There is nothing more devastating than finding out you have an incurable disease, besides being the loved one to someone who was recently diagnosed with a terminal illness. Chronic or terminal illnesses make everyone in the situation feel helpless and anxious. That is why there is growing debate about all the regulations and rules involved in getting new life-saving drugs to market.
The best optometrists in Winnipeg will tell you, even with so many standards for care, it is likely that there are hundreds of pharmaceuticals developed that could save lives, but they are being held up by the red tape of clinical trials and the laws that govern them. With so many leading the charge to push drugs to market in a more timely fashion, the new case being brought forward in France is giving fuel to the Food and Drug Administration and their insistence on taking things slow and protecting the public.
Just last Sunday a man died in a French hospital after taking part in a human clinical trial to test the effectiveness of a painkiller medication. An experimental drug trial, him and five of the other participants became extremely ill.
Leading to one death, the other five are still hospitalized in serious condition. Prosecutors have gotten involved to see if manslaughter charges are necessary, but the biggest consequence may be the re-examination of experimentation on healthy human beings to forward the cause of drugs in the market. Paying human participants to take medications that may harm them, may just be the focus of ethical concerns shortly.
The pharmaceutical company was a Portuguese based company by the name of Bial. Taking full responsibility, they have launched their own investigation to get to the cause of what happened that ended in this tragic outcome.
The trial for the painkilling drug had six male participants all between the ages of 49 and 28, in good health, hospitalized for their participation. Three of the other members are feared brain damaged due to their activity in the trial, hospital officials claim.
The trial began back on January 7th, including 90 healthy volunteer participants who were administered the drug at different doses and different intervals. After learning of the six who were stricken ill, the other 84 members were called in. To date, there have been no other illnesses stemming from participation in the trial known, but an investigation is still underway. There is no further information about whether the others are still being treated or monitored.
An orally given drug, the participants were administered the drug in a phase one clinical trial and then they were being evaluated by a company by the name of Biotrial. It is a Rennes based company doing the legwork for drug maker Bial. The medication was not just a painkilling drug it had a combination, perhaps lethal, of other active ingredients aimed at easing anxiety and mood issues. It also specifically targeted motor problems, which can be linked to degenerative diseases, acting on the endocannabinoid system in the brain.
Although rumors abound, it was not a study on the medical marijuana, the vector was quite different and not cannabis. Not the first time the drug was being tested, Bial started the trial after findings from toxicology tests on over 108 healthy participants who have already received the drug in the absence of any grave or medical side effects to using. The outcome came as a shock to everyone involved, officials insist.
It is extremely rare for these types of things to happen in a phase one drug trial. With very stringent safety regulations in place, it takes a long time for pharmaceuticals to make it to trial phases, which is what is making everyone scratch their heads.
The fear in the medical community is two-fold. First, they are afraid that if it could happen once, the likelihood is that it will happen again. The second fear is that life-saving pharmaceuticals will be held to more regulations and rules that could further slow down the production of them, and the ability to bring them to market to save the lives of those who need them.
With manslaughter charges on the table, many in the medical and legal field are anticipating the results of what caused the drug failure, and for participants to lose their lives and their livelihood. Hopefully, this will not halt the drug development of safe drugs for the future. With so many at stake, this could alter the pharmaceutical world in numerous ways.