by Silviu “Silview” Costinescu_

In 2000 the Washington Post published a major exposé accusing Pfizer of testing a dangerous new antibiotic called Trovan on children in Nigeria without receiving proper consent from their parents. The experiment occurred during a 1996 meningitis epidemic in the country. In 2001 Pfizer was sued in U.S. federal court by thirty Nigerian families, who accused the company of using their children as human guinea pigs.

The trials led to the deaths of 11 children. Dozens more were left disabled.Pfizer’s Unapproved Clinical Trial The unauthorized trial involved tests on 200 children with Pfizer’s antibiotic Trovan. Source: BBC News

In 2011, Pfizer paid $700,000 to four families who lost children during the Trovan trials.

In addition, the company set up a $35 million fund for those affected by Trovan. Pfizer also agreed to sponsor health projects in Kano, Nigeria.

The question that boggled many analysts: How din Pfizer manage to settle so low, after Kano initially filed for $7BILLION damages?

TIMELINE OF THE LEGAL CASE

2006: a panel of Nigerian medical experts concluded that Pfizer had violated international law.

2007: Charges

“After more than a decade of silence, the Nigerian government has decided to sue Pfizer, seeking $7bn (£3.5bn) in damages for the families of children who allegedly died or suffered side-effects in the experiment. Kano State government has also filed separate charges against Pfizer.
But Mr Sani says compensation will not be enough.
“In addition to the compensation, they should be killed like the children they have killed,” he says.
The Pfizer experiment was cited by many as a reason for the mass rejection of polio vaccinations in many parts of northern Nigeria in recent years.
Some local Islamic preachers said there was a western plot to sterilise Muslim women. After several tests were carried out to proving the vaccine’s safety, the programme has now been resumed.
Whether the families ever receive compensation, it will never be enough to bring back Anas’s lost dreams of becoming a soldier.” – BBC

2009: The Nigerian state of Kano settled with Pfizer for $75 million in July 2009. Details of the federal settlement were never reported.

At the end of January 2009, a New York appeal court ruled Mr Etigwe and Mr Altschuler’s case could be heard in the US. The Connecticut attorney says it could still go ahead. “Our case is firmly embedded in the US … so a Nigerian settlement does not foreclose our case. But this is very good news. I’m glad we remained the constant gardener and could see this come to fruition.”

2011:

Eleven of the children died and many more, it is alleged, later suffered serious side-effects ranging from organ failure to brain damage. But with meningitis, cholera and measles still raging and crowds still queueing at the fence of the camp, the Pfizer team packed up after two weeks and left.

That would probably have been an end to the story if it weren’t for Pfizer employee, Juan Walterspiel, the Independent writes in 2014.
” About 18 months after the medical trial he wrote a letter to the then chief executive of the company, William Steere, saying that the trial had “violated ethical rules”. Mr Walterspiel was fired a day later for reasons “unrelated” to the letter, insists Pfizer.

2014: PFIZER TO PAY ONLY $163.50M AFTER DEATHS OF NIGERIAN CHILDREN IN DRUG TRIAL EXPERIMENT!

Out of court settlement in the case inspired ‘The Constant Gardener” movie.

The company claims only five children died after taking Trovan and six died after receiving injections of the certified drug Rocephin. The pharmaceutical giant says it was the meningitis that harmed the children and not their drug trial. But did the parents know that they were offering their children up for an experimental medical trial?

“No,” Nigerian parent Malam Musa Zango said. He claims his son Sumaila, who was then 12 years old, was left deaf and mute after taking part in the trial. But Pfizer has denied this and says consent had been given by the Nigerian state and the families of those treated. It produced a letter of permission from a Kano ethics committee. The letter turned out to have been backdated and the committee set up a year after the original medical trial.

At stake at one point in 2013 was more than $8bn in punitive damages being sought in a string of cases, as well as potential jail terms in Nigeria for several Pfizer staff. “There has been a complex web of cases with proceedings in Connecticut, New York, Lagos, Abuja and Kano,” Mr Etigwe said. “The strategy of big companies when they are dealing with smaller opponents is to stretch the process, to overwhelm us until we are ready to accept whatever they want to offer.”

