French Drug Trial Leaves One Brain Dead and Five Critically Ill (theguardian.com)

jones_supa writes: One person is brain dead and five others are seriously ill after taking part in a phase one drug trial for an unnamed pharmaceutical firm at the Biotrial clinic in France. In medicine, phase one entails a small group of volunteers, and focuses only on safety. Phase two and three are progressively larger trials to assess the drug's effectiveness, although safety remains paramount. The French health ministry said the six patients had been in good health until taking the oral medication. It did not say what the new medicine was intended to be used for, but a source close to the case told AFP that the drug was a painkiller containing cannabinoids, an active ingredient found in cannabis plants. Mishaps like this are relatively rare, but in 2006 six men fell ill in London after taking part in a clinical trial into a drug developed to fight auto-immune disease and leukaemia. All trials on the drug at the French clinic have been suspended and the state prosecutor has opened an inquiry.

Comments

Naughty cannabis

[Anonymous Coward]

Waiting for all the morons to blame cannabis. It's Friday, work's done, I'm stoned. Love you all x

Re:Naughty cannabis

[bondsbw]

Or Slashdot could step into the 21st century and provide an edit mechanism.

Even if is timed to a few minutes, it would be very helpful.

Re:Naughty cannabis

[h4ck7h3p14n37]

Lighten up Francis. It may be psychotomimetic for some, but those sensations go away when the user comes down. If you experience this, then the simple solution is to not consume cannabis again.

As for psychological dependency, many things can lead to that. Typically people that become burnouts already had the type of personality to begin with. There are many brilliant people that use cannabis without issue.

Oh, some people are allergic to marijuana to the degree that smelling second hand smoke can kill them.

You need to provide a citation for this. You are not going to be able to find a report of someone dying from inhaling second-hand weed smoke because it doesn't happen.

Re:Naughty cannabis

[rahvin112]

That's what preview is for. A timed edit doesn't help anything other than those who are in such a hurry to reply they don't actually read their post in the preview pane. And someone that careless should be allowed to demonstrate it.

System working as planned.

[xxxJonBoyxxx]

>> 1 dead 5 wounded in a drug trial

That's why they call it a trial and limit who can be in it (so it's not 1,000 dead and 5,000 wounded).

Re:System working as planned.

[vux984]

Exactly right. And its also exactly right that the prosecutors office investigate to make sure that all protocols were followed.

This sort of thing is rare because the protocols to get a drug approved for human testing generally work. We know occasionally there will be events like this and its a risk we take. But in an event like this we need to establish that nobody was playing fast and loose with the protocols. Make sure data wasn't faked, make sure anything that might have predicted this wasn't suppressed or concealed, make sure the test subjects were being properly monitored, etc.

Re: System working as planned.

[vux984]

Your implicit assertion is that it's fine to sacrifice the few for the many, anyway.

No. It wasn't. The opposite generally.

What is actually fair, just, free, and utilitarian is giving individuals the right over their own body to volunteer for drug trials for the compensation they demand.

Sure. But that's not reality. Negotiation is never on equal footing. The poor and sick don't have the freedom to just walk away from the table if their compensation demands aren't met... they don't have a gun to their head, but they do not have good options. They cannot negotiate good deals for themselves.

And worse, if negotiation itself isn't one of their skills, they lack the resources to hire one to represent their interests better than they could.

Meanwhile, the person on the other side of the table, still eats and lives if they don't close the deal; and in many cases recruitment is their actual job -- this act of negotiation is the specific thing they are trained to do, and they are successul at their job because they are good at it.

To call it a 'free, just, and fair' when one side is severely handicapped is ridiculous bullshit.

Might as well put a guy who only plays poker once a year and barely knows the rules against a guy who plays poker professionally. On top of that the casual player will lose his apartment or be forced to drop school if he doesn't take home some winnings so he's under a lot of pressure to win, to take unnecessary risks, while the pro is financially secure, doesn't need to win, and can easily afford to lose and can make the best decision based purely on the odds (which he actually knows, while the other party is just roughly guessing at them). That's a fair match right? I mean... the deck itself is only metaphorically stacked against the poor guy, its not literally stacked against him. So ... fair?

Bullshit.

And THAT is how fair the average negotiation between a poor person and a corporation is, for anything.. .a job, a dispute, a settlement, anything.

I'll give you a no strings attached voluntary negotiation between parties for compensation for medical testing or anything else, when it's actually a level field.

Worried that poor people will disproportionately sign up for
drug trials because it pays well? Poor people are already at higher risk for injury and death and so for them it makes financial sense to better their lives at a small risk compared to their overall risk due to poverty.

The point being that the risk small to sign up precisely because of the controls in place. If we removed those controls, the risk goes up. Given that the poor do not have good options in the first place, upping the risk just forces them to assume more risk. They don't have the bargaining power to negotiate for more compensation to offset that risk. That becomes exploitation.

Re:Drug trials

[Tranzistors]

> and our Calvinist morality and repressive drug control regime hates this

Oh please! Problem with all current pain killers is that they are NOT EFFECTIVE for chronic pain. Opioids require ever bigger dosage to get the same effect, and your plan to "monitor their therapies" just mean that if the source of the pain is not dealt with, treatment will not be effective. But sure, blame Calvinists.