A scientific panel that shaped the federal government’s policy for testing the safety and effectiveness of painkillers was funded by major pharmaceutical companies that paid hundreds of thousands of dollars for the chance to affect the thinking of the Food and Drug Administration, according to hundreds of e-mails obtained by a public records request.
The e-mails show that the companies paid as much as $25,000 to attend any given meeting of the panel, which had been set up by two academics to provide advice to the FDA on how to weigh the evidence from clinical trials. A leading FDA official later called the group “an essential collaborative effort.”
Patient advocacy groups said the electronic communications suggest that the regulators had become too close to the companies trying to crack into the $9 billion painkiller market in the United States. FDA officials who regulate painkillers sat on the steering committee of the panel, which met in private, and co-wrote papers with employees of pharmaceutical companies.
The FDA has been criticized for failing to take precautions that might have averted the epidemic of addiction to prescription drugs including Oxycontin and other opioids.
“These e-mails help explain the disastrous decisions the FDA’s analgesic division has made over the last 10 years,” said Craig Mayton, the Columbus, Ohio, attorney who made the public records request to the University of Washington. “Instead of protecting the public health, the FDA has been allowing the drug companies to pay for a seat at a small table where all the rules were written.”
Even as the meetings were taking place, the idea of FDA officials meeting with firms that had paid big money for an invitation raised eyebrows for some. In an e-mail to organizers, an official from the National Institutes of Health worried whether the arrangements made it look as if the private meetings were a “pay to play process.”
FDA officials did not benefit financially from their participation in the meetings, the agency said. But two later went on to work as pharmaceutical consultants and more than this, the critics said, the e-mails portray an agency that, by allowing itself to get caught up in a panel that seemed to promise influence for money, had blurred the line between the regulators and the regulated.
In a statement, the FDA said “we take these concerns very seriously.” But, it said, “we are unaware of any improprieties” associated with the group.
The group was organized by two medical professors, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington, and the e-mails for the most part describe their efforts at financing and organizing the group’s meetings.
The two professors received as much as $50,000 apiece for a meeting, money that went to their academic research accounts and paid for research assistants and expenses “or to cover a small percentage of faculty effort,” they said. At one point in the e-mails, they proposed that they receive honoraria of $5,000 apiece for a four-hour meeting at a hotel near the FDA offices.