(no subject)

[rm]

http://www.timesonline.co.uk/article/0,,2087-2092527,00.html

Very disturbing article about a drug test gone horribly horribly wrong. May be more than you can stand to read. Should be read anyway.

via justpat

Comments

[rahalia-cat.livejournal.com]

That has been all over the news here. The worst of it is, it's just coming to light that the drug in question did cause side effects in some monkeys that it was tested on [ BBC report (http://news.bbc.co.uk/1/hi/england/london/4823992.stm) ].

The MHRA are a very strict regulatory body; they could shut down my company in the blink of an eye if we were found to be acting out of our bounds. And if that drug was signed off by a Qualified Person as fit for use on humans? Dear god, that QP should be struck off the register.

[melebeth]

It's going to be very interesting to see how this plays out. I was a researcher at Johns Hopkins when they shut down ALL the studies because of a human subjects violation in a trial (failure to report an adverse event, if I recall correctly.) Every single study at the university had to be re-reviewed before it could continue, with expedited review for those studies that were currently providing, in theory at least, lifesaving or emergency treatent. Many institutional review boards are far too lax about enforcement which is something that needs to change. Yes, many scientists hate having to go through the rigamarole*, but these sorts of horrors should be at least in part preventable. If nothing else, why did they give everyone the drugs simultaneously? If this was a first human administration it should have been in the protocol to at least wait an hour (guessing here, I'm trying to remember protocols I've worked on) to look for severe anaphylaxis. According to the article, these reactions seem to have come on within minutes. With U.S. protocols, at that point the study would need to be halted until the adverse event could be reviewed. And with an event that severe it certainly would have been. It made me very angry. The perception that people are being taken advantage of in these trials is right on target. Most people don't have the education to be fully informed about these trials even if they read the informed consent documents cover to cover. Which they're not doing. Which some of them can't do. There's no way that a 2000 pound fee isn't "coercive."

On an interesting side note, a far more frequently discussed issue with respect to drug testing in developing countries is the fact that these people risk their lives for drugs to which they'll never have access. This is a major issue with HIV prophylaxis, which can only be tested effectively in high prevalence countries where people won't use condoms even if you tell them to... but then the approved drugs are so out of their affordability range to be completely inaccessible.

*sigh* Got Ethics?