Life Extension Magazine®

Issue: Mar 2010

Drug Company Pleads Guilty to Health Fraud

For thirty years, Life Extension® has exposed the unconscionable scientific and financial fraud perpetrated on the American people by drug companies. In an unprecedented development, a pharmaceutical giant has pled guilty to a felony with intent to defraud. For those who harbor any misconceptions about the true motives behind illicit pharmaceutical practices, we expose fresh evidence of drug company deceit.

By William Faloon.

William Faloon 
William Faloon

Life Extension® has spent the last three decades exposing horrific financial and scientific fraud perpetrated by the pharmaceutical industry and the FDA.

We have revealed how pervasive pharmaceutical deceit infiltrates government, academia, and the media, causing consumers to pay outrageous prices for dangerous drugs that provide little or no benefit.

In an unprecedented development, a pharmaceutical giant has pled guilty to a felony with the intent to defraud,and its parent has agreed to pay a record $2.3 billion to reimburse Medicare, Medicaid, and other agencies for drugs that were marketed in violation of various federal laws.1

For those who labor under the misconception that pharma-ceutical companies serve benevolent purposes, the multiple criminal counts you are about to read will eradicate this fallacy.

Lethal Drug Illegally Promoted at Higher than Allowed Doses

Most of you are familiar with the Vioxx® scandal, where pharmaceutical giant Merck has spent billions of dollars defending and settling lawsuits showing that the deadly dangers of this drug were known long before it was withdrawn.

A lesser-known arthritis drug in this category called Bextra® was also withdrawn because of increased risks of heart attacks and strokes, as well as deaths, in patients prescribed it.2-4

Lethal Drug Illegally Promoted at Higher than Allowed Doses

In a startling admission, a subsidiary of pharmaceutical behemoth Pfizer has pled guilty to a criminal charge that it fraudulently sold Bextra® not to treat arthritis, but to be used in higher doses to relieve acute and surgical pain.5

Even at the usual dose, Bextra® inflicted fatal side effects. In a 2004 analysis presented at the American Heart Association, Bextra® was shown to more than double the risk of heart attack or stroke. The lead author of this study commented that “This is a time bomb waiting to go off.”6

The record financial payout by Pfizer is not because Bextra® injured or killed arthritis patients. It is to settle government claims that Pfizer illegally promoted the sale of Bextra® for uses and dosages that the FDA specifically declined to approve due to safety concerns. Of the total settlement, $1.195 billion represents a fine for the fraudulent marketing of Bextra®—the largest criminal fine ever imposed in the United States for any matter.

Life Extension® Members Learned of These Dangers Years Earlier

Years before the public learned about the dangers of Vioxx® and Bextra®, the Life Extension Foundation® warned its members that these drugs would create lethal havoc in the body.

The reason is that by selectively blocking the cyclooxygenase-2 (COX-2) enzyme, an imbalance is created that results in increased amounts of thromboxane A2 and leukotriene B4 being produced.7-9

Life Extension® Members Learned of These Dangers Years Earlier

Thromboxane A2 promotes abnormal arterial blood clots, the leading cause of acute heart attack and stroke.10 Leukotriene B4 inflicts massive inflammatory damage to the arterial wall and other tissues of the body.11

COX-2 inhibiting drugs like Vioxx® and Bextra® can increase thromboxane A2 and leukotriene B4 unless healthy dietary changes are instituted. This means reducing or eliminating from one’s diet arachidonic acid-rich foods (egg yolk, red meat, poultry, and dairy), high- glycemic index carbohydrates, and omega-6 fats. The adverse effects of COX-2 inhibiting drugs may also be mitigated by taking a low-dose aspirin tablet each day, along with fish oil and curcumin.12-14

Based on these deadly under-lying mechanisms, Life Extension knew that Vioxx®, Bextra®, and other drugs in this category would kill thousands of unsuspecting patients. Against us were pharmaceutical companies who spent billions of dollars misleading consumers and doctors into be-lieving these drugs were “safer” than aspirin.

We don’t believe the government even realizes how many needless deaths may have occurred as a result of the unauthorized and illegal promotion of Bextra®. The government focused its criminal charges instead on paperwork violations and financial losses to Medicare-Medicaid, not the patients injured by the illegal sale of this lethal drug.

