Pfizer accused of testing drug on children

By Joe Stephens, Washington
May 8, 2006

A PANEL of Nigerian medical experts has concluded that the world's largest
pharmaceutical company, Pfizer, violated international law by testing an
unapproved drug on children with brain infections at a field hospital.

The explosive finding is detailed in a Nigerian Government report that
remained unreleased for five years, despite inquiries from the children's
attorneys and from the media.

The Washington Post recently obtained a copy of the confidential report,
which is attracting US congressional interest.

The report concludes that Pfizer never obtained authorisation from the
Nigerian Government to give the unproven drug to nearly 100 children and
infants. Pfizer selected the patients at a field hospital in the city of
Kano, where the children had been taken to be treated for a deadly strain of
meningitis during an epidemic in 1996.

Pfizer's experiment was "an illegal trial of an unregistered drug", the
Nigerian panel concluded, and a "clear case of exploitation of the

The test came to public attention in December 2000, when The Post published
the results of a year-long investigation into overseas pharmaceutical
testing. Pfizer contended that its researchers travelled to Kano with a
purely philanthropic motive, to help fight the epidemic, which ultimately
killed more than 15,000 Africans.

The committee rejected that explanation, pointing out that Pfizer physicians
completed their trial and left while "the epidemic was still raging".

The panel said an oral form of Trovan, the Pfizer drug used in the test, had
apparently never been given to children with meningitis.

There are 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 report said.

The panel concluded that the experiment violated Nigerian law, the
international Declaration of Helsinki governing ethical medical research and
the UN Convention on the Rights of the Child.

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.

Aspects of the affair remain mysterious, such as why the report remains

The head of the investigative panel, Abdulsalami Nasidi, said he did not
know why the report was never released. "I did my job as a civil servant,"
said Mr Nasidi, who is quoted in the report as saying he has been the target
of death threats.

A New York City attorney for the families of the children, Elaine Kusel,
said her firm had spent years looking for the report, of which it believed
there were only three copies.

They tracked one to a Nigerian Government safe, but it was reported stolen.
Another copy was reported to have been held by an official who died.

Executives at Pfizer said they had not seen the report. After reviewing a
copy, they responded in a two-page statement: "The Nigerian Government has
neither contacted Pfizer about any of the committee's findings nor are we
aware that the committee has approved a final report. Therefore it would be
inappropriate for the company to respond to specific points in the