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Rohit Singh
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Sun, 09 Apr 2006

Oh boy, this ain't good news...

There is some discussion of a drug trial gone bad and what this disaster could entail in terms of new trial regulations. The long and short is that the drug candidate belonged to a new class of molecules, hitherto not used as drugs, and had cleared the animal trials-- monkeys responded to it and they didn't die. Phase 1 in human trials is to check the dosage and toxicity relationship-- essentially, get a feel for how much of the drug can you give to people without them seeing adverse effects. Once you establish the limits, you then measure the efficacy of drug in curing the disease (Phase 2) and a large scale efficacy vs. side-effect study (Phase 3). Before going into Phase 1, companies typically test the drug on animals (dogs and monkeys etc.), the rationale being that what doesn't kill one mammal (or primate) won't kill another, (i.e, humans). Unfortunately, the drug in question turned out to benign to monkeys and massively toxic to humans--- people nearly died. Actually, it could've been more toxic--- people might've actually died.

It is easy to think of this episode as an evil company trying out its concoction on guinea pigs. But that'd most likely be wrong-- assuming the company followed the rules. There will always be a certain amount of risk when testing a new kind of drug--- that is why they "test" it. A lot of the initial computational modeling and animal model work is meant precisely to weed out the bad candidates. But they won't always work-- afterall, monkeys and humans might both be primates but they are not the same species. Moreover, if the drug industry is to find more drugs for more diseases, new kinds of molecules will have to be looked at. Me-too molecular classes will just produce me-too drugs.

Drug testing is just a price we have to pay for getting better.

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