A report from Nigeria comes to light
Last year, a U.S. Federal judge dismissed a lawsuit that claimed that Pfizer, the world’s largest drug company, was guilty of wrongdoing when the company conducted experiments on children during a meningitis epidemic in Nigeria in 1996. The judge recommended that the case be heard in a Nigerian court. The case apparently had already been discussed in a government report, but it was mysteriously suppressed for the last five years. In that report, released last Saturday, the allegations are unambiguous: Pfizer is accused of violating Nigerian law, the Declaration of Helsinki and the UN Convention on the rights of the child.
The Washington Post has been following this story since its ‘Body Hunters’ series in 2001. Although what precisely happened is still obscure, at least the accusations and counteraccusations are getting clearer. According to Nigerian families and some of the doctors involved, Pfizer tested an unproven experimental antibiotic (Trovan) during a meningitis epidemic, caused the death of six children, and did not obtain adequate consent – the parents did not know the drug was experimental, that they could refuse to give consent for their children’s participation, or that other treatments were available. According to Pfizer, they acted with full knowledge of the Nigerian government and with the approval of the ethics committee at the local hospital where the trial was conducted. Verbal consent was obtained. It has since been alleged that the letter of approval from the (as it turns out, fictitious) hospital ethics committee was written long after the trial ended and backdated – in other words, a forgery.
It will be interesting to see what happens next. Is it really conceivable that Pfizer will be sanctioned, compelled to pay compensation and offer an apology, as the Nigerian government report recommends? It is commonly said that as trials become ‘outsourced’ to developing countries, the latter need to strengthen research ethics capacity and integrate research regulations into law in order to protect their citizens. The ongoing Pfizer case may act as an indicator for how much (or how little) protection such measures currently amount to.
The Washington Post has been following this story since its ‘Body Hunters’ series in 2001. Although what precisely happened is still obscure, at least the accusations and counteraccusations are getting clearer. According to Nigerian families and some of the doctors involved, Pfizer tested an unproven experimental antibiotic (Trovan) during a meningitis epidemic, caused the death of six children, and did not obtain adequate consent – the parents did not know the drug was experimental, that they could refuse to give consent for their children’s participation, or that other treatments were available. According to Pfizer, they acted with full knowledge of the Nigerian government and with the approval of the ethics committee at the local hospital where the trial was conducted. Verbal consent was obtained. It has since been alleged that the letter of approval from the (as it turns out, fictitious) hospital ethics committee was written long after the trial ended and backdated – in other words, a forgery.
It will be interesting to see what happens next. Is it really conceivable that Pfizer will be sanctioned, compelled to pay compensation and offer an apology, as the Nigerian government report recommends? It is commonly said that as trials become ‘outsourced’ to developing countries, the latter need to strengthen research ethics capacity and integrate research regulations into law in order to protect their citizens. The ongoing Pfizer case may act as an indicator for how much (or how little) protection such measures currently amount to.
posted by Stuart Rennie at 3:11 PM
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