 

 

 

 

 

 

Vinorelbine

December 23, 1994

19

 

(Navelbine®)

 

 

 

 

 

 

 

Docetaxel (Taxotere®)

May 14,1996

18

 

 

 

 

 

Gemcitabine (Gemzar®)

May 15, 1996

18

 

 

 

 

 

Irinotecan

June 14, 1996

18

 

(Camptosar®)

 

 

 

 

 

 

 

Capecitabine (Xeloda®)

April 30, 1998

16

 

 

 

 

 

Trastuzumab

September 25, 1998

 

 

(Manufacturing change

15

 

(Herceptin®)

 

2012)

 

 

 

 

 

 

 

Assembly Line Medicine •  237

 

 

 

 

 

 

 

 

Drug Name

Approval Date

Years In Use

 

 

 

 

 

 

 

Epirubicin (Ellence®)

September 15, 1999

14

 

 

Oxaliplatin (Eloxatin®)

August 9, 2002

11

 

 

Pemetrexed (Alimta®)

February 4, 2004

10

 

 

Bevacizumab

February 26, 2004

10

 

 

(Avastin®)

 

 

 

 

 

 

Erlotinib (Tarceva®)

November 18, 2004

9

 

 

Panitumumab

September 27, 2006

7

 

 

(Vectibix®)

 

 

 

 

 

 

Lapatinib(Tykerb®)

March 13, 2007

7

 

 

Pertuzumab (Perjeta®)

June 8, 2012

2

 

 

Regorafenib (Stivarga®)

September 27, 2012

1

 

 

Ado-

 

 

 

 

trastuzumabemtansine

February 22, 2013

1

 

 

(Kadcyla®)

 

 

 

 

Afatinib (Gilotrif®)

July 12, 2013

1

 

 

Average age of

 

19

 

 

chemo drug

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

MOST EFFECTIVE BRAIN TUMOR DRUG NOT APPROVED TO TREAT ANY CANCER

 

Perhaps the most frightening malignancy one can be diag-nosed with is a form of brain cancer called glioblastoma.. This type of brain cancer has a dismal prognosis, with median overall survival of 12 to 14 months, and a two-year survival rate of 15 to 26%..131 Senator Ted Kennedy was diagnosed with glioblastoma in May 2008.. Despite intervention by some of the best brain tumor experts, Kennedy died in August 2009—a mere 15 months later.. A study published in the New England Journal of Medicine on September 5, 2013, may represent the most significant

 

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advance yet discovered in treating glioblastoma..131What follows is an overview of a drug that is not approved to treat any cancer, and thus is likely to be rejected by insur-ance company mandates:

 

„ Valganciclovir (Valcyte®) is an FDA-approved drug used to treat cytomegalovirus infection..

 

„ Cytomegalovirus has been suspected as facilitating the initiation and promotion of brain cancers..132–135 Some 50 to 80% of adults in the US show exposure to cytomegalovirus, but relatively few harbor active viral infection..135

 

„ Doctors followed 75 glioblastoma patients and found the median overall survival of those with low-grade cytomegalovirus infection was 33 months.. In patients with high-grade cytomegalovirus infection, median overall survival was 13 months..131

 

„ All but one of the 75 glioblastoma patients stud-ied had active cytomegalovirus infection, indicating that this virus may be involved in the development of this lethal malignancy.. 131

„ In glioblastoma patients with high-grade cytomegalo-virus infection, median two-year survival was 17..2%.. Patients with low-grade cytomegalovirus infection had median two-year survival rates of 63..6%..131 This suggests that high-grade, active cytomegalovirus infection accelerates tumor progression..

 

„ In a double-blind clinical trial of valganciclovir involv-ing 42 patients with glioblastoma, an exploratory analysis of 22 patients receiving at least six months of antiviral therapy showed 50% overall survival at two years compared with 20..6% of contemporary con-trols..131 This study showed that valganciclovir-treated patients had a median overall survival of 24..1 months

 

Assembly Line Medicine •  239

 

 

compared to 13..7 months in patients not treated with valganciclovir..

 

„ Owing to the promising results of this pilot study, physicians at the world-famous Karolinska Univer-sity Hospital administered valganciclovir to glioblas-toma patients, and results were then compared to a control group.. Both groups received standard con-ventional therapy and both groups had a similar dis-ease stage and surgical-resection grade..

 

„ The researchers retrospectively analyzed the data on 50 of these brain cancer patients and found the two-year rate of survival in the valganciclovir group was 62%, whereas two-year survival was only 18% in the control group..131

 

„ In 40 glioblastoma patients who received valganci-clovir for at least six months, the two-year survival rate was 70%, with a median overall survival of 30..1 months..131

 

„ In 25 glioblastoma patients who received continuous valganciclovir treatment after the first six months, the two-year survival rate was 90%, with a median overall survival of 56..4 months (4..7 years)!131

 

„ The current median survival of glioblastoma patients is only 12 to 14 months (1..0 to 1..16 years)..131 The efforts made to prolong Senator Kennedy’s life by the experts at Duke University Medical Center was

 

  • survival of 15 months (1..25 years)—3..45 years less than the median survival in the 25 glioblastoma patients who received continuous valganciclovir treatment as detailed above..

 

The implication from these findings is that treating active cytomegalovirus infection may dramatically reduce progression, and significantly increase survival time, in

 

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patients suffering from the deadly brain cancer glioblas-toma.. Most exciting is the intriguing data from this retro-spective study showing that in glioblastoma patients with active cytomegalovirus, a treatment protocol employing valganciclovir resulted in a median survival of 4..7 years! Not only does this retrospective data involving the contin-uous use of valganciclovir substantially extend survival in glioblastoma patients, but it also provides an opportunity to incorporate additional complementary therapies that could improve survival even more!

 

WHY BRAIN TUMOR PATIENTS ARE DENIED VALGANCICLOVIR

 

It is illegal for the maker of valganciclovir to promote it as a treatment for brain cancer.. The regulatory system in the United States requires that the maker of a drug conduct extensive clinical trials for each disease a drug claims to treat and then submit the trial results to the FDA for approval.. It is not illegal, however, for an oncolo-gist to prescribe valganciclovir to treat glioblastoma.. The problem is the annual cost for valganciclovir is around $50,000.. Many health insurers will refuse to pay this out-landish price.. If an oncologist tries to prescribe it for a patient it will not be one of the insurance company’s “rec-ommended regimens,” and the oncologists will likely lose his $350/month stipend because he or she did not adhere to the treatment protocols designated by the insurer.. We fear that 12,000 Americans will continue to die prema-turely from glioblastoma every year despite impressive findings showing that valganciclovir could extend the survival times of many of these patients diagnosed with this deadly disease..136


Assembly Line Medicine •  241

 

 

 

INDUSTRY ACTUARIES GUIDE

 

YOUR CANCER TREATMENT

 

The practice of medicine has largely devolved to a place where physicians no longer take the lead in guiding treat-ment. Consider a scenario that plays out day after day in modern cancer treatment. An experienced oncologist sees a Medicare patient suffering from an aggressive cancer. The oncologist realizes that there are several viable options, and that the best therapy is not the usual, cost-effective standard-of-care choice covered by Medicare. Rather, it’s a more expen-sive and newer option with compelling data that shows bet-ter results. However, the newer, more expensive treatment option—the one that’s best for the patient in the opinion of the treating oncologist—is not standard of care and there-

 

fore, is not covered under Medicare.

 

The result? The patient is treated with the Medicare-approved drug. In this case, the federal government’s actuaries at the Cen-ter for Medicare & Medicaid Services have been the guiding force in treatment of this patient, not the experienced oncologist.

 

 

CHANGING CANCER CARE FOR THE WORSE

 

What we are seeing before our eyes are physicians who will give up years of education, creativity, and understanding of the individual patient to instead be directed by an insurance company and rewarded with a monthly stipend of $350 if he or she follows the insurers financially biased “orders..” The term now used for physicians in such a context is “provider..” They provide the treatment, but are not involved in deciding what treatments to use.. Thus, the physician has given up his or her role as “Decider” to become the “Provider..”

 

The $350/month per patient could possibly be a signif-icant income for the oncologist.. Assume that oncologist has 400 active patients and that 100 of them are on the insurers “approved” chemo program.. That’s $35,000 per

 

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month or $420,000 per year.. In most major cities, that’s about what the average medical oncologist makes annu-ally.. If the oncologist surrenders his decision-making to the insurer, he is doing less work and has fewer worries regarding patient outcome since he was only “following orders..” The insurance company decided on the regimen.. Thus, the trade-off to surrender physician autonomy for a substantial monetary reward that involves less stress on the physician becomes an irresistible temptation for far too many highly educated and highly trained medical oncologists..

 

Another concern is what will the insurer decide regard-ing the use of supportive care therapy, such as antiemetic and immune protective treatment prior to chemo.. What will the insurer mandate regarding which imaging stud-ies can or cannot be done, what laboratory studies are to be obtained and how often, and which immune-augment-ing drugs are to be used? Where does the direction of care involving cost-cutting stop? In this newly perverse system brought about by outlandishly high medical prices, why bother using physicians to treat cancer patients? Given this form of cookbook medicine, costs could be further cut by using nurse practitioners or physician assistants to deliver standard care chemo drugs..

 

Insurers are changing how they pay for cancer care, aiming to blunt soaring costs and push oncologists to adhere to

 

standardized treatment guidelines.130

 

Wall Street Journal, May 27, 2014

 

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BLAME THE BROKEN SYSTEM . . . NOT JUST INSURANCE COMPANIES

 

A number of health insurance companies are looking into aggressive ways to cut the soaring costs of cancer drugs by seeking to reduce payments to oncologists if they pre-scribe pricier drugs.. Of the 12 new cancer drugs approved in 2012, 11 were priced above $100,000 a year! Over a hun-dred oncologists signed a protest letter that concluded that the prices of many of these drugs “are too high, unsustain-able, may compromise access of needy patients to highly effective therapy, and are harmful to the sustainability of our national healthcare systems..”137

 

Now we are seeing insurance companies rebel by offer-ing incentives to oncologists to prescribe chemo drugs they perceive as being less expensive.. Here is a quote from the insurance company’s oncology medical director:138

 

This program—while sharing best practices and evidence-based medicine—also helps to support oncologists who require large staffs to treat these complex patients and provides the practice with enhanced reimbursement to offset the lower fees they receive when prescribing less expensive drugs..

 

According to the IMS Institute for Healthcare Informat-ics, in 2013 the United States spent $37 billion on cancer drugs, which is more than any other category..139 Overall costs for treating cancer are well over $100 billion annu-ally and mounting steadily, according to researchers at the National Cancer Institute.. Hospital, diagnostic, and phar-maceutical prices are beyond exorbitant..

 

A patient under the guidance of the International Strategic Cancer Alliance (ISCA) was recently charged $2,500 for a bone density outpatient test at a prestigious university hospital..

 

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The going rate at a diagnostic testing center is around $250.. When ISCA responded by threatening to pay for an adver-tisement in the New York Times indicating this abuse by the university hospital, the hospital drastically reduced their price to this patient (but not to other cash-paying patients)..

 

Still another reason why medical costs are spiraling upward is large hospitals that are buying out individual oncology practices so higher “hospital” prices can be billed to Medi-care, Medicaid, and health insurance companies.. When chemo is administered in an oncologist’s private office, the cost is less than compared to a hospital setting.. Now hos-pitals are employing oncologists to make sure patients receive chemo in the hospital’s oncology outpatient facil-ity and billing insurance company’s higher prices, which means you will be paying higher health insurance premi-ums, along with higher co-pays and deductibles..

 

The financial coffers of insurance companies are being plundered by the excess charges of hospitals and outra-geously high drug prices.. Insurance companies are respond-ing by seeking to pay doctors to provide less costly treat-ments.. This is bad news for cancer victims.. It is important to point out that in many clinical oncology settings, the insur-ance company’s new “recommended regimens” may not be any worse than what patients are getting anyway.. Bureau-cracies have replaced the “special” physician, the one that comes up with creative approaches and who devours the liter-ature looking for clues to help save his or her patient.. Main-stream mediocrity has become the “standard of care” in too many instances, and the public apathetically accepts it until they or a loved one is stricken with cancer..

 

The major factor responsible for the decay and dysfunc-tion of sick-care in the US is the powerful pharmaceutical lobby, the health insurance industry, and the burdensome

 

Assembly Line Medicine •  245

 

 

legislation enacted by Congress that stifles innovation in the medical arena.. None of these revelations should sur-prise Life Extension® members, who long ago learned how regulatory strangleholds inflict harsh economic pain, along with needless suffering and death..

 

AGGRESSIVE APPROACHES

 

CAN CURE TERMINAL CANCER

 

In April of 2000, a patient came to us with advanced head and neck cancer with a primary location in the sinus and infiltration to the brain and orbital (eye) cavity. The tumor was the approximate size of a baseball and every oncologist consulted stated the patient had only months to live. Hos-pice was recommended as there was no conventional ther-apy that could treat this patient due to the complex anatomi-

 

cal locations of the tumor.

 

Just imagine the challenge of treating a tumor of this size growing inside someone’s head. The tumor’s location made it untreatable, according to every oncology expert. The only advantage we had is that no treatment had yet been adminis-tered, meaning the tumor was “treatment naïve,” and thus vul-nerable to eradication by multimodal therapies. Our dilemma was figuring out how to administer therapy to this delicate anatomical region of the body without blinding the patient and creating permanent brain damage. The hospital wanted to administer systemic cisplatin chemotherapy, which would have temporarily shrunk the tumor, but at the cost of horrific side effects and the mutation of the tumor to a virtually invul-nerable stage. We stopped the patient from getting the sys-temic cisplatin in the nick of time.

 

The scientific team at Life Extension® devised an unprec-edented protocol that involved inserting a catheter into the patient’s femoral artery. The catheter was directed into the aorta and from there threaded into the external carotid arter-ies. Using the catheter as a chemotherapy delivery system to

 

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the tumor, a relatively massive dose of cisplatin was initially used to target the tumor. It would have been impossible to deliver enough of this highly toxic chemo drug in any other way. Even by delivering cisplatin directly into the tumor, there were still some side effects (renal impairment) which were able to be reversed. Following initial direct-to-the-tumor cis-platin therapy, the chemo drug paclitaxel was administered via this same intra-arterial route for four additional weeks.

 

These intra-arterial chemotherapy sessions were immedi-ately followed by proton beamaccelerated radiation and the use of numerous drugs not approved to treat this cancer. For example, to enhance the tumor-killing effects of the proton beam-accelerated radiation, the radiation sensitizer 3-chloro-procainamide (3-CPA) was used. This had to be synthesized in our lab, as it was not commercially available to us. To further enhance the proton-beam therapy, the patient ingested 18 grams of arginine before treatment and breathed pure oxygen during treatment. The objective was to thoroughly oxygenate the patient in order to induce maximal tumor cell death during the proton-beam therapy.

 

It took until late June 2000 (the patient was diagnosed in April 2000) to initiate this complex therapy. By September 2000, there was no sign of active tumor. The patient was in complete remission, meaning there was no sign of tumor activity in the patient’s body. Oncologists at Loma Linda Medical Center were so impressed that they used this same protocol on another patient with advanced sinus cancer. We were informed that in this patient a complete remission was also attained.

