Overstepping bounds

originally posted by John

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Richard's blog Double Bluff raises, as he says, some interesting questions about the boundaries of trust. And while the topic of his blog, the technology of warfare, is of concern to us in these times of terror and insurgency, the boundaries of trust are all the while being eroded in many other aspects of our lives. And in pharmaceuticals, just as in war, transgressions of trust come back to bite us. Sometimes quite savagely.

In the west the bodies responsible for clinical testing define a discrete trust space in which tests must be carried out. The nature and aims of the test, the statistical methodology, control mechanism and review processes must all be made clear. The consent of those taking part must be fully 'informed'. There must be no coercion to take part, no 'undue' inducements to do so and no penalties for refusing to take part. Along with test-specific requirements, these, roughly, are the boundaries of the trust space for clinical tests in the west.

Needless to say the don't apply in the third world. Strange as it may seem (in trust terms at any rate if not in commercial terms) authorities in the west readily accept results of tests done in the third world when it comes to licencing drugs. So boundaries become meaningless when the mega rewards of getting a new drug accepted in the west are at stake.

In Kano, in northern Nigeria in 1996, in the middle of an epidemic of bacterial meningitis, Pfizer carried out a test on their new drug, Trovan. They used children with meningitis who were undergoing routine treatment. As a result in 1997 Trovan was approved by the US FDA (Food and Drugs Administration) but, oddly, not for use on children and not for epidemic meningitis. After less than two years' of highly profitable prescription, Pfizer removed Trovan from the market amidst reports that the drug produced 'hundreds of cases' of liver toxicity and 'several' deaths.

Third world tests, first world deaths. Drugs, like bombs, kill us just as readily as they defend us. The boundaries of trust are our only real protection.

See also: Marcia Angell's review of The Constant Gardener (NYReview, October 6th, 2005)