Pfizer Kano Trial: 24 years after, some victims not compensated and still can’t live normal lives
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ONE sunny afternoon in April 1996, Maryam Ibrahim, also known as Ladi, took Maryam Ibrahim Sulaiman, her six-year-old daughter, to the Infectious Diseases Hospital (IDH) in Kano for vaccination after the child had suffered severe headache and fever overnight.
Before dawn, the child’s situation became so severe that she could barely walk. Ladi strapped her daughter to her back and headed for the hospital.
The child was later confirmed by a female European doctor at the IDH to be suffering from Meningitis.
After giving her four rounds of injections, the doctor handed her a wristband and a whistle. She also took her photograph, and gave her mother a copy as gift. And the pink colour registration card was taken from her by the officials of the hospital.
Ladi was excited, especially as the treatment was done free of charge. But her excitement would later be short-lived because, what transpired at the hospital cast doubts on the treatment administered on the poor child.
“…On reaching there (IDH) I entered with Maryam and she was accepted immediately and they took her to a particular room,” she recalls during an interview with The ICIR.
“I peeped through the window where they laid her on a bench but when they discovered that I peeped, they let the curtain down, and as of then they’ve cut her open from the waist to fetch some fluid. I saw something like a TV connected with a cable on her, yes, I saw that. But after that I was not allowed to see anything again. Later they asked me to get a seat for myself, which I did.
“Later, I saw a staff held her by the neck and told me to follow so as to get a bed for her, and I did.
“All that I cared about then was my child’s health and well-being.”
Later, the hospital officials instructed her to come back with the child after a week for check up.
But during the week, the child began to feel chronic pain in the leg and waist region.
On the day she was asked to come back with her daughter, Ladi was amazed when she was told that the white doctor and her colleagues had gone back to their country.
A physician who witnessed the event said the doctors left Kano unceremoniously immediately after the treatment.
Ladi did not know that her daughter had been used as one of the 200 guinea pigs to test the efficacy of a vaccine manufactured by the United States-based pharmaceutical company, Pfizer.
Since then, Maryam has continued to live her life with complications arising from the treatment. Her problem include chronic waist and leg pains and incessant fever. Later, she started complaining of auditory problem, then dizziness, resulting in loss of balance.
The vaccine later affected the mobility of her waist and legs. So, she was being taken from one hospital to another administered with different injections and drugs, Ladi narrated.
It is not clear if the complications affected Maryam’s memory 24 years after but many of her answers to questions were incoherent and she seemed to have forgotten many things about herself.
The treatment, it seems, has changed her life and now all she desires is living a healthy life free of pain.
“Most time, she is sick and to play basketball with her fellow girls is difficult. She complained that some of her school mates poked fun at her and she tried to explain to them that her waist and legs are not strong enough” Ladi said, sadness written all over her face.
She eventually finished high school in 2012, after enduring years of crude jokes and verbal assaults from insensitive peers.
She could not continue with her education because her parents could not afford it. And she also could attract intimate relationships because of her poor health condition, her mother told The ICIR.
“Men are scared to marry her because of her intermittent sickness. And she can’t walk long-distance without feeling pain in her hips”.
When I was young, my future ambition was to be a doctor- Audu Sani
Audu Sani was a 10 years old boy when his father, Alaramma Audu Mai Nasiha, took him to the IDH in 1996 where he was diagnosed with Meningitis.
After being used as one of the guinea pigs for the vaccine trial, Sani told The ICIR that his auditory system was affected and he could not hear for many years until recently. And that was how his dream of becoming a medical doctor got shattered.
“When we were young we used to go to the radio stations and whenever I was asked about the future I used to tell them that I would like to be a doctor in order to help people with their health issues, this really disturbed me whenever I thought of my ambition,” Sani said with a wry smile.
After the test, Sani’s health deteriorated as his parents took him from one hospital to another. Besides his hearing impairment, Sani said he stopped talking two months after the trial which made him relatively ‘deaf and dumb’. This stopped him from school while in Primary 3.
