15 Years After: End Not In Sight For Pfizer/Kano Trovan Trial Controversy

The Guardian

SUNDAY, 16 JANUARY 2011 00:00 BY BERTRAM NWANNEKANMA AND TOPE TEMPLER OLAIYA SUNDAY MAGAZINE - SUNDAY MAGAZINE
http://www.ngrguardiannews.com/index.php?option=com_content&view=article&id=35599:15-years-after-end-not-in-sight-for-pfizerkano-trovan-trial-controversy&catid=104:sunday-magazine&Itemid=567

THE story involving the federal and Kano State governments against pharmaceutical giant, Pfizer, is one of many turns and twists. Yet, the end of the controversy is not in sight; the latest being getting the compensation to the victims. This has been a comedy of errors, as litigations have continued to frustrate efforts.

The fact of the matter remains, that Pfizer conducted a clinical trial in 1996 on 200 patients in Kano State. 110 of the participants took Ceftriaxone, the gold standard medicine for the treatment of meningitis, while 90 others were treated with Trovan, a drug manufactured by Pfizer. Of the 200 participants, 11 persons died; six from those who took Ceftriazone and five from those who took Trovan. There was no record of deformities.

During the 1996 outbreak of cerebro-spinal meningitis – a bacterial infection that causes the inflammation of the tissues that cover the brain and spinal cord – in Kano, the epidemic took almost 12,000 lives over a six-month period and affected close to 110,000 people. As could be imagined, this constituted a serious public health crisis for both the federal and state governments.

Amongst all recorded cases, the fatality rate was as high as 20 per cent at the onset of the epidemic. It reportedly petered down to about 10 per cent when intense treatment commenced.
When at an advanced stage, the disease can lead to brain damage, coma and even death. Survivors can suffer long-term complications such as seizures, hearing loss, mental retardation and paralysis.

Like several other towns and cities in the region, Kano lies within what is known as the ‘Meningitis Belt’ in sub-Saharan Africa. The disease ravages the region during the dry harmattan season, roughly between November and June. Crowded living conditions and poor hygiene contributes to the spread of the disease.
It was against this backdrop that Pfizer offered to conduct a clinical trial of its drug, Trovan, to help stem the tide of the epidemic and also provide a cheaper alternative antibiotic treatment to the patients. Pfizer reportedly sought and got the consent of the Nigerian and Kano State government to conduct the Trovan drug trial in the state.

Interestingly, at the time of the Kano clinical trial, Trovan was in a last stage development and had been tested clinically in more than 5,000 patients in the United States and Europe in both oral and intravenous forms. Pre-clinical studies demonstrated that Trovan was effective against several types of bacteria known to cause meningitis.
Latest developments show that there is a lot of misinformation in both the local and international media about the current status of the implementation of the settlement agreement reached by Kano State and Pfizer in July 2009.

Under the terms of the agreement, Pfizer agreed to establish a Healthcare/Meningitis Fund, with funds expected to be distributed by a board made up of Pfizer and Nigeria appointees, with a maximum of US$35 million, from which valid study participants can receive financial support, underwrite several healthcare initiatives chosen by the Kano State government totaling US$30 million and reimburse the state for $10 million in legal costs incurred with the litigation.
While the pharmaceutical firm has demonstrated commitment to the settlement agreement by already paying the $10 million legal fees and the construction of a new state-of the-art medical centre, which is underway, the main subject of the agreement, which involved the compensation of valid claimants of the Trovan study, has been unnecessarily delayed.
The company showed initial zeal in speeding up the process and expressed its intention to pursue all legal avenues to ensure that the Board of Trustees complete its work and the true participants of the Trovan study compensated accordingly.

The collection and testing of DNA, Pfizer said, is a safeguard included in the settlement agreement, to ensure that the funds reach only those for whom they are intended. It said “DNA testing was absolutely needed because while there were no more than 200 participants in the 1996 clinical trial, the Board received 547 claims.

“Under the agreement, the Board, not Pfizer or the Kano State government, will make the final determinations on eligibility of the claimants and, if applicable, the level of financial support they will receive. Pfizer will provide the Board with the funds to compensate approved claimants,” the company added.

Thus, an amicable resolution reached between Pfizer and Kano State government, 14 years after the sad incident, should have brought relief to the families of the victims. Pfizer has agreed to pay about $35 million of a $75 million settlement to the children affected, with victims getting about $175,000 per person.

