http://www.washingtonpost.com/wp-dyn/content/article/2007/05/29/AR2007052902107.html
Pfizer Faces Criminal Charges in Nigeria
By Joe Stephens
Washington Post Staff Writer
Wednesday, May 30, 2007; Page A10
Officials in Nigeria have brought criminal charges against
pharmaceutical giant Pfizer 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.
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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 that the researchers did not obtain consent from the
children's families and that 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 that 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 statement, Pfizer said it thinks 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.
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