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In May 1999, the FDA fast-tracked Vioxx (the anti-inflammatory NSAID) despite suspicions at the time that Merck knew of dangerous side effects and marketed the drug anyway. Evidence later emerged that the FDA knowingly approved, promoted, and refused to recall it after as many as 100,000 heart attacks were reported and thousands of deaths.
Dr. Richard Horton, editor of The Lancet, said this after reading Wall Street Journal-published insider emails on how Merck hid damaging clinical trials evidence and sold the drug anyway:
"In the case of Vioxx, the FDA was urged to mandate further safety testing after a 2001 analysis suggested a 'clear-cut excess number of myocardial infarctions.' It did not do so. This refusal to engage with an issue of grave clinical concern illustrates the agency's in-built paralysis, a predicament that has to be addressed through fundamental organizational reform....the FDA acted out of ruthless, short-sighted, and irresponsible self-interest" to protect the interests of its own - and it happens regularly by approving dangerous drugs and only recalling them in cases too egregious to ignore. Even then only reluctantly to assure maximum industry profits.
The agency also censors its own scientists as Dr. David Graham, associate director for science in the FDA's Office of Drug Safety, explained in summer 2005:
"....the review and clearance process has been turned into a battleground, full of contention and intimidation because our managers, the people who fill out our performance evaluations, had created a system where it was taking a great risk to stand firm in our scientific beliefs."
He essentially called the FDA a corrupted, industry-controlled tool placing bottom-line considerations over public health and welfare, then punishing whistleblowers who expose abuses.
On September 30, 2004, Merck, not the FDA, voluntarily recalled Vioxx after facing growing numbers of lawsuits (burgeoning later to around 50,000), but admitted no fault or responsibility at the time. It was later learned that around 80% of Vioxx claimants were on Medicare or Medicaid. Government, not Merck, will pay 80% of settlement claims. Merck may later repay some or all of them.
However, under a subsequent FDA preemption policy, no lawsuits may be filed in state courts pertaining to agency-approved drugs so winning them in federal ones, stacked mostly with hard-right Federalist Society-affiliated or approved judges, will prove far more challenging, expensive, and time consuming. In addition, getting approvals for class-actions will be harder.
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