bioethics: Northern Nigeria's Tuskegee?

[cadebamo@hsph.harvard.edu]

>Hello:
>
>I do not recall the procedure for sending stuff to the listserve. I think
>that this story might be interesting to colleagues. It is from the Nigerian
>Guardian Newspaper of 28th of February 2004 and I wonder if the Pfizer Trial
>is going to be Northern Nigeria's Tuskegee
>
>
>
>
>
>
>Why Some States Reject Polio Vaccines
>
>*       Niger Suspends Boycott
>BY MUYIWA ADEYEMI
>
>STRONG opposition to and rejection of the last national polio immunization
>exercise by some states in the North may have been informed by an alleged
>lukewarm attitude of the federal authorities to the plight of children who
>suffered from a clinical trial by Pfizer International Incorporation, United
>States in 1996.
>
>Specifically, the elite from that part of the country are not happy that the
>federal government did not show any interest in prosecuting the
>international pharmaceutical company which experimented the drug
>Trovafloxacin on many Nigerian children in the treatment of cerebro spinal
>meningities(CSM).
>
>For them, it was a case of 'once beaten twice shy' and their rejection of
>the polio vaccines would rather make the federal government to investigate
>the source of the vaccines being giving to the children.
>
>The Guardian investigation revealed that when there was an outbreak of
>Cholera, Gastro Enterities and CSM in Kano State in March 1996 , health
>facilities at the Infectious Diseases Hospital (IDH) were stretched to the
>limit with the number of patients thronging the hospital for treatment.
>
>Investigations further revealed that despite the inadequate government
>facilities to tackle such emergencies, the doctors from Medicines San
>Frontiers (Doctors Without Borders) were at hand to complement government
>efforts and they administered Certrianone, the gold standard drug approved
>by the World Health Organisation (WHO) for the treatment of meningities.
>
>While the MSF and the Red Cross were doing their best, the source said,
>"Pfizer was putting finishing touches to their plans to subject the
>innocent, ignorant and impoverished paediatric population to a human
>experiment in the midst of the epidemic.
>
>According to the source, " Pfizer International chartered a DC9 jet and flew
>to Kano in April 1996 with their doctors, para-medics and the experimental
>drug, Trovafloxacin. They moved to (IDH) where the unsuspecting hospital
>management allocated two wards to Pfizer to carry out their clinical
>experiment on Nigerian children."
>
>It was gathered that "the consent of the parents/guardian of the victims
>were never sought and obtained neither did Pfizer inform the victims that
>the approved and tested drug, Ceftrixone was available free from the MSF at
>the hospital for the treatment of meningities.
>
>The source continued:"All the identifiable infants treated by Pfizer during
>the epidemic in 1996 are dead, deaf and dumb or suffering from permanent
>physical deformities.
>
>"Researchers for Pfizer International doctors conducted the human guinea pig
>clinical trial in two weeks and flew back to Groton, Connecticut, United
>States without a follow up. The victims of the experimental drug did not
>know that they were being used as human guinea pigs until one of the staff
>that participated in the trial complained about the unethical clinical
>test."
>
>The Guardian investigations revealed that the Pfizer researcher, Dr. Juan
>Walterspiel who raised the objection to the unethical and illegal clinical
>test conducted in Kano was sacked but he sued Pfizer for wrongful dismissal.
>
>
>However, Pfizer finally settled with him by paying huge sum of money to
>discontinue the action in court, but the affected Nigerian families are
>still counting their losses.
>
>Although the pharmaceutical company had put up a spirited defence arguing
>that "the 1996 trial in Nigeria was specifically designed to validate the
>safety and efficacy of Trovafloxacin in treating Meingococcal meningities ,
>many Nigerians still believed that the clinical trial "was an act of
>deliberate decimation of Nigerian's paediatric population"
>
>Analysts also believed that the firm stood to reap about one billion dollars
>a year if Trovan had won the approval for all its potential uses.
>
>The Guardian leant that the suit commenced in Nigeria by victims of the
>human experiment against Pfizer international made the federal government to
>set a 12-member commission of enquiry headed by Dr. Ahmmed Nasidi, a
>director in the Federal Ministry of Health and Prof. A.B Nwosu who promised
>to submit thre report to the Federal Executive Council for delibration
>before a white paper was issued.
>
>The source said that the report was never submitted alleging that the
>findings were against Pfizer International, and that the counsel for the
>plaintiffs discontinued action against the Federal Government and its
>agencies to allow the government release the report to the public in
>November, 2001."However, since September 2001 when the committee submitted
>its report till now, the Federal Government has not made any pronouncement
>or release the findings of the report to the public
>
>He said that the affected families strongly believe that both the federal
>government and the judiciary have betrayed them, citing that the judge
>hearing the matter declined personal jurisdiction after delivering a ruling
>on July 4, 2002 and transferred the case to the Federal High Court 1 in Kano
>that has no judge.
>
>Another judge was appointed October last year after the said court declined
>jurisdiction ,he added. " The protracted delay in the prosecution of this
>case while the victims suffered from permanent physical deformities
>traumatised the victims and their relations to the extent that they opted to
>discontinue the action in Nigeria and institute a fresh claim in
>Connecticut, USA.
>
>The source said until the Federal Government proved that any affected
>families from the on-going immunization exercise would be compensated, many
>families from the North may not participate,.
>
>In fact Jama'atu Nasir Islam (JNI) secretary Alhaji Baba Ahmed had during
>the week said "if the federal Government insisted on the vaccine, then it
>would have to make an undertaking to compensate victims, in case of any
>adverse effect.
>
>However, Niger State has lifted the suspension it placed three days ago on
>the national immunisation exercise in the state. The exercise, which was
>abruptly suspended by the state government shortly after it took off on
>Monday, will now continue in all parts of the state.
>
>Governor Abdulkadir Kure announced the resumption of the exercise yesterday
>in Minna, shortly after receiving a team from the national verification
>committee, on the controversial polio vaccine.
>
>He said: "We will go ahead with the immunisation exercise since we have been
>assured of the safety of the vaccine by the committee that had just returned
>from the verification visit to some countries."
>
>Kure who refused to make public comments since the exercise was suspended on
>Monday, told reporters that the state government was now convinced that
>there was nothing harmful in the vaccine.
>
>He justified the initial decision to suspend the exercise on the grounds
>that the verification committee set up by the federal government had not
>disclosed its report, when the immunisation exercise began."Now we have
>heard from them, and our fears have been allayed, so we will mobilise our
>people so that the exercise can continue successfully, the governor said.
>
>Kure noted that in the last four years, Niger had maintained a record of
>being very responsive to the immunisation exercise and said its recent
>objection to it had no religious coloration.
>
>He then ordered all the commissioners and political appointees in their
>state to go to their constituencies to mobilise the people for massive
>participation in the exercise, which, he said, would be extended to allow
>for wide coverage.
>
>The verification team, led by Prof. Umaru Shehu included the Emir of Suleja,
>Alhaji Auwal Ibrahim Shehu of Dikwa, Alhaji Umar Bin-Mohammed, NPI national
>co-ordinator and other stakeholders.
>
>The FPI Manager in Niger, Alhaji Mohammed Kudu, has directed all
>immunisation personnel to resume the house-to-house exercise.
>
>
>
>
>
>
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