= Such Stupid Things =

I don't want to start sounding like a Pharma apologist (though the odds are high that I will one day be in their employ), but I genuinely feel bad for this company Parexel who've been absorbing much of the blame for the disastrous clinical drug trial in England last month. Check out this article in Bloomberg, scrutinizing the consent forms signed by the eight healthy volunteers for TGN1412, accusing the drug-testing company of coersion and presenting misleading information.

Sure, all is not well in the business of drug testing, and it's important to keep a watchful eye on how clinical trials are conducted, but it looks to me that Parexel has become the global whipping boy for watchdogs and ethicists to vent their frustrations with the pharmaceutical industry. Isn't Michael Goodyear, Canadian cancer physician and research ethicist, going a little overboard?...

"I think it was misleading not to tell participants that that this drug was genetically engineered from hamster cells and that it was designed to alter their immune system, . . . Reasonable people would think twice before allowing an experimental drug to change their immune system."

Is he really claiming that it's Parexel's job to disclose that a drug was produced in hampster cells? Would that make the drug in question more or less safe than one produced in bacteria or yeast? Does it matter at all, so long as the production process includes the sufficient, government-mandated purification and sterilization procedures? Nor is it clear why "resonable people" would hold sacred their immune system over their cardivascular, nervous or any other essential system. It's not as though Parexel hid these facts with the intention of disgusing a substance they knew to be toxic. Isn't it far more likely that Parexel, like everyone else in the business, has slipped into a level of regulatory laziness, and just happened to get screwed with this particular molecule? I mean... it's not their job to scare away every blue collar joe and college kid who wants to make some quick cash by talking about the potential dangers of hampster cells.

Those primarily at fault for this calamity are, I think, the scientists who thought it would be a good idea to tinker with the immune system in this way. I'm guessing in vitro testing could have revealed some human-specific cellular response to the drug, thus making everyone wary of using rabbits and mice as model organisms. But that didn't happen.

Clearly in the (near) future they should be paying sharp-minded chemical engineers such as myself to prevent this sort of thing.