The trial by Pfizer Pharmaceutical Company of oral Trovalfloxacin (Trovan) in Kano between April 3 and 8, 1996 during the outbreak of severe meningitis in Nigeria was illegal.
This verdict is contained in the report of an Investigation Committee set up by the Federal Government to probe the trial.
The report of the Investigation Committee obtained by our correspondent shows that the National Agency for Food and Drug Administration and Control, which has the statutory power to issue approval for drugs trial in the country did not issue any such approval to Pfizer.
The then DG of NAFDAC at the time of the trial, Prof. G. Osuide, told the committee that the letter written by the agency was not an approval for Pfizer to carry out drug test in Nigeria but to merely authorise the importation of the drug for investigational purposes.
All the staff of the agency who participated in the correspondences between Pfizer and NAFDAC testified that no approval for clinical drug test was issued.
They are, the Deputy Director in charge of Registration, Dr. Bawa Abubakar, the Former Director of Inspectorate, E.U. Usoro and the Deputy Director, Inspectorate, Kano, Major Aliyu Mohammed (rtd).
The report further states that Pfizer conducted the clinical trial on the premise that NAFDAC�s approval authorising importation of the drugs for investigational purposes was sufficient authority to carry out the test.
Pfizer has already filed an application at a Federal High Court, Abuja, to quash the report on the ground among others, that the investigation committee�s chairman, Prof. Abdulsalam Nasidi, was bias.
It is stated in the report that Nasidi had received several death threats to his life during the commencement of the committee�s work.
The report which was exclusively obtained by the PUNCH states that Pfizer did not follow laid down procedures or conduct of clinical trials in spite of its being conversant with the guidelines.
It further states that Pfizer brought to Nigeria, medical doctors, who though qualified to practice in the United States of America, were not qualified to practice in Nigeria without obtaining the licence to practice. These doctors illegally participated in the clinical trial which left six children dead and others with adverse effects.
The U.S. Doctors in the trial are Scott Hopkins, Debra Williams and Mike Dunne.
�Although medically qualified and experienced in handling infectious diseases of this nature, these doctors who formed part of the medical team were not cleared nor licensed by the Nigerian Medical Council to practice in Nigeria,� the report added.
The report also accuses NAFDAC of failure to stop the illegal trial after it was duly informed of the illegality by the Chairman of the Task Force on the Control of the Epidemic, Prof. Idris Mohammed.
�For breaching the Drug and Related Products (Registration, etc) Decree of 1993, the Helsinki Declaration on Ethical Principles for the Medical Research involving Human Subjects and the 1989 United Nations Convention on the Rights of the Child, Pfizer should be sanctioned appropriately,� the report states.
Pfizer had consistently denied any wrong doing but the report is unequivocal in its findings that the company�s motive for seeking to assist Nigeria in combating the epidemic which was then ravaging the country was far from altruistic.
Prior to the commencement of the trial, the report shows that Pfizer failed to obtain ethical approval which is required for all clinical trials.
The report states, �There was no ethical approval for this trial before and during the trial. This is contrary to the earlier claims by Pfizer that the study could not have been initiated without ethical committee approval which according to them was obtained prior to study.�
The report finds that Dr Isa Dutse who was appointed Principal Investigator for the trial did issue single-handedly an ethical clearance certificate to Pfizer at a time an ethical committee was not in existence in Aminu Kano Teaching Hospital.
In his testimony, Dutse admitted issuing the clearance 6 months after the trial had been concluded following a request for it by Pfizer.
He expressed regrets and begged for forgiveness. The committee nevertheless recommended that he be sanctioned.
As the principal investigator to the trial, he admitted been paid the sum of USD20, 000.00 for his service.
It further notes that there was no proof as argued by Pfizer that it obtained informed consent of the patients recruited for the trial.
The report suggests that Pfizer tender an unreserved apology to the government and people of Nigeria and Kano State in particular. It further recommends that the company make appropriate restitution.
The report also finds that the role of the leadership of NAFDAC and the ministry of health at the time was far from blameless.
�The way Pfizer came in and left showed that their presence in Kano was just for the trial as they left when the epidemic was still raging.�
In their testimonies, Pfizer said that they did not submit the report of the test to NAFDAC because they had no intention of applying for registration.
In all the committee interviewed 26 witnesses including representatives of Pfizer.
The former Chief Executive Officer, Pfizer Nig Ltd, Sam Ohuabunwa also appeared before the committee.
The report also shows that when it became obvious that neither NAFDAC nor the then Minister of Health was going to stop the illegal trial, the then National Security Adviser to the Head of State, Alhaji Isamila Gwarzo was briefed but he did nothing.
The report states that Gwarzo was briefed so that the attention of the then head of state, the Late General Sani Abacha could be drawn to the illegality.
Parts of the recommendations of the committee�s report reads, �NAFDAC as a regulatory agency failed in its responsibility by not stopping the trial or taking any action when alerted by the chairman of the task force.
�By its inappropriate response to Professor Idris Mohammed�s report of the drug trial, the Federal Ministry of Health failed in its duty to protect the health of the ailing children.�
Oct222007