Attempts by his parents to restore his speech and hearing after visiting several hospitals, including Aminu Kano Teaching Hospital, drained their purses. Sani said his parents later gave up and resigned to prayer.
When he could not continue with western education, his paternal uncle suggested that he should be enrolled at Islamic and Arabic school in Borno State. And he needed to relocate to another town.
It was during this period of his relocation that Pfizer’s settlement agreement was reached with other victims but he was not reachable.
Sani told The ICIR that it was at the Islamic school he noticed he was regaining his speech and other people also started noticing. Since then, Sani said he experiences annual sickness rituals ranging from severe headache and ear pains.
Even now, it is difficult for him to be in a noisy area. He chooses where to be at any time, which comes with stigmatisation as many of his friends detest his ‘unusual’ quietness.
In 2011, after his relocation to Wudil, a suburb of Kano, where he settled down to raise a family, Sani approached the Pfizer victims Settlement Trust Committee but he was told ‘he came late’.
“In 2009, we came back to Kano and we heard about it that the people affected with the bad vaccine were compensated even though my parents said they didn’t hear about it,” he said.
We heard they were still paying. My brother tried for me to get the money. We heard they had a meeting with 300 patients but we were told that we are already late despite the evidence (picture) because that was the only evidence given to anybody injected with the bad vaccine by those white people if in the process the patient survived it.”
Sani is yet to be paid while he continues to suffer from the failure of the vaccine trial.
After 24 years, all Maryam want is just to live
Maryam Sani was pregnant while The ICIR visited her home in Sharada, Gindingaru, Kano municipality. The reporter had to repeat each question more than four times before she could hear him.
She was among the children whose life’s trajectory was changed by Pfizer’s ill-fated drug trial.
Maryam seems to have lost her memory, as she could not remember many of the events that have happened in-between the years.
Now 29, the mother of three does not know the exact amount of money Pfizer agreed to pay victims but told The ICIR that if paid, she will use it to care for her health and change the life of her family.
“I heard some people were given 16 million and some are paid 26 million. But I am not sure. The money will change the condition of my husband, family and friends by God’s grace if we can get it. It will help the children in achieving their educational goals and clothing”.
Maryam Ibrahim Sulaiman, Audu Sanni and Maryam Sanni are all victims of an illegal vaccine trial on children suspected to be suffering from meningitis by Pfizer, the pharmaceutical company in 1996.
However, while other victims have received compensation for the company’s illegal action and the life long impact it inflicted on them, these three have suffered the double jeopardy of ill health and denial of compensation.
Pfizer’s costly trick on 200 Kano children
The first half of 1996 marked the beginning of the most serious Cerebral Spinal Meningitis epidemic ever recorded in Nigeria. It was a severe public health crisis for the government at the time.
On April 3, 1996, a six-member research team from one of the world’s biggest research-based pharmaceutical companies in the United States, Pfizer, arrived in Nigeria.
The team headed straight to Kano State to treat children suffering from Meningococcal Meningitis. That year, Nigeria was still under military rule and Kano was also experiencing concurrent epidemics of measles and cholera, besides meningitis.
Before the arrival of the Pfizer team, international aid workers from Medicines San Frontieres (Doctors without Borders), the Nobel Prize-winning relief organization, were already providing free treatment with Chloramphenicol, the cheaper antibiotic that is internationally recommended for treating of bacterial Meningitis, at the IDH.
Pfizer, however, seized the opportunity to test the efficacy of its new antibiotic, Trovafloxacin (Trovan), on 200 children.
Ninety-nine out of the children were treated with Trovafloxacin/Alatrofloxacin as part of its effort to determine whether the drug, which had never been tested on children, would be an effective treatment for the disease.
One hundred and one children were administered with Ceftriaxone, the gold standard for meningitis treatment.
However, five of the children given Trovafloxacin died, along with six others who were given Ceftriaxone and many suffered brain damage, others were partly paralysed, became deaf or suffered slurred speech.
