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Home >  Events >  Show Us the Data
Show Us the Data
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What Will a Mandatory Clinical Trials Registry Mean for Drug Development . . . and Do We Need One?
Start:  Monday, September 20, 2004  9:30 AM
End:  Monday, September 20, 2004  11:30 AM
Location:  Wohlstetter Conference Center, Twelfth Floor, AEI
1150 Seventeenth Street, N.W., Washington, D.C. 20036
Directions to AEI

Last June, New York State Attorney General Eliot Spitzer sued the maker of an antidepressant for withholding unfavorable information about the safety and effectiveness of a drug. The suit, filed in the New York Supreme Court and settled this summer, claimed that GlaxoSmithKline conducted at least five studies on the use of Paxil in children and adolescents but only published the one study showing a positive effect. This intensified calls for a government-sponsored registry of trials so that doctors would have wider access to clinical trial results. The general bid for transparency now has strong support from medical organizations, most prominently the AMA, and major medical journals. Drug companies have begun setting their own disclosure policies, though some remain skeptical that a mandatory registry is warranted. Panelists at this event will discuss the benefits and unintended negative consequences of various public database scenarios. They will also appraise alternative approaches to the subject of disclosure.

9:00 a.m.

Registration

Welcome:

John E. Calfee, AEI

9:30

Panelists:

David Fassler, University of Vermont

 

 

Alan Goldhammer, Pharmaceutical Research and Manufacturers of America

 

 

Bert Rein, Wiley, Rein and Fielding

Sally Satel, AEI
Robert Steinbrook, New England Journal of Medicine

 

Moderator:

John E. Calfee, AEI

 

11:30

Adjournment

Available in Adobe Acrobat PDF format.

More Information
Nell Manning
American Enterprise Institute
 1150 Seventeenth Street, N.W.
Washington, DC  20036
Phone: 202-828-6024
Fax: 202-862-7178
E-mail: nmanning@aei.org

Media Inquiries
Veronique Rodman
American Enterprise Institute
 1150 Seventeenth Street, N.W.
Washington, DC  20036
Phone: 202-862-4870
E-mail: VRodman@aei.org
AEI Print Index No. 17367


Event Materials
  Summary
  Video
Related Material
Steinbrook op-ed  
ICMJE Statement  
Zito et al. article  
AACAP/APA AMA Resolution  
Dickersin/Rennie JAMA article  
Angell's op-ed  
PhRMA proposal  
PhRMA pamphlet  
Speaker biographies
Fassler's presentation  
Goldhammer's presentation  
Satel article
Related Links
Health Policy Studies at AEI