E-drug: Surfaxin trial
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About 6 weeks ago we wrote to you about a proposed study by Discovery
Labs of a surfactant for the treatment of Respiratory Distress
Syndrome in neonates. While the company planned a study comparing
their drug to one of the four FDA-approved surfactants in Europe,
they also planned a placebo-controlled trial in Latin America. We
wrote to Health and Human Services Secretary Tommy Thompson asking
that the trial be redesigned so that all patients received active
treatment. Today we learned that the company will be going forward
with an active-controlled trial instead (no placebos). Beyond the
importance of assuring active treatment for all infants in this
particular study, the decision should be a message that one cannot
conduct studies abroad that one would not conduct in the country of
the sponsoring company. The study is now consistent with the latest
version of the Declaration of Helsinki, which requires that "The
benefits, risks, burdens and effectiveness of a new method should be
tested against those of the best current prophylactic, diagnostic,
and therapeutic methods."
Public Citizen's original letter on this can be found at
http://www.citizen.org/hrg/PUBLICATIONS/1558.htm
Our press release announcing the redesign of the study can be found at
http://www.citizen.org/hrg/PUBLICATIONS/1564.htm
Thanks to those who offered their support
Peter
Peter Lurie, MD, MPH
Deputy Director
Public Citizen's Health Research Group
1600 20th Street, NW
Washington, DC 20009
Phone: (202)588-7781
Fax: (202)588-7796
Email: plurie@citizen.org
Web address: http://www.citizen.org
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