NOTE 1: In 2007 the news of the criminal charges against Pfizer (for murder, as far as I am concerned) was not heard in western countries. It was eclipsed by a same-day scare-story about tuberculosis, see: http://sandrafinley.ca/?p=4369 2007-06-01 Tuberculosis story improbable ?? Same day, Nigerian Government brings criminal charges against Pfizer.
NOTE 2: The book and movie, “The Constant Gardener”, is based on what Pfizer did to the Nigerian children. In the book the drug is for drug-resistant tuberculosis. In Nigeria the drug was trialled during an outbreak of meningitis. BUT (the last short piece) also with a shot at tuberculosis. (I suspect that the big prize would have been if it had worked for TB.)
NOTE 3: #1 can be skipped. I kept it for a couple of not critical details.
CONTENTS
(1) SUMMARY OF THE COURT CASE BY A BLOGGER
(2) PFIZER TO PAY £50m AFTER DEATHS OF NIGERIAN CHILDREN IN DRUG TRIAL EXPERIMENT, APRIL 6, 2009, THE INDEPENDENT
(3) US PHARMACEUTICAL GIANT PFIZER SLAPPED WITH CRIMINAL CHARGES IN NIGERIA OVER NOTORIOUS CLINICAL TRIAL IT CONDUCTED ON CHILDREN June 01, 2007, The Independent
(4) PFIZER’S TRIAL DRUG, TROVAN, ALSO INTENDED AS TREATMENT FOR DRUG-RESISTANT TUBERCULOSIS
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(1) SUMMARY OF THE COURT CASE BY A BLOGGER
Pfizer settles Nigerian drug case out of court
http://blogs.nature.com/news/2009/04/pfizer_settles_nigerian_drug_c.html
Posted by Daniel Cressey
Pfizer has apparently agreed to pay tens of millions of dollars to settle a lawsuit over a drug trial it ran in Nigeria.
According to media reports, lawyers for the pharma giant and Nigeria’s Kano state agreed an out of court settlement over the trial of a meningitis drug, which the state alleges killed 11 children and left others seriously injured. Pfizer has denied its product caused the deaths (Link no longer valid) (Pharma Times).
Reuters says sources told it last Wednesday that the settlement would come to near $75 million, with $30 million going to Kano state, $35 million to victims and $10 million going on legal fees.
The Independent presents some of the back story in its coverage . . . (below).
(Link no longer valid) Bloomberg says Nigeria’s federal government also sued Pfizer for $7 billion in 2007, although the BBC says this case could be dropped as a result of the new settlement.
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(2) PFIZER TO PAY £50m AFTER DEATHS OF NIGERIAN CHILDREN IN DRUG TRIAL EXPERIMENT, APRIL 6, 2009, THE INDEPENDENT
Out of court settlement in the case that inspired ‘The Constant Gardener’
Monday 06 April 2009
A divorce case was all that passed for excitement at Richard P Altschuler’s “kinda small” lawyer’s office in West Haven, Connecticut, when the phone rang nine years ago. On the other end of the line, a world away in the heat of Nigeria, was Etigwe Uwo, a young lawyer with “an incredible story about Pfizer”. The Lagos attorney was going to take on the largest pharmaceutical company in the world in an unprecedented class action pitting African parents against an American corporate giant. And he needed help.
Mr Etigwe had chosen Mr Altschuler because, back in 1979, the Connecticut lawyer had successfully defended a friend of the Nigerian. The unlikely pair were about to embark on a marathon journey into the world of “big pharma”. Nine years on and their efforts have finally been rewarded with a reported $75m (£50m) settlement, the terms of which are likely to be released this week.
If it sounds like the script of a Hollywood blockbuster that’s because it was this story that prompted John Le Carre to write The Constant Gardener, according to Mr Altschuler.
In real life it was to Nigeria, not Kenya, that Pfizer turned. In 1996, the company needed a human trial for what it hoped would be a pharmaceutical “blockbuster”, a broad spectrum antibiotic that could be taken in tablet form. The US-based company sent a team of its doctors into the Nigerian slum city of Kano in the midst of an appaling meningitis epidemic to perform what it calls a “humanitarian mission”. However the accusers claim it was an unlicensed medical trial on critically-ill children.
A team of Pfizer doctors reached the Nigerian camp just as the outbreak, which killed at least 11,000 people, was peaking. They set themselves up within metres of a medical station run by the aid group Médecins Sans Frontières, which was dispensing proven treatments to ease the epidemic.
From the crowd that had gathered at the Kano Infectious Diseases Hospital, 200 sick children were picked. Half were given doses of the experimental Pfizer drug called Trovan and the others were treated with a proven antibiotic from a rival company.
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. 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.
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 last year 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.
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.”
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(3) US PHARMACEUTICAL GIANT PFIZER SLAPPED WITH CRIMINAL CHARGES IN NIGERIA OVER NOTORIOUS CLINICAL TRIAL IT CONDUCTED ON CHILDREN June 01, 2007, The Independent
http://www.commondreams.org/contactingus.htm
Friday, June 01, 2007
Published on Thursday, May 31, 2007 by the Independent/UK
Drugs Giant Faces Criminal Charges Over Clinical Trial
by Andrew Gumbel
LOS ANGELES – The US pharmaceutical giant Pfizer has been slapped with criminal charges in Nigeria over a notorious clinical trial it conducted on children during a meningitis epidemic a decade ago. Patients became unwitting guinea pigs for a new, untested antibiotic and many of them
either died or were left with permanent disabilities.
