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News :: Miscellaneous |
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Premature Infants Would Go Untreated, Die in FDA-approved Drug Trial |
Current rating: 0 |
by Public Citizen/Angela Bradbery
Email: ABRADBERY (nospam) citizen.org (unverified!) |
22 Feb 2001
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Premature Infants Would Go Untreated, Die in Proposed
Latin American Drug Trial
FDA May Endorse Unethical Placebo-Controlled Study
of Drug for Respiratory Distress Syndrome |
WASHINGTON, D.C. -- Hundreds of premature infants with a
potentially fatal medical condition would be given placebos -- and thus
be more likely to die -- in a drug company study in Latin America that
the Food and Drug Administration (FDA) is considering endorsing, Public
Citizen has learned.
In a letter sent today to Health and Human Services (HHS)
Secretary Tommy Thompson, Public Citizen called on the FDA to
immediately halt plans for the study unless it is redesigned to treat
all patients. A copy of the letter is available at
http://www.citizen.org/hrg/publications/1558.htm.
\"One expects drug companies to be profit-driven and act
accordingly,\" said Dr. Peter Lurie, deputy director of Public Citizen\'s
Health Research Group. \"But the FDA\'s job is to stop this kind of
unethical behavior, not encourage or endorse it. The fact that the
agency is seriously considering this study is beyond belief.\"
In the study, hundreds of infants with Respiratory Distress
Syndrome (RDS) would be treated with an experimental synthetic
surfactant drug called Surfaxin, while a control group of hundreds of
premature infants with the syndrome would be given placebos -- instead
of one of four FDA-approved surfactant drugs that could save the
infants\' lives. Many infants given placebos likely would die
unnecessarily, a Public Citizen analysis shows. Surfactant is a kind of
drug that makes it easier to inflate the lungs of newborns with RDS. A
third group of infants would get an already-approved drug.
The study is to be conducted in one or more of the following
four countries: Bolivia, Ecuador, Peru and Mexico. The company proposing
the study is Discovery Laboratories Inc., which is based in Doylestown,
Pa., and which has licensed the drug from Johnson & Johnson. Although
approved surfactants are available in some hospitals in these countries,
Discovery Laboratories plans to conduct the study in hospitals where
surfactant is not available.
The FDA has acknowledged in internal documents that the proposed
study would be unethical in the United States, where the new drug would
be studied by treating one group of infants with the new drug and a
second group with a drug already proven to treat RDS, but no infant
would receive a placebo. One surfactant drug has been approved in the
U.S. on the basis of studies with this design, and Discovery
Laboratories plans to use this design in a European study.
But the FDA has long expressed a preference for studies with
placebo controls, even for conditions that are not minor, and companies
prefer them because it is easier to prove one\'s drug is superior to
nothing than to prove that it is as effective as a competitor\'s drug
that is known to work.
Public Citizen learned about the proposed study through
documents obtained from an internal meeting at the FDA at which the
proposed study was discussed. The meeting was entitled, \"Use of
placebo-controls in life threatening diseases: is the developing world
the answer?\" Because the drug is still under development, some details
of the proposed study -- such as the name of the drug company -- were
not included in the FDA documents. However, in a phone call with Public
Citizen, Discovery Laboratories\' president, Robert J. Copetola,
confirmed that his company is the sponsor of the proposed trial.
Surfactant was heralded in a 1993 New England Journal of
Medicine article as \"without doubt the most thoroughly studied new
therapy in neonatal care.\" A statistical summary of studies of synthetic
surfactant has concluded that the drug reduces neonatal mortality by 34
percent and that \"further placebo controlled trials of synthetic
surfactant are no longer warranted.\"
The use of a placebo in this study violates the Declaration of
Helsinki, an international ethics document. A recent revision to the
Declaration says 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
letter notes that in light of this language, \"the sort of study
contemplated here is expressly forbidden\" by the Declaration.
Discovery Laboratories claims that it will make the drug
available at a reduced cost in thosecountries where it conducts the
study, but it hasn\'t defined those costs precisely. Pharmaceutical sales
in Latin America represented just 7 percent of international
pharmaceutical sales in 1999, compared to 40 percent in North America
and 27 percent in Europe.
\"The infants who would get placebos are being used by the
company for reasons having to do with corporate bottom lines in order to
get their drug approved,\" said Public Citizen\'s Health Research Group
director, Sidney M. Wolfe, MD. Public Citizen also is asking the new
Office of Human Research Protections in HHS to use its influence to
immediately stop the study.
\"If this study occurs, it will be a landmark of unethical and
exploitative behavior, \" Lurie said. \"We have a profit-driven drug
company turning to the developing world to conduct studies that could
never be done in the United States or even in some parts of the study
countries. This company wants to experiment on the poorest of the poor,
and that is despicable.\"
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See also:
http://www.citizen.org/hrg/publications/1558.htm
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