The approval of the antibiotic, Ketek (telithromycin), is another example where the FDA accommodated a drug company, and in this case, despite the fact that the company submitted fraudulent studies to support Ketek's application for approval and repeatedly provided incomplete safety information on the drug.
Internal FDA emails that came to light during Congressional investigations reveal that the FDA was fully aware of the serious problems caused by liver failure associated with Ketek before it was approved, and that at least four safety officials, Dr. David Graham, Dr. David Ross, Dr. Charles Cooper, and Dr. Rosemary Johann-Liang had expressed serious concerns about the safety of the drug.
"It's as if every principle governing the review and approval of new drugs was abandoned or suspended where telithromycin is concerned," Dr. Graham wrote in a later email calling for the "immediate withdrawal," of Ketek.
Former FDA employees have told Senator Grassley, that while he was acting FDA commissioner, Dr Andrew von Eschenbach used sports metaphors during a meeting to hint that FDA employees would be retaliated against or kicked off the team if they discussed their complaints about Ketek outside the agency.
Top FDA officials have not only disregarded warnings from the agency's own scientists, they have also pressured scientists to change their findings regarding the safety and efficacy of pharmaceutical products. Most notably, Dr. Mosholder and Dr. Graham, were pressured to alter their findings regarding SSRIs and Vioxx, but the practice appears to be more wide-spread than previously thought.
A July 20, 2006, report by the Union of Concerned Scientists (UCS) and the Public Employees for Environmental Responsibility (PEER), said that approximately one-fifth of the nearly 1,000 FDA scientists who responded to a survey stated that they had been asked, for nonscientific reasons, to alter or exclude technical information or conclusions.
And, one-fifth said that they have been asked explicitly by FDA decision-makers to provide incomplete, inaccurate or misleading information to the public, industry, the media and government officials.
The UCS also cited an earlier survey by the HHS Office of Inspector General in which nearly one in five scientists said they had been pressured to approve or recommend approval of a new drug despite concerns about its safety, effectiveness, or quality.
Although the FDA claims that there are procedures in place to resolve disagreements, employees continue to say that they experience intimidation and reassignments when they raise issues about the integrity of the FDA's work. In fact, the UCS survey found that over one-third of the scientists said they could not openly express any concerns about public health within the FDA without fear of retaliation.
Congressman Hinchey released a statement on June 24, 2006, in response to the report, which he said, "shed light on the serious and widespread problems at the FDA."
"One of the more disturbing findings of the study," he said, "is that more than half of the scientists at the FDA said their job satisfaction has decreased over the past few years during President Bush's time in office."
"Under this president," he noted, "the FDA has decided to let politics overrule science."
We saw it with the way in which Vioxx, Bextra, and other drugs were mismanaged, Rep. Hinchey stated, and "in the agency's repeated efforts to preempt state law in order to minimize drug company accountability under former Counsel Daniel Troy."
"We must end the financial link and inappropriately close relationship between the drug industry and the FDA, eliminate conflicts of interest on FDA advisory committees, and vastly improve the agency's post-market drug safety operations," he advised.
"We must return the FDA to a time," he said, "when science was the only consideration for approving a drug, not politics."
FDA employees have also complained that they are under constant pressure to approve drugs within deadlines set by the Prescription Drug User Fee Act, and that as a result, patient safety takes a back seat to the fast approval process of products.
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