 

Our client was prescribed a three-year follow up cyclical dosing of interferon alfa-2b and 13-cis retinoic acid to mop up any residual tumor cells that may have escaped the aggres-sive proton beam and intra-arterial chemo that was delivered over an eight-week time period. Within two years, our client developed radiation necrosis of the brain, which was caused by the high dose of proton beam radiation therapy. This is a

 

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common side effect when the brain is irradiated. Once again, conventional doctors pronounced our client “terminal,” since there was no recognized treatment to overcome the raging inflammatory fires destroying the brain.

 

The scientific team here at Life Extension® went back to work and identified two drugs (cabergoline and pentoxifylline), both not approved to treat radiation necrosis. The two-drug com-bination suppressed the radiation necrosis, and once again to the doctor’s amazement, this patient was cured of a side effect that had been pronounced terminal. Our client remains alive today, 14 years since the original “terminal” diagnosis was made. To make more of these kinds of lifesaving therapies avail-able, I helped set up the International Strategic Cancer Alliance (ISCA) to speed innovative cancer treatments to patients who are unable to be helped by conventional oncology.

 

 

WHAT WE ARE DOING TO SAVE LIVES

 

For over 30 years, we at Life Extension® have relentlessly combatted the high cost of medicine, along with conven-tional oncology’s less-than-optimal approach to cancer treatment.. We offer two services for members who develop cancer.. One is free phone/email access to our cancer advi-sors.. There is seldom a call where we can’t suggest vali-dated ways to improve survival, sometimes as simple as adding aspirin and metformin to conventional treatment.. To speak with a cancer advisor, call 1-866-864-3027..

 

The second option is concierge oversight provided by the International Strategic Cancer Alliance (ISCA).. This service has collectively lost us millions of dollars since its inception, but in the process has saved lives and added life-years.. The main cost when using the International Strate-gic Cancer Alliance has been the high hourly rates charged by top-notch oncologists and other personnel involved

 

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in developing personalized and creative treatment strat-egies.. New health insurance exclusions may also increase the patient’s out-of-pocket costs when utilizing ISCA’s Per-sonalized Treatment Protocols.. To reach out to the Inter-national Strategic Cancer Alliance, call 1-610-628-3419.

 

QUOTE FROM AYN RAND REGARDING DOCTORS

 

Ihave often wondered at the smugness with which people assert their right to enslave me, to control my work, to force my will, to violate my conscience, to stifle my mind, yet what is it that they expect to depend on, when they lie on an oper-ating table under my hands? Let them discover the kind of doctors that their system will now produce. Let them discover, in their operating rooms and hospital wards that it is not safe to place their lives in the hands of a man whose life they have throttled. It is not safe, if he is the sort of man who resents it—

 

and still less safe, if he is the sort who doesn’t.

 

Atlas Shrugged, Ayn Rand

 

 

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  1. Weide B, Eigentler TK, Pflugfelder A, et al.. Survival after intra-tumoral interleukin-2 treatment of 72 melanoma patients and response upon the first chemotherapy during follow-up. Cancer Immunol Immunother.. 2011 Apr;60(4):487–93..

 

  1. Slavin S, Ackerstein A, Or R, et al.. Immunotherapy in high-risk chemotherapy-resistant patients with metastatic solid tumors and hematological malignancies using inten-tionally mismatched donor lymphocytes activated with rIL-2: a phase I study.. Cancer Immunol Immunother.. 2010 Oct;59(10):1511–9..

 

  1. Vuoristo MS, Vihinen P, Skyttä T, Tyynelä K, Kellokumpu-Lehtinen P.. Carboplatin and vinorelbine combined with sub-cutaneous interleukin-2 in metastatic melanoma with poor prognosis.. Anticancer Res.. 2009 May;29(5):1755–9..

 

  1. Hallett WH, Ames E, Alvarez M, et al.. Combination ther-apy using IL-2 and anti-CD25 results in augmented natural killer cell-mediated antitumor responses.. Biol Blood Marrow Transplant.. 2008 Oct;14(10):1088–99..

 

  1. Lissoni P, Brivio F, Fumagalli L, Di Fede G, Brera G. . Enhancement of the efficacy of chemotherapy with oxali-platin plus 5-fluorouracil by pretreatment with IL-2 sub-cutaneous immunotherapy in metastatic colorectal cancer patients with lymphocytopenia prior to therapy.. In Vivo.. 2005 Nov-Dec;19(6):1077–80..

 

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  1. Quan WD Jr, Quan FM, Perez M, Johnson E. . Outpa-tient intravenous interleukin-2 with famotidine has activity in metastatic melanoma.. Cancer Biother Radiopharm.. 2012 Sep;27(7):442–5..

 

  1. Hanzly M, Aboumohamed A, Yarlagadda N, et al.. High-dose interleukin-2 therapy for metastatic renal cell carcinoma: a contemporary experience.. Urology.. 2014 May;83(5):1129–34..

 

  1. Schäfer H, Hübel K, Bohlen H, et al.. Perioperative treatment with filgrastim stimulates granulocyte function and reduces infectious complications after esophagectomy.. Ann Hema-tol.. 2000 Mar;79(3):143–51..

 

  1. Wenisch C, Werkgartner T, Sailer H, et al.. Effect of pre-operative prophylaxis with filgrastim in cancer neck dissec-tion.. Eur J Clin Invest.. 2000 May;30(5):460–6..

 

  1. Hill G, Barron R, Fust K, et al.. Primary vs secondary prophy-laxis with pegfilgrastim for the reduction of febrile neutro-penia risk in patients receiving chemotherapy for non-Hodg-kin’s lymphoma: cost-effectiveness analyses.. J Med Econ.. 2014 Jan;17(1):32–42..

 

  1. Tesařová P. . OPERa Study. . Klin Onkol (Czech). 2013 26(6):425–33..

 

  1. Naeim A, Henk HJ, Becker L, Chia V, Badre S, Li X, Deeter R.. Pegfilgrastim prophylaxis is associated with a lower risk of hospitalization of cancer patients than filgrastim prophy-laxis: a retrospective United States claims analysis of granu-locyte colony-stimulating factors (G-CSF).. BMC Cancer.. 2013 Jan 8;13:11..

 

  1. Hadji P, Kostev K, Schröder-Bernhardi D, Ziller V.. Cost com-parison of outpatient treatment with granulocyte colony-stimulating factors (G-CSF) in Germany.. Int J Clin Pharma-col Ther.. 2012 Apr;50(4):281–9..

 

  1. Hirsch BR, Lyman GH.. Pharmacoeconomics of the myeloid growth factors: a critical and systematic review.. Pharmacoeco-nomics.. 2012 Jun 1;30(6):497–511..

 

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  1. Aapro MS, Bohlius J, Cameron DA, et al.. European Organ-isation for Research and Treatment of Cancer.. 2010 update of EORTC guidelines for the use of granulocyte-colony stim-ulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lympho-proliferative disorders and solid tumours.. Eur J Cancer.. 2011 Jan;47(1):8–32..

 

  1. Bonanno G, Procoli A, Mariotti A, et al.. Effects of pegylated G-CSF on immune cell number and function in patients with gynecological malignancies.. J Transl Med.. 2010 Nov 9;8:114..

 

  1. Sehouli J, Goertz A, Steinle T, et al. . Pegfilgrastim vs filgrastim in primary prophylaxis of febrile neutropenia in patients with breast cancer after chemotherapy: a cost-effectiveness analysis for Germany.. Dtsch Med Wochenschr.. 2010 Mar;135(9):385–9..

 

  1. Lyman G, Lalla A, Barron R, Dubois RW.. Cost-effective-ness of pegfilgrastim versus 6-day filgrastim primary pro-phylaxis in patients with non-Hodgkin’s lymphoma receiv-ing CHOP-21 in United States.. Curr Med Res Opin.. 2009 Feb;25(2):401–11..

 

  1. Ramsey SD, Liu Z, Boer R, et al. . Cost-effectiveness of primary versus secondary prophylaxis with pegfilgrastim in women with early-stage breast cancer receiving chemother-apy.. Value Health.. 2009 Mar-Apr;12(2):217–25..

 

  1. Waller EK. . The role of sargramostim (rhGM-CSF) as immunotherapy.. Oncologist.. 2007 12 Suppl 2:22–6..

 

  1. Rini BI, Fong L, Weinberg V, Kavanaugh B, Small EJ. . Clinical and immunological characteristics of patients with serologic progression of prostate cancer achieving long-term disease control with granulocyte-macrophage colony-stimulating factor.. J Urol.. 2006 Jun;175(6):2087–91..

 

  1. Kurbacher CM, Kurbacher JA, Cramer EM, et al. . Con-tinuous low-dose GM-CSF as salvage therapy in refractory

 

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recurrent breast or female genital tract carcinoma.. Oncology (Williston Park). 2005 Apr;19(4 Suppl 2):23–6..

 

  1. Heaney ML, Toy EL, Vekeman F, et al. . Comparison of hospitalization risk and associated costs among patients receiving sargramostim, filgrastim, and pegfilgrastim for chemotherapy-induced neutropenia. . Cancer. . 2009 Oct 15;115(20):4839–48..

 

  1. Available at: http://www..kaiserhealthnews..org/stories/ 2014/june/17/insurers-push-against-cancer-treatment-cost..aspx.. Accessed June 28, 2014..

 

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  1. Ogata K, Yokose N, Tamura H, et al.. Natural killer cells in the late decades of human life.. Clin Immunol Immuno-pathol.. 1997 Sep;84(3):269–75..

 

  1. Kmiec Z, Myśliwska J, Rachón D, Kotlarz G, Sworczak K, Myśliwski A.. Natural killer activity and thyroid hormone levels in young and elderly persons. . Gerontology. . 2001 Sep-Oct;47(5):282–8..

 

  1. Vitale M, Zamai L, Neri LM, et al.. The impairment of natu-ral killer function in the healthy aged is due to a postbinding deficient mechanism.. Cell Immunol.. 1992 Nov;145(1):1–10..

 

  1. Di Lorenzo G, Balistreri CR, Candore G, et al.. Granulo-cyte and natural killer activity in the elderly.. Mech Ageing Dev.. 1999 Apr 1;108(1):25–38..

 

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  1. Dussault I, Miller SC.. Decline in natural killer cell-medi-ated immunosurveillance in aging mice-a consequence of reduced cell production and tumor binding capacity.. Mech Ageing Dev.. 1994 Aug;75(2):115–29..

 

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  1. Camous X, Pera A, Solana R, Larbi A.. NK cells in healthy aging and age-associated diseases.. BioMed Research Interna-tional.. 2012;2012:195956..

 

  1. Lutz CT, Quinn LS.. Sarcopenia, obesity, and natural killer cell immune senescence in aging: altered cytokine levels as a com-mon mechanism.. Aging (Albany NY).. 2012; 4(8):535–46..

 

  1. Wu J, Lanier LL.. Natural killer cells and cancer.. Adv Cancer Res.. 2003 90:127–56..

 

  1. Lodoen MB, Lanier LL.. Natural killer cells as an initial defense against pathogens. Curr Opin Immunol. 2006 Aug;18(4):391–8.
  2. Grégoire C, Chasson L, Luci C, et al.. The trafficking of natural killer cells.. Immunol Rev.. 2007 Dec;220:169–82..

 

  1. Vivier E, Tomasello E, Baratin M, Walzer T, Ugolini S. Functions of natural killer cells.. Nat Immunol.. 2008 May;9(5):503–10..
  2. Mccoy JL, Rucker R, Petros JA.. Cell-mediated immunity to tumor-associated antigens is a better predictor of survival in early stage breast cancer than stage, grade or lymph node status.. Breast Cancer Res Treat.. 2000 Apr;60(3):227–34..

 

  1. Koda K, Saito N, Takiguchi N, Oda K, Nunomura M, Naka-jima N.. Preoperative natural killer cell activity: correlation with distant metastases in curatively research colorectal car-cinomas.. Int Surg.. 1997 Apr-Jun;82(2):190–3..

 

  1. Da Costa ML, Redmond P, Bouchier-Hayes DJ.. The effect of laparotomy and laparoscopy on the establishment of sponta-neous tumor metastases.. Surgery.. 1998 Sep;124(3):516–25..

 

  1. Shakhar G, Ben-Eliyahu S.. Potential prophylactic measures against postoperative immunosuppression: could they reduce recurrence rates in oncological patients? Ann Surg Oncol.. 2003 Oct;10(8):972–92..

 

  1. McCulloch PG, MacIntyre A.. Effects of surgery on the gen-eration of lymphokine-activated killer cells in patients with breast cancer.. Br J Surg.. 1993 Aug;80(8):1005–7..

 

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  1. Rosenne E, Shakhar G, Melamed R, Schwartz Y, Erdreich-Epstein A, Ben-Eliyahu S.. Inducing a mode of NK-resistance to suppression by stress and surgery: a potential approach based on low dose of poly I-C to reduce postoperative cancer metastasis.. Brain Behav Immun.. 2007 May;21(4):395–408..

 

  1. Fehniger TA, Bluman EM, Porter MM, et al.. Potential mecha-nisms of human natural killer cell expansion in vivo during low-dose IL-2 therapy.. J Clin Invest.. 2000 Jul;106(1):117–24..

 

  1. Caligiuri MA, Zmuidzinas A, Manley TJ, Levine H, Smith KA, Ritz J.. Functional consequences of interleukin 2 recep-tor expression on resting human lymphocytes.. Identifica-tion of a novel natural killer cell subset with high affinity receptors.. J Exp Med.. 1990 May 1;171(5):1509–26..

 

  1. Orange JS, Roy-Ghanta S, Mace EM, et al.. IL-2 induces a WAVE2-dependent pathway for actin reorganization that enables WASp-independent human NK cell function.. J Clin Invest.. 2011 Apr;121(4):1535–48..

 

  1. Rowe JM, Andersen JW, Mazza JJ, et al.. A randomized placebo-controlled phase III study of granulocyte-macro-phage colony-stimulating factor in adult patients (> 55 to 70 years of age) with acute myelogenous leukemia: a study of the Eastern Cooperative Oncology Group (E1490).. Blood.. 1995 Jul 15;86(2):457–62..

 

  1. Buchsel PC, DeMeyer ES.. Dendritic cells: emerging roles in tumor immunotherapy. . Clin J Oncol Nurs. . 2006 Oct;10(5):629–40..

 

  1. Spitler LE.. Adjuvant therapy of melanoma.. Oncology (Wil-liston Park).. 2002 Jan;16(1 Suppl 1):40–8..

 

  1. Available at: http://www..manhattan-institute..org/html/ ib_15..htm#..U7BFr2dOXDc.. Accessed July 2, 2014..

 

  1. Available at: http://www..forbes..com/sites/dougbandow/ 2012/06/11/end-the-fda-drug-monopoly-let-patients-choose-their-medicines/3/.. Accessed July 2, 2014..

 

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  1. Peppercorn J, Burstein H, Miller FG, Winer E, Joffe S.. Self-reported practices and attitudes of US oncologists regarding off-protocol therapy.. J Clin Oncol.. 2008 Dec 20;26(36):5994–6000..

 

  1. Available at: http://www..cancer..org/treatment/treatments andsideeffects/treatmenttypes/chemotherapy/off-label-drug-use.. Accessed June 23, 2014..

 

  1. Availableat:http://www.nytimes .com/2012/10/15/opinion/ a-hospital-says-no-to-an-11000-a-month-cancer-drug.. html?_r=1&.. Accessed July 9, 2014..

 

  1. Available at: http://www..ajmc..com/publications/evidence-based-oncology/2012/2012-2-vol18-n5/breast-cancer-will-treatment-costs-outpace-effectiveness.. Accessed July 9, 2014..

