Pfizer faulted over drug trials
Report cites use of unproven drug on African children in mid ’90s
A panel of Nigerian medical experts has concluded
that Pfizer Inc. violated international law during a 1996 epidemic
by testing an unapproved drug on children with brain infections
at a field hospital.
That finding is detailed in a lengthy Nigerian
government report that has 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 congressional interest. It was provided
by a source who asked to remain anonymous because of personal
The report concludes that Pfizer
never obtained authorization 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 an often deadly strain
of meningitis. At the time, Doctors Without Borders was dispensing
approved antibiotics at the hospital.
Accused of ‘exploitating the ignorant’
Pfizer's experiment was "an illegal trial of an unregistered
drug," the Nigerian panel concluded, and a "clear case
of exploitation of the ignorant."
The test came to public attention in December
2000, when The Post published the results of a year-long investigation
into overseas pharmaceutical testing. The news was met in Nigeria
with street demonstrations, lawsuits and demands for reform.
Pfizer contended that its researchers traveled
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."
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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, actually 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 that governs
ethical medical research and the U.N. 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.
Demand for sanctions
The panel recommended that Pfizer be "sanctioned appropriately"
and directed to issue "an unreserved apology to the government
and people of Nigeria." The company should also pay an unspecified
amount of restitution, the report said. The panel recommended
that Nigeria enact reforms to prevent a recurrence.
Aspects of the affair remain mysterious, such
as why the report remains confidential. The head of the investigative
panel, Abdulsalami Nasidi, said in a brief telephone conversation
from Nigeria, "I don't really know myself" why the report
was never released.
"I did my job as a civil servant,"
said Nasidi, who is quoted in the report as saying he has been
the target of unspecified death threats.
A New York City attorney for the families of
the children, Elaine Kusel of Milberg Weiss Bershad & Schulman,
said her firm had spent years looking for the report, of which
they believed there were only three copies. They tracked one to
a Nigerian government safe, but it was reported stolen, she said.
Another copy was reported to have been held by an official who
"It sounds like a mystery novel here, like
John le Carré," Kusel said.
The current Nigerian health minister, Eyitayo
Lambo, did not respond to calls and e-mail messages from a reporter.
Dora Akunyili, director of the Nigerian drug control agency, said
she did not know why the report remained confidential but added
that her agency had independently concluded that "these people
did not have authority to conduct the trial."
Pfizer responds to charges
Executives at Pfizer, the world's biggest drug company, 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 document.
"However, as we have stated repeatedly over
the past several years, Pfizer conducted this trial with the full
knowledge of the Nigerian government and in a responsible way
consistent with Nigerian law and Pfizer's abiding commitment to
Pfizer said it had previously tested the drug
in thousands of patients and found it effective. Local nurses
explained the experiment to Nigerian parents, it added, and obtained
their "verbal" consent. The company said that Trovan
demonstrated the highest survival rate of any treatment at the
"Trovan unquestionably saved lives, and
Pfizer strongly disagrees with any suggestion that the company
conducted its study in an unethical manner," the statement
At the time of the Nigerian experiment, Pfizer
was developing Trovan for release in the United States, where
it was expected to gross up to $1 billion a year.
The FDA 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 severely restrict
its use in 1999. European regulators banned the drug.
Oversight of trial questioned
After The Post published its report, Nigeria's health minister
at the time, Tim Menakaya, appointed a blue-ribbon panel of medical
experts to look into Pfizer's actions, saying, "Let me assure
you that my ministry will take all necessary steps to obtain details
of this incident and make them known to the general public."
The committee collected hundreds of documents and interviewed
at least 26 people.
Pfizer had told authorities that a local Nigerian
doctor directed the experiment. The committee, however, found
that researchers from Pfizer's U.S. office controlled the trial,
and the inexperienced Kano doctor, Abdulhamid Isa Dutse, was the
principal investigator "only by name."
Publications listed Dutse as the lead author
of articles on Trovan, but the committee found that depiction
"did not sufficiently reflect his role." Dutse indicated
he was kept in the dark about the experiment's results and said
he did not see at least one publication until the committee showed
it to him.
"He was shocked that Pfizer could publish
such data without showing him [the data] or intimating him with
details," the report said, concluding that Dutse was "naive
The report quoted Dutse as saying that Pfizer's
motive was far from philanthropic.
"I have trusted people and am disappointed,"
Dutse told the committee. "I regret this whole exercise,
I wonder why on Earth I did this."
Back-dated letter of approval
Dutse admitted that he created a letter after the experiment purporting
to show that the test had been approved in advance by a Nigerian
hospital's ethics committee. He then backdated the letter to March
28, 1996 -- a week before Pfizer's experiment began.
Pfizer used the letter as a key justification
for the trial in discussions with reporters and submitted it to
the FDA. U.S. regulations require the sponsors of foreign medical
research seeking FDA approval to show that the tests have been
reviewed in advance by an ethics committee.
The Post previously reported that the hospital
had no ethics committee in March 1996 and that the letterhead
stationery used was not created until months after the experiment's
IIn a statement last week, Pfizer said that after
that article appeared, the company investigated and found that
the letter was "incorrect."
"Obviously this should not have occurred
and the company very much regrets that it did," the statement
said. "It is important to point out, though, that Pfizer
thought proper procedure had been followed at the time of the
Trial called ‘an act of deception’
The former director of Nigeria's version of the FDA said the agency
had been unaware of the experiment. He told the panel that he
"viewed the conduct of the trial by Pfizer as an act of deception
and misuse of privilege."
The report said the treatment of two children
during the experiment represented unspecified "serious deviations"
from the trial's protocol and concluded that those deviations
compromised their care. One was a 10-year-old girl identified
only as Patient No. 0069, who was given the experimental antibiotic
for three days as her condition deteriorated. She died without
receiving any other antibiotic.
Last week, Rep. Tom Lantos of California, the
senior Democrat on the International Relations Committee, described
the report's findings as "absolutely appalling" and
called on Pfizer to open its records.
"I think it borders on the criminal that
the large pharmaceutical companies, both here and in Europe, are
using these poor, illiterate and uninformed people as guinea pigs,"
Lantos said he expected to introduce a bill requiring
U.S. researchers to give regulators details of tests they plan
in developing countries.
"It's the only ethical thing to do,"
Lantos said. The bill is similar to one his committee approved
in 2001 that did not make it out of the House. "There should
be a lot of bipartisan support for it. This outrages people."
The report's findings also breathe new life into
a lawsuit against Pfizer, according to Kusel, who represents 30
Nigerian families. "It's great news, I'm very excited,"
she said when told of the committee's conclusions.
The families sued Pfizer in federal court in
New York in 2001, alleging that the company had exposed the children
to "cruel, inhuman and degrading treatment."
A U.S. judge dismissed the suit last summer,
saying U.S. courts lacked jurisdiction. Kusel is appealing.
A report like this does not get suppressed without
someone high up being involved," she said.
© 2006 The Washington Post Company