Tuesday, September 20, 2011

Proletarian Agenda screams: Enough of Stealing in the Name of Compensation!

A civil society group, the Proletarian Agenda, has expressed displeasure at recent reports that the lawyers of the Trovan Victims Forum (TVF) are threatening to go back to court to reopen the settled Trovan case in respect of the 1996 trials during the meningitis epidemic in Kano.

In a statement signed by Mallam Umar Sani, the organization said “The Proletarian Agenda notes that the TVF’s cases were settled out of court before their members agreed to be DNA-tested. Indeed, the TVF was responsible for the delay in the DNA process because the body obtained a court injunction to stop it. Investigations carried out by our associates in the civil society movement showed that the 192 TVF members were compensated to the tune of $5,000 each before they agreed to withdraw their cases from court. Now, with the rumour that only six out of the 192 TVF members were DNA-matched with actual participants in the Trovan study, the other pretenders and impostors are being egged on by their greedy sponsors to muddy the waters all over again by casting aspersions on the scientific DNA process and going back to court.”

The Proletarian Agenda also made a startling revelation concerning behind-the-scene happenings that led to the out-of-court settlement. “We insist that even among thieves there must be honour. The TVF lawyers’ fees were settled along with the TVF member’s payment. It is scandalous that a body would willingly give an undertaking after collecting money and then turn round to repudiate its agreement. We dare the TVF lawyers and members to deny that they have collected money before withdrawing their case from court.”

Continuing, the civil society group counseled as follows: “We call on the Meningitis Board not to succumb to blackmail. Only those certified through the agreed processes should be compensated. The TVF is scared that at the end of the day, if only six out of their 192 members pass the test, it would have been scientifically exposed as a 419 body that tried to obtain compensation under false pretences. Some people don’t want the so-called Trovan saga to ever come to an end. They must be stopped in their tracks.”

The organization therefore addressed the following appeal to Governor Musa Kwankwanso of Kano State: “We call on the Kano State Government to be cautious about being used to derail the compensation programme because we know that those behind this attempted scam of claiming compensation for fake victims would stop at nothing to satiate their greed”.

Wednesday, September 7, 2011

Trovan Saga: Not Yet Uhuru?

By Yaya S. Ibrahim

I read Malik Mohammed’s article titled “Brila FM, Trovan, Technology and all that…” (Published in Sunday Trust, 28 August 2011) with keen interest. He is well entitled to his celebration of the restoration of sanity to what has become the Trovan Trial Saga. Maybe he should tarry a little before taking to the dance floor, because the truth is that the dust hasn’t completely settled on the issue.

We know as a matter of fact that the Board of Trustees continues its analysis of claims to identify additional persons qualified to receive compensation from the Healthcare/Meningitis Trust Fund has already announced that so far, 14 individuals -- out of 547 applicants – have been successfully identified as having passed the DNA testing. Four out of the 14 have already been compensated to the tune of $175,000 each (about N26, 250,000 per beneficiary) on the strength of their DNA test-validated claims that they are next-of-kin to persons who did indeed participate in the 1996 Trovan study. The process of compensating the 10 other persons has reportedly commenced.

We also know that DNA is only one of the various criteria for establishing proof of participation in the 1996 study. The Board also took account of identification cards, physical appearance, medical records, photographs from the 1996 clinical trials and whether a claimant’s initials, age, and gender match those on record. In addition, facial resemblance to photographs on file was considered together with possession of relevant verification materials or objects such as the Trovan trials pink card issued to participants in 1996.

What this means is that anyone staking a claim to compensation is expected to pass the DNA and also meet these other criteria. The 14 claimants so far confirmed passed the scientifically verifiable process.

The sad story, however, is that there remains some spanner in the wheel, the type that should dampen the mood of Malik Mohammed and all those craving for a speedy conclusion to the long-drawn saga.

Remember that last year, an organization known as Trovan Victims Foundation (TVF) got a court injunction to prevent the Board from processing DNA test results on the first 355 claimants to the Fund. This resulted in a long delay of the exercise until earlier this year when the injunction was lifted and the Board was able to continue its work.

It appears – again – that TVF may be attempting to frustrate the Board’s work to compensate valid claimants. This time around, one hears that the organization is reversing itself on the DNA testing procedure. Interestingly, however, six members of this group passed the DNA test. The word in town is that the TVF is not satisfied with having only six of its members successful. They want money to go round all their members as if this was a jamboree.

