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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.
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.
The only thing necessary for evil to triumph is for it to be pitted against a slightly greater evil
Expect that in Phase 1 trials, no one is given a placebo.
This is entirely incorrect.
Dose-ranging is usually a phase I or early phase II clinical trial. Typically a dose ranging study will include a placebo group of subjects, and a few groups that receive different doses of the test drug. For instance, a typical dose-ranging study may include four groups: a placebo group, low-dose group, medium-dose group and a high-dose group.
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.
Repeal the 17th Amendment TODAY! Also Please Read http://www.gnu.org/philosophy/right-to-read.html
Morally, justifying something by putting the good of mankind over an individual leads to all kinds of truly ugly nastiness.
Bullshit. As a society, we routinely engage in self-sacrificing activities for "the good of mankind". We donate our time to charities. We donate money. We even donate our very blood, which can have some serious (though rare) consequences.
It's a matter of risk perception. Donating time or money are perceived as being no risk, even though charities are very often the target of homocides and other violent attacks, and monetary donations have an obvious economic detriment for the donor. Blood drives make a big show of their safety procedures, and continuously promote the benefits that are enabled by such donations. There are no advertising campaigns for clinical trials, though.
Stories like this play on fear, promoting the idea that pharmaceutical companies are careless and cavalier about running harmful clinical trials, when the reality is that of the tens of thousands of drug trials run every year, this one is notable specifically because it had a bad outcome.
And medical testing in particular preys on those who are desperate, or financially in need already. They may not have a gun to your head, but in most cases its not like they'd be taking the drugs if they had better choices.
Also bullshit. Medical testing "preys" on mostly-healthy individuals who meet a particular set of criteria and, most importantly, can be found. That last part is often the most difficult. VERY few people go to their doctors and ask what they can do to help others, except for folks who are looking for unconventional ways to make money. Pharmaceutical researchers usually go to hospital networks and run queries against the hospital databases. Those databases are huge, and not tuned for such queries, so the queries take several months. Ultimately, there are very few qualified candidates returned, and they can be approached and asked to participate.
Unfortunately, most patients, unless they actually need a treatment, will not join a trial. They're under the impression that trials are unnecessarily risky, and usually won't try to understand the risk analysis before rejecting it. Out of a few hundred candidate subjects in the US, only a few dozen will actually participate. Those who are "desperate, or financially in need" are the ones who have enough incentive to overcome the prejudice and consider the actual risks.
You do not have a moral or legal right to do absolutely anything you want.