Author: Jon Merz
Date: 05-29-07 22:45
http://www.washingtonpost.com/wp-dyn/content/article/2007/05/29/AR2007052902107.html?hpid=topnews
Pfizer Charged by Nigerian Officials
Firm Faces Criminal Counts in Deaths of Children in 1996
By Joe Stephens
Washington Post Staff Writer
Wednesday, May 30, 2007; Page A01
Officials in Nigeria have brought criminal charges against
pharmaceutical giant Pfizer Inc. for the company's alleged role in
the deaths of children who received an unapproved drug during a
meningitis epidemic.
Authorities in Kano, the country's largest state, filed eight charges
this month related to the 1996 clinical trial, including counts of
criminal conspiracy and voluntarily causing grievous harm. They also
filed a civil lawsuit seeking more than $2 billion in damages and
restitution from Pfizer, the world's largest drug company.
The move represents a rare -- perhaps unprecedented -- instance in
which the developing world's anger at multinational drug companies
has boiled over into criminal charges. It also represents the latest
in a string of public-relations blows stemming from the decade-old
clinical trial, in which Pfizer says it acted ethically.
The government alleges that Pfizer researchers selected 200 children
and infants from crowds at a makeshift epidemic camp in Kano and gave
about half of the group an untested antibiotic called Trovan.
Researchers gave the other children what the lawsuit describes as a
dangerously low dose of a comparison drug made by Hoffmann-La Roche.
Nigerian officials say Pfizer's actions resulted in the deaths of an
unspecified number of children and left others deaf, paralyzed, blind
or brain-damaged.
The lawsuit says the researchers did not obtain consent from the
children's families, and also says the researchers knew Trovan to be
an experimental drug with life-threatening side effects that was
"unfit for human use." Parents were banned from the ward where the
drug trial occurred, the suit says, and the company left no medical
records in Nigeria.
Pfizer and its doctors "agreed to do an illegal act," the criminal
charges state, and behaved "in a manner so rash and negligent as to
endanger human life."
Internal Pfizer records obtained by The Washington Post show five
children died after being treated with the experimental antibiotic,
though there is no indication in the documents that the drug was
responsible for the deaths. Six children died while taking the
comparison drug.
Suspicion stirred by news of the drug trial has been so intense in
Kano, the lawsuit says, that parents last year refused to allow their
children to be immunized against polio, frustrating a program aimed
at wiping out one of the disease's last refuges.
In a written statement, Pfizer said the company believes it did
nothing wrong and emphasized that children with meningitis have a
high fatality rate.
"It is indeed regrettable that, more than a decade after the
meningitis epidemic in Kano, the Nigerian government has taken legal
action against Pfizer and others for an effort that provided
significant benefit to some of Nigeria's youngest citizens," the
statement said.
"Pfizer continues to emphasize -- in the strongest terms -- that the
1996 Trovan clinical study was conducted with the full knowledge of
the Nigerian government and in a responsible and ethical way
consistent with the company's abiding commitment to patient safety.
Any allegations in these lawsuits to the contrary are simply untrue
-- they weren't valid when they were first raised years ago and
they're not valid today."
The criminal charges also name Pfizer's Nigerian subsidiary and eight
current or former executives and researchers. The charges could
result in fines and prison sentences ranging from six months to seven
years per count, according to Aliyu Umar, who served as Kano attorney
general until earlier this month.
Umar said he filed the charges with the backing of federal and state
authorities. He said it took 11 years to bring the action because
officials only learned details in recent years, through a series of
investigative reports in The Post. Three months ago, Umar's office
obtained a six-year-old Nigerian government report that concluded
Pfizer's actions violated international law.
"We realize we are the Third World and we need assistance," Umar
said. "But we frown on people who think they can take advantage of
us, especially if it's for profit. That's why we decided we needed to
take action against Pfizer.
"Those people responsible should be punished, whether in Nigeria or
in the United States, for what they did to our people."
Pfizer's drug trial came to public attention in December 2000, when
The Post published the results of a year-long investigation into
pharmaceutical testing in the developing world. Nigerians met the
news with street demonstrations and demands for reform.
Nigeria's health minister appointed a panel of experts to look into
Pfizer's actions, but its final report was suppressed without
explanation. Last year, The Post obtained a copy, which revealed that
the panel had concluded Pfizer's actions violated Nigerian law, the
international Declaration of Helsinki and the U.N. Convention on the
Rights of the Child.
The panel said Pfizer administered an oral form of Trovan that
apparently had never been given to children with meningitis. It said
there were no records documenting that Pfizer told the children or
their parents that they were part of a drug trial. And it said an
approval letter from a Nigerian ethics committee, which Pfizer used
to justify its actions, was a sham concocted long after the trial
ended.
"The families of the children who [Pfizer] used as laboratory guinea
pigs were led to believe and in fact understood that the Defendants
were providing their children with volunteer relief, clearly focused
humanitarian medical intervention and nothing more," the lawsuit says.
Parents were not told that alternative treatments were available, it adds.
The suit charges that parents were barred from Pfizer's ward, and
that the company's own lab tests had shown Trovan's life-threatening
side effects. Researchers allegedly administered the comparison drug,
Rocephin, in dangerously low doses to make Trovan look more effective.
The lawsuit contends that Pfizer researchers left the area during the
epidemic, took all medical records and "obliterated any evidence" of
the trial.
"Defendant's illegal conduct was deliberate and solely motivated by
financial considerations," it says.
Every surviving child suffered one or more disabilities, the lawsuit
says, adding that the state of Kano has incurred major costs caring
for the children and otherwise dealing with the drug trial's
repercussions.
In its statement, Pfizer said the drug was in "late stage
development" and had been tested on 5,000 patients in a number of
countries. "Pfizer's doctors had solid scientific evidence that it
would provide a safe and effective treatment against the deadly
disease," the statement said. The treatment "indisputably helped save
the lives of almost 200 children," the company said.
The U.S. Food and Drug Administration never approved Trovan for use
in treating American children. After being cleared for adult use in
1997, the drug quickly became one of the most prescribed antibiotics
in the United States. But Trovan was later associated with reports of
liver damage and deaths, leading the FDA to restrict its use in 1999.
It remains available in the United States, but European regulators
have banned it.
Research Editor Alice Crites contributed to this report.
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