Photo of Anas Mohammed: Falsely portrayed as a Trovan victim by the German Der Spiegel, it turned out that he was not treated with Trovan but the control drug. This development has led analysts to suggest that the court cases against Pfizer are largely an attempt at blackmail.The move for an out-of-court settlement between American pharmaceutical giant, Pfizer and the duo of the Federal and Kano State governments over the 1996 Trovan clinical study in the Northern city appears set to hit the rocks as parties to the case seem not ready to shift grounds on their demands. Government and representatives of the patients involved in the drug trial had reportedly turned down an offer of $10 million compensation from the company, as recently disclosed to journalists by Alhaji Mustapha Maisikeli who described himself as the “chairman of the victims' association”.
Sources however disclosed that apart from the offer of monetary compensation, Pfizer also offered to rehabilitate the Kano Infectious Diseases Hospital (IDH) and also sponsor the training of paediatricians working there as part of the package. But the patients’ representatives are insisting on being settled with billions of dollars.
Thus, the stage is gradually being set for full blown legal fireworks in the suit instituted against Pfizer by Kano State, the Federal government and alleged victims of the 1996 Trovan drug trial. Some analysts have consistently maintained that the legal suits look more like an afterthought designed to extort money as they were instituted several years after the outbreak of the most serious meningitis epidemic ever recorded in Nigeria. Statistics indicated that as much as 20 percent of those who contracted meningitis during the period succumbed to the infection in the first few weeks of the outbreak. The high fatality rate and the obvious incapacity of the Nigerian health authorities to contain the epidemic resulted in offers of help from reputable healthcare organizations round the world including Pfizer.
The pharmaceutical giant’s intervention was in two ways - it donated over N18 million to Kano State in medicines, equipment and materials to help fight the concurrent epidemics involving associated diseases such as cholera and measles which were also ravaging the state at the time. This was reportedly acknowledged in writing by the Kano State government.
The company used the opportunity to conduct investigative study on its drug, Trovan, at the Kano’s IDH during the period. Pfizer, according to sources, was encouraged to conduct the investigative trial by the result of the pre-clinical studies which demonstrated that Trovan had excellent activity against all meningitis pathogens and penetrated very well into the cerebrospinal fluid to effectively treat the disease. The drug had also been tested on children in two pharmacokinetic (dosing) studies that showed the medicine to behave similarly in adults as in children.
The result of the 1996 clinical trial of Trovan confirmed results from earlier studies of the drug and the class it belongs to, quinolones. The overall survival rate of patients treated with Trovan during the epidemic was 94.4 percent, an indication that the drug was at least as effective as the best treatment available at Kano’s IDH. This is more so when it is realized that the patients in the Trovan study already had serious symptoms of meningitis before they were treated. Clinical evidence also indicated that the deaths that occurred during the Trovan clinical study at IDH were the direct result of the illness and not the treatment provided to patients.
A panel headed by Dr Abdulsalami Nasidi would later in 2001 conclude that Pfizer Inc. violated international law during the 1996 clinical trial. Dr. Nasidi’s panel sat for two months after doing what was obviously a hatchet job of attempting to nail Pfizer. Dr. Nasidi himself as chairman of the panel was reportedly also a prime witness against Pfizer. Thus he was accuser, witness and judge in his own court. In the report which has remained unavailable to the public until excerpts from it were published by Washington Post, Pfizer was also accused of not obtaining authorization from the Nigerian government before it embarked on the clinical trial of the drug. There were also allegations that Pfizer failed to inform the children and their parents that they were taking part in a clinical trial.
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. It was also claimed in the report that out of the 200 children given Trovan antibiotic during the clinical trial, 11 died and 189 suffered serious injury. The Nasidi panel therefore recommended that the American pharmaceutical company be sanctioned and directed to issue an unreserved apology to the government and people of Nigeria. The Panel also said that Pfizer should be made to pay compensation to the survivors of the dead and those who suffered injuries as a result of their participation in the Trovan trial.
Ironically, Pfizer was not even allowed to cross-examine witnesses at the panel whose report is now the basis of the lawsuits instituted against it by the patients and the Federal and Kano State governments.
For the claims against Pfizer to succeed, according to a legal source, “government has the burden of proof and must prove not only that these patients were in the study, but also that Pfizer knowingly injured them". This definitely will not be a mean task. The company had complained that the Nasidi panel breached every rule of fair hearing. The credibility of the report is also being challenged on the basis that it was initiated at a time the Ministry of Health and Pfizer had been sued in a federal court in Nigeria over the Trovan study. The report is therefore seen as a document hurriedly prepared to exculpate the ministry from liability.
