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Life Extension Magazine

Life Extension Magazine March 2009
AS We See It

Ending the Atrocities

By William Faloon
Ending the Atrocities

Today’s population lives on a railroad track. Everything may be fine for the moment—until a freight train comes along and wipes us out.

We at Life Extension have pled for 29 years to get off the track before the train comes.

A startling number of reports reveal the FDA is in far worse shape than originally thought. Few people comprehend that they are likely to suffer and die prematurely as a result of FDA’s failures.

The media does a decent job reporting on FDA disasters. The apathetic public, however, often forgets what they read the next day. That is, until they are diagnosed with a serious illness. Then they go into a panic mode to find an effective treatment. All too often, however, the cure does not exist because of FDA bureaucratic roadblocks. In other cases, the FDA-approved drugs available induce horrific side effects.

It is our mission to memorialize these tragedies to demonstrate the urgent need to radically reform the FDA. This “state-sponsored” carnage of the American citizenry must be stopped!

FDA Disseminates Fraudulent Safety Data

Ketek® (telithromycin) is a drug the FDA approved to treat mild-to-moderate pneumonia. Ketek® can also cause sudden and serious liver damage. In some cases, complete liver failure develops necessitating the need for a liver transplant. Some patients die before a liver transplant can be performed.1-5

The risks of liver failure (and other toxic side effects) were known before the FDA approved Ketek®. In order to convince an outside scientific advisory committee to recommend that Ketek® be approved, the FDA knowingly allowed a fraudulent safety study to be presented. Here is what the Senate Investigative Committee uncovered:6

  1. FDA accepted the resubmission of a new drug application, which included safety data that were fraudulent, in whole or in part.

  2. FDA employees presented the fraudulent study data to the advisory committee that was tasked with recommending Ketek®’s approval or disapproval.

  3. FDA instructed its employees preparing to appear before the advisory committee that they should present these fraudulent safety data.

  4. FDA approved a pediatric clinical trial of Ketek®, involving infants as young as six months old, despite concerns related to known toxicities affecting the heart, eyes, liver, and vascular system.

  5. FDA continued to knowingly cite the fraudulent study data in publically released safety information on Ketek®.

How fraudulent were these data? While the FDA was presenting these fake data, a criminal investigation was simultaneously being conducted that found the clinic where the “safety” study allegedly occurred was closed during the time the study was supposed to have taken place. It was also determined that documents relating to the safety study had date modifications and signature inconsistencies.

FDA Disseminates Fraudulent Safety Data

Shortly after the advisory committee meeting where the fake safety data were presented by FDA employees, the person who conducted the study was criminally indicted, pled guilty, and was sentenced to almost five years in jail.

It is even more shocking that the FDA continued to cite this safety study long after the principal investigator admitted it was fraudulent. While the perpetrator of this “safety” study was in prison for falsifying the data, the FDA used the very same study to issue a Public Health Announcement stating:

“Based on the pre-marketing clinical data it appeared that the risk of liver injury with telithromycin [Ketek®] was similar to that of other marketed antibiotics.”7

The “pre-marketing clinical data” FDA cited to mislead the public about Ketek® was the fraudulent study, a study that may never have actually occurred. According to the Senate Investigative Committee report, “it defies explanation why the FDA would continue to cite” this fraudulent study to the American public to imply that Ketek® is safe.8

The Senate Committee report concluded by stating that, “Retaliation against these individuals, or any other FDA employees who communicate with the committee with reference to Ketek® will not be tolerated.8

Based on the tone of the Senate investigative report, it would appear that the FDA functioned as a continuous criminal enterprise in this instance.8,9

The Revolving Door

You may wonder why certain officials in the FDA would go to such extreme lengths to get a lethal drug like Ketek® approved.

The Revolving Door

Look no further than the gargantuan economic benefits drug companies reap when a patented compound like Ketek® receives the FDA seal of approval.

When we first exposed the revolving door of FDA employees going to work for companies they regulate, virtually no one believed us. Back in the 1980s, most Americans were deceived by FDA propaganda stating that the agency “is responsible for protecting the public health by assuring the safety…of human drugs.”12

The harsh reality is that the FDA functions primarily to protect the financial interests of the pharmaceutical industry, not the public’s health. If anyone ever questioned this, look no further than the FDA’s attempts last year to ban the safest form of estrogen (estriol). The FDA has no qualms about publically stating that its ban on estriol was based on a petition filed by Wyeth, the maker of dangerous estrogen drugs like Premarin® and Prempro®.

There are a number of estrogen drugs that have not been shown to increase stroke or breast cancer risk.13 The FDA, however, has done nothing to remove Premarin® or Prempro®. Instead, the FDA openly seeks to protect Wyeth’s market share by denying American women access to natural estriol.