It is difficult to determine whose agenda the TVF is pursuing, considering that the group agreed that the Board’s identity verification process was fair, and all 192 TVF members submitted saliva samples for DNA testing. In fact, right from the beginning, the TVF’s legal actions have always smacked of sabotage. Why would the organization now think of discrediting a process it endorsed and was a part of? Some observers have suggested that its negative position on the process is as a result the disqualification of the majority of persons it presented for the testing process. That sounds like sour grapes!

And talking about stories doing the rounds in Kano, is it true that members of the TVF, including their leader Alhaji Mustapha Maisikeli, already have been each compensated $5,000 (US) before they agreed to cooperate with the process? Is it true that, in signing the releases, the TVF members agreed that they are not entitled to any additional money and promised to abide by the Board’s decision as to the use of DNA testing to determine compensation?

Does its present opposition to the process not amount to reneging on an agreement that it has entered into? Isn’t there a word like honour in their dictionary?
Whatever its answers are to these posers, it is clear that TVF wants to undermine the Board, which has taken steps to make the people of Kano aware of its work and educate them on the verification process. As persons in the Kano area will attest to, there have been huge efforts in the area of public awareness. These have included massive media publicity. I live in Kano and have been following these developments with interest.

Perhaps we should remind ourselves that it has been more than 15 years since the Trovan clinical study took place. Many of the people involved have since moved on – relocation, deaths to some who managed to survive the 1996 epidemic, etc. There is also the fact that many of the people who travelled to Kano’s Infectious Diseases Hospital (IDH) in 1996 were from outside Kano State, and mostly from rural areas. They would not know about the settlement agreement without the kind of widespread publicity which the Board has taken care to provide.

Indeed, in spite of such publicity, it is totally conceivable that many would still be left out for a variety of reasons, including misconceptions about DNA testing which some believe is invasive of their privacy or even injurious. It is the same way in which people refuse to take part in immunization. As one of those involved in National Community Mobilization towards Universal Child Immunization (UCI) 1990, I can recall the difficulty of persuading populations in rural communities to make their infants and children available for vaccination. Roles were identified for traditional rulers, religious leaders, artistes, social groups, including women’s groups, professional groups, etc.

In the end, not all of these efforts paid off as expected. Similarly, despite the best efforts of many prominent Nigerians, including our revered father, the Emir of Kano, large numbers of participants in the Trovan trial may not be found. This is not to discountenance Malik Mohammed’s valid point about some valid claimants refusing to come forward on account of their religious belief that Allah gives and Allah takes and that one shouldn’t be seen to be profiting from ‘blood money’.

For Allah’s sake, let those who have been scientifically verified come forward and collect their compensation while the Board sorts out other issues connected with the life-changing settlement process. Enough of the TVF’s antics!

• Yaya S. Ibrahim is a development worker based in Kano

Thursday, August 25, 2011

The Media, Trovan, Technology and all that ...

By Malik Mohammed

Radio sports channel, Brila FM, the brainchild of the indefatigable Larry Izamoje, is currently running a public awareness message that shows that there is only one world for “Goal” from one language group in Nigeria to the other – about 300 of them! No matter the tongue, all our languages have the same word for “goal”.
Nigerians should listen to the message, which in itself has immense entertainment value for its dramatic quality.

We are a country in which consensus on any issue is hard to achieve. It seems that each and every one of the more than 150 million people who make up its population has his/her opinion any issue at any given time.

Where the issue is clear enough for us to instantly agree on, there are professional agents of disunity to introduce extraneous factors into the equation to cause division. The prism could be that of religion or ethnicity. And before you know it, the newspapers and airwaves are awash with different interpretations.

Is the situation about to change? What has technology got to do with it?

But for the tragic dimensions of the 1996 meningitis epidemic in Kano and Pfizer’s trial of its drug Trovan, it would have been apt to say “All’s well that end’s well” to the recent pay-outs by the Meningitis Trust Board to verified participants at the Trovan trial.