How Pfizer got its clearance
In 2001, the Washington Post unearthed a report of the investigation committee on the clinical trial of Trovan by Pfizer. The report of the committee set up by the Federal Ministry of Health chaired by Dr A. Nasidi revealed that the Principal Investigator (PI), Dr Isa Dutse, gave a backdated Ethical Committee Clearance to Pfizer, which means he gave Pfizer a forged approval to do the test in the country.
The ICIR found that the Ethical Committee was established in Aminu Kano Teaching Hospital (AKTH) in October 1996 after the trial. Also, the committee was only involved in trials within the AKTH.
An official document sighted by The ICIR also revealed that the approval letter issued by Dutse on the letterhead of AKTH was irregular while the signatory to the letter, Salisu Isah Adamu, was a confidential secretary to Dutse.
At the time of his selection as the PI, Isa Dutse was a physician at the nearby Bayero Teaching Hospital, Kano State and served as the Deputy Chairman of the Medical Advisory Committee of the Teaching Hospital.
Aside from the fake approval, it was later claimed that Pfizer did not have proper/written consent from parents to use an experimental drug on their children and questions were raised over the documentation of the trial.
The victims, who spoke to The ICIR 24 years later, said that none of their parents were ever told that their wards were being administered experimental drugs and, in effect, being used as guinea pigs. Thus, no one gave Pfizer consent as is required in such procedures.
The ICIR investigation also showed that many of these parents are illiterate persons who could neither read nor write.
The document also revealed that three visiting American doctors of Pfizer (Scott Hopkins, Debra Williams and Mike Dunne) who were not cleared nor licensed by Nigerian Medical Council to practice in Nigeria participated in patient-care while Isa Dutse affirmed before the panel to have done most of the lumbar punctures. Scott Hopkins and Mike Dunne did a few.
Dutse told the panel that, in hindsight, he had regret about the clinical trials and his motive was not negative.
The report also quotes him to have admitted that “although Pfizer might have had legitimate authorisation to come in (to the country) and do the trials, he believes that Pfizer’s primary motive was far from philanthropic.”
In his closing comment before the panel, he said “I regret this whole exercise, I wonder why on earth I did this? I did not do it for any personal benefit. I did not go out to kill anyone or injure or put anyone’s life at risk”
However, when The ICIR sought the comment of Dutse on October 5, 2020, his close allies in Kano city disclosed that the doctor had died on that same day and would be buried the day-after ( October 6).
Dutse was reported dead at Aminu Kano Teaching Hospital after a brief illness and following a post-surgical intervention.
“Pfizer should be sanctioned” – Panel report
In one of the shady procedures followed by Pfizer during the deadly trial, The ICIR obtained a document which shows how the tested 200 children’s names were documented by initials.
Which means as this reporter bears Samad Uthman, the record book of Pfizer would simply record his name as SU. This made the tracking of survivors difficult.
However, Maisikeli Mustapha, one of the affected parents whose children died due to the deadly trial, formed a group of victims and made a contact tracing of all the 200 affected victims.
After the tracking, Mustapha’s group got an attorney, Etigwe Uwa of Streamsowers & Köhn chambers, and started pushing the case to the court and the public.
They then started organising themselves and named the group as Kano Trovan Victims Association (KTVF). Many of the members of this group are parents whose children were used as the guinea pigs by Pfizer.
In December, 2000 and early 2001, many foreign and few Nigerian media papers widely reported the botched trial. This got the attention of the then minister of health, Prof A.B.C. Nwosu and he constituted an investigation committee with specific terms to probe the incident.
Chaired by Abdulsalami Nasidi, the panel, among other things, recommended that Pfizer be sanctioned appropriately for breaching the Drug and Related Products Decree (Registration, etc), the Helsinki Declaration on Ethical Principles for Medical Research involving Human Subjects and the 1989 United Nations Convention on the Rights of the Child.
The panel also proffered that the pharmaceutical giant should tender an unreserved apology to the government and the people of Kano State in particular and accompanied by appropriate restitution.
