Veil of Secrecy to Lift on Drug Tests ; Firms Are under Pressure to Release Results of All Their Clinical Trials, Including the Negative Ones. the Result Could Be a New Level of Industry Openness

Article excerpt

Growing concerns over the safety and efficacy of anti- depressant drugs prescribed to children have caught the eye of Congress and the New York state attorney general. Now they're becoming the catalyst for calls to reform the way clinical trials of all drugs are reported.

Pressure is already causing some changes within the pharmaceutical industry. And it has put the US Food and Drug Administration (FDA), which approves new drugs, in the hot seat. If reforms are carried out, they could bring an unprecedented level of transparency to drug research.

The solution now under consideration: a public database, or registry, of drug trials, where companies would post the results of those trials.

In congressional testimony Thursday, a spokesman for the American Medical Association endorsed the registry and said it should include information on each trial's purpose and objective, its design, and the dates it begins and ends. If the trial is not completed, the registry should include an explanation.

While drug companies have been eager to make public any positive results of their trials, recent revelations suggest they've balked at divulging tests when the results are not what they'd hoped to see. The furor has centered around the use of anti- depressants on children.

Last month, for example, drug giant GlaxoSmithKline agreed to pay $2.5 million and post online summaries of all of its clinical trials to settle a lawsuit brought by Eliot Spitzer, New York's attorney general. The suit charged that Glaxo suppressed evidence that its antidepressant Paxil was ineffective in children and may lead them to have suicidal thoughts.

Then on Aug. 20, the FDA released a review of previous clinical research that confirmed a link between suicidal thoughts and antidepressants. It showed that children taking the drugs were nearly twice as likely to have suicidal thoughts or behavior as those receiving sugar pills. An FDA advisory committee meeting Monday and Tuesday is reviewing that evidence and is expected to determine soon if it is strong enough to warrant FDA action.

Meanwhile, in court, lawyers for a young defendant accused of murder are trying to draw a connection between an antidepressant and violent action. Christopher Pittman, who was taking the antidepressant Zoloft, is charged with killing his grandparents in 2001, when he was 12. According to The New York Times, Pfizer, the drug's manufacturer, is helping prosecutors with their case.

As allegations have piled up against the drug companies, the FDA also has come under scrutiny. In August 2003 the drug firm Wyeth asked the FDA for permission to place a stronger warning label on its antidepressant Effexor, saying it could worsen depression or suicidal thoughts. The FDA denied the request.

At the congressional hearings on Thursday the committee chairman, Rep. Joe Barton (R) of Texas, charged the FDA with "stonewalling, slow rolling, and plain incompetency" in its relations with the committee, which has been investigating the risks that mood- altering medications pose for children and teens.

The industry has begun to make some moves to address the concerns about drug trials. Drug companies have agreed to set up a voluntary system of posting their drug trials on the Internet. …


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