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Clinical Trial Leaves Five Sick, One Brain Dead

Clinical Trials

A clinical trial, taking place in France, has gone horribly wrong. 90 people were administered an experimental drug. To date, one person is brain dead and further five are seriously ill. Of these, at least three are likely to have permanent brain damage.

The drug has not been named, although the BBC has received information indicating that the drug is a cannabis-like painkiller, but that was later denied by the health department. What is known is the drug was manufactured in Portugal by a company called Bial; it was taken in oral form; and the clinical trial was conducted at a private laboratory in Rennes.

People sign up for clinical trials for a variety of reasons. Some are ill and trial drug might be of benefit for them; others are interested in helping medical science develop; and a small number are happy to receive compensation payments. Whatever the reasons, no drug product should reach the stage of a human study without being assessed as safe. The point of the trial is to test the efficacy (‘does it do what it says on the tin?’), not to see if it will harm a human being. Animal studies are supposed to rule this out. So clearly, in this latest incident, something seriously has one wrong.

Although clinical trials are now generally safer, things can still go wrong. In the U.K. there was a major incident at Northwick Park Hospital, which is situated in North London. Here, in 2006, six men suffered major organ failure after being given a drug coded TGN1412 in a clinical trial. The effects were so bad that the men described feeling like their brains were “on fire” and their “eyeballs were going to pop out.”

With the latest French tragedy, Health Minister Marisol Touraine has pledged to find out exactly what went wrong. Those who may well end up in future clinical trials will hope the preventative measures put in place this time are effective.

About the author

Tim Sandle

Dr. Tim Sandle is a chartered biologist and holds a first class honours degree in Applied Biology; a Masters degree in education; and has a doctorate from Keele University.

  • Dinesh Bhandari

    What could have possibly gone wrong with the trail for I went through the history of Bial and the track record shows it to be a highly reputed company. I wonder if the drug passed pre-clinical trail or Phase 0 trail if it was a Phase I/II trail that went wrong. R&D is important for science to progress and contribute for the betterment of living things including Human. However, when it comes to human related science, ethical issue should be the apical concern and R&D should be beneficent rather than maleficent. Business and financial aspect should be trivial to human welfare. Accidents are always unforeseen and errors do occur but scientists should act responsibly.Life threatening errors are never tolerable and zero tolerance approach should be adopted for issues as such if proven to be driven by any temptation or enticement.

  • Nicole King

    If you take more than two seconds to read the BBC report, you’ll see that the drug is NOT a medical cannabis. It is a drug that acts on the same system in the brain but is only structurally related to cannabis, not derived from from it.

    • Victor Grayson

      Isn’t that what a cannabis-like physiological effect means?

  • Bruce Johnson

    This article is in error, nothing to do with medical cannabis. A direct quote from the BBC : ” Reports that the drug is a cannabis-based painkiller have been denied by the health ministry.”

    • Victor Grayson

      It has a cannabis basis.

      • Bruce Johnson

        Direct quote from the article: “although the BBC has received information indicating that the drug is a cannabis-like painkiller, but that was later denied by the health department.”

        Do you have inside information that I am not aware of?

        • Victor Grayson

          Yes, but I cannot disclose it at present.

  • The medicine involved is a so-called FAAH
    inhibitor that works by targeting the body’s endocannabinoid system,
    which is also responsible for the human response to cannabis.

    • Victor Grayson

      That’s correct Tim, and what you said.