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By Tamar Lewin
Thirty Nigerian families sued Pfizer in
federal court August 29, saying the company conducted an unethical
clinical trial of an antibiotic on their children in 1996.
It is the first suit in the United States
seeking damages from an American pharmaceutical company for
what the plaintiffs say was medical
experimentation on foreign citizens without their
consent.
During a meningitis epidemic in 1996,
Pfizer treated 100 Nigerian children with the antibiotic Trovan
as part of its effort to determine whether the drug, which
had never been tested in children, would be an effective treatment
for the disease.
Pfizer treated 100 other children with
ceftriaxone, the gold standard for meningitis treatment, but,
the suit says, at a lower-than- recommended dose.
Eleven children
in the trial died, and others suffered brain damage, were
partly paralyzed or became deaf.
Vanessa McGowan, a spokeswoman for Pfizer,
said yesterday that the company had not yet seen the suit,
which was filed in Federal District Court in Manhattan, and
could not comment on the allegations.
In the past, Pfizer has said that the
number of deaths in the Nigerian Trovan trial was lower than
the overall fatality rate for the meningitis epidemic and
that the trial had been a philanthropic effort that benefited
most of the sick children, not a self-serving effort to obtain
quick clinical data, as the suit contends.
In early 1996, within weeks of learning
about the meningitis epidemic from an Internet site, Pfizer,
the world's largest pharmaceutical company, sent a six-member
research team to the Infectious Disease Hospital in Kano,
Nigeria, a strife- torn city suffering concurrent epidemics
of bacterial meningitis, measles and cholera.
The Pfizer team selected children for
its test from the long lines of ailing people seeking care
at the hospital.
"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," said the suit, which was filed yesterday by
Milberg Weiss Bershad Hynes & Lerach, a New York law firm
that specializes in representing groups of plaintiffs against
large corporations.
Pfizer conducted the trial at the same
hospital where Doctors Without Borders, the Nobel Prize-winning
relief organization, was already providing free treatment
with chloramphenicol, the cheaper
antibiotic that is internationally recommended
for treating bacterial meningitis.
"Rather than provide the children
with a safe, effective and proven therapy for bacterial meningitis,"
the suit said, "Pfizer chose to select children to participate
in a medical experiment
of a new, untested and unproved 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."
Under the Nuremberg Code of 1947 and the
World Medical Associations Declaration of Helsinki, those
seeking to conduct medical tests on human subjects must explain
the purpose, risks and methods of the study and obtain each
subject's voluntary consent to participate.
Elaine Kusel, a Milberg Weiss lawyer who
visited Nigeria this spring to investigate the case, said
many of the parents told her they had had no idea they were
taking part in a test of an experimental drug. "The families
involved understood the Pfizer was providing their children
with volunteer relief, not that their children were `being
volunteered' to help Pfizer," the lawsuit said.
The suit, brought under the Alien Tort
Claims Act, seeks damages and continuing medical care for
those in the study, along with an order enjoining Pfizer from
conducting illegal human experimentation anywhere in the world.
According to the suit and earlier reporting
on the Trovan trial by The Washington Post, Pfizer never received
the necessary approvals to conduct the research, but, when
faced with an audit of its Trovan records by the Food and
Drug Administration in 1997, the company produced a letter
dated March 28, 1996, from the hospital saying the Trovan
study had been approved by the hospital's ethics committee.
But the suit contends that letter was
written a year later and backdated - and that at the time
the Pfizer trial took place,
the hospital had neither an ethics committee nor the letterhead
on which that letter was written.
Pfizer also violated international law,
the lawsuit says, by failing
to inform the families that alternative treatment was available
from Doctors Without Borders, failing to perform the necessary
diagnostic tests to ensure that the children selected in fact
had bacterial meningitis, failing to modify treatment for
children who did not improve after initial drug therapy and
failing to provide follow-up treatment.
The lawsuit said that Dr. Juan Walterspiel,
a Pfizer infectious disease specialist assigned to the Trovan
test, repeatedly told Pfizer management that the company was
violating international law, federal regulations and medical
ethics standards. Dr. Walterspiel was subsequently dismissed.
Pfizer already faces two class-action
lawsuits and a government investigation in Nigeria. And earlier
this month in Washington, the House International Relations
Committee approved an amendment to the pending Export Administration
Act that would bar United States researchers from shipping
experimental medicine to developing nations until they provide
American regulators with the details of their plans and submit
proof that a United States ethics committee has approved them.
When it was developed in the mid- 1990's,
trovafloxacin mesylate, or Trovan, was expected to be an important
new product for Pfizer, generating an additional $1 billion
a year in sales if approved by the F.D.A. for all its potential
uses.
So beginning in 1996, Pfizer conducted
the largest testing program ever undertaken, enrolling thousands
of people worldwide in clinical tests. Trovan went on the
market in 1998 and quickly became one of the most prescribed
antibiotics in the United States, selling more than $160 million
the first year.
But there were soon reports of liver damage,
and the FDA recommended in 1999 that Trovan
be used only for severely ill patients in institutional
settings. Use on children has not been approved.
Pfizer has a mixed record of philanthropy
in Africa.
The company has been widely praised for
its donation of millions of doses of Zithromax to treat trachoma,
a common cause of blindness. But Pfizer's donation of Diflucan
to South Africa, to treat some AIDS-related infections, has
left the company open to criticism from those who say Pfizer
put too many restrictions on how the free drugs are to be
used and has a moral obligation to lower the price of the
drug over all.
The New York
Times August 30, 2001
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