Legislation Targets Public Disclosure Of Clinical Trial Data On Experimental Drugs

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Congress, industry experts and advocacy groups continue to disagreeon how best to create a system for releasing clinical trial data to thepublic, a measure that is part of broader legislation that would expand FDA oversight of prescription drug safety and reauthorize the Prescription Drug User Fee Act, the Los Angeles Timesreports. PDUFA expires on Sept. 30. Currently, the government does notrequire full disclosure of trial data, and there is no easilysearchable, central database that logs trial data.

The Houseand Senate PDUFA bills both include measures that would requireregistration of clinical trials on all drugs, but the "dispute is overhow to publish the results of trials," according to the Times. The House version has a specific plan for creating the database. It would direct NIHto create a database into which drug makers would have to enter resultsof trials within 12 months of their conclusion and display ongoingtrials. In addition, it would require a nontechnical summary of trials.

The Senate measure would require NIH to conduct a feasibilitystudy on how to publish the data. The agency would have to consult withall interested parties, including drug makers, in a process that couldtake more than two years. Critics say the Senate measure would give thepharmaceutical industry too much power in deciding what to disclose.

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Jeffrey Drazen, editor of the New England Journal of Medicine,said, "The situation now is like delivering a wheelbarrow full oftelephone books to somebody and telling them, 'What you want to know isin here somewhere.'" He added, "You need to have a system that requiresregistration (of clinical trials) and a succinct summary of theresults, so you know what the box score is."

Sean Hennessy, an epidemiology professor at the University of Pennsylvania School of Medicine,said, "Human subject research is only ethical if it is used to advancescience, not the interests of a particular company. The major reasonwhy human subject research needs to be made public has to do with thatethical consideration, and the second reason has to do with the publichealth consequences of the information for other people."

Peter Lurie, deputy director of Public Citizen's Health Research Group,said, "The concern is that the Senate version will lead to a kind ofpurgatory in which the database is promised but never emerges in auseful form."

On the issue of nontechnical summaries, Pharmaceutical Research and Manufacturers of Americaspokesperson Ken Johnson said, "It could be very difficult or virtuallyimpossible for companies to translate complex scientific language intoeasy-to-read language without omitting critical details of the clinicaltrial results" (Alonso-Zaldivar, Los Angeles Times, 9/17).

Reprinted with permission from kaisernetwork.org. Youcan view the entire Kaiser DailyHealth Policy Report, search the archives, and sign up for email deliveryat kaisernetwork.org/email. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, afree service of The Henry J. Kaiser Family Foundation.

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