Friday, March 17, 2006

Drug trials

It has become worldwide news that six unfortunate men in England are suffering from the side effects of a drug trial. If you haven't heard, the basics are that a German company, TeGenero, in cooperation with a British company, Paraxel, was conducting the final stages of investigation into a new drug. What, exactly, it was supposed to do is somewhat unclear from the lay press, but it seems it was an immune modulator, which are pretty widely used in cancer chemotherapy and in rheumatology for treating autoimmune arthritis. Anyway, the six test subjects suffered from some deleterious side effects, and two are apparently still in an ICU with multi-system organ failure.

My first reaction to this story was "wow, I'll never be a test subject in a drug trial." This was folowed shortly by sympathy for those involved and their families. But reading some of the articles, I started to get a bit angry. There are already lawyers involved, threating or discussing lawsuits and getting even. Which is probably understandable, but when uninformed people start making grand pronouncements about how a drug company was negligent or liable for an unforseeable circumstance, I worry.

Drug trials like this go through huge amounts of development before a human gets near the pointy end of a needle. And I refuse to believe that this company intentionally put people in harm's way. They may still be in the testing phase, but it has already been run through thousands of in vitro studies, and thousands of animals, and the investigators and their oversight are convinced it is safe for people.

Second major point of contention: these people signed up for the trial. They are knowingly ingesting, or having injected, an unknown substance. That's the whole point here. No one knows exactly what it will do, which is why they are testing it on healthy volunteers. And while no one enjoys such drastic reactions, they are part of the risk you say you understand on the consent you sign.

Now if the company willfully concealed evidence the drug was dangerous, then sure, they should be hung out to dry. But otherwise, I think those slinging hyperbole ought to step back and realize that the test was well planned, believed to be safe, and performed on willing volunteers.

I just get tired of the drug companies being the sterotyped bogeyman. Saying "drug company" in a TV show or movie automatically connotes "bad guys" and this is unfortunate. Sure, they make money off of people's health. But if they didn't, they wouldn't make the drugs they do. And millions of people would die.

But discussing drug companies in general is probably too much for tonight. I need to get to sleep.

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