Drugs Giant Faces Criminal Charges Over Clinical Trial
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 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.
© 2007 Independent News and Media Limited
Bet the massmedia’s not making this into a big thing, as was the case with coke in India:
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From http://www.indiaresource.org/campaigns/coke/index.html
Coca-Cola Crisis in India
Communities across India are under assault from Coca-Cola practices in the country. A pattern has emerged as a result of Coca-Cola’s bottling operations in India.
Communities across India living around Coca-Cola’s bottling plants are experiencing severe water shortages, directly as a result of Coca-Cola’s massive extraction of water from the common groundwater resource. The wells have run dry and the hand water pumps do not work any more. Studies, including one by the Central Ground Water Board in India, have confirmed the significant depletion of the water table.
When the water is extracted from the common groundwater resource by digging deeper, the water smells and tastes strange. Coca-Cola has been indiscriminately discharging its waste water into the fields around its plant and sometimes into rivers, including the Ganges, in the area. The result has been that the groundwater has been polluted as well as the soil. Public health authorities have posted signs around wells and hand pumps advising the community that the water is unfit for human consumption.
In two communities, Plachimada and Mehdiganj, Coca-Cola was distributing its solid waste to farmers in the area as “fertilizer”. Tests conducted by the BBC found cadmium and lead in the waste, effectively making the waste toxic waste. Coca-Cola stopped the practice of distributing its toxic waste only when ordered to do so by the state government.
Tests conducted by a variety of agencies, including the government of India, confirmed that Coca-Cola products contained high levels of pesticides, and as a result, the Parliament of India has banned the sale of Coca-Cola in its cafeteria. However, Coca-Cola not only continues to sell drinks laced with poisons in India (that could never be sold in the US and EU), it is also introducing new products in the Indian market. And as if selling drinks with DDT and other pesticides to Indians was not enough, one of Coca-Cola’s latest bottling facilities to open in India, in Ballia, is located in an area with a severe contamination of arsenic in its groundwater.
No one should be surprised by this, unless you are the person who can tell me all the American Idol contestants for this year. If you do know who these folks are then you probably don’t know that the EU and US major pharma firms have been conducting FORCED trials in the 3rd world, primarilyt Africa, for a long long time now. In fact there is a lot of evidence that supports the theory that the AIDS virus itself is from a US weapons research program gone awry. Wake up folks. When the Pharma firms began nmarketing directly to consumers bypassing the doctors office you should have smelled a terrible stench.
Coke in India, Bolovia… Wherever major US or EU corporations go there seems to be death and destruction in their wake. Hmmm… Freedom and what?
Pfizer should be put out of business.
If corporations were really ‘people’ they might have a conscience. Yet more proof that they have none, they are not ‘people.’ They should have their legislated ‘personhood’ revoked.
Corporations are a legal entity without an ass to kick or soul to save.
Have we had enough of the no regulation, free trade feudalism of the current economic system?
I’m waiting for the evidence to roll in that viagra causes heart damage and leads to heart scarring and heart disease and heart attacks.
Such is the price men will pay to prolong the fiction of eternal youth.
“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.”
It’s not only a Third World country, it’s the second poorest country in the world.
jjpeter: how about some evidence linking old men on viagra with the frequency or intensity of really big shock and awe style wars? Maybe there’s a reason nature gave IT a rest!
They Got COKE in India ???
This should not shock anyone. Not only are we all guinea pigs for the pharmaceutical companies, they also want 0 accountability. Why not go to some 3rd world country a small pittance. I am sure the parents received some form of compensation.
All corporations went overseas just for the slave labor and 0 accountability. I won’t feel sorry for them at all when the “liberal lawyers” from the USA sue the Corporations. They may feel saving a few bucks was not worth it to go overseas.
Didn’t the Constant Gardener deal with this?
Souless bastards. Money, is THEIR God.
To neoconned:
I doubt that people who post here know that much about American Idol. For myself, I thought Paris Hilton was the name of a hotel and I never heard of Anna Nichol Smith until she died.
For many of us, it isn’t a matter of waking up. The problem is that we are not heard. I write letters to my Congress people, I sometimes post comments on the standard news articles (which are removed after 5 minutes).
What we need is some unity and clout. Where do we go for it?
“Where do we go for it?” asks RuthK. RuthK, you go to Washington.
For full instructions see the 1937 Jimmy Stewart classic, “Mr Smith Goes to Washington”.
I’m not kidding. Take no money. Do no evil. You’ll change the world around you, one atom at a time.
Horrible. They should be put out of business. Everyone proven to be involved should go to jail for life and if executives are involved Pfizer should be put out of business!
This is what happens when you have unregulated capitalism and free trade.
neoconned
I think AIDS was manufactured by the far right to eliminate the “undesirables.” And yes, it was tested in Africa and then in NYC with Hepatitis inoculations at clinics serving the gay community. And yes again to it going awry when the developers
failed to realize that it would seep into the general population via bisexual activity and blood donations. Ooops!
I also believe we are frequent guinea pigs as well…
Prescription drugs are the THIRD cause of death, after heart disease and cancer. That is, people taking their prescriptions as the doctor ordered and NOT by overdose. Over 200,000 people a year die from prescription drugs or one person every two minutes. That would be like two jumbo jets falling out of the sky every day. Where’s the FDA on that?? The president of the largest drug company, Merck, said last year in USAToday that only 30 percent of drugs perform as expected. That means that 7 of out 10 prescriptions do nothing. All prescription drugs cause disease according to a Noble Prize winner from a couple years back. The REAL issue is who is dying, today. The FDA is ‘owned’ by the drug companies. And the drug companies board of directors sit on the major media company boards so no one watching TV is gonna hear about it or see it.
A manager at a company I once worked for stated that it is cheaper to pay a fine or judgment then it is to be responsible and do the right thing. It is a risk many corporations are willing to take. They also know that the public (their customers) have too short an attention span to really care if they get caught.
When we start divesting in irresponsible corporations and incarcerating corporate employees and executives then this type of thing will end. In the mean time add Pfizer to your list of companies to boycott.