Reports recently had it that compensations have been made to some qualified claimants of the Healthcare/Meningitis Trust Fund and that more beneficiaries will be announced as more DNA results are received from the testing laboratory. This seems to signal an end to the bickering over the most acceptable approach to managing the compensations. At a point, what was evidently the most efficacious option didn’t go down as the most acceptable to some stakeholders. But what no one doubted was the need for urgent implementation of the July 2009 settlement agreement between Pfizer and the Kano State government, which preferred the DNA approach.

It was always necessary to neutralize the machinations of opportunists. For example, although about 200 persons participated in the trial, some 547 people are known to have staked claims to compensation arising from the 1996 Trovan trials. The claimants offered themselves as direct parents of participants or legal guardian of participants.

If steps were not taken to forestall fraud, compensations to 547 would have significantly reduced the impact of the gesture to the actual claimants, who are about a third of this figure. It would be like an all-comers affair where all one had to do was show up and receive a slice of the largess.

Of course, the controversy over the acceptability – or otherwise – of DNA testing was always unnecessary, given that it is most reliable and internationally recognized method of genetic identity verification. What made opposition to the use of the method surprising is that the testing had been assigned to a state-of-the art laboratory.

In the end, however, sanity prevailed and claimants were educated on the purpose of the DNA test in their native language before they were taken through the rigorous process involving signatures and thumb prints to indicate consent; whereupon a simple cotton swab was used to obtain saliva samples from claimants’ mouths. These were conducted by local medical staff with knowledge of the local languages (Hausa and English).

During a discussion with some journalists who had been following the Trovan case for quite some time, I gathered that the fresh samples of cerebrospinal fluids of participants were compared with those obtained during the 1996 Trovan clinical study. Inevitably, the large number of claimants - 547 individuals – meant a longer period of DNA testing and analysis, including the Board’s review. I was gratified to know that neither Pfizer nor the Government of Kano State was vested with the responsibility for determining eligibility for compensation as that responsibility belongs to the Board.

From the commentaries one has heard and read, it appears that people are generally pleased with the outcomes of the DNA testing procedures. Considering the tragic nature of the epidemic and the long litigation coupled with our people’s belief in Destiny, I won’t be surprised if it turns out that not all the possible claimants showed up for the exercise in spite of the 547 claimants that went through the DNA test. Some religious zealots actually believe that such a payment on account of the tragic circumstances is haram.

Let me come back to the issue of technology. Considering that technology was also very critical to the conduct of the Nigerian general elections in April, even admitting that the results of the elections are being contested in court, it does seem, therefore that we are making progress somehow.

Whatever the legal issues that are been challenged about them, the 2011 elections were a marked improvement on, and significant departure from, previous elections in this country. The electoral process depended largely on technology. And given the rancor-free outcome of the use of DNA testing to verify the victims of the Trovan trial, no one is henceforth going to hold technological approaches to resolving similar issues in suspicion.

Brila FM has taught us that there is only one word for “goal”. Thanks to technology, that message is heard all over the country. In the same vein, the Meningitis Board has shown us that things can be done transparently with the use of technology to sort out the wheat from the chaff. With the state of the art medical complex at an advanced stage of construction in Kano as part of the settlement process, perhaps we shall soon be able to say “All is well that ends well.”.

• Mohammed is an Abuja-based commentator on public health issues.

Thursday, August 11, 2011

POLIO IMMUNIZATION FLAG OFF IN KANO


Governor Rabi’u Musa Kwankwaso of Kano State, North-West Nigeria has disabused the minds of parents in polio endemic communities over negative perceptions about the dreaded child killer disease, saying that polio vaccines do not in any way cause infertility.

The Governor also urged parents of children under the age of five to refrain from resisting the immunization of their children.

Governor Kwankwaso was speaking at the flagging off ceremony of the 2011 fourth round of immunization Plus Days at Yan Alewa in Kumbotso Local Government Area of the state.

He expressed concern over the fresh cases of poliomyelitis recently reported in five local government areas of the state.

Our Correspondent in Kano, Enenche Akogwu reports that the immunization flag off ceremony was held in the most polio endemic community in the country, Yan Alewa in Kumbotso Local Government Area of Kano State.

The choice of Yan Alewa for the flag off ceremony of the 2011 fourth round immunization exercise was not out of place, because it is the most polio endemic community in Kano State, and by extension, the country.

The Governor, who kicked off the immunization exercise, pleaded with parents of children under the age of five to cooperate with immunization officials, adding that the state government would do anything it can to kick out the child killer disease from the state.