Also, the Nasidi-led panel advised that Ethical Committee clearance must remain a mandatory requirement for any trial on humans. It recommended that any individual, group, or corporate organisation intending to conduct clinical trials should be conversant with and made to adhere strictly to all the relevant Nigerian laws, regulations, guidelines and procedures.
In its recommendations, the panel stated that Dr Isa Dutse, the naive and exploited “principal investigator” of the horror trial should be reprimanded and considered for disciplinary action by his institution.
While the restitution was made after a long year of legal battle, The ICIR understands that only three copies of this panel report were printed and it was never made available to the public until years later when the Washington Post exposed the findings of the Nasidi-led panel in a report.
From the US to Nigeria, long years of court wars
In 2001, the KTVF sued Pfizer in US federal court under the Alien Tort Claims Act (ATCA) alleging that the company violated customary international law by administering Trovan to minors in Kano during the meningitis outbreak.
The plaintiffs in Abdullahi v. Pfizer claimed that the drug was given without the informed consent of the children and their parents. The plaintiffs further claimed that the drug trial led to the deaths of 11 children and serious injuries to many others.
A second US lawsuit was filed against Pfizer, Adamu v. Pfizer, in November 2002. These plaintiffs were also a group of Nigerians injured in the Trovan drug trial. The Adamu plaintiffs alleged similar violations under ATCA and violations of Connecticut law. But these cases were dismissed in 2005 on grounds of forum non-conveniens and failure to state a claim under ATCA.
According to the judge, the plaintiffs failed to show a sufficient legal source for an international prohibition of non-consensual medical treatment.
In January 2009, the US court of appeals reversed the lower courts’ dismissal of the case. The Business & Human Rights Resource Center documented that a divided court found that the prohibition of non-consensual medical experimentation on humans is binding under customary international law.
In July 2009, Pfizer petitioned the US Supreme Court asking it to hear an appeal of the Court of Appeals’ January 2009 ruling.
In November 2009 the Supreme Court asked the US Solicitor General to submit a brief to the court in this case.
In May 2010 the Solicitor General submitted this brief to the court urging the court to deny Pfizer’s petition.
On February 23, 2011, the parties announced that they had reached a settlement in this lawsuit. The terms of the settlement were confidential. A joint statement issued by the parties explained that the plaintiffs in the US lawsuit will join the ongoing Healthcare/Meningitis Trust Fund process, which is being managed by an independent board of trustees in Kano, Nigeria.
The ICIR understands that in Kano State Court there was one civil suit and one criminal case and in the Federal High Court, there was one civil suit and one criminal case.
In 2001, a group of Nigerians sued Pfizer in the Federal High Court in Kano. The plaintiffs in this case, Zango v. Pfizer International, alleged that Pfizer’s drug trials were illegal. However, after severe delays, the plaintiffs elected to withdraw this case. Some of the Zango plaintiffs were part of the Adamu action in the US.
In May 2007, the Kano State brought criminal charges and civil claims against Pfizer seeking over $2 billion in damages and restitution. Settlement talks have been ongoing since November 2007. In late January 2009, the state court adjourned the case until late February to allow more time for the parties to reach a settlement out of court.
In a separate action, the Nigerian Federal Government filed suit against Pfizer and several of its employees in June 2007 seeking nearly $7 billion in damages for the deaths of children involved in the Trovan drug trial.
In late January 2009, the government informed the court that it had agreed with Pfizer to settle the lawsuit out of court.
On April 20, 2009, Wikileaks quoted Pfizer’s lawyers, Joe Petrosinelli and Atiba Adams, to have reported that Pfizer and the Kano State government had reached a preliminary settlement on lawsuits arising from the trial.
Petrosinelli said Pfizer agreed to the Kano State Attorney General’s (AG) settlement offer of $75 million, including a $10 million payment for legal fees, $30 million to the Kano State government, and $35 million for the participants and families.