According to the FDA, “bioidentical hormone products are unsupported by medical evidence and are considered false and misleading by the agency.”14 The truth is that bioidentical hormones are far less expensive and pose a major competitive threat to Wyeth, ergo the FDA’s aggressive attempts to disallow them.

In a report issued by the Associated Press just last year, it was revealed that a record number of FDA employees are leaving the agency to go to work for pharmaceutical companies. According to the Associated Press, these FDA staffers are resigning in order to go into “the more lucrative side of the business…”15

The FDA’s Brain Drain

As experienced FDA scientists leave the agency to work for Big Pharma, the remaining staff is leaner and less competent to approve new life-saving medications. As reported by the Associated Press, a consequence of FDA employees going to work for pharmaceutical companies is a clogging of the drug approval pipeline.

As long time Life Extension members know, the FDA drug approval process has always been a bureaucratic quagmire, where life-saving medications languish for years, decades, and sometimes forever. The drug pipeline has been “clogged” for almost 50 years. We are deeply disturbed that it is now taking even longer for life-saving medications to become available to those in need.

The Wall Street Journal continues to support our position with blistering exposés describing human beings who suffer horrendously and die while potential life-saving therapies languish at the FDA. An article published last year titled “Sick Patients Need Cutting-Edge Drugs” disclosed heart-wrenching reports of young cancer patients who were denied compassionate-use access to experimental drugs. The Wall Street Journal article raised the logical questions:

“Why do terminally ill patients have to wait so long to get access to the only treatments that hold any promise of saving their lives? And why is it not their right to decide?”16

These very issues have been discussed in Life Extension’s publications for nearly 30 years. We have analogized in previous articles how it is perfectly legal to engage in all kinds of risky activities, such as parachuting from high bridges, but it is illegal to make experimental medications available to terminally ill people without the FDA’s permission.

According to the Wall Street Journal, the drug delay problem is getting much worse. The problem has been magnified in recent years as the number of new drug approvals has fallen dramatically. The FDA approved just 16 new drugs in 2007 and 24 in 2008.17,18 That’s down from 139 in 1996.

With the approval of life-saving drugs grinding to a snail’s pace, the moronic cruelty of denying experimental drugs to terminal patients must stop. Each day a life-saving drug is delayed, human beings perish. The case for radical reform of the Food, Drug, and Cosmetic Act and the FDA itself has never been stronger.

How Many Drug-Induced Suicides?

The same Senate committee investigating the Ketek® scandal uncovered another study with falsified data. These fake data were used to support the approval of a popular antidepressant drug used by millions of human beings.

According to a report authored by a Harvard medical doctor, when the Paxil® application was submitted to an FDA advisory committee in 1991, the drug company improperly put people who had previously attempted suicide into the placebo group, so that it would appear that the Paxil® group would have the same rate or an even lower rate of suicide than the placebo recipients. This was done to make it appear that there was no increased risk of suicidal behavior in those taking Paxil® compared with placebo.

It took until 2006 for the manufacturer to send a letter to doctors admitting that the risk of suicidal behavior was 6.7 times higher in study subjects taking Paxil® compared with placebo.10

Suicide is the 11th leading cause of death in the United States.11 It killed over 32,000 people in the United States in 2004. The number of suicides attributed to drugs like Paxil® (selective serotonin-reuptake inhibitors) could be in the hundreds of thousands during the 13 years it was fraudulently marketed.8,9

FDA Bungles New System to Track Side Effects

Even when data used to approve a new drug are not fraudulent, there are inherent limitations in assessing toxic side effects in the clinical study setting. Reasons for this include the relatively short time period the drugs are evaluated in a clinical study compared with how long patients use them in the real world. Another problem is that clinical studies are often tightly controlled by doctors with specialized expertise in the particular drug they are evaluating. Practicing physicians, on the other hand, see dozens of patients a day and may not be familiar with the proper way to prescribe drugs that have a narrow safety window. Still another issue is the relatively small number of patients taking the drugs in a clinical study compared with the millions who may eventually be prescribed them.

Due to these serious limitations, post-approval surveillance is critical to identifying lethal side effects of prescription drugs that were not detected in the clinical trials.

According to a report by an independent auditing institute, the FDA squandered $25 million on a bungled computer system to track side effects of approved drugs.19,20 As a result, the FDA will have to rely on a dysfunctional system to track what are record-breaking numbers of adverse reports being made about drugs the agency previously approved as safe.

After this report showing that FDA errors and mismanagement caused this computer system to not be available, the FDA asked that most of the findings of the report be deleted. The independent institute who put the report together refused to capitulate to the FDA’s attempts to obstruct the report’s findings.20,21

Drug Prices Surge

In today’s upside-down regulatory system, Americans are prescribed drugs whose approval may be based on fraudulent or insufficient research data. Experimental therapies that could save their lives are routinely denied. The cost of existing medications meanwhile is skyrocketing.

