The US Food and Drug Administration, rocked by controversy inrecent months, has now admitted that a senior management officialsecretly contacted a whistleblower group. That official attemptedto discredit Dr David Graham, the FDA's scientist who criticisedthe agency during US Senate hearings, saying that the FDA failedto protect the public when it approved rofecoxib (Vioxx, Merck)—despiteevidence suggesting that the drug caused heart attacks and strokes(BMJ 2004;329: 1255[Free FullText], 27 Nov).
The FDA issued a statement on 26 November saying, "FDA had noprior knowledge of any employee's contact with the GovernmentAccountability Project." In addition to acknowledging that theemployee is "not anonymous" to the project, the FDA said the"employee has chosen to not divulge their identity, and FDArespects the right of any of its employees to protect theirprivacy in cases such as this."
Dr Graham's attorney, Tom Devine, legal director of the GovernmentAccountability Project, said the FDA is "fudging on whetherthere was advance planning" to discredit Dr Graham. "There wasmore than one manager who contacted me."
Mr Devine also told the BMJ that Steven Galson, acting directorof the FDA's Center for Drug Evaluation and Research, "engagedin the extraordinary move of personally contacting the Lanceteditor, Richard Horton, to block publication of the Vioxx study."
According to an article in newspaper USA Today, Dr Horton wrotein an email to Dr Galson that his intervention was "very unusualindeed," and appeared to be intended to "delay or stop publicationof research that was clearly of serious public interest."
The timing of the campaign to discredit Dr Graham and of thecalls to the Lancet is significant, said Mr Devine, as they"both climaxed the weekend before Dr Graham's testimony in USSenate hearings."
Senator Chuck Grassley, chair of the Senate committee that heldhearings on rofecoxib, Merck, and the FDA, has called for theInspector General to investigate the FDA's involvement in theattempts to discredit Dr Graham.
Dr Graham told the BMJ that when another drug safety officer,Dr Andrew Mosholder, concluded that selective serotonin reuptakeinhibitor antidepressants caused increased suicidal tendencyamong teens, the FDA prevented him from presenting his findingsat an advisory meeting and suppressed his report. When the reportwas leaked "the FDA's reaction was to do a criminal investigationinto the leak. I was named as one of the targets of the investigationalong with Dr Mosholder."
Calling the investigation a "plumbing operation," Dr Grahamsaid a culture of intimidation and fear permeates the agencymaking it difficult for drug safety officers to protect thepublic.
The criminal investigation was also illegal, according to MrDevine. He said, "The agency continued to try to catch the leakereven after the inquiry showed that Dr Mosholder's findings werecorrect. It's extraordinary. Presumably a scientific agencywould pursue more civil practices. The FDA is in a class byitself for its almost obsessive intolerance of dissent. Otheragencies fire their dissenters. The FDA launches criminal investigations."
Observers inside and outside the beleaguered agency say thatthe recent controversies point to systemic problems that gobeyond any one drug or drug company—or even the FDA itself.
Speaking on condition of anonymity, an FDA drug safety officertold the BMJ that the agency has been virtually paralysed sincethe scandals erupted. "We can't go on like this," said the officer,"Either David will go—or they [management] will have togo." Dr Graham is "somebody we greatly admire and support,"he said, adding that whether or not Dr Graham stays at FDA "theproblems will remain."
"The public is very vulnerable," said the officer, who calledfor provisional approvals of drugs with reviews two years afterthe release of a new drug.
The officer said that a planned investigation by the GovernmentAccountability Office (BMJ 2004;329: 935[Free FullText], 23 Oct) would helpshed light on the ties between FDA and industry. He joined withother critics in calling for an end to the FDA being partiallyfunded by fees paid by drug companies for drug reviews.
"That money needs to completely go. The NIH [National Institutesof Health] budget is enormous, but we get next to nothing. MaybeCongress could give us [funding]."
The FDA has declined to comment on questions regarding Dr Grahambeyond their prepared statement.
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