November 30, 2004

Medical Schools Are Faulted on Studies Focus Turns to Academics’ Close Relationship With Drug Companies

Last December, medical school researchers went to a professional meeting in Puerto Rico with a sense of urgency. U.S. government drug regulators were reviewing unpublished data from their studies on the use of antidepressants in children and adolescents to see if the drugs increased suicide risks.

The group included many of the researchers whose published positive findings had helped persuade doctors to prescribe antidepressants like Paxil, Zoloft and Prozac to young patients. Now, faced with growing safety questions, the researchers had been trying for months to gather all the test data about those and similar drugs to see if they had missed a pattern not apparent in any single trial.

But they could get only pieces of that information. Some drug companies refused to turn over data to the group, even though these researchers had helped come up with the information. In other cases, the researchers could not freely share their own data with colleagues who had not worked on a test. The reason, they said, was that medical schools, in agreeing to carry out the tests, had signed contracts with the drug makers that required them to keep the data confidential.

Academic institutions and researchers are widely viewed as the impartial, independent heart of the system that the United States uses to test drugs and medical devices. But that independence often comes with strings attached, sometimes making academic institutions and their researchers obstacles to the exchange and discussion of test results.

The upshot is that doctors may not get all the information they need. In the wake of revelations about unpublished test data showing the potential risks of pediatric antidepressants, some doctors have stopped prescribing them. And even doctors who continue to prescribe the drugs question why they were kept in the dark.

"I think it would have been more helpful for everyone to have known what was going on at the time that it was happening," said Robert Feder, a psychiatrist in Manchester, New Hampshire.

In recent months, drug companies, faced with widespread criticism of their handling of test information, have promised to release more of it. Legislation has been introduced in Congress that would require all makers of drugs and medical devices to list clinical trials and their results in a public database.

Critics say, however, that academic institutions and their researchers need to examine their own practices, because they share part of the blame.

The problem starts with the terms of the contracts that some universities sign for clinical trials, but of equal importance is how researchers choose to describe study results and even whether they pursue publication.

"People who are blaming this all on industry are missing the point," said Robert Califf, associate vice chancellor for clinical research at Duke University Medical Center. "I think that academia is part of the problem right now, and not part of the solution."

Virtually all the pediatric antidepressant studies were run in part at medical schools, and in many cases the tests were led by academic scientists. But while one study of Paxil, which showed positive results in depressed children, was published, another study showing that it was ineffective was not submitted to a medical journal, by either the drug's maker, GlaxoSmithKline, or the academic investigators involved in that test. Makers of drugs and medical devices frequently turn to medical schools and academic teaching hospitals to run clinical trials and recruit patients for them. The industry pays many academic institutions millions of dollars a year to run such trials; the involvement of a leading academic researcher in an industry-sponsored test gives it both prestige and credibility. Medical researchers who attract studies reap the benefits of bigger research budgets and career advancement.

Drug companies say that because they pay for a trial they own the data it generates. They say that contract clauses including ones for confidentiality are not intended to suppress negative trial findings but to make sure that data is properly analyzed before it is released.