Trials and Tribulations

A furor over clinical data jeopardizes pediatric exclusivity provisos.
Oct 01, 2004

Jill Wechsler
Did sponsors of pediatric antidepressant studies sweep unfavorable results under the rug by failing to publicize ones showing product ineffectiveness? That was the line of questioning directed at medical officers from GlaxoSmithKline and Forest Laboratories by members of the House Energy and Commerce Committee at a hearing in September. The panel's most pointed questions, though, were aimed at FDA officials who had not responded adequately to requests for information.

FDA Acting Deputy Director Janet Woodcock, in the hot seat, explained the legal curbs on what FDA can disclose and why it wanted all major antidepressants to carry the same cautions instead of allowing some manufacturers to strengthen label warnings.

Better Late Than Never
Rep. Henry Waxman (D, California) said he is developing legislation to mandate drug trial registration, including information on sources of funding and anticipated timelines. He vowed to put teeth in the program by linking trial registration to institutional review bureau (IRB) protocol approval and by levying fines on noncompliant sponsors. He also threatened changes in current six-month pediatric exclusivity policy to deny patent extensions to sponsors that "don't tell the whole story." He and other legislators want to limit the provision to products that change labels as a result of new pediatric studies.

To head off reformers, sponsors are listing more studies at after years of making excuses for not doing so. Pharma companies also say they will make public clinical trial results—negative and positive—to help doctors practice better medicine.

Open Access to NIH Research Worries Journals
Pushing for Disclosure The clamor over unbalanced drug data erupted in June when New York attorney general Eliot Spitzer charged Glaxo with concealing clinical results on the safety and efficacy of the antidepressant Paxil (paroxetine) when used by children. Glaxo denied any wrongdoing but agreed in August to post on the internet summaries of all its clinical trials conducted after December 27, 2000. Spitzer also pressured Forest, marketer of the selective serotonin reuptake inhibitor Celexa (citalopram), which similarly promised to create an online registry of clinical trial results.

Other health organizations quickly made linking trial registration to public disclosure of trial results the key issue:

  • The American Medical Association (AMA) called for a comprehensive registry of all clinical trials conducted in the US to track research activity and ensure public access. Already overloaded IRBs would make public registration a condition for approving protocols, an added chore that hasn't pleased them.
  • The World Health Organization (WHO) proposed to create an international clinical trials registry slated to be discussed by national health ministers in November.
  • The Pharmaceutical Research and Manufacturers of America (PhRMA) announced last month that it will establish a new online database with summaries of unpublished clinical trials sponsored by members. A voluntary program limited to "hypothesis testing" studies, which exclude early-stage exploratory trials, it applies only to drugs approved in the United States, and will not require companies to list incomplete studies or provide raw data.

Eli Lilly had announced plans to post data from its trials for recently approved drugs, and Merck said it would add trial results to its listings on the FDA website. These companies and others may shift disclosure activities to PhRMA's site, where they can post more information, such as earlier or successful studies, if they so choose.

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