-Caveat Lector-

Children Used as Guinea Pigs By U.S. Company

By Toye Olori

LAGOS, Jan 9 (IPS) - A recent report by a U.S. newspaper that a
major international pharmaceutical company carried out unapproved
tests of a risky drug on Nigerian children which led to tragic
consequences, has put the company on a firing line in Nigeria.

The report, by the Washington Post, said Pfizer, the American
pharmaceutical company, in 1996 carried out the clinical test that
led to the death of 11 Nigerian children and the deformation of
200 others.

The drug, ''Trovan Floxacin'', was developed for the treatment
of meningcocal meningitis, a form of Cerebro-Spinal Meningitis
(CSM) which ravages part of northern Nigeria during the hot
season. Nigeria has two weather conditions - dry season and rainy
season.

Unconfirmed reports say Pfizer did not obtain the approval of
the Food and Drug Administration, the agency which regulates
pharmaceutical products in the United States, before embarking on
on the test.

''The action of Pfizer is most detestable,'' says Peter Ebigbo
of ChildRights Africa, a Network for the Prevention and Protection
against Child Abuse and Rights.

''Our leaders must not allow Nigerians to be used as guinea
pigs by any company to make money. We must now begin to claim back
our rights. My organisation will look into it and come up with an
appropriate statement on the issue,'' says Ebigbo.

Medical experts in Nigeria believe there was gross abuse of
professional ethics as internationally accepted standards seemed
to have either been poorly enforced or completely ignored.

They argued that the patients and their families were not
adequately educated on the parameters of the test and its possible
consequences.

In its first official reaction, contained in a statement
released in Lagos over the weekend, Pfizer maintained that
approval was received from all appropriate agencies before trial
was carried out for its test on CSM patients at the Infectious
Disease Hospital in Kano.

The statement, signed by the Pharmaceutical Division Director
and Medical Director of Pfizer Specialities, Lere Baale and Segun
Dogunro respectively, expressed shock at the report which they
described as lopsided.

''It is unimaginable that a company like ours would be involved
in a clinical trial without the approval of the appropriate
agencies. Indeed relevant agencies and government bodies were
fully involved in our drive to save lives during the crisis,'' the
statement said.

It added that only 90 CSM patients were treated with Trovan
during the trial while another 97 were treated with the company's
Cefiriaxone which is the gold standard for the CSM treatment even
in the United States.

But, Sadiq Wali, Chief Medical Director of the Aminu Kano
Teaching Hospital (AKTH), has denied that the hospital's medical
ethics committee gave approval to Pfizer to use the drug at the
Infectious Diseases Hospital in Kano.

He says for any pharmaceutical company to get approval to test
any drug, it must get the approval of a local ethics committee in
the community made up of senior medical personnel and members of
the community where the test would be carried out.

''Pfizer did not do that. I am not sure if they had the consent
of the people used as guinea pigs, because that means informed
consent in medical parlance. Such consent has to do with the
patients being told the good as well as the side effects of the
drugs to be administered'', he says.

The Kano State government has instituted a probe into the
matter.

While inaugurating a three-man team mandated to investigate the
issue, Commissioner for Health, Dr. Mansur Kabir, said the
ministry was appalled by the news reports on the trial of the CSM
drug.

He warned that anybody indicted by the committee expected to
submit its report within a week, would be made to face the full
wrath of the law no matter his position in the society.

Getting proper records would, however, not be easy. Reports
from Kano say the medical records of 350 CSM patients, who were
treated between April and June 1996, had disappeared from the
hospital.

So far, the growing public pressure appears to be forcing the
government to take action against the company. A Ministry of
Health memorandum on award of contracts for the supply of CSM
vaccines this year shows that 11 pharmaceutical companies would
supply 33 million doses of the vaccine valued at 9 million
dollars, but Pfizer's name was conspicuously missing from the
list.

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