Merck Accounting Scandal
Concerns about the FDA's lack of oversight in the Marck Scandal jumped in 2004 when a leading FDA scientist, Dr. David Graham, acknowledged that Merck's arthritis drug Vioxx caused as many as 139,000 heart attacks, strokes and deaths.
Testifying before the Senate, Graham charged that Vioxx had killed between 28,000 and 55,000 people since the FDA placed it on a fast track for approval in 1999. The FDA approval came despite reports that Vioxx carried a high risk for heart attack and stroke.
Internal Merck documents reveal that the company has known about the dangers of Vioxx for several years but suppressed the data and marketed it aggressively.
The FDA jumped to Merck's defense and denounced Graham as "irresponsible" and
his opinions as "junk science." Previously, Graham said the agency suppressed his
findings of increased risks after he reviewed 1.4 million patient records from Kaiser
Permanente health care systems, showing that heart attack rates were five times higher with Vioxx, when compared to another drug.
Graham announced that he was facing pressure from FDA officials to move out of drug safety into an administrative role, which would sidetrack him from criticizing FDA enforcement procedures. Graham warned that the FDA has abandoned its watchdog role in favor of a cozy relationship with the pharmaceutical industry and that the public can no longer expect government protection from deadly medications.
The pharmaceutical industry has given over $38 million to the Republican Party since the 2000 election cycle, according to the Center for Responsive Politics.
Curt Furberg, a professor at Wake Forest University, publicly questioned the safety of Pfizer's Bextrawas and was also removed from an FDA advisory panel which was set to review the safety of COX-2 inhibitors. A University of Pennsylvania study indicated that Bextra doubles patient risk for heart attack and stroke. Furberg said FDA informed him that he would no longer participate in a committee meeting next year to review the safety of COX-2 inhibitors, including Bextra, Pfizer's Celebrex and Merck's Vioxx. This came on the heels of his quote in the New York Times where he said Bextra appeared to have similar risks as Vioxx - which was withdrawn from the market in September for safety reasons and Pfizer tried to conceal that information.
In 2004, the FDA failed to meet 70 percent of their own benchmarks for proposed rulemaking, final deadlines and reaching decisions on petitions with deadly consequences. For example, in October 2003, the FDA announced they would issue warnings about the risks and fatal side effects of a toxic heart drug, Cordarone.
After over a thousand deaths and thousands of severe medical complications, The FDA asked the drugs manufacturer, Wyeth, to write their own regulations.
The lack of FDA enforcement is consistent with Bush's policy of allowing corporations to regulate themselves.
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