Moves for amicable settlement between patients involved in the 1996 Pfizer drug trial in Nigeria and the pharmaceutical giant gathers momentum
By Oluokun Ayorinde/Abuja
Moves to bring an end to the flurry of legal cases involving American pharmaceutical giant, Pfizer and patients involved in the test of its antibiotic, Trovan during the 1996 outbreak of the triple epidemic of meningitis, cholera and measles in the ancient city of Kano may have begun. Indeed, Anthony Idigbe, SAN and Aliyu Umar, counsel to Pfizer and Kano State government which is suing the pharmaceutical company on behalf of patients involved in the drug trial, had at the resumed hearing of the criminal and civil suits before Justice Shehu Atiku and Justice Patricia Mahmud of the High Courts of Kano State on 27 October 2008, asked for adjournment of the case to give room for exhaustive discussion on out-of-court settlement between the parties.
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| •A victim and his father. |
Kano State is reportedly seeking $2.6billion in compensation from Pfizer, on the allegation that the tests of the experimental antibiotic on children in the ancient city in 1996 were carried out without obtaining consent of the parents or the Nigerian government. The state government also alleged that the drug trial led to the deaths of 11 children and deformities like deafness, blindness, paralysis and brain damage in 189 others. Apart from the criminal and civil suits initiated by Kano, the federal government has also filed a suit and charges against the corporation in which it is seeking $7billion in damages from the multinational drug manufacturer.
About 12,000 children lost their lives over a six-month period during the 1996 outbreak of meningococcal meningitis, which has been described as the worst of such epidemic in the country. Pfizer had, in the thick of the epidemic set up the process of testing its then experimental drug, Trovan, at the Infectious Diseases Hospital, IDH, Kano where most of the patients were being treated. The clinical study in Kano involved 200 children. Half of the patients in the study were treated with Trovan, while the other half received a dose of an already approved meningitis drug, Roche’s Rochephin (Ceftriaxone). The company said before the Nigerian trial, the drug had already been tested on 5,000 patients in the United States and Europe in both oral and intravenous forms and pre-clinical studies demonstrated that Trovan was effective against several types of bacteria known to cause meningitis.
The trial was a forgotten issue until December 2000 when a United States-based daily, Washington Post, published a negative story about the trials. Two months after the publication, the federal government, through the Federal Ministry of Health, set up a committee headed by one Dr. Abdulsalam Nasidi who was also involved in the 1996 efforts to control the epidemic in Kano, to investigate the trial. Nasidi had criticised the study back then. Thus, Pfizer raised objection to the headship of the committee and asked the Chairman to disqualify himself from heading it.
Nevertheless, the committee went on with its work, with Nasidi reportedly being one of the major witnesses against Pfizer at the same panel he was presiding over. Pfizer claimed it was also not allowed to cross-examine any of the witnesses who appeared before the Nasidi committee. The committee completed its task and submitted its report after two months. But the report has not been officially released and nothing was heard about the Trovan trial again until Washington Post published what it claimed were excerpts from the report in 2006.
As published in the United States-based newspaper, the Nasidi committee report concluded that Pfizer violated Nigerian laws and the UN Convention on the Rights of the Child during the 1996 Trovan drug trial in Nigeria. The committee also alleged in the report that Pfizer failed to obtain all the required approvals for the trial and did not get proper consent from the patients’ families. The excerpt published from the report is the basis of the rash of suits against the pharmaceutical giant. However, Pfizer, in July last year also asked a Federal High Court based in Abuja to quash the report, which it described as “illegal, inaccurate”. In the same vein, the drug manufacturer, in a 26-page defence it filed in response to the civil suit against it by the Kano State government, denied every allegation against it.
While asking the court to throw out the $2billion suit, Pfizer said its operatives did no harm and in fact saved lives when they administered Trovan during the 1996 meningitis epidemic. For one, the pharmaceutical giant argued that Kano State government had no locus standi to bring the civil lawsuit since it was families and not government that suffered from the alleged effects of the drug used for the trial. The company also argued that the Kano and Federal governments should have instituted their case within three years of the drug trial. Pfizer said it engaged the services of local nurses who told parents in Hausa language that they could choose whether their children would be treated by Pfizer or by Doctors Without Borders. The company said it fully explained the trial to parents and obtained their consent orally before enrolling their children in the study.
The pharmaceutical company added that it “sought and obtained all necessary approvals from relevant federal and state government agencies in Nigeria”. The firm also said it has more than 12 letters between it, the United States and Nigerian regulatory agencies in which the 1996 clinical trial of the drug was discussed and approved. The drug manufacturing giant also said it has letters between it and Kano State authorities which authorised Pfizer doctors to treat patients with Trovan during the epidemic. “Approval is also hereby given for your staff to participate in treating patients at our hospitals,” reads a letter from Kano State Ministry of Health to Pfizer Products plc on 2 April 1996. “Government approval is at the heart of these cases. Pfizer has said all along that both the Kano State and federal governments were fully aware and approved of the Trovan clinical study. Now, the Nigerian people can confirm that with their own eyes,” noted Pfizer spokesman Chris Loder. Both sides seemed prepared for a long-drawn and potentially costly legal battle. But this may be averted if the talks to settle out of court succeed. Idigbe reaffirmed to journalists at the resumed hearing of the case filed by the pharmaceutical giant to nullify the 2001 report of the Investigative Committee on Trovafloaxin (Trovan) in Abuja last week that the different parties to the cases are still exploring the out-of-court settlement option.