However, getting the compensation to the victims has been a comedy of errors, as litigations have continued to frustrate efforts. Alhaji Mujitaba Maisikeli and the Trovan Victims Forum (TVF) are seeking compensation to the tune of US$348 billion dollars, which resulted in a Federal High Court in Abuja granting an injunction on DNA testing and analysis last year. The court order, which is a temporary procedural measure has however, delayed the timing of payments to valid claimants.

The interim injunction on DNA testing and analysis has adversely affected the 355 Nigerians who voluntarily submitted to DNA samples and are awaiting results and potential compensation from the Meningitis Trust Fund.

Part of reasons given by Maisikeli for the legal tussle was the demand by Pfizer for the DNA of claimants, who had grown from initial number of 200 to 500, even though, only 11 children were reported dead in the trial, which later led to the ban of Trovan in the United States and Europe.

According to the counsel of the claimants, Etigwe Uwa, the main contention remains determining the existence of the victims as at when the trial was conducted in 1996, DNA testing notwithstanding. To Uwa, the suit was meant to safeguard the victims, whose DNA may have been mixed up with others.

Though many observers believe that Pfizer’s demand for the DNA of claimants was a step in the right direction following the claims by Nigerian officials of losing their list of victims, 14 years after. More so, when suspicion abound of maneuvering from some quarters for a slice of the pay out. There is however, the need to douse the fears being expressed by the Maisikeli’s group.
Even with the suspicion of maneuverings from some quarters for a slice of the pay out, the contentious clause could be amended to ensure that delay in compensating victims of the Trovan trial is stopped, especially after a out of court settlement was reached by the parties, a move expected to have put the incidence to rest.

According to Pfizer’s counsel, Chief Anthony Idigbe , Pfizer is in possession of files and documents containing medical records and photographs of those who took part in the test. He said “the records will be very helpful, while the DNA tests by doctors to determine the real patients will be at no cost to those who have come to make claims.”
Already a non-governmental organization, the Proletarian Agenda, has commended Pfizer and the Kano State government for the epoch-making turning of the sod of the N4 billion Naira healthcare facility.

The group in a statement by its coordinator, Northern Zone, Danlami M. Balami, noted that something good was at last visibly coming out of the protracted settlement of the controversial 1996 Trovan trials, the organization also commended the Board of Trustees, led by Prof. Shehu Galadanci, for a job well done.

“It is gratifying that Kano’s landscape will soon be graced by functional structures for disease control, diagnosis, laboratory analysis, reference laboratory and a housing estate for the staff of the healthcare establishment.”

Reviewing progress made on the compensation of patients who participated in the controversial Trovan trials, Mr. Balami called on the Trovan Victims’ Forum to withdraw their suits from the law courts and submit themselves for DNA verification so that genuine claimants can receive the agreed compensation packages currently being stalled by litigation.
“Let all genuine Trovan participants go for the DNA test and collect their compensation. That is the civilized thing to do. We appealed to the Trovan Victims’ Forum not to stand in the way of those who have already done the tests and are awaiting the lifting of the court injunction so that they can receive their deserved compensation.”

Also, a health sector civil society group, Mens Sana in a statement signed by its national coordinator, Hajia Muslima Kadi, expressed delights that the 200-bed medical centre under the supervision of the Healthcare Programmes Trust, the body set up by Pfizer Incorporated and the Kano State government as part of the out-of-court settlement, is underway with the turning of its sod.

“We are delighted that the construction of the complex comprising a Diagnostic Centre, the Centre for Disease Control, the Public Health Laboratory, the Micro Biological Reference Laboratory and Staff Housing for the centre will go a long way in improving healthcare delivery for the people of Kano and neighbouring states.

“We had been in the vanguard of civil society groups calling for a positive conclusion to the settlement process of the 1996 Trovan saga and we are delighted that both parties have kept faith. We salute the transparent method used in selecting contractors and consultants for the projects and hope that this would govern the rest of the process to ensure qualitative work and timely completion.

“We call on all those foot-dragging on DNA test to cooperate with the Board of Trustees and submit themselves to the process so that the other leg of the settlement – the actual payent of compensation – can be concluded expeditiously.” She added.