Monday, August 03, 2009

Pfizer Settles Trovan Case with Kano State

As reported by the Washington Post, and many news sources outside of the US, Pfizer Inc has settled another lawsuit,

Pfizer signed a $75 million agreement Thursday with Nigerian authorities to settle criminal and civil charges that the pharmaceutical company illegally tested an experimental drug on children during a 1996 meningitis epidemic.

Nigerian authorities say Pfizer's test of the antibiotic Trovan killed 11 children and disabled scores more. Pfizer says the deaths and injuries were the result of meningitis.

An attorney for the state of Kano, where the charges were lodged, said the settlement was a long time in coming but welcome because it set the record straight about Pfizer's culpability. 'People and entities can and must be held accountable for the consequences of their conduct,' the attorney, Babatunde Irukera, said. 'People around the world are no different and must be accorded the same levels of protections, always.'

Pfizer is not quite done with this case.

Charges filed against Pfizer by Nigeria's federal government, which is seeking about $6 billion in damages, are unaffected by the settlement, Irukera said. Two lawsuits related to the Trovan experiment also remain pending in New York.

The Post's article summarized the issues in the case, thus:

Details of the drug trial were first made public in December 2000 in a Washington Post investigative series. The articles reported that the trial did not conform to U.S. patient-protection standards and that the oral form of the drug used in the trial had not been previously tested in children. Pfizer had no signed consent forms for the children, the articles said, and the company relied on a falsified ethics approval letter.

Five years later, in May 2006, The Post obtained and published a confidential report that concluded that Pfizer violated Nigerian and international law in the experiment. That set in motion the criminal charges.

We first posted about this case in 2006, here. We posted about Pfizer's heretofore most recent legal settlement, here. I wonder again whether multi-million, or even billion dollar settlements have that much effect on the leadership of a company as big as Pfizer? Such settlements do not affect the leaders directly, and their financial effects one a company so big are negligible.

Be that as it may, do we need more examples to remind us that strong skepticism should be the rule when evaluating clinical research done or sponsored by pharmaceutical companies, or other health care corporations with vested interests in the research turning out a certain way? Such skepticism is warranted whatever the clinical context, whatever the product being evaluated, and whatever country in which the research is done.

Here in the US, debate has been swirling about health care reform. Many of the arguments have been about how costs can be controlled while health care quality is increased. Better research about the benefits and harms of specific drugs, procedures, devices and tests might enable physicians to choose the most appropriate care for each patient, potentially improving quality while also reducing costs. This example, plus many others discussed on Health Care Renewal, suggests that putting at least an arm's length between companies which sell drugs and devices and the clinical research meant to evaluate these drugs and devices has the potential for making better quality, less biased, more accurate clinical research available (see the topics: suppression of medical research and manipulating clinical research.)

Maybe putting this topic on our local US health care policy radar would increase the chances of achieving meaningful health care reform. Maybe if the US took the lead in separating clinical research meant to evaluate drugs, devices, procedures, or tests from the corporations selling them, the result would be a movement that would benefit health care around the world?

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