Cash Kickbacks Paid to Doctors to Prescribe Drugs

Part of the $2.3 billion settlement involves allegations that Pfizer paid doctors kickbacks to induce them to prescribe the following drugs:

Drug Indication
Aricept® Alzheimer’s
Celebrex® Arthritis
Lipitor® High Cholesterol and LDL
Norvasc® Hypertension
Relpax® Migraine
Viagra® Impotence
Zithromax® Antibiotic
Zoloft® Depression
Zyrtec® Allergy

The government’s complaint describes how Pfizer compensated doctors to prescribe these drugs in some instances by providing cash payments or so-called “gifts” such as travel, entertainment, and meals. Illegal remuneration was also allegedly paid to doctors in the form of speaker fees, mentorships, preceptorships, and journal clubs.

When one reviews the diverse list of drugs that Pfizer is claimed to have paid doctors to prescribe, it is no wonder they grew to become the largest pharmaceutical company in the world.

Physicians Paid to Illegally Prescribe Drugs

It’s one thing to break the law by paying doctors to prescribe drugs that at least have some degree of documented efficacy, but Pfizer went further than this.

Physicians Paid to Illegally Prescribe Drugs

The government’s complaint describes how Pfizer created new uses for its patented drugs and then engaged in all kinds of devious schemes to illegally promote these “new uses” to physicians. For instance, Pfizer claimed their drug Lyrica® was superior to lower-cost generic medications to treat neuropathic and surgical pain, and then illegally compensated doctors to prescribe Lyrica® for these indications.15

Geodon® is a drug approved to treat schizophrenia or acute bipolar mania, but the government outlined in its complaint that Pfizer was inappropriately and illegally promoting it for use in children and adults to treat autism, attention deficit hyperactivity disorder, mood disorders, and depression. The government contended that Pfizer illegally promoted Geodon® at dosages that were off-label and “offered and paid illegal remuneration to health care professionals to induce them to promote and prescribe Geodon in violation of the Federal Anti-Kickback Statute.”16

Zyvox® is an antibiotic Pfizer makes to treat deadly antibiotic-resistant MRSA staph infections. The settlement agreement outlined various alleged misconduct relating to the illegal marketing of this drug, including how Pfizer falsely advertised that Zyvox® was superior to generic vancomycin and then illegally paid doctors to prescribe it.17

Pfizer Gets By with a Slap on the Wrist

In the settlement agreement, Pfizer only has to agree to admit to the Bextra® criminal charge. In exchange for paying a total of $2.3 billion, Pfizer is allowed to claim a denial of the government’s other allegations.

Pfizer Gets By with a Slap on the Wrist

To give you an idea what a drop in the bucket this payout is to Pfizer, when a one-time tax break was given to corporations that repatriated offshore profits, Pfizer brought back $37 billion of cash stashed away from its foreign operations.18 Pfizer did this because the tax rate was only 5.25% that year. Considering how much more they made in their largest market (the United States), writing a $2.3 billion check to settle these massive fraud claims is pocket change to a company the size of Pfizer.

This is not the first time Pfizer was caught committing these illegal acts. Prosecutors noted that this was Pfizer’s fourth such settlement since 2002.1 In fact, according to the US Attorney, while Pfizer was negotiating deals over past misconduct, they were continuing to violate the same laws with other drugs.19

Contrast Pfizer’s “slap-on-the-wrist” fine to what the FDA does to those who practice alternative medicine. Under far less egregious circumstances, the government seizes everything owned by alternative practitioners and often subjects them to harsh jail sentences.

Drug Companies Pay Ghostwriters

According to a study released by editors of the Journal of the American Medical Association, drug companies pay doctors with prestigious university affiliations to put their name on so-called “scientific papers” that are written by ghostwriters.20

These pharmaceutical company-financed articles, carefully calibrated to sell expensive prescription drugs, slip by the peer-review process and make it into the top medical journals. Not only do these articles influence physician prescribing practices, but the media often picks up on them and runs favorable news articles about these deceptively promoted drugs.

As Life Extension reported last year, drug company Wyeth faces 8,400 lawsuits from women who claim Premarin® or PremPro® caused them to become ill. Court documents from these cases reveal that Wyeth paid ghostwriters to produce 26 “scientific” papers supporting the use of their dangerous female hormone drugs.21

The Wyeth-funded articles extolled purported benefits of these unnatural hormone drugs while downplaying their lethal risks. Nowhere in these articles was Wyeth’s role in initiating and paying for them disclosed.

Court documents show how Wyeth contracted with private companies to outline articles, draft them, and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing to them. These tainted articles were published in medical journals between 1998 and 2005, and helped generate billions of dollars of sales for Wyeth.21

The latest corroboration of large-scale drug company-induced ghostwriting substantiates what Life Extension uncovered decades ago: drug companies manipulate scientific data to deceive doctors into prescribing dangerous drugs.

