Pharmaceutical firms paid to sit at meetings with a scientific panel that advised the U.S. Food and Drug Administration (FDA).
The panel was involved with safety and efficacy testing policies utilized by the federal regulator and was funded by drug makers, which paid hundreds of thousands of dollars, the Washington Post reported. According to hundreds of emails obtained by a public records request, the pharmaceutical companies paid about $25,000 to attend a meeting.
Two academics scheduled the meetings in order to provide the FDA with advice on how to measure evidence from clinical trials. According to the Post, an FDA official described the group as “an essential collaborative effort.”
Consumer advocates disagree, saying that the agency was becoming too comfortable with drug makers that were seeking to become a part of the $9 billion pain killer market in the United States, the Post reported. FDA officials met privately and co-authored papers with drug companies; the FDA states that its officials received no financial benefit from their participation in the meetings, according to the Post. Yet, two officials later secured positions as pharmaceutical consultants. The FDA issued a statement that “we take these concerns very seriously” adding that, “we are unaware of any improprieties” tied to the group.
The group was developed by Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington; the emails, for the most part, concerned the meetings’ financing and organizing, the Post reported. The professors received about $50,000 each per meeting, they said went toward their academic research accounts, research assistant costs, expenses, “or to cover a small percentage of faculty effort,” the pair said. The emails also indicated that the academics issued a proposal for them to receive honoraria of $5,000 each for a four-hour hotel meeting near FDA offices, according to the Post.
Meanwhile, the Milwaukee-Wisconsin Journal Sentinel reported that some drug companies paid up to $35,000 each for representation at the IMMPACT meetings. At the meetings, the attendees could discuss clinical trial testing procedures with officials at the FDA and other government agencies. The stated goal for IMMPACT is to reach an improvement of clinical trial design for the development of new pain medications.
Michael Carome, director of health research for the watchdog group Public Citizen said that the emails raise concerns over the so-called “pay-for-play arrangement” that involves drug makers purchasing access to invitation-only meetings with FDA officials and which could impact FDA pain drug policy, the Sentinel reported. “The whole picture is a troubling one and it warrants an independent investigation,” said Carome, who has seen the emails.
Douglas Throckmorton, the FDA’s deputy director for regulatory programs, said agency officials who attended the meetings were not setting policy and were just listening to scientists. “Pay-for-play is just not the way the FDA operates,” Throckmorton said. “That’s not part of the culture of the FDA,” he added, according to the Sentinel.
A 2003 email authored by Raymond Dionne, an official with the National Institutes of Health (NIH), discussed the closed, invitation-only meetings, suggesting that instead of closed meetings, that the attendees meet publicly at the NIH, the Sentinel wrote. “The major advantage of having the meeting on the NIH campus would be the ability to open the meeting to all interested parties and avoid the stigma that this initiative is a ‘pay to play’ process,” Dionne wrote in his email. Dionne also later wrote that the meetings were “paid for by a few large pharmaceutical firms who are assumed to be influencing the outcomes” and that ”if they play by the book should not accept dinners for meetings at the Four Seasons Hotel. I may even bring a brown bag.”
In response, Dworkin wrote that the organization could order “inexpensive sandwiches for lunch for the government folks…. The rest of us undoubtedly will feel guilty, but we will probably resist the temptation to have tuna fish in respect for your plight,” according to the Sentinel.