Indian Vaccine Trial Halted over Infant Death

Who’s to blame if a useful medicine is delayed in getting to sick children because a trial had to be stopped due to a violation of ethics rules?

Here’s a relevant story from LiveMint (the website for an Indian newspaper published by the Wall Street Journal)… Wyeth drug tests fall foul of watchdog. Here are the first bits:

New Delhi: Patient trials of an advanced pneumonia vaccine by the domestic unit of US drug giant Wyeth Inc. have been suspended by India’s drug quality regulator after the death of an infant on whom the vaccine was tested in a trial in Bangalore.

The child had a pre-existing cardiac disorder. Indian drug rules prohibit testing on human subjects with such conditions without the prior approval of the drugs controller general of India (DCGI), the drugs quality regulator.

Also worthy of note:

Though the Indian regulator has suspended several drug trials in the past, all of them have been over adverse reactions or efficacy issues, and not for violation of the rules themselves, according to drug regulation experts.

Just who is to blame is not yet clear:

It was not immediately clear at which link in the testing chain the mistake occurred. Wyeth Ltd, the Indian unit, said the tests were conducted by GVK Biosciences, contracted for the trials, LiveMint writes, although Singh [India’s Drugs Controller General] says Wyeth had conducted the trials on its own.

So, some will say this is a regulator/bureaucrat slowing down research over a technicality. (Note that the trial was topped over a violation of the rules, not over the infant’s death per se.) But the blame more properly sits with those conducting the trial: Wyeth, GVK, and the physicians actually on the front lines. How to apportion the blame is a harder question, the answering of which will have to await further information.

But it’s another example of how bad ethics ends up also being bad science, and bad for the very people such research is designed to help.

Hat tip to Pharmalot.

~ by Nancy Walton on November 14, 2008.

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