Yet another contention was the suitability of Dr Nasidi as the head of the panel given the fact that he was opposed to the drug trial in the first place. Nasidi according to reports personally went to the IDH and tried to stop the clinical trial when it was on in 1996. To worsen matters, like a complainant sitting as a judge over his own case, Nasidi also testified during the Panel’s hearing. The report of the Panel was therefore primarily based on the evidence provided by Dr Nasidi himself. In another obvious display of bias, sources said 19 pieces of evidence that were in favour of Pfizer were ignored in the report. The Panel Chairman has not denied these two allegations.
Legal sources say Pfizer is fully prepared for the full blown trial of the case because the company is desirous of clearing its name. The company is confident that it has a good case. Judging from documents filed at the courts, it is clear that Pfizer is ready to tender before the courts more than 12 letters between it, the United States FDA as well as NAFDAC, Federal and Kano State Ministries of Health and the Ministry of Finance through which approval for the clinical trial was sought and got. These include an approval letter obtained from NAFDAC on March 20, 1996 and a letter of approval obtained from Kano State’s Ministry of Health in which an official of the ministry, Ms. Gadanya gave her approval for the study after discussions with representatives of Pfizer. Furthermore, Pfizer said as at the time of the study, there was no regulation in Nigeria requiring ethical committee approval before conducting a clinical trial or investigative study and there was no formal ethics committee sitting at either Kano’s IDH or at the nearby Bayero University Teaching Hospital.
They also insist that the clinical trial was done using the best medical knowledge available at the time and the protocol approved by Nigerian authorities which anticipated risks involved and detailed procedures to manage those risks. Nigerian nurses were employed to explain details of the drug trial and the procedures to patients’ parents and/or guardians in Hausa and English before the commencement of the trial. The oral consent of each participant was also obtained before their admission into the trial.
The company said the patients were adequately monitored by Dr. Isa Dutse, the Nigerian doctor who served as Principal Investigator, performed rounds twice daily in the clinics and was assisted by Nigerian residents from Bayero Teaching Hospital.
Pfizer also said there is no evidence to support allegation that the reduced dosage of Trovan used to treat patients in the Nigerian study put them at greater risk as indicated in the report. The company backs up this claim with a the report of a clinical study of Ceftriaxone sponsored by Doctors Without Borders in 2003 which confirmed that a total dose of 100 mg/kg, significantly lower than the one used in the Trovan study in Nigeria , was effective in treating epidemic meningococcal meningitis.
The company also denied the allegation that it shut down the Trovan study when the epidemic was still raging. Rather, it contends that it was Dr. Idris Mohammed, Chairman, of the National Task Force for the Epidemic who ordered the stoppage of the drug trial though he was provided a copy of the protocol for the trial before its commencement which he approved. An official of the Ministry of Health was to later described Mohammed’s action as “totally indefensible”. The drug trial continued only on the authority of Kano State government after the disruption.
Perhaps, there is no better example of the difficulty the patients and governments suing Pfizer may have than the case of one Anas Mohammed who was featured in at least seven local and international media from June 2007 to March 2008 as one of those who suffered brain damage as a result of their participation in the Trovan trial. The bottom was knocked off this claim when Der Spiegel, a German journal published the picture of the alleged Trovan victim holding his pink patient card as an illustration for a lengthy article on the drug trial. Patients who received Ceftriaxone, during the epidemic were given a pink identification, card or both while those who received Trovan were given bracelet. Mohammed was not treated with Trovan. How many more of such claims will go burst when full trials commence? Perhaps now is the time for those concerned in the corridors of both the Federal and Kano State governments to shun sentiments and reach an out-of-court settlement with Pfizer. As far as the facts in this particular set of cases go, they may just be gunning for the wind.
It is an undisputed fact that Trovan helped save lives. The Kano State Government itself does not dispute the fact that the Pfizer team had a better survival rate of 94.4% compared with the about 90% of the Medicin Sans Frontiers (Doctors Without Borders).
In the final analysis, the best possible outcome is still an out-of-court settlement. It has been 12 years since the study, and there are too many issues in dispute. The trio of the Federal Government the Government of Nigeria, the Kano State Government and the pharmaceutical giant, Pfizer, have to work together amicably to resolve the cases by making important contributions to the families of participants and at the same time help to improve health care in Nigeria .
