Pain drugs aren't easy to develop. Investigators have often had to struggle to design a trial that could effectively demonstrate a new treatment's efficacy to the FDA's satisfaction. So when a pair of prominent academics in the field assembled a closed summit meeting on the subject involving FDA officials and pharma representatives, there was considerable interest in the industry.University of Rochester Professor Robert Dworkin
There was also a pay-to-play element that has now hit the pages of The Washington Post, raising serious questions about the influence that the industry has in developing agency guidelines on drug development and the pharma industry's willingness to pay hefty amounts to make sure they have a place at the table.
The two academics are the University of Rochester's Robert Dworkin, who's done work on analgesic clinical trial design, and Dennis Turk at the University of Washington. Turk is editor-in-chief of The Clinical Journal of Pain. Bob Rappaport, who heads of up the FDA's analgesic group, attended some of the sessions, going on to do a PowerPoint presentation on their influence in getting new analgesics approved. And there were emails aplenty highlighting the academics' sales process, which made their way into the Post today.
Clearly, holding the line on the $25,000 price for a ticket to attend was important.
"He didn't realize we were inflexible on the 25k, and then asked, a bit testily, how many companies were already on board and when I said 10 he then asked whether it costs 250K to hold a meeting in DC," Dworkin wrote Turk at one point, after one of the companies said they had scraped together only $10,000 to date. "I gave our standard response to this, which appeared to mollify him fine."
At one point, an unnamed NIH staffer offered to hold an open meeting at their facilities, concerned that the industry payments could be criticized if they were ever revealed, but Dworkin nipped that in the bud saying that "It is difficult to imagine how an open meeting would develop consensus recommendations."
The FDA has been severely criticized for neglecting to prevent the abuse of Oxycontin, which swept the country from coast to coast. And the agency's involvement in the meetings left the FDA wide open to a charge of being in bed with the industry, rather than objectively regulating their development work.
"These e-mails help explain the disastrous decisions the FDA's analgesic division has made over the last 10 years," attorney Craig Mayton, who obtained the documents, tells the Post. "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."
- here's the feature from The Washington Post