Pfizer and its representatives will be called to account at hearings due to begin next month in the Nigerian state of Kano, where public anger over the clinical trial – and the assurances of any pharmaceutical company – remains so high that the local population won’t even trust the Nigerian government to immunise their children against polio.
The episode, which has already led to one unsuccessful suit in the US courts, was the inspiration for John Le Carré’s novel The Constant Gardener and is frequently held up as an instance of scientific inquiry gone shockingly awry.
The Nigerian authorities say Pfizer researchers selected 200 children and infants from a crowded epidemic camp in Kano in 1996 and gave about half of them an untested antibiotic called Trovan. The lawsuit alleges that the researchers did not obtain consent from the children’s families even
though they knew from their own research that Trovan might have life-threatening side effects and was “unfit for human use”.
The suit further contends that the researchers gave the other half a comparison drug made by Pfizer’s competitor Hoffman-La Roche, but deliberately underdosed them to make their own product look better. Pfizer and its doctors “agreed to do an illegal act,” the suit says, “in a manner so rash and negligent as to endanger human life”.
Once the trial was over, the suit continues, Pfizer left the area, removed all medical records and “obliterated any evidence” of the trial. A Nigerian government report, which appears to have spurred the criminal charges, previously found that Pfizer never told the children or their parents they were participating in a trial and did not inform them that alternative treatments were available – most obviously chloramphenicol, a relatively cheap
antibiotic usually recommended for bacterial meningitis.
The government report found that of the 11 children who died, five were taking Trovan and six were taking low doses of the comparison drug, ceftriaxone. An unknown number suffered deafness, blindness, paralysis and other disabilities.
The Kano authorities have charged Pfizer on eight counts of criminal conspiracy and voluntarily causing grievous harm. They have also filed a civil suit seeking more than $2.7bn (£1.3bn) in damages. Pfizer has responded to the lawsuit by insisting it did nothing wrong. “Pfizer continues to emphasize – in the strongest terms – that the 1996 Trovan clinical study was conducted with the full knowledge of the Nigerian government and in a
responsible and ethical way consistent with the company’s abiding commitment to patient safety,” a company statement said. “Any allegations in these lawsuits to the contrary are simply untrue – they weren ’t valid when they were first raised years ago and they’re not valid today.”
Back in 1997, when Pfizer faced a US government audit of its records on Trovan, the company produced a letter from a hospital in Kano saying its study had been approved by the hospital’s ethics committee. The company’s accusers contend that the letter was fabricated after the fact, using
a forged letterhead. The hospital, according to the suit, has no ethics committee.
Nigeria’s decision to prosecute Pfizer marks the first known instance of a Third World country going after a pharmaceutical multinational. Until now, the Nigerians have trod very carefully around the issue – commissioning an investigation but then suppressing the results until they were
leaked to The Washington Post a few years ago.
But the episode has got in the way of successive public initiatives, including a polio vaccination drive that prompted an 11-month boycott in Kano.
Trovan has never been approved for use on US children. It was cleared for adults in 1997, but its use was restricted two years later following reports of liver damage and death. It is banned throughout Europe.
© 2007 Independent News and Media Limited
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(4) PFIZER’S TRIAL DRUG, TROVAN, ALSO INTENDED AS TREATMENT FOR DRUG-RESISTANT TUBERCULOSIS
A search on “trovafloxacin tuberculosis” comes up with this, for example: http://www.ingentaconnect.com/content/ben/cpd/2011/00000017/00000027/art00007
(trovafloxacin is a “novel ” FQ)
Fluoroquinolones (FQs) are important drugs to treat drug-resistant tuberculosis. In this review we integrated pharmacokinetic properties (PK) and microbiological susceptibility against M. tuberculosis and eventually evaluated the pharmcodynamic (PD) properties, as well as the influence of co-administered agents on these characteristics, for the currently used FQs (ciprofloxacin, ofloxacin, levofloxacin, gatifloxacin and moxifloxacin) in TB treatment. Future FQs that are being developed may overcome the problems with FQs that are used in daily practice. Therefore PK and pharmacodynamic (PD) properties of novel FQs (clinafloxacin, garenoxacin, lomefloxacin, sitafloxacin, sparfloxacin, trovafloxacin, gemifloxacin, grepafloxacin and DC-159a) were evaluated in TB treatment as well. Integrating both excellent PK and PD properties, moxifloxacin, possibly at a higher dosage, may fulfil a far more important role in the treatment of multi-drug and early-generation FQ resistant TB than proposed in the current WHO guideline. Sparfloxacin, trovafloxacin and sitafloxacin are upcoming novel FQs that may be useful for drug-resistant TB based on their favourable PK properties or microbiological susceptibility against M. tuberculosis. Finally, the 8-methoxy moiety, as present in the chemical structure of MFX, will possibly provide DC- 159a with promising PK/PD characteristics and consequently this FQ may develop into a key FQ in future drug resistant TB treatment.