E-drug: Drug company sued over research trial in Nigeria
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[This clinical trial was discussed on E-drug some time ago. Pfizer
has now been sued. Copied as fair use. KM]
Lancet 2001; 358: 815 (8 September 2001)
Drug company sued over research trial in Nigeria
A group of Nigerian families has taken legal action against the
pharmaceutical company, Pfizer. The lawsuit, which was filed in a
US court on Aug 29, claims that the families' children were entered
into a trial of Pfizer's Trovan (trovafloxacin) for bacterial meningitis
in 1996 without informed consent. The families accuse the
US-based drug company of violating "international law, federal
regulations and medical ethics, in its zeal to carry out its test".
Pfizer gave the children a "new, untested and unproven drug
without first obtaining their informed consent, or explaining to the
children or their parents that the proposed treatment was
experimental and that they were free to refuse it and instead
choose the safe, effective treatment for bacterial meningitis offered
at the same site, free of charge, by a charitable medical group",
according to the lawsuit.
Responding to the suit, Pfizer maintained that the Trovan trial had
been approved by the Nigerian government and that consent of the
families of participants had been obtained. The study "was an
important clinical investigation, and Pfizer is proud of the way the
study was conducted, in the midst of a deadly meningococcal
meningitis epidemic", a statement said. The statement added: "The
study was well conceived, well executed and saved lives". "We
stand by our statement", Pfizer's Bob Huber told The Lancet.
In 1996, when Nigeria's Kano city was in the grip of concurrent
epidemics of meningitis, cholera, and measles, Pfizer sent
researchers to the Infectious Disease Hospital in Kano to test
Trovan. In Kano, the non-governmental organisation, M�decins
Sans Fronti�res (MSF) was using chloramphenicol to treat people
with meningitis. The lawsuit contends that Pfizer assigned 100
children Trovan and 100 controls a lower than recommended dose
of ceftriaxone.
"Pfizer took the opportunity presented by the chaos caused by the
civil and medical crises in Kano to accomplish what the company
could not do elsewhere--to quickly conduct on young children a test
of the potentially dangerous antibiotic Trovan", stated the lawsuit.
"This [the launch of Pfizer's trial] created a great deal of friction
between MSF and Pfizer", says MSF's Jean-Michel Piedagnel, who
as a member of the MSF mission to Nigeria in 1996 witnessed part
of Pfizer's operations during the outbreak. "The introduction of a
new treatment protocol by Pfizer created serious problems for
health workers managing the cases in the ward. Therefore we
asked Nigeria's ministry of health to intervene", he said. To diffuse
the situation, the ministry gave a separate ward to Pfizer, he added.
Pfizer said: "the fatality rates in the Kano study, approximately 6%
for both Trovan and ceftriaxone, were lower than published results
for other forms of treatment in this epidemic." But, the suit alleges
that the deaths and injuries among controls were the result of a
lower than recommended dose of ceftriaxone.
The case was raised by the Washington Post last year and sparked
widespread anger in Nigeria and abroad. According to ethicist
Arthur Caplan (Center for Bioethics, University of Pennsylvania, PA,
USA) the Trovan case represents yet another in a growing list of
controversial experiments involving western pharmaceutical
companies doing research in very poor nations. "Given that the twin
protections of informed consent and [intitutional review board]
review are under attack as inadequate for protecting the interests of
subjects in the developed world, it is very unlikely that these
protections, or weaker versions of them, will suffice in the
underdeveloped world", he argued. He added that inadequate
attention had been paid to the moral duties incumbent on those
doing research in poor nations and warned that until remedial
measures are taken, more and more Trovan-type cases could be
expected to be brought.
The Trovan trial supports the veracity of the international concerns
that developing countries will merely be used as test areas for
medical treatments designed for developed countries, adds Charles
Weijer (Dalhousie University, Halifax Nova Scotia, Canada).
International law, he said, requires that research done in developing
countries be reviewed by both host and sponsor country, as well as
upholding requirements for informed consent. "The comparison of
Trovan to a low dose of ceftriaxone violates the central requirement
of the Declaration of Helsinki by knowingly exposing children in
need of treatment to inferior therapy", Weijer added. The new
Declaration of Helsinki (2000) specifically 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".
Weijer called on the international community to guard against the
exploitation of developing countries, and ensure that all research
participants receive equal protection. "The pharmaceutical industry
has, as illustrated in this case, demonstrated its willingness to
exploit the vulnerable."
Khabir Ahmad
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