NYT,pg1: (Drug maker) Contracts Keep Drug Research Out of Reach

[DeepModem Mom]

THE ACADEMIC CONNECTION
Contracts Keep Drug Research Out of Reach
By BARRY MEIER

Published: November 29, 2004


Last December, medical school researchers went to a professional meeting in Puerto Rico with a sense of urgency. Federal drug regulators were reviewing unpublished data from their studies on the use of antidepressants in children and adolescents to see if the drugs increased suicide risks.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 it, the researchers recalled. In other cases, they 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 run the tests, had signed agreements with the drug makers that kept the data confidential.

Academic institutions and researchers are widely viewed as the impartial, independent heart of the system this country uses to test drugs and medical devices. But that independence often comes with strings attached, sometimes making those 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 In the wake of revelations about unpublished test data showing the potential risks of pediatric antidepressants, some doctors have stopped prescribing them.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....


http://www.nytimes.com/2004/11/29/business/29research.html

[OzarkDem]

1. Congress should enact legislation

requiring pharma companies to publish all test results of drug trials once completed. All the top medical journals are trying to force disclosure on a voluntary basis by requiring pharma companies to register their clinical trials when they're begun and require reporting on them for later publication. Its a start, but even the medical journal editors themselves want Congress to enact legislation.