Devine said that after several conversations, he persuaded the callers to provide documents to support their accusations, and Devine then challenged Graham based on what was provided.
"It became clear to me that Dr. Graham could reasonably explain any questions about the research, and that the callers were trying to smear him," Devine said. "After that, I called their bluff for more information and that was the end of it. It was all a red herring, and it made me believe Dr. Graham far more."
David J. Graham, a drug safety official at the Food and Drug Administration, told a Senate hearing that FDA policies have left the American public "virtually defenseless" against the kind of safety problems that led to the withdrawal in September of the popular arthritis drug Vioxx.
(Kevin Lamarque -- Reuters)
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Devine said that, under his organization's rules, he could not identify the callers because they initially contacted GAP as whistle-blowers themselves. But he said he is certain they were supervisors at the FDA because of the details of the arguments they made and the phone numbers from which they called. In addition, he said that, after identifying the callers to his satisfaction, he referred to them by name during subsequent phone conversations. He said the callers were surprised by his identifications but did not tell him he was wrong.
The allegations follow weeks of bruising criticism of the FDA, which has been accused of being lax on drug safety and was sharply assailed in Congress over its oversight of the British plant that was supposed to produce half of this winter's U.S. supply of flu vaccine. The plant was closed by British health officials because of contamination problems.
The criticism on drug safety issues has led to calls for the creation of a more independent Office of Drug Safety within the FDA, or perhaps outside of it.
Currently, the office is overseen by the Center for Drug Evaluation and Research, which also supervises the Office of New Drugs. To critics of the current setup, the much larger and better-financed Office of New Drugs dominates the safety office, in part because drug reviewers involved in approving a new drug for marketing also play a role in deciding whether the drugs should be withdrawn when safety issues crop up.
In his Senate testimony, Graham said a more independent drug safety office is essential. His position was supported this week by the editors of the Journal of the American Medical Association.
"The drug approval process must be decoupled from the post-marketing safety and surveillance system," the editorial said. "It is unreasonable to expect that the same agency that was responsible for approval of drug licensing and labeling would also be committed to actively seek evidence to prove itself wrong."
The FDA and drug industry officials have generally opposed a more independent safety office, saying it is unnecessary and would serve to de-emphasize the benefits of medications. But the FDA recently asked the congressionally chartered Institute of Medicine to review its drug safety procedures, and top officials said the agency will consider whatever recommendations the institute makes.
Although the drug safety issue involves a number of medications, companies, patients and officials, it has increasingly revolved in recent days around Graham's personality and positions. He has been at the center of the Vioxx controversy and has touched off more heated words and debate with his congressional criticisms of five other drugs, but his impact on drug safety issues goes well beyond those.
