Healthy Skepticism Library item: 463

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Publication type: news

Meier B
Democrats Take a Look at Drug Tests
The New York Times 2004 Jun 23

Full text:

Two medical groups involved in the issue of the disclosure of clinical drug trials are expected to meet tomorrow with staff members of several Democratic senators who may soon introduce legislation that would require drug makers to divulge the results of tests in a government-run database.

The groups involved in the meeting include the American Psychiatric Association and the American Academy of Child and Adolescent Psychiatry, representatives of those organizations said in interviews yesterday.

Both groups belong to the American Medical Association, the nation’s largest doctors’ group, which adopted a resolution last week calling on federal officials to create such a database, which is sometimes called a trial registry.
Under the proposal, companies would be required to register a test when it starts and report its results or the reasons it was ended.

The three Democratic lawmakers involved are Tim Johnson of South Dakota, Edward M. Kennedy of Massachusetts and Christopher J. Dodd of Connecticut, representatives for two of those officials said. One of those lawmakers, Senator Kennedy, has said he plans to introduce legislation calling for a federally run trial database.
Representatives for both of the groups and the lawmakers who are expected to take part in tomorrow’s meeting described it as preliminary. But the move by the three senators, which comes just a week after the A.M.A.‘s adoption of its proposal, suggests that a Congressional debate over how the drug industry discloses and presents information about drug trials could soon unfold.

Dr. David Fassler, a trustee of the American Psychiatric Association, said in a phone interview yesterday that the group was interested in discussing with elected officials how a government-run trial registry might best work to make sure the information was both complete and accurate. “We certainly view this as a bipartisan issue,” said Dr. Fassler, a child psychiatrist in Burlington, Vt., and a co-author of the A.M.A. resolution. “Physicians and patients need as much information as possible to make medical decisions.”

The debate over clinical trial results has emerged in recent months after the disclosure that some manufacturers of antidepressants highlighted positive findings in tests on youngsters for those drugs while playing down negative or inconclusive ones. Senator Charles E. Grassley, Republican of Iowa, is playing the lead role in a Congressional investigation into whether the Food and Drug Administration suppressed a study by an agency official who thought that several widely used antidepressants might pose safety risks to children and adolescents.

Yesterday, a spokeswoman for Senator Grassley, who has recently stated that he also plans to investigate the F.D.A.‘s handling of some other drug tests, said that to date he has not decided whether to introduce legislation supporting a drug trial registry.
A few drug companies have supported calls for more-comprehensive drug test disclosure but a unified industry position has yet to emerge.

A spokeswoman for the A.M.A. said yesterday that the offices of several lawmakers have contacted the group in recent days expressing interest in the registry issue.
She added that the A.M.A., which represents about a third of the country’s doctors, thought that a federal law requiring trial registration was necessary to make such a database effective.

Policy makers said last week that they took the action because of concerns that drug industry sponsorship of such tests was affecting quality and because companies, as well as medical journals, tend to spotlight tests with positive findings compared with those having negative or inconclusive results.

Senator Kennedy has already said that he plans to reintroduce a bill that would expand, among other things, protections for people taking part in clinical trials. The Boston Globe reported Saturday that he now intended to also address the issue of a trial registry in that bill, though he has yet to formulate any specific proposal.

Jim Manley, a spokesman, said he thought that Senator Kennedy had decided to take the added step after several recent news reports about trial registries.
“The public should have access to the results of all clinical trials – not just the ones that show favorable results,” Senator Kennedy said in a statement issued yesterday.