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http://www.fdareview.org/

Drug Company Pleads Guilty to Health Fraud

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of dollars defending and settling lawsuits showing that the deadly dangers of this drug were known long before it was withdrawn.

A lesser-known arthritis drug in this category called Bextra® was also withdrawn because of increased risks of heart attacks and strokes, as well as deaths, in patients prescribed it.2-4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

Continued on Page 2 of 2

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