Tuesday, October 7, 2008

TROVAN TRIALS IN NIGERIA: BETTER TO SETTLE OUT OF COURT

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 .

16 comments:

Anonymous said...

This is an eye-opening article. I had been led to believe that Pfizer was just out to use our people as guinea-pigs. Now I know better. If I was Governor Shekarau of Kano, I will quickly settle this matter out of court because it is clear that in the long run, the government will look bad. Their case is not as good as they want the world to believe.

Unknown said...

Interesting article. It is good to see that our people are now digging deep to unearth the story behind the story, just like in other international media. I just read another interesting piece on the Nigerian villagesquare called Nigerianmuse. Catch it on this link: http://www.nigerianmuse.com/20081022094643zg/articles/between-shekarau-and-maisekeli-one-a-statesman-the-other-an-opportunist

Anonymous said...

What about the recent Appeals Court ruling the the US empowering the Nigerian patients to sue Pfizer in US courts? What are the implications for quick settlement of the Nigerian cases? If you haven't seen the story, I have copied it out here from one of the sources on the net:

US Appeals Court Rules Nigerians Can Sue Pfizer in the US




Nigerian families can sue the Pfizer drugs giant in the US over its alleged role in the deaths of children, a US appeals court has ruled. The decision overturns a ruling by a lower court that the case must be heard in Nigeria. Pfizer is accused of killing 11 children and injuring 181 others when an antibiotic was tested on them during a meningitis epidemic in 1996. Pfizer denies the claims, saying they were victims of the outbreak. The epidemic killed 12,000 children in Nigeria in six months. The families say that Pfizer tested out an oral antibiotic called Trovan on some 200 ill children in hospital in Kano, without first getting the consent of their parents. They say the drug killed 11 children and caused blindness, deformities and brain damage in others. Their original law suit had been dismissed on the grounds that it could not be pursued under the Alien Tort Statute, an old law allowing foreigners to sue in the US courts. But the Second Circuit US Court of Appeals in New York ruled that the statute could be used. Peter Safirstein, a lawyer for the Nigerians, said the ruling was "very, very important".
Pfizer has always maintained that the tests were carried out with the approval of the Nigerian government and that the children's parents were fully informed. In a statement, the company said it had great sympathy for those affected by the epidemic but that "all clinical evidence points to the fact that any deaths or injuries were the direct result of the illness, and not the treatment provided to patients in the Pfizer study". Pfizer said it remained "confident that it will prevail".

jumai said...

The Trovan case has lingered for so long and it may still drag on if the warring parties don’t come to the drawing table and find an amicable settlement to the case. It is unfortunate that some children died in the epidemic but I strongly think this thing has dragged on long enough. The contending parties should seek a way out as no amount of warring or compensation can bring back the lives of the dead.
It is already 13 years since the unfortunate incident – and still no way out in the controversy. If the case is to be pursued to its logical conclusion, another 13 years may pass before the case is finally rested – possibly at the Supreme Court level.
I submit that the out-of-court settlement is the most reasonably course to follow at this juncture. Pfizer is presumed innocent until proven guilty – and we all know that he who alleges must prove. We can do without all that rigmarole.

jumai said...

The Trovan trial in Kano has generated so much controversies, no thanks to the huge scam industry being set up to ensure that compensation fund ends up in private pockets.
Adequate understanding of the nature of Meningitis should erode from the minds of people the erroneous believe that Trovan was responsible for the nos. of death that occurred during the Trovan trial period and those left with permanent deformities.
Meningitis is an infection of the nervous system that can kill in hours if left untreated or leaves one with permanent deformity, little wonder did it claim over 12,000 lives within the period of six months.
Lets not be in a hurry to forget the fact that some participants in the trial responded well to Trovan. There were patients that equally responded poorly to chroramphenicol treatment and died, hence the deaths would have probably occurred anyway even if Pfizer had not come on board.
It is so pedestrian to say that no patients consent was obtained due to the fact that the patients were illiterates, Pfizer merely provided the antibiotic to be tested and other resources. The Trovan trial was led by a local Nigerian physician with some local Nigerian Nurses and Doctors participating,thus they had a mood of communication.
continues throwing of tantrum will do the victims no good.

jumai said...

When two elephant fights, it’s the ground that suffers. The out-of-court settlement is a welcome development as that is the only way to ameliorate the pains and suffering of the victims.
Another food for thought is how do we prove that Trovan was actually responsible for the nos. of death and damaged to the victims health, when there was records of death associated with use of Chloramphenicol treatment.
Dispute over the amount to be agreed upon as compensation fund should be laid to rest. The compensation fund should be large enough to give the victims better lives, the rehabilitation of the Infectious Disease Hospital and the training of medical personnel to be able to combat future epidemic break-out.

Unknown said...

Forgive my cynicism. I am a Niger-Deltan and I can list out a litany of broken promises and failed dreams. I have only two worries: (1)Is it really true that Pfizer is ready to play ball- that they are serious about the settlement talks?
(2) How are you sure that the money, if and when released, will not end up in the pockets of the notorious Maisekelis of Kano?

jumai said...