 

  1. Available at: http://www..biomedcentral..com/content/ pdf/1472-6963-11-305..pdf.. Accessed July 9, 2014..

 

  1. Available at: http://www..beckershospitalreview..com/finance/ wellpoint-to-pay-monthly-bonuses-to-oncologists-who-comply-with-clinical-pathways..htm.. Accessed June 24, 2014..

 

  1. Available at: http://www..fiercepharma..com/story/cancer-drugs-beware-docs-get-monthly-paybacks-sticking-pre-ferred-meds/2014-05-28.. Accessed June 24, 2014..

 

  1. Chattopadhyay M, Kodela R, Kashfi K.. P09 Therapeutic potential of NOSH-aspirin, a dual nitric oxide-and hydro-gen sulfide-donating hybrid in colon cancer.. Nitric Oxide.. 2013 Sep 1;31 Suppl 2:S37–8..

 

  1. Fraser DM, Sullivan FM, Thompson AM, McCowan C.. Aspi-rin use and survival after the diagnosis of breast cancer: a population-based cohort study.. Br J Cancer.. 2014 Jun 19..

 

  1. Yue W, Yang CS, DiPaola RS, Tan XL.. Repurposing of met-formin and aspirin by targeting AMPK-mTOR and inflam-mation for pancreatic cancer prevention and treatment.. Cancer Prev Res (Phila).. 2014 Apr;7(4):388–97..

 

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  1. Ucbek A, Ozünal ZG, Uzun O, Gepdıremen A.. Effect of metformin on the human T98G glioblastoma multiforme cell line.. Exp Ther Med.. 2014 May;7(5):1285–90..

 

  1. Zhang ZJ, Bi Y, Li S, et al.. Reduced risk of lung cancer with metformin therapy in diabetic patients: a systematic review and meta-analysis.. Am J Epidemiol.. 2014 Jul 1;180(1):11–4..

 

  1. Wang Z, Lai ST, Xie L, et al.. Metformin is associated with reduced risk of pancreatic cancer in patients with type 2 diabetes mellitus: A systematic review and meta-analysis.. Diabetes Res Clin Pract.. 2014 Apr 18..

 

  1. Fasih A, Elbaz HA, Hüttemann M, Konski AA, Zielske SP.. Radiosensitization of Pancreatic Cancer Cells by Metformin through the AMPK Pathway.. Radiat Res.. 2014 Jul;182(1)50–9..

 

  1. Queiroz EA, Puukila S, Eichler R, et al.. Metformin Induces Apoptosis and Cell Cycle Arrest Mediated by Oxidative Stress, AMPK and FOXO3a in MCF-7 Breast Cancer Cells.. PLoS One.. 2014 May 23;9(5):e98207..

 

  1. Takahashi A, Kimura F, Yamanaka A, et al.. Metformin impairs growth of endometrial cancer cells via cell cycle arrest and concomitant autophagy and apoptosis.. Cancer Cell Int.. 2014 Jun 16;14:53..

 

  1. Joshua AM, Zannella VE, Downes MR, et al.. A pilot ‘window of opportunity’ neoadjuvant study of metformin in localised prostate cancer.. Prostate Cancer Prostatic Dis.. 2014 May 27..

 

  1. Preston MA, Riis AH, Ehrenstein V, et al.. Metformin Use and Prostate Cancer Risk.. Eur Urol.. 2014 May 21.. pii: S0302-2838(14)00408-4..

 

  1. Zhang T, Zhang L, Zhang T, et al.. Metformin Sensitizes Pros-tate Cancer Cells to Radiation Through EGFR/p-DNA-PKCS In Vitro and In Vivo.. Radiat Res.. 2014 Jun;181(6):641–9..

 

  1. Miyoshi H, Kato K, Iwama H, et al.. Effect of the anti-dia-betic drug metformin in hepatocellular carcinoma in vitro and in vivo.. Int J Oncol.. 2014 Jul;45(1):322–32..

 

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  1. Cho SW, Yi KH, Han SK, et al.. Therapeutic potential of metformin in papillary thyroid cancer in vitro and in vivo.. Mol Cell Endocrinol.. 2014 Jun 3;393(1–2):24–29..

 

  1. Yen YC, Lin C, Lin SW, Lin YS, Weng SF.. Effect of metfor-min on the incidence of head and neck cancer in diabetes.. Head Neck.. 2014 May 7..

 

  1. Sun XJ, Zhang P, Li HH, Jiang ZW, Jiang CC, Liu H.. Cispla-tin combined with metformin inhibits migration and inva-sion of human nasopharyngeal carcinoma cells by regulat-ing E-cadherin and MMP-9.. Asian Pac J Cancer Prev.. 2014 15(9):4019–23..

 

  1. Cerezo M, Tomic T, Ballotti R, Rocchi S.. Is it time to test biguanide metformin in the treatment of melanoma? Pig-ment Cell Melanoma Res.. 2014 May 24..

 

  1. Nenu I, Popescu T, Aldea MD, et al.. Metformin associated with photodynamic therapy-A novel oncological direction.. J Photochem Photobiol B.. 2014 May 21;138C:80–91..

 

  1. Kantarjian H, Giles F, List A, et al.. The incidence and impact of thrombocytopenia in myelodysplastic syndromes.. Can-cer.. 2007 May 1;109(9):1705–14..

 

  1. Quintás-Cardama A, Kantarjian H, Ravandi F, et al.. Bleed-ing diathesis in patients with chronic myelogenous leu-kemia receiving dasatinib therapy. . Cancer. . 2009 Jun 1;115(11):2482–90..

 

  1. Rickles FR, Falanga A, Montesinos P, Sanz MA, Brenner B, Barbui T.. Bleeding and thrombosis in acute leukemia: what does the future of therapy look like? Thromb Res.. 2007;120 Suppl 2:S99–106..

 

  1. Avvisati G, Tirindelli MC, Annibali O.. Thrombocytopenia and hemorrhagic risk in cancer patients.. Crit Rev Oncol Hematol.. 2003 Oct 15;48(Suppl):S13–6..

 

  1. Kris MG, Johnson BE, Berry LD, et al.. Using multiplexed assays of oncogenic drivers in lung cancers to select tar-geted drugs.. JAMA.. 2014 May 21;311(19):1998–2006..

 

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  1. Available at: http://www. .mdanderson. .org/newsroom/ news-releases/2012/key-discovered-to-how-chemotherapy-drug-causes-heart-failure..html.. Accessed July 12, 2014..

 

  1. Available at: http://www..ncbi..nlm..nih..gov/pmc/articles/ PMC2848530/.. Accessed July 12, 2014..

 

  1. Swain SM, Whaley FS, Ewer MS.. Congestive heart failure in patients treated with doxorubicin: a retrospective analy-sis of three trials.. Cancer.. 2003 Jun 1;97(11):2869–79..

 

  1. Delozier T, Vernhes JC.. Comparative study of adriamycin, epirubicin and mitoxantrone in cancer of the breast. Review of the literature.. Bull Cancer.. 1991 Nov;78(11):1013–25..

 

  1. Wiseman LR, Spencer CM.. Mitoxantrone.. A review of its pharmacology and clinical efficacy in the management of hormone-resistant advanced prostate cancer.. Drugs Aging.. 1997 Jun;10(6):473–85..

 

  1. Henderson IC, Allegra JC, Woodcock T, et al.. Randomized clinical trial comparing mitoxantrone with doxorubicin in previously treated patients with metastatic breast cancer.. J Clin Oncol.. 1989 May;7(5):560–71..

 

  1. Available at: http://www. .cancer. .org/cancer/lungcancer-smallcell/detailedguide/small-cell-lung-cancer-survival-rates.. Accessed July 3, 2014..

 

  1. Available at: http://www..cancer. .org/cancer/colonand rectumcancer/detailedguide/colorectal-cancer-survival-rates.. Accessed July 3, 2014..

 

  1. Available at: http://www..cancer..org/cancer/breastcancer/ detailedguide/breast-cancer-survival-by-stage.. Accessed July 3, 2014..

 

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  1. Soderberg-Naucler C, Rahbar A, Stragliotto G.. Survival in patients with glioblastoma receiving valganciclovir.. NEJM.. Sep 5 2013;369(10):985–6..

 

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  1. Dziurzynski K, Chang SM, Heimberger AB, et al.. Consen-sus on the role of human cytomegalovirus in glioblastoma.. Neuro Oncol.. 2012 Mar 14(3):246–55..

 

  1. Barami K. Oncomodulatory mechanisms of human cytomeg-alovirus in gliomas.. J Clin Neurosci.. 2010 July 17(7):819–23..
  2. Soroceanu L, Cobbs CS.. Is HCMV a tumor promoter? Virus Res.. 2011 May 157(2):193–203..

 

  1. Available at: http://www. .cdc. .gov/cmv/overview. .html. . Accessed June 26, 2014..

 

  1. Available at: http://www..webmd..com/cancer/brain-cancer/ news/20130904/antiviral-drug-may-extend-brain-cancer-survival-researchers-say.. Accessed June 26, 2014..

 

  1. Available at: http://www.lef.org/magazine/mag2014/apr2014_ Unsustainable-Cancer-Drug-Prices_01..htm.. Accessed June 30, 2014..

 

  1. Available at: http://ir..wellpoint..com/phoenix..zhtml?c= 130104&p=irol-newsArticle&ID=1934999&highlight.. Accessed June 30, 2014..

 

  1. Available at: http://www. .imshealth. .com/portal/site/ imshealth/menuitem..c76283e8bf81e98f53c753c71ad8c22a/ ?vgnextoid=19b381d71adc5410VgnVCM10000076192ca2R CRD&vgnextfmt=default.. Accessed June 30, 2014..

JULY 2014

 

Intolerable Delays!

 

The first surgical attempt to cure pancreatic cancer

was demonstrated in Germany in 1909..1

 

In 1935, a doctor named Allen Whipple devised a more effective way to remove the pancreas and adjacent body parts..2 Dr.. Whipple’s technique involves the removal of the head of the pancreas, along with portions of the stom-ach, small intestine, gall bladder, and common bile duct.. The surgical impact on the body is severe.. There is a higher death rate from this procedure than many other hospital operations..3 Sometimes the rearranged internal organs do not hold together and infection spreads inside the patient.. This leads to follow-up surgery where the remainder of the pancreas and the spleen are removed to correct problems caused by the first operation..4

 

Some patients do not heal well and leak pancreatic juice from where body parts are sewn together.. This happens so frequently that the surgeon leaves in drainage catheters for fluids to exit so they don’t accumulate inside the patient..4,5 Another complication is paralysis of the stomach that can

 

 

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take over a month to heal.. During this time, a feeding tube is surgically placed into the small intestine to provide nour-ishment..6 Some patients develop type I diabetes because the insulin-producing areas of their pancreas are removed, requiring life-long insulin injections..7 Despite these horrific surgical side effects, most patients who survive the painful hospital ordeal die from metastatic pancreatic cancer.. Few are cured..

 

The name of this surgery is the “Whipple Procedure.” While it’s been refined since Dr.. Whipple’s work in 1935, pancreatic cancer is still killing the vast majority of its victims—79 years later!8 The snail’s pace of progress against malignan-cies like pancreatic cancer should provoke societal outrage against the establishment.. Yet like lambs standing in line awaiting slaughter, the public tolerates mediocre medicine that is inflicting horrific suffering and massive numbers of needless deaths.. We view these bureaucratic lags as intolera-ble delays that will be ridiculed by future medical historians.. This article describes a drug long ago approved by the FDA that can improve outcomes in pancreatic and other cancer cases.. This treatment, however, is not being incorporated into conventional practice..

 

Steve Jobs was criticized for delaying a Whipple Proce-dure for nine months after being diagnosed with pancre-atic cancer..9 The initial approaches Jobs tried (acupuncture, vegan diet, herbs, spiritualists) had no chance of eradicating his primary pancreatic tumor.. It’s hard to blame the then 49-year-old co-founder of Apple, however, for not wanting his body cut up via a Whipple Procedure. Steve Jobs even-tually died at age 56 after undergoing multiple aggressive treatments, including a liver transplant..10–12

 

How many technologies developed in the early 1900s do consumers still use today? Even the stethoscope (invented

 

Intolerable Delays!           •  265

 

 

in 1819) remains state-of-the-art in today’s archaic world of medical practice.. If one is diagnosed with pancreatic cancer at a relatively early stage, the Whipple Procedure is still the best treatment option.. Overlooked are myriad adjuvant therapies that can markedly improve long-term survival and reduce the horrific complications inherent to the Whipple surgical procedure.. The cancer treatment I describe next is not new.. It has long been recommended to Life Extension® members..

 

INTERLEUKIN-2 VERSUS PLACEBO

IN PANCREATIC CANCER TREATMENT

 

The subcutaneous administering of 9 million international units a day of the drug interleukin-2 to pancreatic can-cer patients three days before surgery induced the following benefits compared to placebo patients administered saline:

 

 

Interleukin-2 Group

Control

 

 

 

 

 

Two-Year Survival

33%

10%

 

 

 

 

 

Three-Year Survival

22%

0%

 

 

 

 

 

Postoperative

33%

80%

 

Complications

 

 

 

 

 

 

 

 

This study should have made headline news. Instead it was buried in a 2006 edition of the journal Hepato-Gastroenter-ology.46 Life Extension® has been recommending moderate dose interleukin-2 as an adjuvant cancer treatment since the late 1990s.

 

Skeptics point to studies in advanced melanoma and renal cell carcinoma patients where interleukin-2 provides only modest survival improvements. These narrow-focused cyn-ics neglect evidence that interleukin-2 is most effective when administered before immune-suppressing surgery, radiation, and chemotherapy begins.33–37,47,48


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INTERLEUKIN-2 IMPROVES SURVIVAL 3-FOLD!

 

Interleukin-2 (IL-2) enhances overall immune function, most notably by enhancing natural killer cell activity..13–15 Natural killer cells are among the body’s most important immune defenses against malignant and viral-infected cells..16–20 (Cells infected with certain viruses are more prone to convert to malignant cells..)21 IL-2 was long ago approved to treat kid-ney cancer22–26 and metastatic melanoma..27–29 Its efficacy was likely limited by the advanced disease stage patients are at by the time IL-2 is administered..30 There is toxicity associ-ated with high-dose IL-2..31,32

 

Intriguing research suggests that administering moder-ate-dose IL-2 to patients before surgery and chemotherapy may improve survival and other outcomes..33–37 It does this by boosting immune function prior to it being impaired by conventional treatments.. Surgery results in significant immune impairment, something we warned against long before the mainstream considered it a factor in the poor survival rates seen in many types of cancer..38–43 Immune suppression that occurs during chemotherapy is a well-established treatment complication..44,45

 

In a study conducted on pancreatic cancer patients, half the group was administered moderate dose IL-2 for three consecutive days prior to a Whipple Procedure.. Two years after the operation, 33% of patients pre-administered IL-2 were alive compared to only 10% of control surgical patients.. Three-year survival was 22% in the IL-2 group compared to 0% of the controls..46

 

Surgical complications occurred in 80% of the control surgical patients compared with only 33% in the IL-2 pre-treatment group.. While the control group spent 19..5 days confined to the hospital after their Whipple Procedure, the IL-2 group escaped the hospital in 12 days..46


Intolerable Delays!           •  267

 

 

Life Extension® has been recommending moderate-dose IL-2 since the 1990s, yet the mainstream oncologists behave as if these drugs are limited to advanced cancers for which they originally gained FDA approval.. The reality is that IL-2 and other immune-boosting drugs may have far greater efficacy when administered early in the disease process against of a wide range of solid tumors and some types of leukemia..

