Toxic Experimental Drug Blamed for Fatal French Clinical Trial

by Reshma Anand on  April 20, 2016 at 6:32 PM Clinical Trials News
RSS Email Print This Page Comment bookmark
Font : A-A+

Death of a man in a French drug trial was likely caused by the compound itself, as it is said to be toxic in nature.

Publishing their final report into January's drug trial in the western French city of Rennes, experts said the accident was "clearly linked to the compound tested."
Toxic Experimental Drug Blamed for Fatal French Clinical Trial
Toxic Experimental Drug Blamed for Fatal French Clinical Trial

Six volunteers were hospitalized after taking part in the trial, one of them was killed and four suffered brain damage.

"The most credible hypothesis is that the molecule itself was toxic," said the report ordered by French medical agency ANSM.

Lead author Bernard Begaud said the rules "generally seem to have been respected" in the trial run by Portuguese pharmaceutical firm Bial, even if "common sense" appeared to have been neglected.

The trial was testing a compound less efficient than another already on the market, and "no more effective than several others from the same family that had already been abandoned because they were ineffective," Begaud told AFP.

"The first recommendation is that at a minimum, it should be ensured that the medication has the chance of serving some purpose."

Bial welcomed the report, noting that it had "identified no failure to comply with current rules and guidelines."

The compound, BIA 10-2474, is part of a family of FAAH-enzyme inhibitors that can have an impact on pain and anxiety by boosting the endocannabinoid system involved in appetite control, pain sensation, mood and memory.

The experts said the problem with the drug was likely its poor ability to bind to its target, the FAAH enzyme.

Their report added that "a likely gradual accumulation in the brain" would explain "why the accident only occurred on the fifth day of the administration of a dose of 50 milligrams and not in the volunteers who had received a single dose that was twice as strong."

They urged a tougher selection process for volunteers when testing drugs on humans for the first time.

The dead man had previously suffered a head injury and another of the victims had hypertension, ailments that should have ruled them out, the report said.

"The seriousness of the accident at Rennes justifies changes to the regulations and international best practice," it said.

A total of 108 volunteers took part in the study. Ninety received the drug at varying doses, and the rest were given a placebo. Those hospitalized had received the highest dose.

Source: AFP

Post a Comment

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
Notify me when reply is posted
I agree to the terms and conditions

Recommended Reading

More News on:

Drug Toxicity Clinical Trials Clinical Trials - The Past and The Future Clinical Trials - Different Phases of the trial Signature Drug Toxicity Drugs Banned in India Placebo Effects: Rare Insights 

News A - Z


News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Stay Connected

  • Available on the Android Market
  • Available on the App Store

News Category

News Archive