Dong redux, but with less pain

Kahn was a leading investigator on the largest randomized trial among HIV-infected persons conducted during the 1990s. The subject of the study was IRC’s drug Remune, which was designed to stimulate an immune reaction to HIV (the AIDS virus) in people already infected. IRC hoped that Remune treatment would decrease the number of HIV-infected people progressing to full-blown AIDS.

Fortunately for the study subjects, but unfortunately for IRC, protease drugs came along during the trial with dramatic effects. As IRC’s CEO Dennis Carlo explains, "without enough patients getting AIDS in the control group, it is difficult to show a treatment effect with Remune."

For this and perhaps other reasons, the trial failed to show promise and was halted five months early, in May 1999. Kahn claims that he then requested the final data set (the study was conducted at 77 different centers), at which point the company asked for veto power over the final draft of any manuscript. Kahn refused, and went ahead to publish the results that he did have in JAMA. IRC disagrees with the omission of certain data that it believes are positive, but Kahn says the company "picked and chose the analysis method" to get something that came out positive. "This was something I wouldn’t attach my name to because I think it is wrong," he says. IRC has initiated binding arbitration proceedings and is requesting damages.

Unlike the Dong case, here "the protocol gave us an ability to publish our results," says Kahn. But the research contract did not stipulate that all results had to be turned over to the academics. "Based on this I think we’ll learn to write better contracts," says Kahn.

Why do companies and academics submit themselves to all this turmoil? Scott believes the two need each other. Increasingly companies have some of the best research tools and leads, while clinical academic researchers have access to patients. Plus "sponsors need to have good honest investigators to do work," says Kahn. "But if they want the ethos of independence that university research brings, they have to abide by the rules of that independence."

Whether by better contracts or clearer regulations, academics and industry alike hope to avoid both direct conflicts and bias from conflicts of interest. Every publicized dispute damages the public’s trust in the accuracy of medical research and, as JAMA’s editor Catherine DeAngelis stated in the November 1 2000 issue, "without trust, medical research is doomed."