Trovan never became the blockbuster that Pfizer had hoped for and it is no longer in production. The EU has banned the drug and it has been withdrawn from sale in the US.

It appears that Pfizer has finally ended the public relations nightmare with Friday’s settlement. But the Trovan battle may not be over yet.

2015: Nigerian govt withdraws civil lawsuit in preparation for new case against Pfizer. New case never followed.

Reuters: Nigerian government lawyers have withdrawn a 7 (b) billion US dollar civil lawsuit against US drugmaker Pfizer on Friday in preparation for filing a new case, with new material they believe will strengthen their case. The criminal case, is one of three currently being brought in Nigeria against the company. The government has accused Pfizer, the world’s largest pharmaceutical company, of taking advantage of a 1996 meningitis epidemic to test an experimental drug without authorisation or full understanding of the families involved – allegedly contributing to the deaths of some of the children and making others sick. Pfizer denies wrongdoing. The civil case is in addition to a federal criminal case and separate from civil and criminal cases launched at the state level in the northern state of Kano. All the cases stem from the same mid-1990s drug study. Pfizer treated 100 meningitis-infected children with an experimental antibiotic, Trovan. Another 100 children, who were control patients in the study, received an approved antibiotic, ceftriaxone – but the dose was lower than recommended, the families’ lawyers alleged. Up to 11 children in the study died, while others suffered physical disabilities and brain damage. Pfizer always insisted its records show none of the deaths was linked to Trovan or substandard treatment. Barrister Abdulateff Thomas said that he did not accept any of the company’s excuses that the studies were conducted through a deal with the Nigerian government. “If there was any deal at all it was made by an individual against the interest of the government, against the interest of a nation,” he said. “Could they do that deal in America? Can they do it in the UK? Or in any of the European countries? No,” he added. Speaking before the latest development, he added that he did not believe that Pfizer would suffer any consequences as a result of the – now withdrawn – lawsuit. “Nothing is going to happen to Pfizer, if anyone tells you otherwise. Pfizer is going to remain strong, he said. Authorities in Kano state are blaming the Pfizer controversy for widespread suspicion of government public health policies, particularly the global effort to vaccinate children against polio. Islamic leaders in largely Muslim Kano had seized on the Pfizer controversy as evidence of a US-led conspiracy. Vaccination programmes restarted in Nigeria in 2004, after an 11-month boycott.

So we have over a decade of legal battles in which Pfizer saves about $7billion in penalties. As spectacular as it is mysterious. No one has ever revealed an official explanation that satisfies that kind of success, you would expect some solid steel evidence that crushed the cases and the demands from the plaintiffs, but that is unheard of.

The answer might be hidden is some classified U.S. State Department cables made public in 2010 by Wikileaks, which indicated that Pfizer had hired investigators to dig up dirt on Nigeria’s former attorney general as a way to get leverage in one of the remaining cases. Pfizer had to apologize over the revelation in the cables that it had falsely claimed that the group Doctors Without Borders was also dispensing Trovan during the Nigerian meningitis epidemic. And by doing so, validated the cables.

 

A Pfizer representative in a phone interview with Washington Post declined to discuss specifics of the cable or Liggeri’s alleged comments. In its written statement last week, Pfizer said it negotiated the confidential settlement with the federal government “in good faith and its conduct in reaching that agreement was proper.” Pfizer said it had agreed to pay the legal fees and expenses incurred by the federal government in the litigation and no payment was made to the federal government of Nigeria itself.

According to the cable, Liggeri also told U.S. officials that the lawsuits were “wholly political in nature,” and that the humanitarian group Doctors Without Borders also gave children Trovan. Officials with the organization said that is not the case, and other records suggest that only Pfizer would have had access to Trovan at the time.