 

WHY CANCER PATIENTS NEED TO BOOST NATURAL KILLER CELL ACTIVITY

 

Natural killer cells are the part of the immune system that is capable of recognizing and killing virus-infected and malignant cells, while sparing normal cells..49,50

 

The importance of killing virus-infected cells is that cells infected with human papilloma virus (HPV) and other viruses have greater propensity to mutate into cancer cells.. Chronic infection with some of these viruses also exhausts vital immune functions..51

 

In mice deficient in natural killer cells, tumors grow more aggressively and are more metastatic..52–54

 

Natural killer cells play an important role in the control of tumor growth..55

 

Infusion of immune enhancers like interleukin-2 boosts natural killer cell activity, which can lead to the death of tumor cells..56

 

Leukemia patients have benefited using natural killer cells obtained from hematopoietic stem cell donors, which is an exciting area of cancer research..57–59

 

Non-drug ways of boosting natural killer cell activity include garlic,60–64 melatonin, 65–67 Reishi extract,68–71 and other supplements used by Life Extension® members.. When treating cancer, however, interleukin-2 should be considered

 

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to provide an exponential improvement in natural killer cell activity prior to initiation of conventional treatments..

 

CONTRAST MEDIOCRE CANCER TREATMENT TO HIV

 

Cancer is not relegated to modern times.. It has killed human beings forever, but has become prominent as people live longer and cancer incidence markedly increases.. Pancre-atic cancer, for instance, increases sharply in individuals over age 50, and most patients are 60 to 80 years old when diagnosed..72

 

HIV rose to prominence in the early 1980s, though the virus existed in the human population before then.. The problem was that no one paid attention until thousands started dying..

 

Within 15 years of HIV infection becoming pandemic, effective anti-viral “cocktails” were discovered that turned AIDS from a death sentence into a manageable chronic disease..73–75

 

In 1981, AIDS was a disease of unknown origin..76 It is controllable today because of rapid scientific innovation.. Pancreatic cancer, on the other hand, still kills virtually all its victims with the best hope for long-term survival being the Whipple Procedure first refined in 1935..8

 

So why were AIDS treatments discovered so quickly while effective cancer therapies languish?

 

The difference was the aggressive way that experimen-tal multi-modal therapies were implemented in HIV/AIDS patients compared to the suffocating bureaucracy that sty-mies cancer research..

 

In the early days of AIDS treatment, any therapy that might work was tried immediately on dying patients and the results evaluated and documented.. These treatments were often administered by those infected with HIV who

 

Intolerable Delays!           •  269

 

 

faced pending death if a cure were not discovered quickly.. The FDA was cast by the wayside as AIDS activists made certain that potentially effective treatments were not obstructed by bureaucratic red tape..77

 

We at Life Extension® are proud of the part we played in saving the lives of AIDS patients by defying FDA attempts to shut us down.. An editorial published late last year in the New England Journal of Medicine revealed how HIV revolutionized the way global health is pursued, and how it resulted in accelerated delivery of innovative life-saving treatments..78

 

NEW ENGLAND JOURNAL OF MEDICINE PRAISES WORK OF EARLY AIDS ACTIVISTS

 

Allan Brandt, PhD, is a professor of medical history at Har-vard Medical School.. Dr.. Brandt’s perspective, titled “How AIDS Invented Global Health,” was published in the June 6, 2013 edition of the New England Journal of Medicine..79 Here are some quotes from his perspective:

 

„ “AIDS has reshaped conventional wisdoms in public health, research practice, cultural atti-tudes, and social behaviors..”

 

„ “The rapid development of effective antiret-roviral treatments, in turn, could not have occurred without new forms of disease advo-cacy and activism..”

 

„ “But AIDS activists explicitly crossed a vast chasm of expertise.. They went to FDA meet-ings and events steeped in often arcane sci-ence of HIV, prepared to offer concrete pro-posals to speed research, reformulate trials, and accelerate regulatory processes..”

 

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„ “This approach went well beyond the tradi-tional bioethical formulations of autonomy and consent.. As many clinicians and scientists acknowledged, AIDS activists, including many people with AIDS, served as collaborators and colleagues rather than constituents and sub-jects, changing the trajectory of research and treatment..”

 

Omitted from Dr.. Brandt’s complimentary statements were the harassment, persecution, and incarceration of AIDS activists by government agencies that sought to suppress burgeoning development of AIDS therapies..80,81

 

WE WERE JAILED!

 

The FDA did not like our aggressive stance when it came to accelerating medical research, particularly as it related to helping AIDS victims.. The FDA did everything in its power to shut Life Extension® down and imprison us for life..82 According to the FDA, we were ripping off dying AIDS patients by recommending unproven therapies..

 

The Journal of the American Medical Association (Novem-ber 27, 2013) featured an article describing a 54% reduc-tion in the risk of progressing from HIV to full-blown AIDS using selenium and multi-vitamins..83 Life Extension® first recommended these nutrients in the October 1985 edition of this publication (called at that time Anti-Aging News).. While the study published in the Journal of the American Medical Association was conducted in a region of Africa where malnutrition is rampant, and the study had other flaws (like a 25% dropout rate in both groups), the delay in HIV-induced immune suppression in patients taking these nutrients was remarkable.. A number of previous studies support the benefits of certain nutrients in delaying HIV

 

Intolerable Delays!           •  271

 

 

progression79,84–86 Even FDA Consumer Magazine eventu-ally acknowledged the value of AIDS patients using nutri-ent supplements..

 

We also recommended a drug called isoprinosine to AIDS patients in the October 1985 issue of Anti-Aging News.. This contributed to our being arrested by the FDA because iso-prinosine was not an approved drug.. In the June 21, 1990 edition of the New England Journal of Medicine, a study found that HIV-infected humans who took isoprinosine were eight times less likely to progress to AIDS compared to placebo..87 This was not enough, however, to keep us from being indicted in 1991.. What helped save us was the con-tinuing publication of research findings corroborating that isoprinosine and certain nutrients significantly delayed dis-ease progression in HIV-infected patients, thus negating the FDA’s argument that we were “ripping off AIDS patients” by recommending “unproven” therapies..

 

The FDA was on the wrong side when it sought to destroy us in the 1980s–1990s.. Regrettably, millions of Americans continue to perish from needless bureaucratic red tape from virtually all diseases except AIDS.. The reason AIDS is the exception is that AIDS activists made it clear to the FDA that there would be no bureaucratic delays in deliver-ing experimental therapies to HIV-infected patients.. The FDA capitulated and this enabled rapid medical innovation to occur in a free-market environment..

 

Cancer patients, on the other hand, sit by like timid sheep, as the FDA decides which experimental therapy they are “allowed” to try and how far their disease must progress before the experimental therapy is made available on a so-called “compassionate-use” basis.. FDA’s granting of “com-passionate-use” sometimes occurs weeks after the patient dies, or is so close to death that it has no chance of working..

 

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In conclusion, our data suggest the relevance of NK (natural killer) cells as primary effectors not only against high-risk leukemias, but also solid tumors.. 44*

 

NOT FAST ENOUGH!

 

In 2010, the Life Extension Foundation® pledged a sub-stantial amount of money to a prestigious cancer research institute to evaluate many of the components contained in our published “Pancreatic Cancer Treatment Protocol..” The institution eagerly pushed this project forward, gen-erating reams of paperwork in order to obtain Institu-tional Review Board approval.. Here we are in 2014, and the total number of pancreatic patients enrolled in this study is zero.. Bureaucratic delays like this are beyond rational understanding.. These are human lives we are talking about!

 

When we devised unique treatments for AIDS in the 1980s, they were provided to dying AIDS patients almost overnight.. Not all of them worked, but the ones that did built on a foundation that has resulted in HIV patients liv-ing for decades, as opposed to pancreatic cancer patients who often die in a matter of months.. Contrast the rapid development of AIDS therapies to most pancreatic cancer patients who die even after enduring the Whipple Proce-dure that was first described in 1935.. It is clear that meth-ods employed by AIDS activists are far superior to today’s regulatory quagmire that stymies cancer research..

 

 

 

 

 

 

 

* Quote from study published in the April 2013 edition of the journal Oncoimmunology.

 

Intolerable Delays!           •  273

 

 

CITIZENS SHOULD REVOLT

 

Cancer will likely kill over 570,000 Americans this year..88 Already-approved treatments could be saving lives, such as administering moderate dose interleukin-2 early in the dis-ease process.. Yet even these simple treatment enhancements are ignored by the oncology mainstream that prefers to prac-tice assembly line medicine.. These kinds of delays would have never been tolerated by AIDS activists, who experimented with any potentially effective drug on large numbers of dying patients to quickly discover what worked and what didn’t..

 

The New England Journal of Medicine credits the work of AIDS pioneers as revolutionizing the way medical research is conducted today.. We at Life Extension® disagree with this Pollyanna assessment, as cancer therapies we uncovered decades ago remain bogged down in FDA red tape.. Many are not being pursued at all despite a continuous stream of favor-able data flowing out of research facilities.. The slogan below was chanted by AIDS activists who surrounded FDA head-quarters in 1988 and shut down the agency for one day:89,90

 

“Act Up, Speak Out .. .. .. Silence = Death!”

 

PROTEST NOW RATHER THAN WAIT FOR FUNERALS

 

I do not know why every cancer patient and their fam-ily does not march on Washington to demand the same exemption from bureaucratic suffocation that enabled HIV to become a manageable disease in a relatively brief win-dow of time.. Perhaps cancer patients should write their family and friends and state something to the effect:

 

In lieu of attending my funeral, would you mind marching on the Capitol in Washington, DC, and insist that cancer patients have unfettered access to any therapy that might work?

 

274   •  Pharmocracy II

 

 

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  1. Salup RR, Wiltrout RH.. Adjuvant immunotherapy of estab-lished murine renal cancer by interleukin 2-stimulated cyto-toxic lymphocytes.. Cancer Res.. 1986 Jul;46(7):3358–63..

 

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  1. Wang J, Walle A, Gordon B, et al.. Adoptive immunotherapy for stage IV renal cell carcinoma: a novel protocol utilizing periodate and interleukin-2-activated autologous leuko-cytes and continuous infusions of low-dose interleukin-2.. Am J Med.. 1987 Dec;83(6):1016–23..

 

  1. Fisher RI, Coltman CA Jr, Doroshow JH, et al.. Metastatic renal cancer treated with interleukin-2 and lymphokine-acti-vated killer cells.. A phase II clinical trial.. Ann Intern Med.. 1988 Apr;108(4):518–23..

 

  1. Chu MB, Fesler MJ, Armbrecht ES, et al.. High-dose interleu-kin-2 (HD IL-2) therapy should be considered for the treat-ment of patients with melanoma brain metastases.. Che-mother Res Pract.. 2013 2013:726925..

 

  1. Atkins MB, Kunkel L, Sznol M, Rosenberg SA.. High-dose recombinant interleukin-2 therapy in patients with meta-static melanoma: long-term survival update.. Cancer J Sci Am.. 2000 Feb;6 Suppl 1:S11–4..

 

  1. Keilholz U, Conradt C, Legha SS, et al.. Results of interleukin-2-based treatment in advanced melanoma: a case record-based analysis of 631 patients.. J Clin Oncol.. 1998 Sep;16(9):2921–9..

 

  1. Petrella T, Quirt I, Verma S, et al.. Single-agent interleukin-2 in the treatment of metastatic melanoma.. Curr Oncol.. 2007 Feb;14(1):21–6..

 

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  1. Acquavella N, Kluger H, Rhee J, et al.. Toxicity and activ-ity of a twice daily high-dose bolus interleukin 2 regimen in patients with metastatic melanoma and metastatic renal cell cancer.. J Immunother.. 2008 Jul-Aug;31(6):569–76..

 

  1. Schwartz RN, Stover L, Dutcher J.. Managing toxicities of high-dose interleukin-2.. Oncology.. 2002 Nov;16(11 Suppl 13):11–20..
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  1. Böhm M, Ittenson A, Klatte T, et al.. Pretreatment with interleukin-2 modulates perioperative immunodysfunction in patients with renal cell carcinoma.. Folia Biol (Praha).. 2003 49(2):63–8..

 

  1. Nichols PH, Ramsden CW, Ward U, Sedman PC, Prim-rose JN.. Perioperative immunotherapy with recombinant interleukin 2 in patients undergoing surgery for colorectal cancer.. Cancer Res.. 1992 Oct 15;52(20):5765–9..

 

  1. Lissoni P, Brivio F, Fumagalli L, Di Fede G, Brera G. Enhancement of the efficacy of chemotherapy with oxaliplatin plus 5-fluoro-uracil by pretreatment with IL-2 subcutaneous immunother-apy in metastatic colorectal cancer patients with lymphocyto-penia prior to therapy.. In Vivo.. 2005 Nov-Dec;19(6):1077–80..

 

  1. Ades EW, McKemie CR 3rd, Wright S, Peacocke N, Pantazis C, Lockhart WL 3rd..Chemotherapy subsequent to recombinant interleukin-2 immunotherapy: protocol for enhanced tumor-icidal activity.. Nat Immun Cell Growth Regul.. 1987 6(5):260–8..

 

  1. Da Costa ML, Redmond P, Bouchier-Hayes DJ.. The effect of laparotomy and laparoscopy on the establishment of sponta-neous tumor metastases.. Surgery.. 1998 Sep;124(3):516–25..

 

  1. Shakhar G, Blumenfeld B.. Glucocorticoid involvement in suppression of NK activity following surgery in rats.. J Neu-roimmunol.. 2003 May;138(1–2):83–91..

 

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  1. Rosenne E, Shakhar G, Melamed R, Schwartz Y, Erdreich-Epstein A, Ben-Eliyahu S. Inducing a mode of NK-resistance to suppression by stress and surgery: a potential approach based on low dose of poly I-C to reduce postoperative cancer metastasis.. Brain Behav Immun.. 2007 May;21(4):395–408..

 

  1. Marik PE, Flemmer M.. The immune response to surgery and trauma: Implications for treatment.. J Trauma Acute Care Surg.. 2012 Oct;73(4):801–8..

 

  1. Yokoyama Y, Sakamoto K, Arai M, Akagi M.. Radiation and surgical stress induce a significant impairment in cellular immunity in patients with esophageal cancer.. Jpn J Surg.. 1989 Sep;19(5):535–43..

 

  1. Sano T, Morita S, Tominaga R, et al.. Adaptive immunity is severely impaired by open-heart surgery.. Jpn J Thorac Car-diovasc Surg.. 2002 May;50(5):201–5..

 

  1. Rasmussen L, Arvin A.. Chemotherapy-induced immunosup-pression.. Environ Health Perspect.. 1982 Feb;43:21–5..

 

  1. Zandvoort A, Lodewijk ME, Klok PA, et al.. After chemother-apy, functional humoral response capacity is restored before complete restoration of lymphoid compartments.. Clin Exp Immunol.. 2003 Jan;131(1):8–16..

 

  1. Angelini C, Bovo G, Muselli P, et al.. Preoperative interleukin-2 immunotherapy in pancreatic cancer: preliminary results.. Hepatogastroenterology.. 2006 Jan-Feb;53(67):141–4..