According to Adams, several final details needed to be worked out on the mechanism for payment, but Pfizer recommended setting up a $35 million trust fund for the victims to be administered by a neutral third party and for the $30 million for the Kano State Government to be used for improving health care in the state.
The state government agreed to this. Justice Abubakar Bashir Wali was appointed as the board chairman of the Meningitis/Healthcare Trust Fund.
Out of the 200 victims, The Guardian UK reported on 12 August 2011 that the parents of four Nigerian children who died of meningitis were the first winners of the 15-year legal battle against Pfizer. The families of four of the children each collected cheques for $175,000 (N26.6M, calculated based on prevailing dollar rate of 1$=N152) from the compensation trust fund, after submitting DNA samples to show that the dead were their offspring.
Later, another batch of victims were paid, making about 14, leaving out 186 out of 200.
The ultimate search for claimants
After the filling of the compensation model, Pfizer Meningitis Trust announced on the radio in both Hausa and English in 2009 the intake of another set of claimants. The committee asked claimants to fill forms.
The ICIR saw proof of the distributed forms being used to wrap Suya, the open-fire barbecued steak, by sellers.
After the exercise, aside from the already existing 186 KTVA claimants, the committee got 337 new claimants through the process. They are named “Media Invited Claimants” due to the way they were ushered into the case through media publicity.
Our source told us that many controversies trailed the action of the committee which made it lose integrity. It was smeared by sheer politicisation by the Kano State government.
During the out-of-court settlements talks between the government of Kano State and Pfizer, the parties signed two different Memorandum of Understanding, MoUs, on different occasions which were never made available to the public.
The ICIR on October 2, 2020, wrote a Freedom of Information (FOI) request to the Attorney General and Commissioner of Justice of Kano State to request for the first and second MoU signed by parties in 2016 pertaining to the Pfizer Trovan case and documents pertaining to the trial.
However, as at press time, the Kano State government has not responded to the request. The law provides for a maximum of seven days for response to requests.
In 2016, most of the KTVA and the Media Invited Claimants were paid. But not all.
Maryam Ibrahim Sulaiman, Audu Sanni and Maryam Sanni as of press time have not been paid a dime while they still suffer eternal sickness from the trial.
Many were paid, but not as stipulated
A source close to the case told The ICIR that in the second MoU signed by the Kano State government and Pfizer in 2016, each KTVA victim is profiled to get $25,000 while the Media Invited Claimants were to get $10,000 each.
However, in an exclusive email obtained by The ICIR sent by A.B. Mahmoud (SAN), former President of Nigeria Bar Association (NBA) and counsel to the Kano State government representing the 337 Media Invited Claimants, to Anthony Idigbe (SAN), Pfizer’s lawyer, at exactly 6:44 pm on April 30, 2015, he proposed that out of the $32million available, Pfizer should retain 20 per cent of it, which is $6.4million. Etigwe Uwa, the counsel to the KTVA, was copied in the email which was sent at exactly 6:44 pm on April 30, 2015.
Mahmoud also proposed that each of the 337 Media Invited Claimants to receive $10,000 each while the Mesikelil group, KTVA get $25,000 each. He added that legal costs will be pegged at $10.6million.
He suggested that a total sum of $7.919million goes for the construction of a medical centre, settlement of the liquidation expenses and refund to Professor Muhammad Idris, the chairman of the task force appointed by the then Minister of Health, all personal expenses incurred by him in the course of controlling the epidemic.
Idris was the first to raise alarm on the illegal trial and also wrote to the Minister of Health over the illegality while he also declined to approve the trial over non-provision of all needful and relevant approval letters from NAFDAC and the minister.
Comments from the members of KTVA and Media Invited Claimants revealed that they were paid below the budgeted amount.
Copies of the “release agreement” signed separately by the two groups show that $7,000 was paid to each of the Media Invited Claimants and $20,000 for KTVA instead of $10,000 and $25,000, respectively, as contained in Mahmoud’s letter.
It is believed that each of the victims were ‘shortchanged’ by $5,000 and N3,000 respectively.