Drug price increases often exceed the inflation rate. The average cost increase for the top 50 best-selling drugs was 7.82% in 2007, 6.73% in 2006, and 6.22% in 2005.22

Some very popular drugs are increasing at astronomical rates. The cost of the antidepressant Wellbutrin XL® went up by 44.5% from 2005 to 2007. The cost of the attention-deficit drug Adderall XR® went up by 33.5%. The price of the sleep aid drug Ambien® shot up 70.1% during this period.22

On less popular drugs, the price surges are worse than obscene. A drug used to treat heart problems in premature babies went from $136.10 to $1,875 in one year. A drug used to treat a certain cancer (Cosmegen®) increased from $16.79 to $593.75 in one year. A drug used to treat spasms in babies (Acthar®) was increased from about $1,650 to more than $23,000 in one year. Just imagine your baby suffering spasms and being asked to fork over $23,000 for one drug!23

Whether you use these drugs or not, you still suffer. The thoroughly corrupt Medicare Prescription Drug Act passed at the behest of pharmaceutical lobbyists mandates that taxpayers pay full retail prices for these drugs.24 Taxpayers will fork over $600 billion for these egregiously overpriced drugs in the first 10 years.25

Where consumers are really hurting is in their ever-increasing health insurance premiums. If you are fortunate enough to have someone else paying your premiums, you cannot help but note the higher deductibles and greater exclusions.

The FDA enables drug companies to financially rape the American consumer by stifling competition. There are so many regulatory hurdles to getting FDA approval for even a competitive generic drug that consumers often pay eight times more than they need to.

Under the guise of “consumer protection,” the FDA has been manipulated by pharmaceutical interests to restrict free market forces that would drive down drug costs.

FDA Botches Public Relations Campaign

The FDA has been pummeled by Congress and the media about its many scandals, including poor inspections of tainted foods, drugs, and other products it regulates.

Needless to say, this has created a severe image problem. So FDA officials decided to hire a public relations agency that would “create and foster a lasting positive public image of the agency for the American public,” according to agency documents.26

When taxpayer dollars are involved, the law mandates that a bidding process is used to ensure that the contract goes to the lowest cost contractor. According to an exposé published by the Washington Post, the propaganda contract went instead to a public relations firm with ties to the FDA official who arranged the deal. A loophole was used to avoid putting the contract up for bid.27

After being made aware of this apparent corrupt act, an FDA deputy commissioner suspended the public relations contract and ordered an independent investigation.

Congress responded by launching still another investigation into the FDA. According to the chairman of the House committee that oversees the FDA, “The agency chose to use its limited resources to save face instead of saving the public health.27

The FDA retains the power to make life and death decisions that affect all of us. When it comes to analyzing new therapies to extend human longevity, this involves the scientific and common sense ability to understand complex biochemical interactions that occur within living organisms. The FDA’s botched attempt to launch a misinformation campaign to cover up its inadequacies further calls into question its competency and moral legitimacy.

Do Drug Companies Have Any Decency?

It is beyond my comprehension to understand how pharmaceutical companies can look themselves in the mirror when they know they are selling drugs proven to kill.

Back in 1994, our best-selling product was shark cartilage. The problem we uncovered was that it was not curing cancer patients. We immediately notified our customers that a survey we conducted of those who bought shark cartilage showed it to be ineffective. We urged these people to seek other therapies.

The supplement industry was shocked at our findings, but most stopped promoting shark cartilage as an anticancer therapy. Our findings about shark cartilage’s lack of efficacy were confirmed several years later in a controlled study.

We were a relatively small organization in 1994 and losing our best-selling product was financially challenging. In no way, however, could we continue telling cancer patients that shark cartilage might help them when our own findings showed it did not work.

The fact the multibillion dollar pharmaceutical companies have no qualms about using fraudulent data to support the approval and continued sale of lethal drugs is an atrocity. That certain people within the FDA collude with pharmaceutical companies to allow dangerous and ineffective drugs on the market is an act so heinous that words do not exist to describe it.

Fighting Back

In 1994, we established the FDA Museum to document how the FDA’s failings were responsible for the needless deaths of millions of Americans.

Sadly, every assertion we made about the FDA back then has been validated by third parties and the FDA itself. I lament that we were proven correct, because this means that millions more Americans perished unnecessarily over the past 15 years… and the cost of today’s corrupt health care system threatens to financially decimate our country.

The FDA’s credibility is at an all-time low. There has never been a better time to enact legislation to reform the way health care is regulated in this country. With a new Congress in session, health freedom activists are aggressively seeking to have the law changed to allow free market forces to tear down the corrupt wall of bureaucracy that causes the needless deaths of thousands of Americans each day.

