Ensuring Drug Safety

http://www.nytimes.com/2002/04/30/opinion/L30DRUG.html

April 30, 2002
 

Ensuring Drug Safety
 
Related Articles
Panel Advises Lifting Ban on Drug for Bowel Ailment (April 24, 2002)

 

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To the Editor:

As you say in "F.D.A. Advises Lifting Ban on Drug for Bowel Ailment" (news article, April 24), Public Citizen has opposed remarketing Lotronex because of its serious risks, but we have supported doing a carefully controlled clinical trial. This would define whether there is a population for whom the drug's benefits outweigh its risks.

During the meeting, the drug's maker, GlaxoSmithKline, again callously rejected the possibility of making Lotronex available only in such a trial, with its rigorous monitoring. It argued, without evidence, that 100,000 patients would want the drug, too many to accommodate. Two previously withdrawn drugs, phenformin and cisapride, were made available under such trials to 3,000 and 1,000 patients, respectively. It is likely that the number of people wanting Lotronex would be in that range.  
SIDNEY M. WOLFE, M.D.
Director, Public Citizen
Health Research Group
Washington, April 24, 2002
 

 

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