The Governor also emphasized the importance of cleanliness to healthy and civilized living, a realization, he explained, informed the decision of his administration to reintroduce the monthly sanitation in the state.

Traditional rulers, religious and community leaders were at the occasion to demonstrate their commitment to the fight against poliomyelitis, with each of them pledging to redouble their efforts to see to the end of the scourge in Nigeria.

The flag-off ceremony of the 2011 polio immunization exercise represents a final push to kick out polio out of Nigeria by the end of this year, and with just five months away, the realization of this tall target would require all hands on deck.

Kwankwaso told the gathering that it was unfortunate that Nigeria still featured among the four polio endemic countries in the world despite efforts by the government and international donor agencies to eradicate it.

He was particularly disturbed that polio virus was recently identified again among children in five local government areas in the state, and emphasized on the need for the people to collaborate with the state government to wipe out the disease.

Furthermore, Kwankwaso maintained that "scientific evidence has shown that the disease is not associated with genie or evil spirits and the Polio vaccine is not administered with ulterior motives. We can all see the physical damage it has done to some of our children", the governor asserted.

Reiterating his administration’s commitment to do all it can to eradicate polio, the governor pledged that the State government will give all the logistical and financial support toward achieving the set goals.

In a speech on the occasion, the Emir of Kano, Alhaji Ado Bayero was who represented by the district head of Ajingi, Sarkin Yakin Kano, Alhaji Wada Aliyu Gaya noted that diseases, especially those affecting children can be prevented by inoculation, hence the need for husbands to allow their wives to make available their children for routine immunization.

The National Primary Healthcare Development Agency representative, Dr. Adamu Nuhu and the representative of international donor agencies, Dr. Sulaiman Abdullahi restated the willingness of the agency to partner with the state government to safe guard the lives of children in the state.
- Channels TV Nigeria
-

Tuesday, February 22, 2011

PFIZER, PLAINTIFFS ANNOUNCE GLOBAL SETTLEMENT

Good news! There are firm indications that the Trovan saga in Nigeria will soon come to an end.

Pfizer Inc. and all plaintiffs in the cases related to the 1996 Trovan clinical study today released the following joint statement regarding their global settlement of the cases.

“We are pleased to announce that we have reached a final agreement to settle the Trovan cases pending in the United States and Nigeria. The parties agree that settlement is in the best interests of all involved.

“Under the terms of the settlement agreement, the plaintiffs will join the ongoing
Healthcare/Meningitis Trust Fund process, which is being managed by an independent
Board of Trustees in Kano, Nigeria.

“The cases have been amicably resolved after many years of litigation. The settlement will bring an end to all litigation pertaining to Trovan in the United States and Nigeria and allow for just compensation for participants in the study and their families.”

Monday, January 24, 2011

Trovan and the NEXT Bout of Misinformation

By

Raheem Mustapha

A contributor to the debacle once drew an analogy between the Trovan issue and the Trojan horse. His focus was on whether the offer of monetary compensation for victims of the unfortunate trial of the drug conducted by Pfizer in Kano in 1996 was as a dangerous a proposition as what the Greeks offered the Romans.

Another analogy seems quite appropriate to an issue that just won’t leave the pages of newspapers. Eneke, the bird in China Achebe’s Things Fall Apart, says that since the hunter has learnt to shoot without missing, it has decided to fly without perching!

On the one hand in this tussle are those who, acting as government agents or purporting to represent the interest of the victims of the trial, have the penchant for feeding the media with streams of disinformation out of frustration that they can’t have access to the compensation package that has been negotiated for the settlement of the victims. They are the hunters. Their media offensives are, of course, complemented with spurious legal actions that have stalled the process of administering the compensation package. On the other hand are those of us who have seen through these unwholesome tactics and feel entitled to provide the other sides to their stories. We are determined to stop perching until the hunters exhaust their armory of poisoned arrows.

While there has really not been any let in the spate of bad publicity around the issue, there has, recently, been renewed focus on the case, with articles in a variety of media outlets. This intervention is a response to the recent series of Next reports in which the paper seems to regal in the belief that it had recorded a breakthrough in investigative journalism. The paper needs to be reminded, however, that the Nasidi report is more than a decade old. It was done when Nasidi was director of the department of vaccines, Federal Ministry of Health. The report, although conducted at the instance of the Federal Government, was never officially released. Interestingly, in October 2007, a federal court in Abuja heard a case brought by Pfizer charging that the Nasidi Report was illegal, inaccurate, and should be quashed. Indeed, a lot of the issues raised in the Next report are rehashed allegations that have been challenged in a court of law.

