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Bill would make drug trial results public

The FACT Act would force drug makers to post test results on a public
database and provide updates.
Sunday, December 19, 2004 | 12:00 a.m. CST; updated 10:16 a.m. CDT, Wednesday, July 16, 2008

Prescription-drug users and doctors soon could have greater access to information about possible adverse effects of medications after a legal battle over the popular antidepressant Paxil.

Six federal lawmakers introduced the Fair Access to Clinical Trials Act in October as part of an effort to make clinical drug trials more transparent to the public. The law would require drug companies to publicly release the results of such trials, positive and negative, on a government-run database.

Lawmakers were prompted by a legal battle between New York state and the British drug company GlaxoSmithKline. New York Attorney General Eliot Spitzer sued GlaxoSmithKline on charges of deliberately suppressing negative data on Paxil.

Company data not released to the public show that in some instances Paxil increased suicidal tendencies among younger users. The positive results the company disclosed led some physicians to prescribe the drug to children with severe depressive disorders, critics said.

In August, GlaxoSmithKline settled with the state for $2.5 million and agreed to make the data on its clinical trials available to the public through an online database by December 2005.

Federal law already requires drug companies to disclose clinical trials to a government database run by the National Library of Medicine. That information can be found on the Web at www.clinicaltrials.gov.

But unlike that 1997 law, the FACT Act would require mandatory registration of all trials, followed by updates provided every six months. Failure to comply with the requirements would result in penalties of up to $10,000 per day as well as ineligibility to receive federal grant money and contracts.

The American Medical Association supports a mandatory registration of all clinical trial results. The AMA also has decided to publish results of clinical trials only if the study also is registered at a public database.

The Pharmaceutical Research and Manufacturers of America, an industry trade group, has countered with calls for a voluntary system of disclosure of clinical trial results on its Web site, www.clinicalstudyresults.org.

The Web site contains trial results for 21 drugs manufactured by 13 drug companies. GlaxoSmithKline listed only two of its drugs, one for asthma and one for Type 2 diabetes; results for Paxil are absent.

Arguing against a voluntary reporting system in the Journal of the American Medical Association, deputy editor Drummond Rennie cited the shortcomings of a voluntary system of drug trial registry in Great Britain that started in 2003 but failed to produce as much research data as initially promised.

Locally, the proposed change doesn’t seem to be on doctors’ radar screens, at least publicly. Lynn Hostetler, a Boone Hospital Center representative, said no one from the hospital was available to comment.

Kristin Hahn-Cover, a primary practice physician at MU’s Fairview Internal Medicine center, said she did not know enough about the particulars to weigh in, either.

“I have read about it, but I don’t know enough,” she said. “I am afraid I don’t really have an informed opinion.”

In New York, an attorney general representative said any move toward additional disclosure, whether through a federal or voluntary standard, is positive.

“We believe that any initiative by pharmaceutical companies to enhance the transparency of the clinical trial process would be beneficial to the public,” Brad Maione said. “And I think other drug companies are taking Glaxo’s lead to disclose clinical trials.”


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