If you wonder how pharmaceutical companies have been able to defraud the American public for so many decades, look no further than the incestuous relationship they maintain with the FDA. By providing the pharmaceutical industry a virtual monopoly over drug sales in the United States, as the FDA does, consumers have only limited options when they contract a serious illness.

Those who offer alternatives to FDA-approved drugs often find themselves under criminal or civil investigation by any number of federal agencies, thus impeding or outright blocking their ability to compete against pharmaceutical behemoths.

Where to Find Unbiased Drug Information

Not all prescription drugs are fraudulently sold. In fact, some medications confer longevity benefits. The problem is that pharmaceutical companies exert so much control over the FDA that consumers cannot rely on this agency to protect them against dangerous and ineffective drugs.

The Life Extension Foundation is not a patent holder of expensive prescription drugs, nor are we economically beholden to the pharmaceutical industry. Our track record of warning against dangerous drug side effects, while recommending safer and more effective drug uses, exceeds anything that the FDA has ever done to protect consumers.

As a Life Extension member, you obtain unbiased scientific data, free from the scandalous and criminal pharmaceutical company deception most Americans are vulnerable to.

For longer life,

For Longer Life

William Faloon

References

1. Available at: http://www.miamiherald.com/101/story/1216716.html. Accessed October 21, 2009.

2. Available at: http://www.medicinenet.com/script/main/art.asp?articlekey=46601. Accessed October 21, 2009.

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

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

5. Available at: http://online.wsj.com/article/SB125190160702979723.html. Accessed October 21, 2009.

6. Available at: http://www.medscape.com/viewarticle/538008. Accessed October 21, 2009.

7. Khanapure SP, Garvey DS, Janero DR, Letts LG. Eicosanoids in inflammation: biosynthesis, pharmacology, and therapeutic frontiers. Curr Top Med Chem. 2007;7(3):311-40.

8. Mao JT, Tsu IH, Dubinett SM, et al. Modulation of pulmonary leukotriene B4 production by cyclooxygenase-2 inhibitors and lipopolysaccharide. Clin Cancer Res. 2004 Oct 15;10(20):6872-8.

9. Snyderman CH, Abbas MM, Wagner R, D’Amico F. Inhibition of growth of a murine squamous cell carcinoma by a cyclooxygenase inhibitor increases leukotriene B4 production. Arch Otolaryngol Head Neck Surg. 1995 Sep;121(9):1017-20.

10. Cheng Y, Austin SC, Rocca B, et al. Role of prostacyclin in the cardiovascular response to thromboxane A2. Science. 2002 Apr 19;296(5567):539-41.

11. Subbarao K, Jala VR, Mathis S, et al. Role of leukotriene B4 receptors in the development of atherosclerosis: potential mechanisms. Arterioscler Thromb Vasc Biol. 2004 Feb;24(2):369-75.

12. Leaberry BA. Aspirin for the prevention of cardiovascular disease: systematic review. J Nurs Care Qual. 2010 Jan-Mar;25(1):17-21.

13. Lavie CJ, Milani RV, Mehra MR, Ventura HO. Omega-3 polyunsaturated fatty acids and cardiovascular diseases. J Am Coll Cardiol. 2009 Aug 11;54(7):585-94.

14. Srivastava G, Mehta JL. Currying the heart: curcumin and cardioprotection. J Cardiovasc Pharmacol Ther. 2009 Mar;14(1):22-7.

15. Available at: http://www.ahrp.org/cms/content/view/633/9/. Accessed October 28, 2009.

16. Available at: http://www.justice.gov/usao/pae/News/Pr/2009/sep/pfizerrelease.pdf Accessed October 28, 2009.

17. Available at: http://www.reuters.com/article/pressRelease/idUS160827+02-Sep-2009+PRN20090902. Accessed October 28, 2009.

18. Available at: http://www.nytimes.com/2008/06/24/business/24tax.html. Accessed October 28, 2009.

19. Available at: http://www.msnbc.msn.com/id/32657347/ns/business-us_business/. Accessed October 28, 2009.

20. Ross JS, Hill KP, Egilman DS, Krumholz HM. Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. JAMA. 2008 Apr 16;299(15):1800-12.

21. Available at: http://www.nytimes.com/2009/08/05/health/research/05ghost.html. Accessed October 29, 2009.

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