Abigail, I do share in your sentiment, but we need to realize that Pfizer Pharmaceutical company is rank no.1 in the world in sales, Pfizer has been in business for several decades and as such will not be playing pranks as regards the out-of –court settlement talk. Hence that is the most rational thing to do.
As regards your second question of the money not ending up in the pocket of the maisekeli of our world, patriotic Nigerians will continue to be at alert and as watch dogs so that the like of maisekeli donot devour the compensation fund when the agreement is eventually reached.

Anonymous said...

The Trovan trial case has continued to drag for too long. We can do without all the rigmarole. The continuous prolonging of the case in the name of not reaching an agreed amount for the out-of-court settlement will do the warring parties no good.
The trovan victims & their families are the people feeling the pinch more than all others in this case, hence their interest should be the propelling factor in all that we do.
The lawyer to the federal Govt., Babatunde Irekera was quoted to have denied report that an agreement has been reached. For details of the story, catch it on this link.
http://www.voanews.com/english/2009-03-02-voa15.cfm

Anonymous said...

Jonah’s comment made me quickly visited the link site where I became rather sad after reading the position of the plentiff lawyer. We were beginning to rejoice because we thought at least, the Trovan Victims & families at last can smile again, well it seems this may not be happening for them soon.
Some of the Victims have died, its only fair for those of them still alive to benefit from the compensation fund while they are still breathing.

Anonymous said...

The stalling of the Trovan trial settlement case is discouraging.
As depressing as the question of what will eventual get to the victim & their families may be, the most important issue at hand is reaching a final & amicable settlement in the Trovan trial case. We’ll cross the bridge when we get there. The so call notorious corruption should not be the reason why these victims should be further deprived. It is important to allow victims still living to benefit.
You can get the whole gist on the link below.

http://industry.bnet.com/pharma/10001274/pfizer-close-to-settling-trovan-case-in-nigeria/#comments

Pharmawatch said...

Pfizer Trovan Case: Doctor Sues Over Link to Nigerian Attorney General Who Allegedly Wants Slice of Settlement
By Jim Edwards | December 30th, 2008 @ 7:46 am

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A Texas doctor helping the Nigerian government in its claim against Pfizer in the Trovan drug testing case has sued an African investigative reporting website, SaharaReporters, for $25 million, according to Black Star News. SaharaReporters had written that the doctor was a cousin of Nigeria’s attorney general and that the attorney general threatened to scuttle any settlement in the Trovan case unless he received a fee “in the millions of dollars” from Pfizer. The doctor denies the allegations.

The Nigerian government sued Pfizer for $7 billion after testing for Trovan, a meningitis vaccine, left nearly a dozen children dead. (See link to a Trovan backgrounder in this BNET story.)

Assisting the Nigerian government in its suit was Dr. Paul Botwev Orhii of Texas, according to BSN:

Dr. Orhii, it would be remembered, is the Texas doctor who, last December, wrote to President Yar’Adua volunteering to be an expert witness against Pfizer. On January 21, in what must rank as the federal government’s quickest hiring in 48 years, [Attorney-General Michael] Aondoakaa announced his engagement in a lavish letter which was curiously published in the press. Everyone knows that in the real world, the Nigerian government does not work that quickly, if it works at all.

Orhii, in a suit filed in federal court in Texas’s Southern District, says he is not a cousin of the attorney general and that there is no sheme for the attorney general to collect $10 million from the settlement. “Such false statements are libel, per se,” Orhii’s suit states. You can download a copy of the suit here.

Complicating matters further are reports detailing alleged fraud among Nigerians hoping to get a piece of the Pfizer settlement. Nigeria and Pfizer had been leaning toward a deal of between $10 million and $650 million earlier this year. The settlement would cover about 200 children who had been given the vaccine in tests.

Nigerian newspapers then alleged that local politicians were assembling deformed children pretending to be Trovan victims, in order to get a slice of the as-yet-unbaked pie. As you can see here and here, rampant speculation and rumor has replaced reliable information coming out of Nigeria on the current state of talks.
http://industry.bnet.com/pharma/1000543/pfizer-trovan-case-doctor-sues-over-link-to-nigerian-attorney-general-who-allegedly-wants-slice-of-settlement/

Anonymous said...

It is time we stop chasing shadows & start going after the substance. If the assertion that Dr. Orhii wrote to President Yar’Adua, volunteering to be an expect witness against Pfizer in the Trovan trial case is in any way true, my question to him will then be; where was he when the approvals Pfizer says they have was given?
I therefore plead with all parties involved in the case to let the fear of God & respect for humanity shape their thoughts.

jumai said...

Whatsoever we do in life we should always remember that there is a day called a day of reckoning.
If any one not minding the agonies of the Victims & their families decides to scuttle the reconciliation process due to selfish interest, to such I will say don’t forget posterity will some day judge us. The evil that men do no longer live after than, but lives with them.

Anonymous said...

ruthI have been trying to really understand certain fact as regards the case under discuss for some time now, the most reactions I’ve notice is that, parties do not want to accept responsibility. Assuming responsibility is not a sign of weakness but that of courage & bravery.

Anonymous said...

Enough! Let's all open our eyes wide and not succumb to slumber, otherwise the settlement funds will grow wings and condense in some smart people's private account. It has happened before. It can happen again.