This magazine gathered that the move for amicable settlement out of court is being actively encouraged by leading traditional authorities in the ancient city. A source close to the negotiation team thus told this magazine that all proposals being made by the American drug giant were on the basis of no admission of liability.
But negotiations for out-of-court settlement have not been particularly smooth sailing, according to a source at the last meeting of Pfizer, Kano State and the federal government held in Dubai last June. First, there was the issue of the novelty of the whole negotiation process, which has been described as very complex. The Kano State government, it was gathered, has also been cautious in the negotiations because the whole drug test issue has been politicised. Perhaps the most difficult snag in the process of the negotiation so far, it was gathered, is the attitude of lawyers representing the patients who claimed to have suffered from the drug test. “There is also the issue of the varying interest within the team of lawyers. Like you have the federal government and their lawyers and even within the lawyers, you have different groups who are pursuing different interests,” added the source. Prominent among the private lawyers is US-based Nigerian legal practitioner, Babatunde Irukera. The lawyer who has been in practise in the United States for about 11 years, has touted himself as an expert in class action suits.
Apart from the Kano meningitis case, Irukera is also the prime motivator in the suit by the Nigerian government against three leading international tobacco companies operating in the country. In the suit, the federal government is asking for about $40billion in damages, from British American Tobacco plc, Philip Morris International and International Tobacco Limited on the accusation that the three companies are promoting underage smoking in Nigeria. The government is also seeking for an injunction to compel the companies to stop the marketing and sale of cigarettes. All this is despite the fact that there is yet no law prohibiting the production and sale of cigarettes in Nigeria and several regions of the country had reaped huge economic benefits from the cigarette manufacturers in the past. Pfizer is however concerned that those involved in the process seemed to be constituting hindrances to the settlement by asking for excessively high monetary compensation for patients involved in the Trovan test.
Sources said the pharmaceutical giant was worried that the lawyers were asking for unrealistically huge compensation without stating how it would be utilised or applied. Kano government originally asked for $2.5billion from Pfizer, but it was gathered that at the last meeting between the parties in Dubai, the pharmaceutical company had offered a total package of $31million as settlement. It was gathered that the proposal by the drug manufacturing company included funds for the patients, funds to rehabilitate the IDH hospital in Kano and funds to cover what the company described as the “legitimate legal costs” of government. The US firm was also insisting that there would be well defined criteria for access to the funds if it was eventually able to reach agreement with parties to the case.
But so-called representatives of the patients were reported to have insisted that until they were paid $350million as compensation the criminal and civil suits would continue. The real wishes of the voiceless patients have been subsumed in the cacophony of voices with varying interests claiming to be representing their interests.
Indeed, Alhaji Mustapha Garba Maisikeli, chairman of the 30 families taking part in the civil and criminal cases, had last year warned non-governmental and civil society organisations to stay clear of the court case.
The camp of the alleged victims, under the umbrella of Trovans Victims Forum being led by Maisikeli, has also been whirling with various scandals. There have been various stories which tend to suggest that the mostly illiterate victims of the of the drug trial have been turned into tools of exploitation by their leaders. Many informed analysts are of the opinion that if the company just puts down its cheque and turns its back, the destination of the funds is pretty predictable – the bottomless pockets of smart do-gooders who are already salivating ahead of the baking of the settlement cake.
The numerous fictitious names emerging as ‘victims’ of the Pfizer Trovan test is capable of truncating all efforts resolve the matter. According to Pyramid, a local newspaper published by Alhaji Kabiru Muhammad Gwangwazo, former chairman, Kano State chapter of the All Nigeria Peoples Party, ANPP, boycotted moves to screen the list of the victims, as he allegedly insisted that Pfizer must deal with his own list or nothing. “The representatives of the concerned parties involved in the negotiations already suspect, or even know in some cases, that Maisikeli and his cohorts are no good Samaritans at all. And that Pfizer may actually have been the true Good Samaritan in the whole affair that has been dragging on in Kano, Abuja and other international arena for more than a decade,” the Pyramid report stated.
However, there are indications that the local authorities in Kano have perfected plans to short-change those who fell victim of the Trovan experiment should the company pay the compensation. TheNEWS investigations revealed that some local government councils have started paying the victims peanuts ahead of negotiations between Kano State and Pfizer. According to our source, each victim was billed to be paid a miserable sum of N10,000 as compensation by the local authorities.
Pyramid went further to state that Ungogo Local Government, for instance, “planned to pay N10,000 to each victim, using the council vouchers and other documents as validation for further settlements by the state government.”
Our source revealed that a good number of deformed people who were not victims of the Pfizer Trovan test have already benefited from an arranged pre-paid largesse sponsored by unscrupulous council officials who wished to make a fortune from the proposed Pfizer compensation for the Trovan victims.
This magazine learnt that in Dan Rimi village of Ungogo Local Government Area, Auwalu Magaji, grandson of the Village Head, was included as one of the Trovan victims, whereas investigations revealed that Auwalu was in no way affected by the incident though he was born with a deformed leg. Auwalu’s case is just but a tip of the iceberg, as some influential people in Kano who have deformed people in their family jostle to partake in the Pfizer “generosity.’’
Concerned citizens of Kano want the issue of fictitious names being smuggled into the list of victims deserving of compensation resolved quickly. Meanwhile, investigations show that since 2003, the Trovan drug has been retired from pharmaceutical markets by Pfizer.
•Additional report by MMERIBEH MADUABUCHI/Kano.
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