Doctors Without Borders published this response in 2011: “Among the US government diplomatic cables recently published by the Wikileaks website were details of a meeting between an official from the pharmaceutical company, Pfizer, and US Embassy officials in Nigeria in April 2009.

At the time of the meeting, Pfizer was in the midst of a legal battle with Nigerian government officials regarding a medically unethical antibiotic clinical trial in children. The clinical trial took place in Kano State in 1996 during a massive meningitis outbreak.

Pfizer carried out the trial of the oral antibiotic trovafloxacin, branded Trovan, even though there had not been any previous medical evidence that it could be effective against meningitis. The Pfizer researchers conducted the trial in Kano State Hospital, where a Doctors Without Borders/Médecins Sans Frontières (MSF) team was treating children using a preferred and clinically approved antibiotic regimen for bacterial meningitis.

A US$75 million settlement with the State of Kano was reached July 30, 2009. Other cases are still pending before the US courts and the Nigerian federal government continues to pursue legal claims against Pfizer.

It is against this backdrop that Pfizer falsely accused MSF in the US diplomatic cables of using Trovan. Documented evidence has shown that these accusations are patently false. MSF did not, at any time, administer Trovan to patients. Litigation connected to this case and comprehensive investigative reports on the matter suggest that Pfizer’s attempts to rewrite history are intended to deflect responsibility for the company’s actions.

MSF was not working in the same part of the hospital in Kano State as Pfizer clinical researchers, and MSF staff had no connection to Pfizer. When MSF staff became aware of what Pfizer was doing, they were appalled at the practices of the company?s team. MSF personnel on the ground communicated their concerns to both Pfizer and the local authorities.

“It was not a time for a drug trial,” says Jean Hervé Bradol, former president of MSF France, to whom the Kano teams were reporting at the time. “They were panicking in the hospital, overrun by critically ill patients. The team were shocked that Pfizer continued the so-called scientific work in the middle of hell.”

Pfizer officials have made no attempt to clear the record as of yet and retract these unsubstantiated claims against MSF. A handful of internet reports have adopted the version of events proffered by the Pfizer official.

An exhaustive Washington Post investigation, drawing on extensive background information and interviews provided by MSF staff, published on December 17, 2000, makes clear the distinction between Pfizer?s activities and the work of MSF during the meningitis outbreak:

‘Behind a gate besieged by suffering crowds stood two very different clinics. A humanitarian charity, Doctors Without Borders, had erected a treatment center solely in an effort to save lives. Researchers for Pfizer Inc., a huge American drug company, had set up a second center. They were using Nigeria’s meningitis epidemic to conduct experiments on children with what Pfizer believed was a promising new antibiotic?a drug not yet approved in the United States.’

The article later triggered the various legal proceeding taken by the victims and Nigerian authorities against Pfizer.

With proven treatments at hand, Pfizer instead chose to carry out tests for an unproven drug on children whose lives hung in the balance. ‘The situation called for using treatment protocols known to be effective rather than carrying out clinical trials on a new antibiotic, with uncertain results,’ said Dr. Bradol.”

 

BBC reported it too at the time (2010):

“According to a US cable released by WikiLeaks, Pfizer wanted to “put pressure” on Michael Aondoakaa. He was heading a lawsuit against the company over a 1996 drug trial during a meningitis epidemic.
The trial allegedly led to the deaths of 11 children – charges Pfizer denies.
Pfizer reached a $75m settlement last year with Nigeria’s Kano government over the case, which also allegedly left dozens of children disabled.

In a statement released by Pfizer in response to the leaked diplomatic cable published by the UK’s Guardian newspaper, the pharmaceutical company said it “negotiated the settlement with the federal government of Nigeria in good faith and its conduct in reaching that agreement was proper”.

The cable quoted conversations said to have taken place between US embassy staff and Pfizer’s head in Nigeria, Enrico Liggeri. It referred to a meeting between Mr Liggeri and US officials on 9 April 2009.

“According to Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases,” the cable released by the whistle-blowing website WikiLeaks said. “He said Pfizer’s investigators were passing this information to local media.”

