(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

[roadnotes.livejournal.com]

Mother of gods.

[savateuse.livejournal.com]

how horrible!

[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?

so much for self-regulation...

[drfardook.livejournal.com]

I think the end result coming out of this is that we'll start to see drug testing moved to the third world. If you have people lining up to to sell their kidney for a few hundred, it shouldn't be any more difficult to get them to be shot up with experimental drugs for a fraction of what it would cost in the west. I don't know if the MHRA currently allows this, but I wouldn't be suprised if they change their mind in the future.

Re: so much for self-regulation...

[redstapler.livejournal.com]

Exactly.

"Better them than us."

I hate humans.

Re: so much for self-regulation...

[hangedwoman.livejournal.com]

Start to see? It's been happening for a while now.

[hangedwoman.livejournal.com]

Yeah, I've been following this via the BBC for a little while now. It makes me sad that it doesn't shock me more.

[feyandstrange.livejournal.com]

Here's a response from a US bioethicist which mentions that US laws are in theory a little tighter. It also mentions a similar case in Canada.

http://msnbc.msn.com/id/11927387/

I almost signed up for a drug trial myself - not this sort of thing, the "healthy people for cash" ones, but an experimental treatment for my illness. Several thousand dollars for the drugs alone, let alone the travel and other costs, and the scariness of the drug, deterred me. But desperately sick people will do all kinds of silly things for a possible cure.

Why this particular incident didn't stop after the first set of human trials gone wrong is beyond me.

[neo-nym.livejournal.com]

When I was in grad school, I signed up for drug trials all the time, but only for very select ones, mostly drugs that were on the market that were being tested for diurnal variances in metabolism, therapeutic doses, etc. Even with those limited criteria and close monitoring, I found myself on something that felt like speed.

Drug testing is NEVER inocuous. Never. But the money tempts. Animal data only suggests effects so far.

It doesn't make any sense that they could continue after the first case of such an unepxected event.

[raaven.livejournal.com]

Holy fucking crap. That's just horrific.