 

  1. Hietanen T, Kellokumpu-Lehtinen P, Pitkänen M.. Action of recombinant and interleukin 2 in modulating radiation effects on viability and cytotoxicity of large granular lym-phocytes.. Int J Radiat Biol.. 1995 Feb;67(2):119–26..

 

  1. Boise LH, Minn AJ, June CH, Lindsten T, Thompson CB.. Growth factors can enhance lymphocyte survival without committing the cell to undergo cell division.. Proc Natl Acad Sci U S A.. 1995 Jun 6;92(12):5491–5..

 

Intolerable Delays!           •  279

 

 

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  1. Sanchez-Correa B, Morgado S, Gayoso I, Bergua JM, Casado JG, Arcos MJ, Bengochea ML, Duran E, Solana R, Tarazona R.. Human NK cells in acute myeloid leukaemia patients: analy-sis of NK cell-activating receptors and their ligands.. Cancer Immunol Immunother.. 2011 Aug;60(8):1195–205..

 

  1. Brunner S, Herndler-Brandstetter D, Weinberger B, Gru-beck-Loebenstein B.. Persistent viral infections and immune aging.. Ageing Res Rev.. 2011 Jul;10(3):362–9..

 

  1. Kozlowski JM, Fidler IJ, Campbell D, Xu ZL, Kaighn ME, Hart IR. Metastatic behavior of human tumor cell lines grown in the nude mouse.. Cancer Res.. 1984 Aug;44(8):3522–9..

 

  1. Kim S, Iizuka K, Aguila HL, Weissman IL, Yokoyama WM. In vivo natural killer cell activities revealed by natural killer cell-defi-cient mice.. Proc Natl Acad Sci USA.. 2000 Mar 14;97(6):2731–6..

 

  1. Smyth MJ, Swann J, Cretney E, Zerafa N, Yokoyama WM, Hayakawa Y.. NKG2D function protects the host from tumor initiation.. J Exp Med.. 2005 Sep 5;202(5):583–8..

 

  1. Vacca P, Martini S, Mingari MC, Moretta L.. NK cells from malignant pleural effusions are potent antitumor effectors: A clue for adoptive immunotherapy? Oncoimmunology.. 2013 Apr 1;2(4):e23638..

 

  1. Bhat R, Watzl C.. Serial killing of tumor cells by human nat-ural killer cells—enhancement by therapeutic antibodies.. PLoS One.. 2007 Mar 28;2(3):e326..

 

  1. Bradstock KF.. The use of hematopoietic growth factors in the treatment of acute leukemia.. Curr Pharm Des.. 2002 8(5):343–55..

 

  1. Ruggeri L, Mancusi A, Burchielli E, Aversa F, Martelli MF, Velardi A.. Natural killer cell alloreactivity in allogeneic hematopoietic transplantation.. Curr Opin Oncol.. 2007 Mar;19(2):142–7..

 

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  1. Locatelli F, Pende D, Mingari MC, et al.. Cellular and molec-ular basis of haploidentical hematopoietic stem cell trans-plantation in the successful treatment of high-risk leuke-mias: role of alloreactive NK cells.. Front Immunol.. 2013 Feb 1;4:15..

 

  1. Ishikawa H, Saeki T, Otani T, et al.. Aged garlic extract prevents a decline of NK cell number and activity in patients with advanced cancer.. J Nutr.. 2006 Mar;136(3 Suppl):816S-20S..

 

  1. Nantz MP, Rowe CA, Muller CE, Creasy RA, Stanilka JM, Percival SS.. Supplementation with aged garlic extract improves both NK and gd-T cell function and reduces the severity of cold and flu symptoms: a randomized, dou-ble-blind, placebo-controlled nutrition intervention.. Clin Nutr.. 2012 Jun;31(3):337–44..

 

  1. Tang Z, Sheng Z, Liu S, Jian X, Sun K, Yan M.. [The prevent-ing function of garlic on experimental oral precancer and its effect on natural killer cells, T-lymphocytes and interleu-kin-2].. Hunan Yi Ke Da Xue Xue Bao.. 1997 22(3):246–8..

 

  1. Kyo E, Uda N, Suzuki A, et al.. Immunomodulation and antitumor activities of Aged Garlic Extract.. Phytomedicine.. 1998 Aug;5(4):259–67..

 

  1. Butt MS, Sultan MT, Butt MS, Iqbal J.. Garlic: nature’s pro-tection against physiological threats.. Crit Rev Food Sci Nutr.. 2009 Jun;49(6):538–51..

 

  1. Miller SC, Pandi-Perumal SR, Esquifino AI, Cardinali DP, Maestroni GJ.. The role of melatonin in immuno-enhance-ment: potential application in cancer.. Int J Exp Pathol.. 2006 Apr;87(2):81–7..

 

  1. Currier NL, Miller SC.. Echinacea purpurea and melatonin augment natural-killer cells in leukemic mice and prolong life span.. J Altern Complement Med.. 2001 Jun;7(3):241–51..

 

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  1. Srinivasan V, Spence DW, Pandi-Perumal SR, Trakht I, Cardi-nali DP.. Therapeutic actions of melatonin in cancer: possible mechanisms.. Integr Cancer Ther.. 2008 Sep;7(3):189–203..

 

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  1. Zheng S, Jia Y, Zhao J, Wei Q, Liu Y.. Ganoderma lucidum polysaccharides eradicates the blocking effect of fibrinogen on NK cytotoxicity against melanoma cells.. Oncol Lett.. 2012 Mar;3(3):613–16..

 

  1. Zhu XL, Lin ZB.. Effects of Ganoderma lucidum polysaccha-rides on proliferation and cytotoxicity of cytokine-induced killer cells.. Acta Pharmacol Sin.. 2005 Sep;26(9):1130–7..

 

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  1. De Clercq E.. Anti-HIV drugs: 25 compounds approved within 25 years after the discovery of HIV.. Int J Antimicrob Agents.. 2009 Apr;33(4):307–20..

 

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  1. Fawzi WW, Msamanga GI, Spiegelman D, et al.. A randomized trial of multivitamin supplements and HIV disease progres-sion and mortality.. N Engl J Med.. 2004 Jul 1;351(1):23–32..

 

  1. [No authors listed] AIDS advocates returning to their activ-ism roots.. Protesters welcome arrests and publicity.. AIDS Alert.. 2004 Aug;19(8):90–3..

 

  1. Available at: http://www..tcnj..edu/~borland/2006-aids/cassy2.. htm Accessed March 14, 2014..

 

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  1. Baum MK, Campa A, Lai S, et al.. Effect of micronutrient supplementation on disease progression in asymptomatic, antiretroviral-naive, HIV-infected adults in Botswana: a ran-domized clinical trial.. JAMA.. 2013 Nov 27;310(20):2154–63..

 

  1. Fawzi WW, Msamanga GI, Kupka R, et al.. Multivitamin sup-plementation improves hematologic status in HIV-infected women and their children in Tanzania.. Am J Clin Nutr.. 2007 May;85(5):1335–43..

 

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  1. Mehta S, Fawzi W.. Effects of vitamins, including vitamin A, on HIV/AIDS patients.. Vitam Horm.. 2007 75:355–83..

 

  1. Pedersen C, Sandström E, Petersen CS, et al.. The efficacy of inosine pranobex in preventing the acquired immunodefi-ciency syndrome in patients with human immunodeficiency virus infection.. The Scandinavian Isoprinosine Study Group.. N Engl J Med.. 1990 Jun 1;322(25):1757–63..

 

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Intolerable Delays!           •  283

 

 

  1. Available at: http://theconversation..com/how-the-dallas-buyers-club-changed-hiv-treatment-in-the-us-22664.. Accessed March 17, 2014..

 

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DECEMBER 2011

 

Bureaucratic Assault on New Cancer Therapies

 

 

One American dies every hour from melanoma..1 Inci-

dences of this deadly skin cancer are on the increase. Although no cure exists for advanced melanoma, virtually 100% of its victims can be saved if the malignancy is caught early..2 The problem is that dermatologists cannot accurately diagnose a melanoma based on a visual examina-tion alone.. A biopsy is needed to definitely ascertain if a skin lesion is a melanoma.. Biopsies require expenditure of money and time, along with some minor trauma.. Patients and der-matologists have to make decisions as to whether a particu-

 

lar skin lesion warrants a biopsy..

 

In a clinical trial involving 23 dermatologists around the US, a hand-held non-invasive scanning device called MelaFind® was tested on suspicious lesions.. Its accuracy in detecting melanoma was 98%—which equaled or bested the top doctors in avoiding unnecessary biopsies..3 MelaFind® was submitted for FDA approval in June 2009.. Despite clinical trial results documenting its unprecedented (98%)

 

 

  • 285

 

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ability to detect early stage melanoma, the FDA refused to approve it and insisted on further review..4,5

 

FDA’S LETHAL ILLOGIC

 

According to bureaucratic illogic, the FDA was concerned that non-dermatologists might use MelaFind® to screen for melanoma, even though the company promised to only sell it to dermatologists.. Since the FDA cannot regulate doctors, the agency felt that the best way of keeping MelaFind® out of the hands of non-dermatologists was to not approve it at all..

 

The FDA expressed other concerns such as its misuse by dermatologists.. This is rather bizarre since dermatolo-gists are the most highly trained in our society to diag-nose and treat skin diseases, yet the FDA did not want them to use this new device that was 98% accurate in diag-nosing melanoma..6,7

 

THE REAL WORLD OF MEDICAL PRACTICE

 

FDA bureaucrats live in a cave when it comes to the intri-cacies and expenses involved in the real-world medical set-ting.. Hurried people too often ignore suspicious skin lesions until it’s too late.. Patients often go to their primary care doc-tor when it comes to suspicious skin lesions.. More enlight-ened individuals visit a dermatologist.. Either way, medical efficiency comes into play when deciding whether a suspi-cious lesion should be biopsied or merely kept an eye on.. A dermatologist charges for each biopsy, and there is a sepa-rate expense for the pathology lab.. Return visits are often needed.. All this adds up to medical costs that MelaFind® could otherwise render far more efficient..

 

MelaFind® is not 100% accurate.. That means it may miss a few (2%) suspicious lesions that a dermatologist would then have to decide warranted a biopsy nonetheless.. The FDA is

 

Bureaucratic Assault on New Cancer Therapies   •  287

 

 

using this as another reason not to approve it.. Using this logic, MRI and ultrasound testing would never have been approved because these are not 100% reliable diagnostic tools either..

 

If ever approved, MelaFind® will provide doctors with an efficient method to detect early stage melanoma.. According to some dermatologists, it has the potential to “save many lives..”8 There were 68,130 new cases of melanoma in 2010 and 8,700 deaths..9 These numbers show that melanoma can be easily cured—if caught in the early stages before it infiltrates and metastasizes.. We at Life Extension® envision a day when devices like MelaFind® will be used in large screening campaigns where early stage melanomas can be easily detected and removed.. None of this will happen as long as the FDA is allowed to erect bureaucratic barriers that suppress this kind of medical innovation..

 

FDA APPROVES EXPENSIVE MELANOMA DRUG

 

Cynical individuals might question the timing of the FDA’s denial of MelaFind®, a device that could spare thousands of agonizing deaths from metastatic melanoma.. Just a few weeks after saying no to MelaFind®, the FDA approved a new drug by pharmaceutical giant Bristol-Meyers Squibb to treat advanced melanoma trademarked Yervoy™..10 In a study involving 676 patients with advanced melanoma, those receiving Yervoy™ survived for 10 months compared to 6..4 months for those who did not receive it.. Fourteen patients died from side effects caused by Yervoy™..11 The FDA hailed this as a breakthrough and granted approval for widely spread melanoma..

 

Shares of Bristol-Meyers Squibb surged as analysts pre-dicted a $1.7 billion blockbuster.12 The reason so much money will be made is that it will cost each patient an astounding

 

288   •  Pharmocracy II

 

 

$120,000 for the four-course treatment..4 For what used to be the price of a nice home, one with terminal melanoma can buy an extra 108 days of life.. The average cost per day of added life will be over $1,000—further exacerbating today’s healthcare cost crisis!

 

The generic name for Yervoy™ is ipilimumab.. If you ever wonder why you cannot pronounce the names of new com-pounds (like ipilimumab), it is because pharmaceutical com-panies intentionally create names that no one can readily comprehend.. Pharmaceutical companies do this to make it harder for future generic drug makers to enter the mar-ket with lower-cost versions, since virtually no one can pro-nounce the generic name..

 

The reason that Yervoy™ (ipilimumab) is expected to sell so well is that current FDA-approved therapies have not been shown to substantially extend survival, but the FDA allowed them to be used for decades anyway.. We are not against the FDA’s approval of Yervoy™ as it may prove to work better when treating less advanced melanoma.. What bothers us are the bureaucratic barriers.. They are so cum-bersome that few new therapies ever get approved.. This enables companies to charge extortionist prices for the few that receive the FDA’s coveted anointment..

 

FDA FAILS TO APPROVE EFFECTIVE LYMPHOMA DRUG

 

Each year about 65,000 Americans are diagnosed with non-Hodgkin lymphoma..13 It is estimated to have killed over 20,000 in the US in 2010.. Jackie Kennedy Onassis died from non-Hodgkin lymphoma at the age of 64..15 Non-Hodgkin lymphoma is one of the few cancers where establishment medicine can brag about treatment breakthroughs.. Over the past 50 years, survival rates have more than doubled..16 Often overlooked are long-term side effects like cumulative

 

Bureaucratic Assault on New Cancer Therapies   •  289

 

 

heart muscle damage that precludes long-term use of cer-tain conventional treatments..17 Lymphoma patients who fail treatment with FDA-approved chemotherapy have a life expectancy measured in weeks or months..

 

A next-generation compound called pixantrone is designed to be less toxic and more effective than current anthracy-cline chemo drugs.. It has successfully gone through phase I and phase II human clinical trials.. In 2004, a randomized phase III trial mandated by the FDA was initiated.. Pixan-trone was administered to non-Hodgkin lymphoma patients who had already failed conventional therapy.. The control group received whatever their oncologist thought would work best for them.. In these extremely difficult-to-treat lym-phoma patients, 20% of those receiving pixantrone showed a complete response, compared to only 6% receiving conven-tional care..18 A follow-up analysis of the data showed 24% of patients attaining complete response status as opposed to 7% in the standard group..19 These are unprecedented findings!

 

A complete response is not a cure, but it can buy a patient precious time in remission and the opportunity to identify potential curative therapies.. Despite almost four years of phase III clinical studies showing that pixantrone works three times better than what’s available today, the FDA declined to approve it.. In an FDA briefing as to why pixantrone was not approved, the FDA stated, “The study was not stopped at a planned interim analysis and early study stopping inval-idated the applicant’s Special Protocol Assessment..”20 The “Special Protocol Assessment” is an agreement between the FDA and a drug maker regarding how a clinical study should be done..21 It originally envisioned enrolling 320 patients over a 36-month time period.. For various reasons, it took 45 months to recruit 140 patients..22 This is not unusual as some 60% of phase III studies do not meet patient recruitment

 

290   •  Pharmocracy II

 

 

objectives, but nonetheless generate statistically significant data that are used to approve a new drug..

