E-drug: Public Citizen letter to U.S. Health & Human Services Secretary
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Today Public Citizen released a letter to U.S. Health and Human
Services Secretary Tommy Thompson urging him to put an immediate halt
to a proposal to conduct a placebo-controlled trial of the drug
Surfaxin (Discovery Labs), a kind of surfactant used in premature
infants with Respiratory Distress Syndrome, in Mexico, Ecuador,
Bolivia or Peru. Although a meta-analysis shows that surfactant can
reduce neonatal mortality by 34%, and even though the company is
planning an active-controlled trial (no placebos) in Europe, the U.S.
Food and Drug Administration (FDA) is seriously considering endorsing
this study. At an internal FDA meeting with the title: "Use of
placebo-controls in life threatening diseases: is the developing
world the answer?" on January 24, 2001, FDA admitted that "Conduct of
a placebo controlled surfactant trial for premature infants with RDS
is considered unethical in the USA."
The research is clearly in violation of the new 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."
However, loopholes in the current draft of the U.S. National
Bioethics Advisory Commission report on international research ethics
would permit such a trial. See our letter for more details.
**Our letter, with the internal FDA documents attached as a pdf file,
can be viewed at http://www.citizen.org/hrg/PUBLICATIONS/1558.htm
We urge you to write to Tommy Thompson (with a cc to us) to criticise
these trials and to post this message as widely as possible (his
address is part of our letter). Letters to the NBAC are also
appropriate.**
Please feel free to contact us with any questions.
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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