| Roman Bystrianyk 2006-05-08, 1:30 am |
| "Pfizer broke law with 1996 Nigeria drug test-paper", Reuters, May 8,
2006,
Link:
http://today.reuters.com/investing/...ALTH-PFIZER.XML
Nigerian medical experts concluded Pfizer Inc. violated international
law during a 1996 epidemic by testing an unapproved drug on children
with brain infections, the Washington Post reported in Sunday editions,
citing a copy of the panel's confidential report.
The report, completed five years ago but never released, found that
Pfizer was never authorized by the Nigerian government to give the
unproven drug Trovan to nearly 100 children and infants at a field
hospital in Kano, where they were being treated for an often deadly
strain of meningitis.
Pfizer's experiment was "an illegal trial of an unregistered drug," and
violated Nigerian law, the international Declaration of Helsinki that
governs ethical medical research and the U.N. Convention on the Rights
of the Child, the panel concluded, according to the Post.
Five children died after being treated with the experimental antibiotic
and others contracted arthritis, although there is no evidence the drug
played a part. Six children died while taking a comparison drug, the
Post said.
At the time, Doctors Without Borders was dispensing approved
antibiotics at hospital, according to the Post.
Pfizer, the world's biggest drug company, told the Post it conducted
the trial with the full knowledge of the Nigerian government and
consistent with Nigerian law. Local nurses explained the experiment to
Nigerian parents and obtained their "verbal" consent, the company told
the Post.
"Trovan unquestionably saved lives, and Pfizer strongly disagrees with
any suggestion that the company conducted its study in an unethical
manner," the Post quoted it as saying.
A U.S. federal judge last November dismissed a lawsuit that accused
Pfizer of not properly warning Nigerian families about the risk of its
meningitis drug Trovan, then awaiting U.S. Food and Drug Administration
approval, during a clinical test. He said the case should be heard in a
Nigerian court.
The lawsuit argued that some of the children in the trial died and
others suffered brain damage because the drug makers did not explain to
the Nigerian families that the antibiotic was experimental, that they
could refuse the treatment for their children, or that other medicines
were available.
Pfizer has denied the accusations.
The Nigerian government report obtained by the Post said there were no
records indicating that Pfizer told the children or their parents that
they were part of an experiment.
An approval letter from a Nigerian ethics committee, which Pfizer used
to justify its actions, was a falsified document that had been
concocted and backdated by the company's lead researcher in Kano, the
Post said, citing the report.
The panel recommended that Pfizer be "sanctioned appropriately," that
it issue "an unreserved apology to the government and people of
Nigeria," and pay an unspecified amount of restitution, according to
the Post.
It urged Nigeria to enact reforms to prevent a recurrence.
The FDA cleared Trovan for adult use in 1997, although it never
approved the drug for use by American children.
Trovan was later associated with reports of liver damage and deaths,
leading the FDA to severely restrict its use in 1999. European
regulators banned the drug.
Rep. Tom Lantos of California, the senior Democrat on the International
Relations Committee, described the report's findings as "absolutely
appalling," and said he would introduce a bill requiring U.S.
researchers to give regulators details of tests they plan in developing
countries.
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