Big Pharma drug trials critically injure six, leaving one brain dead; mainstream media points finger at marijuana not used in experiment

Thursday, January 28, 2016 by: Julie Wilson staff writer
Tags: Big Pharma drug trials, brain injury, medicinal marijuana

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(NaturalNews) A Portugal-based drug maker is being accused of trying to conceal details about a clinical drug trial that went severely awry earlier this month, leaving one person brain-dead and four others seriously injured. The trial took place in Rennes, France, and was conducted by Biotrial, a third-party drug evaluation and pharmacology research firm with offices in London and Newark, New Jersey.

The drug being tested was a painkiller manufactured by Bial, one of the largest and oldest pharma companies in Portugal that was founded nearly a century ago. Following the botched trial, the drug maker has been accused of taking a "secretive stance" and muddying the waters, making it difficult for outside researchers to understand what went wrong.

"The first reports on the Rennes tragedy were understandably confused. Adding to the shock of the tragedy, the secretive stance taken by the drug manufacturer made things even murkier," said Dr. Daniele Piomelli, Louise Turner Arnold Chair in Neurosciences and Professor of Anatomy & Neurobiology at the University of California, Irvine School of Medicine, told Outsourcing-Pharma.com.

Scientists demand transparency

"One person died and several were hurt. This is a tragedy and we cannot turn away from it," Dr. Piomelli added. "As a scientist active in the field, I feel an obligation to understand what went wrong. And to demand transparency from the drug manufacturer."

Early reports claimed that the experimental painkiller may have contained or was derived from cannabis. But that theory was quickly debunked when researchers clarified that the drug was a long-action inhibitor of FAAH (Fatty Acid Amide Hydrolase). Reports that the painkiller was somehow related to marijuana originated from an unidentified source who claimed to be close to the case.

The confusion may have stemmed from the fact that the drug being tested "targeted the body's pain-controlling endocannabinoid system, which is also responsible for the human response to cannabis," according to.

Ninety individuals received the experimental painkiller, while 30 others were given a placebo. Six of the volunteers aged 28 to 49 were taken to the hospital, including the brain-dead man, said French Health Minister Marisol Tourain, who called it "an accident of exceptional gravity."(3)

All of the participants were healthy before the clinical trial.

Medical workers told Sky News that three of those who were hospitalized may have a "handicap that could be irreversible." One of the men injured has neurological problems, according to doctors, who said they have no information on how to reverse the drug's effects.

Clinical trial was the first on humans

European agencies calling for transparency and safety urged the French government's drug agency that validated the trial protocol to release information about the procedure, but it refused and insisted on keeping the information secret while authorities investigate, reports the French daily newspaper Le Figaro.

However, Le Figaro was able to obtain a copy of the protocol and sent it to experts for review. They concluded that the procedures were in fact "complicated." The clinical trial was the first to be tested on humans. Early testing was done on mice, dogs and monkeys – none of which showed any evidence of toxicity.

A similar incident happened in Britain in 2006 when six formerly "healthy men were treated for organ failure only hours after being given an experimental drug targeting the immune system," the Daily Mail reports.

"That prompted a review of procedures and resulted in the U.K. regulatory agency imposing new testing standards, including recommendations to use the lowest possible dose and to test new drugs only in one person at a time.

"The six men in Britain now apparently have a higher risk of cancer and autoimmune diseases tied to their exposure to the experimental drug."

Sources:

in-PharmaTechnologist.com

FT.com

News.Sky.com

Sante.LeFigaro.fr

DailyMail.co.uk