Don’t fall for this dog and pony show. The FDA will become even more of a ball-less wonder now that Bubble Boy has stolen a second term:
The Food and Drug Administration — reacting to claims that it lets dangerous drugs stay on the market despite warnings from its own scientists — said Thursday it will bolster its safety oversight division.The action came as a prestigious medical journal accused the FDA of tolerating “lethal weaknesses” in its method of tracking serious side effects that can surface as newly approved drugs move into wider use.
The FDA’s safety oversight came under fire as the widely prescribed painkiller Vioxx was withdrawn Sept. 30 because it was found to increase the risk of heart attacks and strokes, a danger scientists both inside and outside the agency had warned of.
Drugs must go through a rigorous testing process before they are approved by the FDA. On Thursday, the agency said it had commissioned an outside study of the way it monitors whether already approved drugs pose serious health risks that went undetected during the initial testing process.
The FDA remedies were unveiled as the British journal the Lancet posted articles concluding that Vioxx should have been withdrawn from the market as early as 2000 — just a year after its FDA approval as an arthritis drug.
A commentator in the journal said new evidence reveals that Merck & Co., the manufacturer of Vioxx, was aware by 2000 that the drug increased the risk of heart attacks and strokes.
“This discovery points to astonishing failures in Merck’s internal systems of post-marketing surveillance, as well as to lethal weaknesses in the U.S. Food and Drug Administration’s regulatory oversight,” the Lancet’s editor, Richard Horton, wrote.
In the past year, the FDA has been accused of suppressing warnings raised by its in-house scientists about anti-depressants, as well as the conclusion of a drug safety staffer, Dr. David Graham, that Vioxx was unsafe. This week, the FDA published Graham’s report before rolling out its safety program improvements.
Without conceding any fault by the agency, acting FDA Commissioner Lester Crawford said staff scientists will now be guaranteed a voice in drug safety discussions when disagreements arise within the agency.
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Larry Sasich, a research analyst with the consumer watchdog organization Public Citizen’s Health Research Group, said the FDA’s actions miss the mark. “It’s a whitewash,” he said.Sasich said the underlying frailty in FDA oversight is that its safety division, charged with catching signs that new drugs have unacceptable risks, lacks independent power to overturn decisions by the FDA staffers who grant drug approvals — and whose reputations could be hurt by a reversal. The Office of Drug Safety should have independent power to recommend drug withdrawals and add warnings to drug labels, he said.
Sasich also faulted FDA’s plan for the Institute of Medicine — a unit of the National Academies, a government advisory organization — to conduct an assessment of FDA’s post-marketing safety surveillance process. Sasich said the review should also focus on how dangerous drugs get approved in the first place. And the probe should be conducted by Congress, which has the power to demand documents from private companies, he said.
“Twenty years ago, if a drug came off the market, FDA officials would be hauled up on the Hill” for a postmortem on how the drug managed to slip through the approval process, Sasich said. “Was something missed? Did the company withhold data from the FDA or muddy the waters?”
A scientific analysis posted by the Lancet Friday said both FDA and Merck should have realized several years ago, based on 29 clinical trials and other studies, that Vioxx was a dangerous drug and should be withdrawn.