Mr Aondoakaa was removed from the position of justice minister in February this year by Nigerian President Goodluck Jonathan.”

Thing is no one has ever proven a Wikilieaks cable to be fake, definitely not this one.

Another good report on the cables I found in mainstream-media comes from the Atlantic (2010):

“In 2000, following the Post revelations, a cry for justice in the Nigerian media triggered street protests and an investigation by Nigeria’s health ministry, whose report on the incident went missing until 2006, when a leaked version revealed that the health officials had reached more or less the same verdict as the fired Pfizer expert: The experiment was “an illegal trial of an unregistered drug,” a “clear case of exploitation of the ignorant,” and a violation of Nigerian and international law.

These disclosures prompted a raft of civil and criminal lawsuits in Kano State Court on behalf of the families and in Federal High Court on behalf of the nation itself, as it were. But Pfizer kept the suits tangled up in proceedings to postpone any settlement.

A State Department cable dated April 20, 2009 and released by WikiLeaks, however, suggests that Pfizer’s legal strategy was not simply to delay–it was also to blackmail. Written by an economic counselor at the US embassy in Abuja, Nigeria, the cable reports minutes of meetings during which Pfizer representatives informed the U.S. ambassador that the firm had agreed to settle the Kano State suit for $75 million, mere pocket change for the pharma giant. The ambassador was told that Pfizer “was not happy settling the case, but had come to the conclusion that the $75 million figure was reasonable because the suits had been ongoing for many years costing Pfizer more than $15 million a year in legal and investigative fees.”

It was how Pfizer deployed these fees that dropped a bombshell:

According to [Pfizer country manager Enrico] Liggeri, Pfizer had hired investigators to uncover corruption links to Federal Attorney General Michael Aondoakaa to expose him and put pressure on him to drop the federal cases. He said Pfizer’s investigators were passing this information to local media, XXXXXXXXXXXX. A series of damaging articles detailing Aondoakaa’s ‘alleged’ corruption ties were published in February and March. Liggeri contended that Pfizer had much more damaging information on Aondoakaa and that Aondoakaa’s cronies were pressuring him to drop the suit for fear of further negative articles.

Blessed with immense reserves of oil, Nigeria, like many oil-rich developing nations, has in turn been cursed with extravagant corruption. Aondoakaa was among those caught up in it. The cable does not mention Pfizer’s settlement of the $6 billion federal lawsuit, which was signed in secret by lawyers from Pfizer and the Aondoakaa-led Nigerian ministry of justice in October 2009. With the settlement’s terms under wraps, how much Pfizer paid and to whom remains a mystery.

In February 2010, Aondoakaa was booted from the government over charges of corruption. Pfizer denies the version of events reported by the U.S. Department of State official. “Any notion that the company hired investigators in connection to the former attorney general is simply preposterous,” Christopher Loder, a Pfizer spokesman, told The New York Times.

When I emailed Loder asking for comment about the allegations in the WikiLeaks cables, he repeated his statement to the Times verbatim, adding that the cases had been “resolved in 2009 by mutual agreement” and that Pfizer’s conduct was “proper.”

The 1996 Trovan tragedy has cast a long shadow. In 2003, the parents of Kano State boycotted a U.S.-made polio vaccine, threatening to single-handedly short-circuit the global initiative to eradicate the disease. These parents bore the legacy of the Trovan trial and the ensuing years of failed and foiled litigation. Suspicion and cynicism of Western motives ran so deep that they accepted their local clerics’ warnings that the polio vaccine was a plot by Christians to sterilize their daughters, relenting only when health officials switched to a vaccine manufacturer based in Indonesia, a Muslim nation.