 

PIXATRONE NOT OWNED BY BIG PHARMA

 

Unlike Bristol-Meyers Squibb, which had the wherewithal to fund a huge clinical study and whose stock soared in response to the FDA’s approval of Yervoy™,23 the maker of pixantrone’s auditors handed management a notice that the company (Cell Therapeutics) may not be able to continue as a going concern in response to the FDA’s refusal to approve their drug..24,25 Cell Therapeutics’ initial challenge in enroll-ing enough study subjects was convincing oncologists and hematologists that pixantrone might work.. Patient incen-tive to participate was minimized because the FDA man-dated that only 50% of the study subjects would receive the promising drug (pixantrone)..

 

Despite these limitations, Cell Therapeutics believes it generated statistically significant data and has taken the unusual step of appealing the FDA’s denial of pixantrone.. The reason appeals are seldom filed is fear of FDA retaliation on future drug applications.. In the case of Cell Therapeutics, which is not part of Big Pharma, it may have little to risk in asking for a common-sense review of the impressive data it generated in terminally ill lymphoma patients.. The inability of Cell Therapeutics to adhere to the FDA’s impossible-to-achieve dictates is an example of a federal agency that went out of its way to railroad a promising cancer therapy..

 

HOW LIFE EXTENSION® IS HELPING TO ACCELERATE MELANOMA TREATMENT

 

Scientists supported by the Life Extension Foundation® long ago discovered a novel method of treating advanced mela-noma (stages 3 and 4).. In an FDA-approved clinical trial, a

 

Bureaucratic Assault on New Cancer Therapies   •  291

 

 

topical cream (called imiquimod) is applied to the exposed tumor twice a day for a total of six weeks.. At weeks two and four, the doctors expose the area to an infrared laser.. The top-ical imiquimod cream binds with receptors on cancer cells and stimulates them to activate proteins that “broadcast” the pres-ence of the tumor cells to the immune system.. In essence, the patient’s own tumor cells become a unique anti-tumor vac-cine.. The laser portion of the treatment is designed to hyper-activate the imiquimod with the objective of inducing a sys-temic immune response against metastatic melanoma cells..

 

This same protocol is being done in the Bahamas for mela-noma, and a modified version is being studied to treat breast cancer.. In order for this treatment to be administered, a tumor lesion must be present near the surface of your skin, such as a breast lump, a chest wall breast lesion, or a super-ficial melanoma tumor.. To inquire about clinical programs being offered in the Bahamas, call the International Strate-gic Cancer Alliance (ISCA) at 610-628-3419 or visit www..is-canceralliance..com..

 

THE REAL ISSUE . . .

 

The way this country tolerates FDA behavior, it is as if only large pharmaceutical companies are capable of discovering effective new drugs.. Those without deep pockets are often shut out of today’s Byzantine approval process, where it can cost over $100 million to have a new compound “approved” for sale.. Most troubling is what this is doing to medical innovation across the entire spectrum.. We at Life Exten-sion® know of pioneering physicians who have discovered and are utilizing novel therapeutic protocols to treat the dis-eases of aging.. Yet these inventions have virtually no chance of making it out of these private practices because of FDA overregulation..

 

292   •  Pharmocracy II

 

 

To see how much more efficient an unregulated environ-ment functions, look no further than the breakthroughs that have been made in the treatment of AIDS.. This disease appeared in America around 1980.. It took several years just to identify the HIV virus as the cause.. In the first half of the 1980s, virtually everyone who contracted AIDS died within 1–2 years.. The difference was that AIDS activists were acutely aware that FDA-mandated randomized clinical trials were the roadblock to the discovery of effective therapies.. Unlike cancer support groups who too often capitulate to FDA sup-pression, AIDS activists rebelled and forced the FDA to back down from restricting any therapy that might be effective..

 

Removed from the artificial constraints of controlled trials designed by uncaring and incompetent bureaucrats, front-line doctors and researchers were able to collect data from actual medical practice on AIDS patients and had the flex-ibility of trying whatever therapy might work.. Life Exten-sion® partnered with these groups early on and witnessed the miraculous results that occurred when doctors could prescribe therapies without regard to FDA dictates.. When Life Extension® attempted to introduce this same strategy to dying cancer patients, the FDA stood in the way and said absolutely not!

 

LOW CoQ10 LEVELS ASSOCIATED WITH 790% INCREASED RISK OF MELANOMA METASTASIS

 

In a study published in the Journal of the American Academy of Dermatology, plasma coenzyme Q10 levels were measured in 117 consecutive melanoma patients upon enrollment.. 125 matched volunteers without any clinically suspected pig-mented lesions were utilized as the control group.. Research-ers found that CoQ10 levels were significantly lower in mel-anoma patients compared to control subjects.. Further, it

 

Bureaucratic Assault on New Cancer Therapies   •  293

 

 

was noted that for melanoma patients with CoQ10 blood levels of less than 0..6 mg per liter, the risk of developing metastatic disease increased by 790%, compared to those melanoma patients with blood levels of 0..6 mg per liter or higher.. In addition, melanoma patients with higher blood levels had a metastasis-free interval that was almost double compared to patients with lower levels..29

 

Of the 82 patients with low CoQ10 levels, 17 died during the study, compared to none of the 35 patients with higher CoQ10.. CoQ10 levels did not vary by sex..29 Levels of CoQ10 correlated well with tumor thickness, which is currently the best indicator of melanoma progression.. Specifically, lower CoQ10 levels correlated with increased tumor thick-ness and poorer prognosis..29 The study notes that abnormally low plasma levels of CoQ10 previously have been known in patients with cancer of the breast, lung, and pancreas.. This study may be the first to indicate that lower blood levels of CoQ10 can have an extremely adverse effect.. The lead author of the study concluded that analysis of their find-ings suggested baseline CoQ10 levels are a powerful and independent prognostic factor that can be used to esti-mate risk for melanoma progression..

 

Statin drugs are known to lower CoQ10 levels.. Will we find that melanoma progression is another side effect of statins? If so, this side effect can be readily overcome with CoQ10 supplements..

 

LOOK AT THE DIFFERENCE BETWEEN AIDS AND CANCER

 

Those afflicted with AIDS today are prescribed an arma-mentarium of medications and take huge quantities of dietary supplements to keep their infections under control.. What used to be a near-certain death sentence has turned into a manageable chronic disease for most people.. That

 

294   •  Pharmocracy II

 

 

happened more than a decade ago! Contrast this with can-cer, where a melanoma drug that gives patients an extra 108 days of life (that costs $120, 000)10 is hailed as a break-through in 2011.. Americans have been dying of melanoma for hundreds of years.. The FDA’s approval of expensive and mediocre drugs like Yervoy™ and suppression of common-sense approaches (like MelaFind® and pixantrone) are stark examples of the FDA’s bureaucratic assault on novel cancer therapies..

 

At the June 2011 conference of the American Society of Clinical Oncology (ASCO), the results from several human studies were announced about new compounds that prolong the lives of advanced melanoma patients..26 Despite an unusual amount of enthusiasm shown by oncol-ogy researchers, it may take years before the FDA will allow combinations of these compounds to be used in desperately ill melanoma patients .. .. .. who are dying at the rate of one each hour.. One of the new targeted mela-noma drugs featured at the June ASCO meeting is called vemurafenib and is being developed by Roche Holding AG and Daiichi Sankyo’s Plexxikon unit.. It inhibits a mutated form of a gene called BRAF found in more than half of patients with advanced melanoma.. It has vir-tually no benefit on patients with a normal version of the gene.. Results from a 675-patient trial showed that those taking vemurafenib were 63% less likely to die over a six-month period compared to those taking che-motherapy called dacarbazine..28 The median time before the disease progressed for patients on vemurafenib was

 

  • .3 months compared with 1..6 months on dacarbazine chemotherapy..

 

Based on this trial, we believe that melanoma patients with a mutated BRAF gene should have been allowed

 

Bureaucratic Assault on New Cancer Therapies   •  295

 

 

immediate access to vemurafenib if they were willing to sign a disclaimer acknowledging that it is not yet FDA-approved.. Instead, thousands of melanoma patients are dying prematurely in the FDA’s waiting room..

 

MY GRANDMOTHER’S FUNERAL

 

At age 13, I stood over the casket of my grandmother, who had died a horrific death from melanoma.. She was only 54 and suffered terribly as metastatic lesions invaded every part of her body.. Her death was preventable, as she ignored a melanoma lesion on her leg for many years.. At that funeral in 1968, no one would have predicted that more Americans than ever would be dying of melanoma in 2011—43 years later! Like others back then, our family believed that medi-cine would advance and find a cure for cancer, just like anti-biotics wiped out most bacterial infections..

 

While major technological advances are routine in virtu-ally all disciplines, clinical medicine is the exception.. It has devolved into a bureaucratic monstrosity that suffocates innovation while rewarding the politically well-connected.. How much longer will Americans tolerate a system that is a proven failure?

 

As This Article Was Being Finalized . . . FDA Partially Capitulates on MelaFind®

 

In response to intense legal and political pressure put on the FDA, a limited conditional approval has just been granted for the MelaFind® skin cancer detection device..30 This pend-ing approval comes after a seven-year battle between the company that makes MelaFind® and the FDA.. After FDA rejected MelaFind® last year, the company filed a citizen’s petition with FDA Commissioner Margaret Hamburg seek-ing to overturn the denial..

 

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The House of Representatives held a hearing in the sum-mer of 2011 where the FDA’s top device regulator acknowl-edged the agency mishandled the MelaFind® applica-tion.. The error occurred when the FDA denied approval of MelaFind® before it held a meeting of its own scientific advisors—talk about bureaucratic mix-up! This does not mean that MelaFind® will definitely become available, but the FDA is at least moving off its refusal to approve it at all.. MelaFind® did win approval in early September in 27 European nations..

 

In order for MelaFind® to be approved in the US, the FDA needs to agree on the device’s final labeling, a user guide, details of a training program for doctors, and the design of a post-approval clinical trial.. The CEO of the company that makes MelaFind® was uncertain about when the FDA would approve MelaFind® and was careful to downplay if and when the company can begin selling the device.. He acknowl-edged that discussions with the FDA were still going “back and forth” and therefore not complete.. Before MelaFind® can be sold in the US, the FDA wants additional “beta tests” with doctors to be conducted to make technical and usabil-ity improvements to the device. . The FDA insists that MelaFind’s label be longer and more complicated than the company ever envisioned.. Until these issues are resolved, MelaFind® will not be allowed on the American market..

 

There are examples of other products in the past that received this kind of conditional FDA approval but never made it to the market, though it seems the political heat has forced the FDA in a direction regarding MelaFind® that it previously refused to consider.. If you ever wonder why medical advances take so long and then cost so much, the expense and delay in pushing MelaFind® through the FDA’s cumbersome bureaucracy provides a stark example..

 

Bureaucratic Assault on New Cancer Therapies   •  297

 

 

References

 

  1. Available at: http://www..melanomafoundation..org/facts/ statistics..htm.. Accessed May 18, 2011..

 

  1. Available at: http://www..projectmelanoma..com/a-national-challenge..php.. Accessed May 18, 2011..

 

  1. Monheit G, Cognetta AB, Ferris L, et al.. The performance of MelaFind: a prospective multicenter study.. Arch Dermatol.. 2011 Feb;147(2):188–94..

 

  1. Available at: http://www..marketwire..com/press-release/ MELA-Sciences-Announces-FDA-Panel-Review-MelaFind-PMA-Application-on-August-26-2010-NASDAQ-MELA-1266362..htm.. Accessed May 18, 2011..

 

  1. Available at: http://www..thestreet..com/story/10944267/3/ biotech-calendar-fda-drug-approvals-in-2011..html.. Accessed May 18, 2011..

 

  1. Available at: http://www..medpagetoday..com/Dermatology/ SkinCancer/23448.. Accessed May 19, 2011..

 

  1. Available at: http://www..modernmedicine..com/modern medicine/Modern+Medicine+Now/MelaFind-device-raises-concerns-among-some-dermato/ArticleStandard/Article/ detail/706390.. Accessed May 19, 2011..

 

  1. Available at: http://online..wsj..com/article/SB10001424052 748704559904576230562290013904..html.. Accessed May 20, 2011..

 

  1. Available at: http://seer..cancer..gov/statfacts/html/melan.. html.. Accessed May 20, 2011..

 

  1. Available at: http://www..bloomberg..com/news/2011-03-25/bristol-myers-squibb-wins-u-s-fda-approval-for-new-melanoma-medicine..html.. Accessed May 20, 2011..

 

  1. Hodi FS, O’Day SJ, McDermott DF, et al.. Improved survival with ipilimumab in patients with metastatic melanoma.. N Engl J Med.. 2010 Aug 19;363(8):711–23..

 

298   •  Pharmocracy II

 

 

  1. Available at: http://www..mmm-online..com/fda-approves-bms-skin-cancer-biologic-yervoy/article/199258/.. Accessed May 21, 2011..

 

  1. Available at: http://www..non-hodgkins-lymphoma-cancer.. org/news/non-hodgkins-news0026..htm.. Accessed May 20, 2011..

 

  1. Available at: http://seer..cancer..gov/statfacts/html/nhl..html.. Accessed May 23, 2011..

 

  1. Available at: http://www..nytimes..com/learning/general/ onthisday/bday/0728..html Accessed May 23, 2011..

 

  1. Available at: http://www. .lls. .org/diseaseinformation/ getinformationsupport/factsstatistics/nonhodgkin lymphoma/.. Accessed May 23, 2011..

 

  1. Available at: http://www. .drugs. .com/health-guide/non-hodgkin-lymphoma..html.. Accessed May 24, 2011..

 

  1. Available at: http://www. .drugs. .com/clinical_trials/ cell-therapeutics-pixantrone-phase-iii-extend-pivotal-trial-successful-achieving-primary-endpoint-6168..html.. Accessed May 24, 2011..

 

  1. Available at: http://www. .fda. .gov/downloads/advisory committees/committeesmeetingmaterials/drugs/ oncologicdrugsadvisorycommittee/ucm199560..pdf.. Accessed May 25, 2011..

 

  1. Available at: http://online..wsj..com/article/SB10001424052 748703766704576009512990553104..html.. Accessed May 26, 2011..

 

  1. Available at: http://www. .fda. .gov/downloads/Advisory Committees/CommitteesMeetingMaterials/Drugs/ OncologicDrugsAdvisoryCommittee/UCM204335..pdf.. Accessed May 26, 2011..

 

  1. Available at: http://www..pharmalot..com/2010/02/the-fda-and-special-protocal-assessments/.. Accessed May 26, 2011..

 

Bureaucratic Assault on New Cancer Therapies   •  299

 

 

  1. Available at: http://www.bloomberg .com/news/2011-03-25/ bristol-myers-squibb-wins-u-s-fda-approval-for-new-melanoma-medicine..html.. Accessed May 30, 2011..

 

  1. Available at: http://seekingalpha..com/article/198401-fda-s-early-verdict-on-cell-therapeutics-pixuvri-comes-as-no-surprise.. Accessed May 30, 2011..

 

  1. Available at: http://www. .ipdatadepot. .com/archives/ ipp070402..pdf.. (pg.. 13/45).. Accessed May 30, 2011..

 

  1. Available at: http://online..wsj..com/article/SB1000142405 2702304432304576367802580935000..html?mod=WSJ_ hp_MIDDLENexttoWhatsNewsTop.. Accessed May 31, 2011..

 

  1. Available at: http://www..bloomberg..com/news/2011-05-25/roche-leads-deadly-skin-cancer-turnaround-as-dozen-drugs-coming..html.. Accessed May 31, 2011..

