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An experimental painkiller that killed one volunteer and severely damaged the brains of five others in a clinical trial in Rennes, France, may have acted on parts of the brain that it was not supposed to, a committee investigating the incident has concluded. It recommends that safety rules for clinical trials be tightened up globally.
The trial was looking at a drug called BIA 10-2474, a painkiller developed by Portuguese firm Bial. In total, 90 volunteers received the drug. The six who were harmed received the highest total dose: 50 milligrams per day up to cumulative amounts of between 250 and 300 milligrams, at which point symptoms rapidly kicked in.
The investigators suspect that at the high doses some volunteers received – 40 times above what is needed to block all FAAH – the drug may start disrupting brain enzymes other than FAAH. Another possibility is that the surplus anandamide may cause damage either by activating other molecules in the brain or by breaking down into harmful substances.
Anandamide, also known as N-arachidonoylethanolamine or AEA, is a fatty acid neurotransmitter derived from the non-oxidative metabolism of eicosatetraenoic acid (arachidonic acid) an essential polyunsaturated fatty acid. The name is taken from the Sanskrit word ananda, which means "joy, bliss, delight", and amide.
The reality is that clinical trials are necessary to proof drugs. I'm not making excuses for this trial but they are part of the process. I have to do more digging but if they were giving 40X the does needed then that should be criminal IMHO.
Speaking as a pharmaceutical chemist, I wonder what phase of trials this was?
The drug is being developed by Portuguese firm Bial. It was a “phase one” trial, in which a new drug that has been tested in animals is tested for the first time in humans. The idea is to make sure it is safe, and to measure its effects. Usually a range of relatively low doses are used in such trials.
originally posted by: chr0naut
a reply to: eisegesis
Most pain killers are toxins in high doses.
It sounds like those given the highest doses were worst affected and the testing was to determine toxicological effects.
I also notice that the drug generally targets the Fatty Acid Amide Hydrolase (FAAH) in the endocannabinoid system (normally affected by Tetrahydrocabanninol or THC), but BIA 10‐2474 (the drug under test) was notedly less specific in targeting FAAH (indicating that it could have many other interractions and targets).
It is sad that people were hurt. I would assume that toxicology reports in vitrio would have missed the specific interactions that caused brain damage. Either way, it does sound like careless and excessive dosing at 40x.