The ICIR on October 2, 2020, wrote to A.B. Mahmoud over this discrepancy in the settlement fees to the victims. In the letter, questions were raised on the use of the phrase “an agreed period of time” in a private email sent by him to other attorneys involved in the case in 2015.
He had noted that Pfizer retains 20 percent of the available funds worth $6.4million for an unspecified time to mitigate future risk.
The ICIR’s letter also questioned, “when is the right time?”
In his October 6 response, written on his behalf by his chamber, Mahmoud responded that his firm only acted on behalf of the “Kano State government during the phase of the renegotiation of the settlement agreement between 2011 and 2019”.
He added that his firm is no longer acting on behalf of the state government and due to the confidentiality clause in the terms of the settlement, he is not in a position to respond to The ICIR’s request.
My members thought I embezzled their money- Muhammad
Bello Muhammad, the leader and the chairman of the Media Invited Claimant group told The ICIR that after the payment of the settlement into his members’ accounts, many began to question him and believed he and his other executives connived with the Pfizer lawyer to rip-off $3,000 out of the over 300 claimants.
“…it got to the point where most of our people pointed fingers at us. They accused us of having a hand in the money reduction saying we connived with them to have the money deducted,” Muhammad said.
He expressed that he has used all possible language to explain to the members that he knew nothing about the deduction. He added that it was because of the reduction without explanation that some members of his group stood not to accept the payment.
“We can’t do anything about that because we don’t have any power over that. It was because of this reduction that those among my group said they will not accept the half payment.”
“This was because they had initially raised our hopes on 10,000 before they failed us with the reduction of $3,000.”
Besides the reduction, Muhammad said he and others were paid in bits which made most of them not able to manage and monitor the inflow while some have not got part of their payment.
“They suffered us seriously because they did not release the money in full, they released it bit by bit,” he claimed.
” Please sir, help us, please help us find out what happened to the rest of the $3,000,” he pleaded with The ICIR.
However, while many were paid in Muhammad’s group, The ICIR understands that about 6 persons have not been paid. Out of the 6, three can not be located while the cases of the remaining three have been pushed before Pfizer for compensation.
Maisikeli Mustapha, the chairman of the sister group, KTVA, declined to speak to The ICIR. He explained that one of the payment clauses they signed with Pfizer was not to speak about the matter with the press.
The copy of the document sighted by this reporter showed that violation of this may result in another legal battle between an erring party or victim and the pharmaceutical company.
Victims were paid as stipulated- Pfizer
Nelson Uzuegbu, a lawyer and the representative of Anthony Idibe, Kano State Pfizer representative, told The ICIR in an interview that all the victims who have come forward have been paid.
“To the best of my knowledge, all those who put in a claim have been paid, remaining just a few who have not come forward, because maybe they are not aware or they lost track of what is happening. I am not sure of the exact number but there are few, perhaps 3, 4, 5,” Uzuegbu said.
He denied any engagement that stipulated $10,000 for media invited claimants and $25,000 for KTVA.
In another response, Nelson wrote to The ICIR that his firm (Nelson Uzuegbu & co) did not take part in the negotiations and making of an agreement between the Kano State government and relevant parties.
“Each party or set of parties was represented by senior counsel who ensured that obligations to their client were fully discharged and in strict terms”.
Nelson added that each party and its counsel in the Trovan Trial Case are “bound by confidentiality clauses in the settlement which they must adhere to. They have neither waived the said clause nor empower me to speak for them”.
However, O’Neill Lisa Margaret, Pfizer’s Global Media Relations Director for Europe, Middle East and Africa, in response to an email enquiry from The ICIR, said that the company “has met all of its obligations under these and successive agreements, which did not include any admission of liability by the company”.
“There have been multiple opportunities under the settlements spanning seven years for people with legitimate claims to submit the required information, including to an independent trust in Nigeria that was created to evaluate claims. All of those who have done so and who were verified as proper claimants have been paid. These matters were fully and finally resolved in 2016,” she explained.