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
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.