 

  1. Chapman PB, Hauschild A, Robert C, et al.. Improved sur-vival with vemurafenib in melanoma with BRAF V600E mutation.. N Engl J Med.. 2011 Jun 10 30;364(26);2507–16..

 

  1. Rusciani L, Proietti I, Rusciani A, et al.. Low plasma coenzyme Q10 levels as an independent prognostic factor for melanoma progression.. J Am Acad Dermatol.. Feb 2006;54(2):234–41..

 

  1. Burton TJ.. New tool in skin-cancer fight.. FDA reversal clears path for a device that helps doctors diagnose melanoma.. Wall Street Journal.. September 26, 2011..

DECEMBER 2011

 

Cancer Establishment Hides Radiation Side Effects

 

 

 

 

 

In a shocking exposé of the cancer establishment, Dr.. Ralph Moss in his frequently updated book The Cancer Industry revealed the sordid history of radiation ther-apy.. The first victims were researchers and physicians who succumbed to radiation’s lethal effects without even sus-pecting it posed a danger to them.. The next set of medi-cal victims was patients who received severe burns from radiation overdoses that left them painfully mutilated or dead from acute radiation poisoning.. As radiation doses were refined, the cancer establishment proclaimed a major treatment breakthrough.. Yet the statistics were manipu-lated to cover up what was really happening to irradiated patients.. For instance, patients with progression-free sur-vival of 5 years (or less) are often listed as successes even if

 

the same cancer later returns..1,2


 

  • 301

 

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Most disturbing are statistical methods that ignore lethal side effects such as radiation necrosis in the brain that kills the majority of its victims, but are not always officially tabu-lated as cancer deaths..3,4 This enables statisticians to say the radiation “cured” the patient of cancer, while omitting the fact that the therapy itself killed the patient.. Radiation ther-apy is an important part of treating certain head and neck tumors and is often used after surgery,5 but lethal radiation necrosis to the brain is one potential side effect..6 Radiation therapy is routinely used to treat primary brain tumors.. The cure rate for the most common brain tumors is disturbingly low,7 but even in those fortunate enough to have their brain tumors destroyed by the radiation, a large percentage suc-cumb shortly thereafter to radiation necrosis of the brain..8

 

The more prevalent and omitted cover-up relates to the long-term impact of radiation therapy.. For example, another danger of radiation therapy to the head is increased risk of stroke..9 A study of head and neck cancer patients who received radiation therapy found that stroke rates were five times greater than expected..10 This elevated stroke risk was found many years after administration of radia-tion.. The average time between radiation treatment and stroke was 10..9 years, but the increased risk of stroke persisted for 15 years after radiation therapy.. For cancer patients treated with radiation therapy that later die from a stroke, the official cause of death is stroke, even though the radiation therapy often caused the stroke.. This is an example of how cancer cure statistics are misleading.. The government contends that radiation therapy is curing cancer patients, yet long-term radiation side effects cause many deaths that are not attributed to cancer..

 

The government claims that more cancer victims are liv-ing beyond five years, but ignores the fact that the toxic

 

Cancer Establishment Hides Radiation Side Effects          •  303

 

 

therapies used to eradicate cancer can themselves cause premature death..11

 

High-dose radiation to the chest cavity increases heart disease risk .. .. .. and this side effect may not occur for 20 years or later..12 Some of the side effects from radiation ther-apy to the breast include a breakdown of the skin or such severe pain in the breast that surgery is needed for treat-ment..13 Radiation therapy given to the axillary lymph nodes can increase the risk of patients developing arm swelling (“lymphedema”) following axillary (armpit) dissection..14–17 Radiation to this area can cause numbness, tingling, or even pain and loss of strength in the hand and arm years after treatment..14,16 Some patients develop “radiation pneumoni-tis,” a lung reaction that causes a cough, shortness of breath, and fevers three to nine months after completing treat-ment..16 These side effects may go away within a relatively short time or persist over an extended period..

 

The primary concern with radiation therapy is that it may initiate secondary cancers years or decades after the pri-mary cancer was “cured..” This does not mean that all can-cer patients should refuse radiation therapy, as it often adds years or decades to their lives, and is in many cases cura-tive.. But as Ralph Moss, PhD, graphically described in his Cancer Industry books, oncology researchers are motivated to achieve complete responses that they can later claim to be cancer “cures..” Overlooked from the statistics are horrific long-term side effects that leave patients permanently muti-lated, in constant pain with loss of bodily functions, and under chronic medical care to deal with the damage inflicted by the “cancer cure..” Patients suffering side effects from con-ventional treatments are often never the same again, yet the cancer establishment uses these cases to create statistical models to pretend their toxic therapies are a panacea..

 

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In Suzanne Somers’ case, she has long regretted her sub-mission to radiation therapy after her lumpectomy.. While she made the right choice in saying “no” to chemotherapy, she has suffered for ten years from the destructive effects caused by the intense amount of radiation delivered to her breast and surrounding tissues..

 

HOW RADIATION CAUSES LONG-TERM DAMAGE TO BREAST TISSUES

 

Radiation therapy has long been used to treat breast can-cer.. For patients who choose breast-conserving surgery, have multiple positive lymph nodes, or have a local recur-rence, radiation therapy will likely be part of the treat-ment plan.. Radiation acts directly on the cell nucleus.. Cancer cells grow rapidly compared to normal cells, so by radiating the cancerous area, cancer cells are damaged and many of them destroyed.. Unfortunately, radiation also has a negative effect on normal cells.. By mutating genes in the nucleus of healthy cells, these normal cells are more likely to later develop into cancer..

 

This damage to genes in the cells’ nucleus also causes the expression of pro-inflammatory factors that result in a constant bombardment (inflammatory fires) by one’s immune cytokines against the irradiated cells.. As the cells initially damaged by radiation are destroyed, the “inflammatory fires” spread to nearby healthy cells and create a chain reaction whereby more healthy cells come under chronic cytokine-inflammatory attack.. Radiation damages the blood supply to normal skin at a microscopic level.. This results in a significantly greater risk of compli-cations following surgery.. These risks include infection, delayed healing, wound breakdown, and fat necrosis, as well as implant-related problems..18 Radiation therapy can

 

Cancer Establishment Hides Radiation Side Effects          •  305

 

 

be the source of serious problems when it comes to breast reconstruction..

 

THIS EXPLAINS WHY SUZANNE SOMERS STATED:

 

There should be a book written on the realities of radiation and all the things that are never men-tioned beforehand.. With radiation, the breast grad-ually gets flatter and flatter until it looks as though there has been a complete mastectomy .. .. .. when the swelling subsided it was considerably smaller than I had at first realized, and then it (Suzanne’s breast) began to degrade, gradually losing more and more volume until it became non-existent..

 

IMPORTANT SUMMARY

 

This article is not meant to dissuade cancer patients from utilizing radiation therapy, as when properly used against specific tumors it can produce significantly higher cure rates that offset the risk of side effects.. For instance, if you are diagnosed with Hodgkin lymphoma in the chest cavity, radi-ation has a high probability of curing you.. Even though your risk of heart disease increases because of the radiation, it can buy you decades of additional life and you can take assertive steps to reduce your odds of suffering a heart attack know-ing that you are at increased risk..12,19–21 Same for stroke risk in those who receive radiation to the head.. Aggressive stroke prevention may enable you to avoid the five-fold increase in stroke risk caused by the radiation..10,22,23

 

For women with breast cancer, there are established cri-teria for determining if radiation therapy is likely to provide a benefit that offsets the side effect risks.. A careful analy-sis of one’s individual breast cancer that includes primary tumor molecular profiling, tumor size, lymph node involve-

 

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ment, presence of circulating tumor cells, whole-body PET scans and CT scans, and many other diagnostics are critical to determining if radiation therapy is an appropriate choice..

 

Life Extension® published an extensive Cancer Radia-tion Protocol long ago that provides validated methods of improving the ability of radiation to eradicate cancer cells, while sparing healthy cells from radiation’s many potential side effects.. One can access the most recent version of the Cancer Radiation Protocol by logging on to www..lef..org/ radiation_therapy.. If you have any questions on the scien-tific content of this article, please call a Life Extension® Health Advisor at 1-866-864-3027..

 

References

 

  1. Available at: http://www..cancer..org/Treatment/Survivorship DuringandAfterTreatment/UnderstandingRecurrence/

 

  1. WhenYourCancerComesBack/when-cancer-comes-back-com-mon-questions-about-recurrence.. Accessed September 28, 2011..

 

  1. Available at: http://www..cancer..net/patient/All+About+ Cancer/Newly+Diagnosed/Understanding+Survival+Statistics.. Accessed September 28, 2011..

 

  1. Wang X, Hu C, Eisbruch A.. Organ-sparing radiation therapy for head and neck cancer.. Nat Rev Clin Oncol.. 2011 Jul 26..

 

  1. Welch HG, Black WC.. Are deaths within 1 month of cancer-directed surgery attributed to cancer? J Natl Cancer Inst.. 2002 Jul 17;94(14):1066–70..

 

  1. Hunter SE, Scher RL.. Clinical implications of radionecrosis to the head and neck surgeon.. Curr Opin Otolaryngol Head Neck Surg.. 2003 Apr;11(2):103–6..

 

  1. Eisbruch A, Dawson L.. Re-irradiation of head and neck tumors.. Benefits and toxicities.. Hematol Oncol Clin North Am.. 1999 Aug;13(4):825–36..

 

Cancer Establishment Hides Radiation Side Effects          •  307

 

 

  1. Available at: http://emedicine. .medscape. .com/article/ 1156220-overview.. Accessed October 5, 2011..

 

  1. Available at: http://emedicine. .medscape. .com/article/ 1157533-overview.. Accessed October 5, 2011..

 

  1. Abayomi OK.. Neck irradiation, carotid injury and its conse-quences.. Oral Oncol.. 2004 Oct;40(9):872–8..

 

  1. Dorresteijn LD, Kappelle AC, Boogerd W, et al.. Increased risk of ischemic stroke after radiotherapy on the neck in patients younger than 60 years.. J Clin Oncol.. 2002 Jan 1;20(1):282–8..

 

  1. Lassen UN, Osterlind K, Hirsch FR, Bergman B, Domber-nowsky P, Hansen HH.. Early death during chemotherapy in patients with small-cell lung cancer: derivation of a prog-nostic index for toxic death and progression.. Br J Cancer.. 1999 Feb;79(3–4):515–9..

 

  1. Boivin JF, Hutchison GB, Lubin JH, Mauch P.. Coronary artery disease mortality in patients treated for Hodgkin’s disease.. Cancer.. 1992 Mar 1;69(5):1241–7..

 

  1. Meric F, Buchholz TA, Mirza NQ, et al.. Long-term compli-cations associated with breast-conservation surgery and radiotherapy.. Ann Surg Oncol.. 2002 Jul;9(6):543–9..

 

  1. Kissin MW, Della Rovere GQ, Easton D, Westbury G.. Risk of lymphodema following treatment of breast cancer.. Br J surg..1986;73:580–84..

 

  1. Stahlberg CI, Jorgensen T.. Arm morbidity after axillary dissection for breast cancer. . Ugeskr Laeger. . 2001 Jun 11;163(24):3356–9..

 

  1. Available at: http://www..radiologyinfo..org/en/info..cfm? pg=breastcancer#part_seven.. Accessed September 29, 2011..

 

  1. Warmuth MA, Bowen G, Prosnitz LR, et al.. Complications of axillary lymph node dissection for carcinoma of the breast: a report based on a patient survey.. Cancer.. 1998 Oct 1;83(7):1362–8..

 

308   •  Pharmocracy II

 

 

  1. Available at: http://www..breastreconstruction..org/Recon structionOverview/RadiationandReconstruction..html.. Accessed September 30, 2011..

 

  1. Mert M, Arat-Ozkan A, Ozkara A, Aydemir NA, Babalik E.. Radiation-induced coronary artery disease.. Z Kardiol.. 2003 Aug;92(8):682–5..

 

  1. De Backer G, Ambrosioni E, Borch-Johnsen K, et al.. Euro-pean guidelines on cardiovascular disease prevention in clinical practice.. Third Joint Task Force of European and other societies on cardiovascular disease prevention in clin-ical practice (constituted by representatives of eight soci-eties and by invited experts).. Arch Mal Coeur Vaiss.. 2004 Oct;97(10):1019–30..

 

  1. Davis W.. A new paradigm for stroke prevention.. Life Exten-sion Magazine®.. 2005 Apr;11(4):30–8..

 

  1. Yu JG, Zhou RR, Cai GJ.. From hypertension to stroke: mech-anisms and potential prevention strategies.. CNS Neurosci Ther.. 2011 Oct;17(5):577–84..

 

  1. Ozner M.. The great American heart hoax.. Life Extension Mag-azine®.. 2009 May;15(5):42–8..

Taking Action

 

MARCH 2017

 

Unsustainable High

Drug Prices!

 

In the February 2000 issue of Life Extension Magazine® I wrote an editorial about high drug prices titled “Are We to Become Serfs of the Drug Monopoly?”

 

My article ignited a firestorm of activity in Congress aimed squarely at the FDA..

Back then, many members of Congress were upset that the FDA prohibited Americans from importing lower cost medications from other countries.. To underscore this con-sumer rip-off, I compiled a chart showing how much more Americans were paying for pharmaceuticals compared to Europeans.. The same chart also showed that the cost of the active drug ingredient was virtually nothing compared to what consumers had to pay..

 

This chart was enlarged by a congressman and shown on the floor of the House of Representatives.. The purpose was

 

 

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312   •  Pharmocracy II

 

 

to educate other lawmakers about the magnitude of the price gouging American farce..1 The eventual result was pas-sage of a bill by Congress and signed into law by President Bill Clinton.. The bill allowed Americans to import prescrip-tion medications from countries that sold them at a frac-tion of the price Americans were paying..

 

The bill had one fatal loophole.. If the FDA determined that it lacked the resources to ensure the safety of imported drugs, then the Secretary of Health and Human Services could nullify the bill with one stroke of a pen.. And that’s exactly what Donna Shalala did on December 27, 2000 dur-ing the final (lame-duck) month of Bill Clinton’s term.. This cruel act of sabotage by an unelected bureaucrat set the stage for the staggering increases in drug prices that now make headline news..

 

The burden of high medical costs has reached a point that is unsustainable by the American economy.. This problem will not abate until the public regains some control over Congress, which is currently controlled by pharmaceuti-cal lobbyists.. As you’ll read in this article, the FDA wants to further benefit pharmaceutical interests by suffocating innovation in the dietary supplement industry..

 

THE CURRENT CRISIS

 

No one has fought longer or harder against high drug prices than Life Extension®..2 We’ve exposed how off-pat-ent generic drugs whose active ingredient costs only pen-nies are sold to desperate consumers for hundreds of dol-lars.. We have shown that this price gouging is caused by over-regulation of the prescription drug marketplace..

 

What’s sparked recent media outrage is that the health-care burden now falls squarely on the shoulders of mid-dle-class America..3 That represents the majority of citizens

 

Unsustainable High Drug Prices!                •  313

 

 

who are facing severe economic hardships via high medi-cal insurance premiums, high deductibles, and restricted access to the best doctors..

 

MAGNITUDE OF PROBLEM

 

There was a time not so long ago where most employers paid 100% of their employee’s health insurance premiums.. This included the spouse and children of each employee.. If a serious medical issue arose, the company-paid insurance covered virtually 100% of the expenses.. There was no such thing as first having to pay a large deductible, or being told of denial of coverage for a physician-prescribed therapy, or even denial of payment to the physician you chose..

