Pills and bills

At annual meetings in posh hotels in Washington, D.C., beginning in 2002, two academics invited 30 or 40 federal regulators, pharmaceutical representatives, and researchers to sit down and discuss better ways to get new drugs to market. Officials from the Food and Drug Administration and the National Institutes of Health attended for free. The price for drugmakers to attend: up to $35,000 per year.

The payments and private meetings, hosted over the past 11 years by an academic group named IMMPACT, were revealed in 400 pages of emails brought to light by a public records request. They suggest an uncomfortably close relationship between drug companies and the regulatory agencies meant to police them. The meetings aimed to create new consensus standards for painkiller safety testing, and several of the group’s consensus statements have since appeared in medical research journals.

According to the Milwaukee Journal Sentinel, IMMPACT (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials) influenced a new approach to safety trials—called “enriched enrollment”—to cut time and expense and tease out drug effectiveness. Last December the FDA issued draft guidance on enriched enrollment, with the agency’s deputy director for clinical science, Bob Temple, calling it a “potentially powerful” strategy. But expert reaction to enriched enrollment has been mixed: Some believe it makes new drugs appear more effective than they are.

The FDA did not organize the meetings. But at least one NIH official who attended worried they looked like a pay-to-play arrangement. In a 2003 email he said he was thinking of bringing a “brown bag” meal to the hotel to avoid eating an expensive dinner paid for by industry representatives.

In response to the revealed emails, the FDA said it was “unaware of any improprieties” regarding IMMPACT.

Emails between the two professors who led the group, Robert Dworkin of the University of Rochester and Dennis Turk of the University of Washington, suggest pharmaceutical companies were well aware of the value of meeting in a closed-door session where they could potentially lobby officials. In 2003 Dworkin wrote to Turk that drug representatives were pleased with the meetings, in spite of the high attendance fees. “They are getting a huge amount for very little money (impact on FDA thinking, exposure to FDA thinking, exposure to academic opinion leaders and their expertise, journal article authorship, etc.) and they know it,” Dworkin wrote, according to a Washington Post transcript.

Dworkin and Turk received as much as $50,000 apiece for organizing each meeting. They used the money to fund their academic research. After an Eli Lilly representative complained of a $20,000 fee, Dworkin wrote, “20k is small change, and they can justify it easily if they want to be at the table.”

Botched shots

Scientists at an October AIDS conference in Barcelona, Spain, brought a bad report about an HIV vaccine made by Merck, recently tested in two clinical trials. Not only did the vaccine fail to work, it appears to have made trial participants more likely to contract HIV, though it’s not clear why. One researcher estimated the vaccine increased the risk of HIV by 41 percent. Two other HIV vaccines show early signs of effectiveness, however. —D.J.D.