In the end, with the prevalence of good judgment, through the intervention of credible Nigerians and the realistic position of Governor Ibrahim Shekarau, the Pfizer offer was as safe as any agreement could be – except, of course, in the warped thinking of opportunists posing as defenders of the rights of the genuine claimants of compensation.

We are familiar with the issues raised in the report to understand where those behind it are coming from.

It is important to note the various falsifications in consideration of the Nasidi report

Next should realize that the report was prepared from the perspective of trying to exonerate the Ministry of Health from culpability and liability in the Trovan misadventure in the face of a federal court action.

If the Next correspondent were interested in balance, and had the willingness to do a thorough job, s/he would have provided a comprehensive perspective to the issues, including Pfizer’s objections against the Nasidi report, focusing on fairness and impartiality of the process by which the report was generated. To the extent that these perspectives are not presented, NEXT’s report cannot be said to be complete, accurate, and fair. For the information of impartial observers, Pfizer’s objections to the report were on the following grounds:

Dr. Nasidi, Chairman of the Investigation Committee that issued the report, had been personally involved in the federal government’s response to the 1996 epidemic, and openly stated his objection to the study during a visit to Kano’s Infectious Disease Hospital (IDH) with Professor Idris Mohammed, himself a well known critic of the trial. Normally, Dr. Nasidi should have excused himself from the investigation, given his personal views. Even though Pfizer objected to Dr. Nasidi’s role as committee chairman, due to his lack of impartiality, Dr. Nasidi refused to step down. Indeed, he would go on to provide evidence to the committee. Hence, he acted as committee chairman, witness and judge in the investigation.

Pfizer was neither given any opportunity to hear the witnesses’ testimonies before the committee nor were Pfizer’s lawyers able to cross-examine them, making the report void and in breach of the company’s constitutional right to fair hearing under Nigeria’s 1999 Constitution.

The report was largely based on the submissions of Dr. Nasidi and Dr. Idris Mohammed, and downplayed or completely ignored all pieces of evidence that favoured Pfizer, including the following;

o The Kano State office of National Agency for Food, Drug Administration and Control (NAFDAC) approved the Trovan study.
o Several staff members of Kano’s Ministry of Health, including Dr. Shehu Yusuf and Mr. Badulkadir, assisted in the study.
o The Trovan trial saved lives, reducing the fatality rate 30% to 6% in the group treated with Trovan.
o NAFDAC not only granted Pfizer the authority to import Trovan into Nigeria but also approved Trovan for investigational (clinical trial) use.
o Pfizer obtained informed consent from the children’s relatives and family.

It is also important to note that Nigerian government neither accepted the report, nor considered the report in the Federal Executive Council, nor issued a white paper on it.

The media in Nigeria should realize that both the Federal Government of Nigeria and the Kano State government have reached a settlement agreement with Pfizer regarding all four cases related to the Trovan clinical study. There has been real progress in the implementation of such settlement agreement, including the foundation-laying for a new, state-of-the-art, medical center in Kano.

There has, of course, been some spanner in the wheel of administering the rest of the compensation package, arising from litigations by those who are frustrated by their inability to make material gains from the situation. In effect, Next’s reports, like other reports that have been inspired by these frustrated “stakeholders,” are backward-looking and irrelevant to the current state of the Trovan case.

Newspapers will continue to find scoops for exclusive reports fascinating. But the point needs to be made that not all of the sources of such scoops are credible – and not all of the motives behind “leaking” “secret” reports are noble. The sources of the newly resurrected Nasidi report are, in my opinion, ignoble.

The challenge that interested members of the public, including the media, should address at this stage is: Who is holding up the process of administering compensation to those who were genuinely affected by the Trovan trial? Let’s us also see this as the Next challenge.

 Mustapha is public affairs commentator based in Abuja

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




SUNDAY, 16 JANUARY 2011 00:00 BY BERTRAM NWANNEKANMA AND TOPE TEMPLER OLAIYA SUNDAY MAGAZINE - SUNDAY MAGAZINE

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.

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.