MONTREAL — When members of the Food and Drug Administration's advisory panels make recommendations about placing “black box” labels on selective serotonin reuptake inhibitors, many factors influence their decision making, Philip J. Candilis, M.D., said at the annual meeting of the American Academy of Psychiatry and the Law.
First is the obvious issue of direct pharmaceutical industry influence on the panels, as seen in the cases of Bextra, Vioxx, and Celebrex, Dr. Candilis said. “Early on in the debate on anti-inflammatories, the panels had endorsed their continued use,” he said. “But look at the experts who declared ties to the pharmaceutical industry.” Of the 32 experts on the panel, 10 had declared some ties to the pharmaceutical industry. Each panelist had to vote “yes” or “no” to recommending each of the three medications.
“Those [10] who had consulted to the pharmaceutical industry voted 28 of their total of 30 votes in favor of these medications. Those without such conflicts cast 37 of their 66 votes in favor,” he said. “So there was a substantial and statistically significant difference in how people were supported and how they voted.”
But broader influences are at play as well. For instance, the FDA regulates one-quarter of the gross national product, which comes to “hundreds of billions of dollars,” said Dr. Candilis, of the law and psychiatry program at the University of Massachusetts, Worcester. And to do part of that job, the agency receives millions in fees from the pharmaceutical industry, he said.
“So there's already a dependence there: 40%–50% of the [FDA's] budget comes from fees that industry pays in order for the FDA to govern the medications that they submit.”
The agency also exerts pressure on its own employees, he continued. He noted that one physician testified before Congress that he'd been asked by FDA officials to alter his affidavit concerning the increased risk of suicide in children and youth taking antidepressants.
Slowly, people are becoming more aware of these conflicts and taking action to mitigate them, Dr. Candilis said. For example, Congress is now insisting that pharmaceutical companies register the results of all clinical trials, including negative results. And some professional organizations are precluding experts from peer review entirely if they have conflicts of interest.
The take-home message is this: “If we don't regulate it, Congress will, others will, people with an agenda will,” he said. “We have to start doing full public disclosure of [conflicts of] interest, a transparency model, more explicit policies, less management and more recusal. We must step away from just saying, 'I'm going to tell you what I own.'”