Life Extension Magazine October 2012
As We See It
By William Faloon
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 suppress data showing the lethal dangers of this once-popular 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 piling 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 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 compensation 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Before it was withdrawn, Merck racked up $11 billion in Vioxx® sales.8 So with the criminal fine paid to the government and the money paid out so far to victims, Merck appears to be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Four years before Vioxx® was withdrawn, the results from a large clinical trial were published comparing patients using naproxen or Vioxx®.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, performed and paid for by the drug industry. The findings from this trial should have resulted in the FDA withdrawing approval of Vioxx®.
Instead, the drug industry (working in cahoots with FDA) came up with a ridiculous 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.
As you'll read in an eye-opening interview in this month's issue, Dr. Graham's battle to expose the lethal dangers of Vioxx® almost got him fired from the FDA.
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 promotion 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 no where 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 Medicaid regulations.12
Interestingly, there are published studies 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 government 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 behemoths 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 companies must maintain access to these government spigots to remain in business.
If a drug company is convicted of "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 enables 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 misdeeds. 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 Bextra® 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 company 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 subsidiary to plead guilty to the Bextra® charges enabled Pfizer to continue receiving lucrative Medicare/Medicaid reimbursement on its other drugs.
By allowing the Vioxx® atrocities to be settled on misdemeanor charges instead of felony counts, Merck will continue receiving billions of dollars of annual payments from Medicare/Medicaid.