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

Re:One thing's for sure

[Nidi62]

You know the other 2 are suddenly REALLY happy they got the placebo

Expect that in Phase 1 trials, no one is given a placebo. The purpose of Phase 1 trial is testing for safety, not efficacy, and is given to a very small number of healthy test subjects.

It has been reported in several media outlets that 6 were given the trial medication and 2 were given placebos in this particular round. In all around 90 people have participated in the Phase 1 trial so far, The article in the summary specifically states that some of the 90 were given placebos while the rest were given differing strengths of the drug. Everything I've read states that this particular round used the highest concentration of the drug and implies that with the other rounds the dosage increased with each round. So sounds like they were trying to find a maximum safe dosage. Basically they were looking for side effect or potential harm, in which case you certainly need a placebo group in each round to determine a baseline. And I would say they were wildly successful at determining the dosage at which the drug is unsafe.

Re:Naughty cannabis

[DarkOx]

It offers incredible potential for modulation, far beyond what cannabis can do, and I for one welcome our Pharma Overlords to throw their resources at these problems.. provided that they don't botch things up like this, for fucks sake.

That's great in the meantime I wish we could get nice legal packaged THC/CBD products to market. Its clear of the centuries (maybe longer) of not exactly controlled application of these compounds on human test subjects they are pretty darn safe, and at least not chemically habit forming. They are also at least somewhat effective in many people with a wide variety of chronic pain conditions.

Meanwhile our various overloads continue pushing a condition where the widely available strong pain killers are opiate. Which are highly habit forming, tend to negative side effects for the liver and kidneys when over used and have a much much narrower therapeutic dose than THC/CBD. So we have all kinds of people over dosing on them all the gwad damn time, others becoming addicts and shifting to their street drug relatives when they can no longer get them and subsequently over dosing on those. In short the irrational resistance to cannabis is killing lots of people.

As a libertarian I am generally in support of letting people do what they want. Letting a doctor prescribe medical cannabis is a no brainier. I have some reservations about it being totally legal for recreational use although I lean in favor; at the vary least it should be fully decriminalized. Being caught with or even selling weed should be like getting a parking ticket.