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Nigerian Court Postpones Pfizer Case to April 21

Health & Wellness  (tags: big pharma, guinea pigs, human trials, Africa, Nigeria )

- 3663 days ago -
A Nigerian court Thursday adjourned to April 21 the case in which US pharmaceutical giant Pfizer Inc. is seeking to quash a government report on a controversial clinical trial by the firm. (See details of story in comment below.)

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Past Member (0)
Saturday April 12, 2008, 6:08 pm

Many thanks to Paul M. for sending me the details of this story. Here's the background:

Drugs giant faces criminal charges over clinical trial
By Andrew Gumbel in Los Angeles
Published: 31 May 2007

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 Carre'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.

Joycey B (750)
Saturday April 12, 2008, 7:11 pm
Noted with thanks Mark.

Eleanor B (909)
Sunday April 13, 2008, 6:49 am
They should not only be made to compensate they should be charged and closed down. If an individual abused people in this way they would be in the jail.

Past Member (0)
Sunday April 13, 2008, 8:39 am

That's the reason corporations are formed, Eleanor, and why they are also called LLC or Limited Liability Corporations -- it is a way for individuals to commit horrendous crimes against humanity and avoid legal liability.

Past Member (0)
Sunday April 13, 2008, 7:11 pm
Quote;"..We are saying this case doesn't concern them (victims)...".

Well at least not those who died I suppose!.Wow this Pfizer lawyer has some serious issues!.I hope relatives of the deceased victims didnt get that comment let alone the surviving victims many now young adults.

Peace Monger (185)
Monday April 14, 2008, 2:39 am
Another story of Big Pharma using unsuspecting patients, in this case without the permission of the parent or guardian, to test drugs they might know or suspect may cause death or have serious side effects. The fact that Pfizer under-dosed some patients with a competitor's drug in order to make their drug seem better is reprehensible.
It appears Pfizer (along with other Big Pharma) assumes life is cheap and has no regard for the welfare of others.
Makes you wonder about the drugs prescribed by your doctor doesn't it? On one hand the drugs may be life saving, on the other, you may be one of the unsuspecting guinea pigs in their latest test$.

Past Member (0)
Monday April 14, 2008, 6:39 am
I think Pfizer and many other Big Pharma have the twisted ethical opinion that in order to save"millions"that allows them morally to risk the health and lives of a"few".Not that it also has anything to do with profit of course!.Recently a ex Nazi Officer was finally convicted of personally shooting and killing 6 people in cold blood.Pfizer killed 11 but I dont think that garantees that court procedings will come to a just verdict much quicker!.
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