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Pfizer Trovan: Keeping faith with the people

By Isa Abdulahi

Following the out-of-court settlement agreement entered into by Pfizer Inc, the globally renowned pharmaceutical giant, and the Kano State government in 2009 over the conduct of the Trovan Clinical trials in 1996, the litigants, under the terms of the settlement established the Healthcare/Meningitis Fund from which the clinical study participants can receive financial support, and underwrite several healthcare initiatives chosen by the Kano State government.

The independent six-member Board of Trustees comprised of highly reputable Nigerian citizens, including two former Supreme Court justices, is to verify the eligibility of all applicants, determine the amount of compensation and actually hand over the compensation to the eligible candidates.

The Board is also to ensure that the Board’s work is conducted with a high degree of transparency to maintain trust in the process and the settlement itself. The Board will also manage the construction of the international medical diagnostic facility as contained in the settlement agreement.

The funding duo, Pfizer Inc and the Kano State government, promptly released money to the board to commence its work of compensating eligible study participants as well as the construction of a 200-bed diagnostic disease control centre. On the construction of the diagnostic centre, work commenced in earnest.

The hospital, widely touted as one of the best in the West Africa sub-region, has been completed and expected to be officially opened soon. It has a diagnostic centre, a disease control centre, a public health laboratory, a micro biological reference laboratory, and housing for the centre’s staff. The Board met with a hurdle when it called for study participants to come forward for compensation as a total of 547 claimants came forward. This was despite the fact that only 200 persons took part in the study.

The issue became how to sieve out the actual participants in this trial from this largely impostor crowd in such a way that will enjoy the acceptance of all informed stakeholders. A rehash of the events leading to this issue will be apt to appreciate the wisdom needed if the HMTB was to navigate the troubled waters.

In 1996, a serious Cerebro Spinal Meningitis (CSM) epidemic ravaged Kano and parts of Northern Nigeria claiming over 12,000 lives (WHO records), affected close to 110,000 people over a six-month period, and constituted a severe public health crisis for the government of Nigeria. International organizations and agencies like the World Health Organization, Doctors without Borders, Red Cross and Red Crescent Societies stepped in to intervene in the management of the epidemic. Pfizer Inc, a multinational pharmaceutical company also intervened, donating anti-CSM vaccines and medical equipments and personnel worth thousands of dollars. It also provided its latest antibiotic, Trovafloxacin, which was in the last stages of trial for a comparative study with Ceftriaxone.

The appeal of Trovafloxacin, marketed under the trade name of Trovan, was that it is an orally administered drug, making it easier to administer in epidemic situation than Ceftriaxone, an intravenous injection. Pfizer conducted a clinical study on 200 CSM patients in Kano. One hundred of them were administered with Ceftriaxone, the gold standard medicine commonly in use against CSM, while one hundred others took Trovan. Eleven study participants died – six from the Ceftriaxone group, and five from the Trovan group.

The federal government, alleging that Pfizer Inc did not get full authorization to conduct the trials, that resulted in the death of eleven children and maiming 189 others, sued the pharmaceutical giant.

The Kano State government also followed suit. Both governments instituted criminal and civil cases against Pfizer in 2007. As the litigation commenced, Pfizer made it clear that it did get all required approvals for the conduct of the clinical trials. The pharmaceutical giant also provided evidence that the drugs being used were able to achieve results and significantly lowered the mortality rate at the time of the trials.

Alhaji Mujtaba Mustapha Maisikeli founded the Trovan Victims Association, a group of people making claims to participating in the 1996 clinical study. He made effective use of the media to bring the cases to the court of public opinion. To decipher the real participants for the compensation, the HTMB board adopted DNA testing, the most efficient and internationally recognized way of testing for genetics and verifying identity and parental relationship. In order to ensure that the credibility of the process was guaranteed, Bode Laboratories, an internationally recognized leader in DNA testing, was engaged to conduct the tests.

All parties to the dispute were obviously amenable to this scientific procedure judging by the identification and filling of forms for the testing by all claimants including members of the Trovan Victims Forum, the group chaired by Alhaji Maisikeli. The challenge was not over, however. In a desperate bid to delay the compensation process, probably because the group knew that many of its members were ineligible, the TVF got an injunction halting the DNA testing process for eight good months.

Nevertheless, the Board got the injunction lifted and concluded the DNA testing. Of the 192 members of the TVA only six provided DNA samples that matched the DNA of the 1996 Trovan clinical study participants.

It is also worthy to note that none of Mr. Maisikeli family members passed the DNA test. In the end, the fourteen claimants who passed the DNA test have been fully compensated. Depending on the degree of disabilities suffered, they have received compensation ranging between $87,500 and $175,000.

The search for other legitimate claimants is not over yet. The HTMB has said that the door of possible compensation is still open to other claimers who failed the DNA test but possess other proofs of participation. This is because the Justice Abubukar Bashir Wali led board is relentless in its efforts to ensure that no genuine victim is left out of the compensation rightly due to them. Abdulahi writes from Kano.

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February 2016
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