Despite all this, Pfizer apparently perceives itself as the real victim. As detailed in the leaked cable, Liggeri portrayed Pfizer to the ambassador as entirely the injured party, dismissing the lawsuits as “wholly political in nature” and asserting that during the meningitis outbreak in 1996, MSF also administered Trovan to children. (When asked for comment by the Guardian, Jean-Hervé Bradol, former president of MSF France, said, “We have never worked with this family of antibiotic. We don’t use it for meningitis. That is the reason why we were shocked to see this trial in the hospital.”) Liggeri warned darkly that the lawsuit against Pfizer had so chilled the entire pharmaceutical industry that “when another outbreak occurs no company will come to Nigeria’s aid.” Whether or not that’s true, it’s not clear that Nigerians would want Pfizer’s help after all.”

 

However, it took some real alternative independent media to reveal the gravity of the situation, in 2010, when the Democracy Now! news outlet hosted an Washington Post reporter involved in the case and a Nigerian journalist. Dhe deadliest details came together:

“After our stories, there was an official federal investigation in Nigeria. But it was never made public. It disappeared. And many years later, we finally got a copy of this report. It concluded that Pfizer had violated both Nigerian law and international law and was very critical. It also mentioned that members of the investigative panel had been the target of death threats during their investigation. We were told there were three copies of this report. Attorneys in the U.S. who brought a class action lawsuit said they had spent years trying to find this report that we came up with. One they tracked to a safe. And when they opened the safe, it was not there. Another was supposedly in the possession of a man who died before lawyers got to him.
After we made this report public, there was a new set of public officials in power in Nigeria, and they decided to bring criminal and civil charges against Pfizer, including homicide — both Pfizer and some current and former employees of Pfizer. The state of Kano in the northern Nigeria settled for $75 million. The federal charges, which initially were seeking $7 billion from Pfizer, just sort of evaporated. We never knew what happened to them. And now, this new revelation comes out and raises very serious questions about why those charges just evaporated.” – Joe Stephens is a staff writer for the Washington Post. He was part of the investigative team that broke the story in 2000

Musikilu Mojeed, a Nigerian journalist  who has worked on this story for the NEXT newspaper in Lagos, commented the following:
“Nigerians are clearly outraged by this revelation that Pfizer hired investigators to smear the attorney general, to blackmail him to drop the federal charges. But not a lot of people are entirely surprised in Nigeria, because before the WikiLeaks cable came out, our newspaper, NEXT, had exposed the mysterious disappearance of the federal charges against Pfizer. You know, suddenly, the case just disappeared. Nobody knew how the case was withdrawn. Nigerians were not told. It was just done in secret. And our newspaper broke this story. That is, a $6 billion federal suit against Pfizer disappeared secretly, that the attorney general simply did — went into a secret deal with Pfizer and a few Nigerian lawyers without anybody knowing about it. In fact, Pfizer may have violated U.S. law, because Pfizer refused to disclose the details of that settlement, even in its filing for the quarter of 2009 to the U.S. government. So, Nigerians are clearly outraged.

And even the attorney general, the former attorney general, himself, is threatening that he might sue Pfizer for blackmailing him. But in any case, the attorney general himself is known to be terribly corrupt. So a lot of people are not surprised, because he’s know to be a corrupt man. He cannot enter the United States, because the U.S. government has barred him, has withdrawn his visa and that of his family, because he’s known to be corrupt. But a lot of people are outraged that Pfizer could go to that extent to hire an investigator to blackmail a Nigerian official.”

Evidences of various forms of wrong-doing on the Pfizer side kept appearing the following years, see this 2011 CBS news piece:

Pfizer Bribed Nigerian Officials in Fatal Drug Trial, Ex-Employee Claims

“A former Pfizer (PFE) employee’s letter to a federal judge alleging that the company put a courier on a KLM flight to Nigeria carrying bribes for local officials is a classic example of how hard it is to get away with corporate skullduggery: The letter cites 40 Pfizer executives, FDA officials and other witnesses who allegedly have inside knowledge of the scandal — not very secret for a secret conspiracy.(…)

The letter was written by Dr. Juan Walterspiel, who in 1996 was a pediatric research physician in Pfizer’s Groton, Conn., facility. He worked on the Trovan trials, but he objected to the testing method being used. Pfizer dismissed him in 1998. His letter claims that:

• Pfizer paid a bribe to continue the study of Trovan.
• Pfizer did not get informed consent from parents of children in the test.
• Pfizer gave fake ethics documents backing the test to the FDA.
• Corners were cut because “Speed was of the essence and stock options and bonuses at stake.”
  Pfizer ignored Trovan’s poential reaction with antacids, which are often given to patients who have had surgery.
• The FDA started but mysteriously called off an investigation into the scandal.
• One patient in the Trovan arm of the experiment died without being taken off Torvan or given medical care. Normally, if patients react badly to experimental drugs researchers take them off the therapy and give them medical care.
• Pfizer has photographs of the members of its Kano team.

The letter was previously dismissed in a previous ruling in the case as “speculative” and too filled with hearsay to be regarded as evidence. Pfizer told BNET:

Dr. Juan Walterspiel’s employment with Pfizer was terminated in 1998 for legitimate and proper reasons. Dr. Walterspiel did not travel to Nigeria to participate in the 1996 Trovan clinical trial and thus has no direct or first-hand knowledge of the conduct of the clinical trial. Dr. Walterspiel made these similar allegations over 10 years ago, and has repeated them from time to time since then. Pfizer investigated the allegations and found that they were not supported by the facts.”

Walterspiel’s letter was based on an affidavit filed in the case in the early 2000s. At the time, much of the case was under seal and documents were not electronically filed, so Walterspeil’s allegations went largely unnoticed beyond the lawyers who saw them. Walterspiel then wrote to former Pfizer CEO Jeff Kindler in 2007, repeating his claims. He sent a copy of that letter it to Judge William Pauley on Jan. 28, 2011, who entered it onto the record a few days ago.

The letter does not name names. Instead, Walterspeil uses numbers to stand in for the identities of the people he links to the Trovan trial. Three of them knew that Pfizer had sent a cash courier to some Nigerian officials who “needed to be paid off” before the trial could continue.
Pfizer had not obtained the proper ethics committee approvals before the test began, Walterspeigel claims. (Research on human subjects usually requires approval of an independent institutional review board before it can start.) So the paperwork was faked.
The FDA began investigating the Trovan trial but the probe was suddenly ended.
The older ruling supplies some of the names behind the numbers. Local sources also accused corruption between the corporation and the government.”

In addition to blaming Pfizer, many local media commentators also lamented what they saw as a corrupt Nigerian administration that had rubber-stamped the trial without due diligence. “The propensity for corrupt practices on the part of a few venal Nigerians has apparently permitted our people to be used as a laboratory for the unregulated testing of a new drug with obviously bad consequences thereof,” read a Feb. 8 editorial in Lagos’s independent weekly Tempo.

Meanwhile, the residents of Kano have been left with a legacy of fear. The News, a weekly magazine from Lagos, reported on Jan. 29, 2001 that people in the district are refusing new immunizations for CSM, cholera, and measles. “The bature (white men) will kill us again if we allow them to give us…tablets and injections,” they told the magazine.

According to John Murphy’s report for the Baltimore Sun, the Trovan trial may have left some Nigerians distrustful of Western interventions: “Some of Kano’s fears of the vaccine stem from its experience with the U.S. pharmaceutical giant Pfizer Inc.”

“The country’s health authorities say that the Pfizer controversy is partly responsible for many families in northern Nigeria refusing to allow their children to be vaccinated against polio. That in turn has been blamed for an outbreak that spread across parts of Africa. The Kano authorities also refused to distribute the polio vaccine.” – The Guardian 2007

EPILOGUES:

1

2. Meet Nigerian born Dr Onyeama Ogbuagu, who is allegedly at the core of developing the Pfizer vaccine. He is one of the twin sons of Prof. Chibuzo Ogbuagu. His parents had the twins in New Haven CT when they went for their doctoral programs at Yale. The Ogbuagu’s returned to Nigeria where Onyeama studied medicine and then returned to the US and Yale.

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Corruption Unltd. 2: Pfizer in Nigeria – dead kids, death threats and deadly drugs