The outside experts who advise the government on drugs sometimes have financial conflicts that may sway some of their votes, a situation that would never be tolerated among jurors in legal cases, consumer advocates say.
Nearly one in three experts relied on by the Food and Drug Administration for advice on drugs, including whether to approve new pharmaceuticals, has a financial conflict, according to a Public Citizen study that is to appear Wednesday in The Journal of the American Medical Association. Just 1 percent of panelists were excluded because of those conflicts, which can include tens of thousands of dollars in corporate grants, contracts and consulting fees.
In September 2001, Public Citizen, a private group, had threatened to sue the FDA to force greater disclosure of conflicts of interest among panel members. In January 2002, the FDA issued disclosure guidelines that panelists now must follow.
The group’s study found that conflicts of interest can slightly increase the likelihood that panelists will vote to recommend the agency approve a drug. The group’s analysis of voting data, culled from drug advisory committee meetings held in 2001 through 2004, showed, however, that eliminating the panelists with declared financial conflicts would not have changed the outcome of any votes.
Nevertheless, Dr. Peter Lurie, the lead author, said even a slight influence on voting behavior is something Americans would never tolerate in a 12-person jury.
“We think we have demonstrated that there is in fact a relationship,” Lurie said. “The juror analogy is good: 'Three out of 12 people were biased, but that still wouldn’t have given a majority, so that’s OK.' That wouldn’t be acceptable.”
Others countered that the findings underscore the adequacy of FDA’s disclosure requirements.
A sign new policy is working?
“To me, it basically says that the current disclosure of conflict policy is working quite well,” said Alan Goldhammer of the Pharmaceutical Research and Manufacturers of America.
The industry group — along with the FDA itself — has maintained it would be impossible to attract the best possible scientists if those with ties to industry were excluded.
“No one participates in an advisory board capacity until they have been fully vetted by FDA staff and we are convinced they will make an unbiased, productive contribution to the scientific process,” said FDA spokeswoman Susan Bro.
One lawmaker said there was no need to use any panel members with a conflict.
“There is an extraordinary amount of talent out there with no conflicts, no ax to grind and nothing to gain except the interest of the public,” said Rep. Maurice Hinchey of New York, the top Democrat on the Appropriations subcommittee that oversees the FDA.
Last year, he sponsored a rider to an appropriations bill that would have barred the FDA from using waivers that allow panelists with conflicts of interest to serve. Other lawmakers in September asked the Government Accountability Office to review the practice. The GAO said it has yet to begin that study.
Conflicts of interest widespread
The JAMA study underscored how pervasive the conflicts are: In 73 percent of drug advisory committee meetings, at least one panelist reported a financial conflict of interest.
Dr. Karl Kieburtz, chair of the FDA’s Peripheral and Central Nervous System advisory committee, said conflicts of interest can modify behavior in both conscious and unconscious ways.
“One way of mitigating that is through disclosure, so that people who are reading an article or hearing a debate can take that into context,” Kieburtz said. “The question then becomes, is that sufficient? Is disclosure sufficient or is recusal required? That is where the debate lies.”
Kieburtz recently voted to recommend allowing Biogen Idec Inc. to return its multiple sclerosis drug Tysabri to the market. The University of Rochester neurology professor has consulted for the company but said that did not influence his decision.
The FDA relies on its advisory committees for outside advice on roughly one of every five new drugs it approves. It does not have to follow a panel’s recommendation but usually does.