We at Life Extension are working with the American Association for Health Freedom (AAHF) to make our voices heard in Congress. AAHF is a coalition of integrative physicians, health care consumers, and health freedom activists committed to a complete reform of the FDA. Its Reform FDA Petition is available for signing at www.reformfda.org. AAHF and its coalition allies will hand deliver the petition to Congress and urge immediate and comprehensive FDA reform. For this to be successful, we need your help and signature now. Please log on to www.reformfda.org and join this petition campaign.

Why Your LEF Membership is so Important

More scientific innovation is occurring in the medical field than at any time in human history. This progress is irrelevant, however, if a regulatory barrier denies the fruits of this research to people in need, or allows drugs to be sold with lethal side effects, or renders the cost of medications unaffordable.

The Life Extension Foundation has been battling FDA ineptitude for three decades. Your support through membership dues and product purchases enables us to continue this ongoing struggle to convince Congress to radically reform the way health care is controlled in this country.

References

1. Gleason PP, Walters C, Heaton AH, Schafer JA. Telithromycin: the perils of hasty adoption and persistence of off-label prescribing. J Manag Care Pharm. 2007 Jun;13(5):420-5.

2. Ross DB. The FDA and the case of Ketek. N Engl J Med. 2007 Apr 19;356(16):1601-4.

3. Graham DJ. Telithromycin and acute liver failure. N Engl J Med. 2006 Nov 23;355(21):2260-1.

4. Mathews AW. Fraud, errors taint a key study of widely used Sanofi drug; despite some faked results, FDA approves antibiotic; one doctor’s cocaine use; company defends safety. Wall St J (East Ed). 2006 May 1:A1,A12.

5. Available at: http://www.drug-injury.com/druginjurycom/2007/12/ketek-case-repo.html. Accessed December 5, 2008.

6. Available at: http://www.druginjuryblog.com/2008/06/11/ketek-fraudulent-clinical-trials-prove-fda-not-doing-its-job-congress-says/. Accessed December 5, 2008.

7. Available at: http://www.fda.gov/ora/about/enf_story2006_archive/ch3/default.pdf. Accessed December 5, 2008.

8. Available at: http://finance.senate.gov/press/Gpress/2005/prg050106.pdf. Accessed December 5, 2008.

9. Available at: http://finance.senate.gov/press/Gpress/2007/prg122007a.pdf. Accessed December 5, 2008.

10. Available at: http://us.gsk.com/docs-pdf/media-news/Paxil-CR-and-Paxil-Adult-Suicide.pdf. Accessed December 5, 2008.

11. Available at: http://www.cdc.gov/ncipc/dvp/suicide/SuicideDataSheet.pdf. Accessed December 5, 2008.

12. Available at: http://www.fda.gov/opacom/morechoices/mission.html. Accessed December 5, 2008.

13. Birge SJ. Hormone therapy and stroke. Clin Obstet Gynecol. 2008 Sep;51(3):581-91.

14. Available at: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01772.html. Accessed December 5, 2008.

15. Available at: http://www.msnbc.msn.com/id/24953413/wid/7279844/. Accessed December 5, 2008.

16. Available at: http://online.wsj.com/article/SB121944789005365195.html?mod=opinion_main_commentaries. Accessed December 12, 2008.

17. Available at: http://www.pharmacistsletter.com/pl/newdrugs/FDA2007.pdf?cs=&s=PL. Accessed December 5, 2008.

18. Available at: http://online.wsj.com/article/SB123084693842347229.html. Accessed January 5, 2009.

19. Available at: http://www.ahrp.org/cms/content/view/476/28/. Accessed December 5, 2008.

20. Available at: http://www.ahrp.org/cms/index2.php?option=com_content&do_pdf=1&id=476. Accessed December 5, 2008.

21. Available at: http://finance.senate.gov/press/Bpress/2007press/prb030707a.pdf. Accessed December 5, 2008.

22. Available at: http://online.wsj.com/article/SB120355185318681367.html. Accessed December 5, 2008.

23. Available at: http://www.usatoday.com/money/industries/health/drugs/2008-08-07-costlydrugs_N.htm. Accessed December 11, 2008.

24. Available at: http://www.ustreas.gov/offices/public-affairs/hsa/pdf/pl108-173.pdf. Accessed December 5, 2008.

25. Available at: http://www.aafp.org/fpm/20050300/49what.html. Accessed December 5, 2008.

26. Available at: http://www.nytimes.com/2008/10/05/opinion/05sun4.html?ref=opinion. Accessed December 5, 2008.

27. Available at: http://www.washingtonpost.com/wp-dyn/content/article/2008/10/01/AR2008100103061_pf.html. Accessed December 5, 2008.