It is now common knowledge that Pfizer used a drug trovafloxacin (commonly called Trovan) to treat Nigerians in a 1996 cerebrospinal meningitis (CSM) outbreak in Nigeria’s Kano district. This drug was not licensed for use for meningitis. The critical issue has been the company’s possible breach of global ethical guidelines on pharmaceutical trials.
Of the 200 children who participated in the trial, five of those given Trovan died and many others were left with disabilities.
Many believe that this single event, has led to the mistrust by the population of public health interventions that in turn was probably responsible for the rejection of polio vaccination, resulting in a massive outbreak in Northern Nigeria in 2003. This set back the entire polio eradication programme several years, costing the world billions of dollars. Today, many public people have become pessimistic on the achievability of this goal.
Pfizer has always rejected the allegations saying “Pfizer rejects the charges, saying in it is ‘proud of the way the study was conducted’ the study was ‘well conceived and well executed,’ and it ‘saved lives.’
The company’s exonerating claim has been that it obtained prior consent from both the Nigerian government and patients' families.”
For several years the families of those affected have been pursuing lawsuits in Nigeria and the US unsuccessfully. The official report of the incident conducted by a panel led by Dr Abdulsalami Nasidi, a virologist and one of the top civil servants in Nigeria’s Ministry of Health was never released by the Government until now!
It concludes that “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” and crucially stated that “concludes that Pfizer never obtained authorization from the Nigerian government to give the unproven drug to nearly 100 children and infants.”
Suddenly there are 2 lawsuits, by the Governments of Kano State and the Federal Government suing Pfizer.
Questions Nigerians are asking:
1. Who is lying?
Pfizer’s Managing Director, Nigeria Director, Miss Ngozi Edozien, insists that the 1996 clinical study was undertaken with the full knowledge of the Nigerian government in a responsible and ethical way consistent with the company’s abiding commitment to patient safety. The Nigerian government says "The plaintiff contends that the defendant never obtained approval of the relevant regulatory agencies ... nor did the defendant seek or receive approval to conduct any clinical trial at any time before their illegal conduct.
2. Why has this report been kept locked up for 11 years? A report like this does not get suppressed without someone high up being involved.
3. What have Ministers of Health since 1996 been doing in this regard?
4. Who takes responsibility for trials conducted in Nigeria, who authorises foreign interests to conduct trials in Nigerian clinical settings and who leads on the trials?
5. Who protects the interests of patients when trails are conducted? What is the role of the National Health Research Ethics Committee ...one would expect a stand from them?
6. Was informed consent got from the patients?
7. Why does Pfizer, the world’s largest drug maker, with a net profit of Net $268.4 million in 2006 not pay these few hundred patients they treated, or at least the families of those that lost their lives a reasonable compensation package as proposed by the now released report?
8. Who is responsible for the ongoing duty of care for the patients that the doctors on this Phizer clinical trail provided?
9. Will Polio ever be eradicated, and will this outbreak mark the begining of the failure?
10. Where is the public health leadership? Where are the voices advocating for the rights of the citizens.