 

Employees today pay a growing percentage of their own medical insurance premiums and usually 100% for their spouse and children.. (Recall this was a free employee ben-efit just a few decades ago..) In today’s upside down world of so-called health “insurance,” the middle class is often limited to using physicians only in their insurance com-pany’s narrow “network..” These physicians relinquish decision-making regarding diagnostics and prescribing to what the insurance company permits, which is often sub-standard care based on Life Extension’s comprehen-sive treatment protocols..

 

Before the insurance company covers anything, a deduct-ible has to be paid out-of-pocket that can easily run $4,000– $6,000.. This deductible must be paid every year for treating the same medical condition.. (Deductibles vary considerably depending on the plan chosen..)

 

So what used to be a benefit for most working Americans is now a farce.. The typical working person does not run up $4,000–$6,000 in medical expenses.. So they may wind up paying 100% of the healthcare costs they do incur out-of-

 

314   •  Pharmocracy II

 

 

pocket—even though they are paying higher health insur-ance premiums!

 

High co-pays (ranging from 10%-40%) even after the annual deductible is met mean that the middle class cannot afford to fall ill, especially as skyrocketing premiums for sub-standard insurance depletes their savings.. (Low-income individuals are eligible for government subsidies to offset many of these costs, which mean they are borne instead by taxpayers..)

 

ALARMING NEW REPORTS

 

Last year, a report published by the Brookings Institute revealed the nightmare facing middle-income Americans.. The findings showed that middle-income household spend-ing on healthcare has risen 25% from 2007 to 2014..4 The only reason the middle-class has survived this sharp price increase is that the costs of other necessities have plum-meted during that same time period..

 

A Kaiser Family Foundation report confirmed this bleak picture.. Deductibles for individual workers have risen 67% since 2010, which is roughly 7 times more than earnings growth over the same period..5 A separate Kaiser analysis of tens of millions of insurance claims found that patient “cost-sharing” has skyrocketed since 2004.. This has been driven by a 256% surge in deductibles that consumers now have to bear..6 Recall in the not-so-distant-past when deductibles were only a few hundred dollars..

 

With many generic drugs now costing thousands of dol-lars, and some new medications costing $100,000 each year, it is clear that only the wealthy or very poor have affordable access to healthcare in America..

 

Very low-income individuals have Medicaid coverage, which usually pays 100% of medical costs, even for expen-sive drugs that exceed $100,000 annually..

 

Unsustainable High Drug Prices!                •  315

 

 

Like those with today’s substandard insurance, however, Medicaid recipients are refused treatment by some of the better physicians.. They at least don’t have to pay out their life savings in premiums and deductibles only to be told by their insurance carrier that the therapy they need to live is “not medically necessary” or “not approved by the FDA for their specific indication..”

 

These two excuses are routinely used by insurance car-riers to deny seriously ill people access to drugs that pub-lished studies indicate are efficacious.. This healthcare cost crisis is projected to worsen as employers increasingly shift more healthcare costs to workers..

 

WHY GENERIC DRUG PRICES ARE SKYROCKETING

 

Back in 2003, it cost less than $1 million to file a generic drug application with the FDA.. That price was way too high as most generics can easily copy the branded drug and deliver the same bioequivalence..11

 

Today’s cost of gaining FDA approval of a generic is $5 million and sometimes much higher.. As a result of these oppressive approval costs, many generic drugs face no competition.. This results in consumers paying almost as much as the patented version..

 

Excessive regulatory burdens have resulted in new generics being delayed for years while the costs of mak-ing them have been needlessly driven up by regulatory burdens.. None of this excludes the probability of collusion among certain generic makers, as many cease producing a generic even after paying the costs of FDA approval.. This sometimes happens when one company pays another to cease production, at which time the remaining generic pro-pels upwards in price..

 

316   •  Pharmocracy II

 

 

 

CHART PUBLISHED BY LIFE EXTENSION® IN 1999

 

EXPOSING SCANDALOUS HIGH DRUG PRICES*

 

OUTRAGEOUSLY HIGH DRUG PRICES

 

When we established the FDA Museum in 1994, one of the areas of malfeasance we exposed was the inflated prices Americans pay for their medicines compared to citi-zens of other countries. In March 1999, The Life Extension Foundation® conducted a survey of popular European and US drug prices to see what the actual difference was. We compared these drugs brand name to brand name. We are reprinting the following chart to show just how badly Ameri-cans are being defrauded by the FDA-protected drug cartel:

 

Drug

 

Potency

US Price

European Price

 

 

 

 

 

Premarin

 

28 0 .6 mg

$14.98

$4.25

 

 

 

 

 

Synthroid

 

50 100 mg

$13.84

$2.95

 

 

 

 

 

Coumadin

 

25 10 mg

$30.25

$2.85

 

 

 

 

 

Prozac

 

14 20 mg

$36.12

$18.50

 

 

 

 

 

Prilosec

 

20 28 mg

$109.00

$39.25

 

 

 

 

 

Norvasc

 

30 5 mg

$44.00

$23.00

 

 

 

 

 

Claritin

 

20 10 mg

$44.00

$8.75

 

 

 

 

 

Augmentin

 

12 500 mg

$49.50

$8.75

 

 

 

 

 

Zocor

 

28 20 mg

$96.99

$45.00

 

 

 

 

 

Paxil

 

28 30 mg

$63.69

$43.00

 

 

 

 

 

Zestril

 

28 0.6 mg

$53.49

$15.00

 

 

 

 

 

Prempro

 

50 850 mg

$23.49

$4.75

 

 

 

 

 

Glucophage

 

60 5 mg

$54.49

$4.50

 

 

 

 

 

Cipro

 

20 500 mg

$87.99

$62.75

 

 

 

 

 

 

 

 

 

 

 

 

* (This problem has exponentially worsened since then)

 

Unsustainable High Drug Prices!                •  317

 

 

 

 

 

 

 

 

 

Drug

Potency

US Price

European Price

 

 

 

 

 

 

 

 

Zoloft

100 50 mg

$80.00

$65.00

 

 

 

 

 

 

 

 

Pravachol

28 10 mg

$55.60

$31.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

THERE IS A FREE-MARKET SOLUTION

 

We at Life Extension® have long espoused an easy solution to drug price gouging, which is to amend the Food, Drug, and Cosmetic Act to allow competition in the generic mar-ketplace.. If enacted, generic prices will plummet to lev-els so low you won’t even worry about what percentage your insurance company pays.. When generic drugs drop this much, it will push down many patented pharmaceuti-cal prices because generic substitutes often work as well as newer branded drugs..

 

Against us are pharmaceutical lobbyists who will do vir-tually anything to protect their lucrative monopoly against free-market competition.. On our side are 330 million Amer-ican consumers, most of whom cannot afford to fall ill even if they have health insurance.. That’s because the deduct-ibles, co-pays, and exclusions result in enormous out-of-pocket expenses that are today’s leading cause of personal bankruptcies..

 

FIGHT BACK AGAINST FDA TYRANNY!

 

In 1992, the FDA proposed to re-classify certain dietary supplements as prescription drugs.. This ignited an ava-lanche of protests by consumers..

 

Congress was inundated with letters demanding legis-lation to prevent the FDA from censoring access to natu-ral ingredients that had demonstrated health benefits.. The result was passage of the Dietary Supplement Health and

 

318   •  Pharmocracy II

 

 

Education Act in 1994..12 This Act spared many lives by pro-viding consumers with affordable access to nutrients like coenzyme Q10 and higher-potency vitamin D..

 

Life Extension® continues to coordinate with other health freedom groups to stop Big Pharma from further monopo-lizing consumer access to effective conventional medical care.. We need the support of readers of this book to win these battles..

 

For those who think it’s not worth the effort, consider the consequences of failing to take action..

Innovation in the natural ingredient marketplace will be stifled while pharmaceutical companies take the same ingre-dients and gain FDA protection to sell them as prescription drugs.. Many retired seniors will have to take jobs to afford their medications.. Those working full time may have to find additional part-time work to pay the high premiums and many out-of-pocket expenses no longer covered by medi-cal insurance.. These problems can be partially resolved if free-market competition is allowed in the generic drug and dietary supplement marketplaces..

 

LOG ON TO OUR LEGISLATIVE ACTION WEBSITE

 

Life Extension® has ongoing grassroots campaigns to over-whelm lobbyists that dominate Congress and federal agen-cies.. We maintain a website with the current Representa-tives and Senators so you can easily send emails protesting legislation that restricts competition, stifles biomedical innovation and unnecessarily drives up drug prices..

 

To let your voice be heard on Capitol Hill please log on to: StopFDA..org

 

Unsustainable High Drug Prices!                •  319

 

 

References

 

  1. Life Extension Wins in the House and Senate.. Available at: http://www..stopfda..org/sep2000_awsi..htm.. Accessed Oct.. 27, 2016..

 

  1. New England Journal of Medicine Exposes Generic Price

 

Scandal. . Available at: http://www. lifeextension.. com/. Magazine/2016/3/New-England-Journal-of-Medicine-Exposes-Generic-Price-Scandal/Page-01.. Accessed Oct.. 27, 2016..

 

  1. Burden of Health-Care Costs Moves to the Middle Class.. Available at: http://liveclinic..com/blog/healthcare-news/ burden-u-s-health-care-costs-moving-middle-class/.. Accessed Oct.. 27, 2016..

 

  1. Under Pressure: Shifts in Household Spending Over the Past

 

30 Years.. Available at: https://www..brookings..edu/blog/ up-front/2016/06/03/under-pressure-shifts-in-household-spending-over-the-past-30-years/.. Accessed Oct.. 28, 2016..

 

  1. 2016 Employer Health Benefits Survey.. Available at: http:// kff..org/report-section/ehbs-2016-summary-of-findings/.. Accessed Oct.. 28, 2016..

 

  1. Payments for Cost Sharing Increasing Rapidly Over Time.. Available at: http://kff. .org/health-costs/issue-brief/ payments-for-cost-sharing-increasing-rapidly-over-time/.. Accessed Oct.. 28, 2016..

 

  1. The price of an EpiPen has skyrocketed more than 500% since

 

2009 — and senators are asking for answers.. Available at: http://www..businessinsider..com/epipen-price-increases-about-500-percent-2016-8.. Accessed Nov.. 1, 2016..

 

  1. People are furious about the price of the EpiPen — here’s how much it’s increased in the last decade.. Available at: http:// www..businessinsider..com/how-much-price-of-mylans-epipen-has-increased-2016-8.. Accessed Nov.. 1, 2016..

 

320   •  Pharmocracy II

 

 

  1. It’s Jaw-Dropping How Little It Costs to Make an EpiPen.. Available at: http://time..com/money/4481786/how-much-epipen-costs-to-make/.. Accessed Nov.. 1, 2016..

 

  1. The $300 generic EpiPen from Mylan shows drug pricing is broken in the United States.. Available at: https://mic.. com/articles/152912/generic-epipen-mylan-half-price-300-dollars-still-shows-drug-pricing-crisis-in-the-united-states#.. U1vUJo97O.. Accessed Nov.. 2, 2016..

 

  1. How Obama’s FDA Keeps Generic Drugs off the Market.. Available at: http://www..wsj..com/articles/how-obamas-fda-keeps-generic-drugs-off-the-market-1471645550.. Accessed Nov.. 2, 2016..

 

  1. Dietary Supplement Health and Education Act of 1994.. Availableat:https://www.congress .gov/bill/103rd-congress/ senate-bill/784..

Epilogue

 

 

As I was concluding this book, some interesting devel-

opments were occurring that corroborate what you’ve read up until now.. I summarize these in this con-

cluding epilogue:

 

BRAND-NAME DRUG PRICES RISE AT SHOCKING RATE

 

A study published in the final days of 2016 found that older Americans are being gouged by the prices of brand-name drugs, which skyrocketed last year at a rate 130 times faster than inflation..*

 

Researchers at the nonprofit organization AARP discov-ered that the retail prices of 268 brand-name prescrip-tion drugs rose, on average, 15..5% in 2015 against a 0..1% increase in the rate of general inflation.. The drugs, which are commonly taken by seniors, include 49 that are used to treat diabetes, high cholesterol, high blood pressure and other wide-spread, chronic conditions..

 

Debra Whitman, chief public policy officer at AARP, stated in a news release, “What’s particularly remarkable is

 

* Available at: http://tinyurl.com/jpr8p5q. Accessed December 15, 2016.

 

 

  • 321

 

322   •  Pharmocracy II

 

 

that these incredibly high price increases are still occurring in the face of intense public and congressional criticism of prescription drug pricing practices..”

 

On average, the elderly take 4..5 prescriptions monthly.. Couple that with the average cost of regular use for one brand-name drug, which rose to over $5,800, and that brings average annual drug cost to around $26,100.. Medicare benefi-ciaries’ average median income is just $24,150..

 

“Prescription drug therapy is not affordable when its cost exceeds the patient’s entire income,” said report co-author Leigh Purvis.. “Even if patients are fortunate enough to have good healthcare coverage, high prescription drug costs translate into higher out-of-pocket costs..”

 

Editor’s Note: According to the study, of the six drugs with the highest price increases, five were from Vale-ant Pharmaceuticals.. The study’s authors found the price of Ativan, the company’s antianxiety drug, shot up over 2,800% between 2006 and 2015.. The cost of the active ingredient in this drug is virtually nothing, but the price nonetheless spiraled upwards.. The next update summary explains how a generic drug price could escalate so high.. The answer is price fixing among generic makers, a sit-uation that could not occur if there was a real free mar-ket when it comes to generic drug manufacture and sale.. Instead, all generic makes need the FDA’s blessing before selling an off-patent drug that is no more complex to man-ufacture than a dietary supplement..

 

FORMER DRUG COMPANY EXECS CHARGED IN PRICE-FIXING PLOT


 

As part of an ongoing Department of Justice investigation into the generic drug industry, charges have been brought

 

Epilogue              •  323

 

 

against two ex-drug company executives for allegedly par-ticipating in a bid-rigging and price-fixing plot..*

Named in separate two-count felony cases were Jason Malek, the former president of Heritage Pharmaceuticals, and Jeffrey Glazer, the company’s former CEO.. The alleged scheme involved two drugs: the diabetes medication gly-buride and doxycycline hyclate, an antibiotic.. According to court papers filed in Philadelphia, the scheme was in effect possibly dating back to April 2013 and continued to December 2015..

 

The cost of 500 tablets of doxycycline is reported to have gone from $20 in October 2013 to a whopping $1,845 in May 2014..

 

Deputy Assistant Attorney General Brent Snyder charged that the two executives entered into unlawful agreements to fix prices and “sought to enrich themselves at the expense of sick and vulnerable individuals who rely upon access to generic pharmaceuticals as a more affordable alternative to brand-name medicines..”

 

Following an internal investigation, Heritage had fired both men in August.. Reacting to the charges, the company stated the former executives had engaged in “a variety of serious misconduct..”

 

Editor’s Note: In a prepared statement, Special Agent in Charge Michael Harpster of the FBI’s Philadelphia divi-sion commented, “Conspiring to fix prices on widely-used generic medications skews the market, flouts common decency, and very clearly breaks the law.. It’s a sad state of affairs when these pharmaceutical executives are deter-mined to further pad their profits on the backs of people whose health depends on the company’s drugs..”

 

 

* Available at: http://tinyurl.com/z9rl3yo. Accessed December 15, 2016.

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