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         Drug Trial Disaster in France Leaves Volunteers Seriously Ill

   by Reuters

   One man has been left brain dead and five others are in serious
   condition after taking part in a clinical trial in France of an
   experimental painkiller made by Portuguese drug company Bial, the
   French Health Ministry said on Friday.

   The medicine that was being tested works by targeting the body's pain-
   controlling endocannabinoid system, which is also responsible for the
   human response to cannabis.

   All trials on the drug involved have been suspended.

   The health ministry said the six volunteers had been in good health
   until they took the oral medication at a private facility in Rennes, in
   western France, that specializes in carrying out clinical trials.

   The man described as brain dead was hospitalized on Monday, two days
   before the other victims. The volunteers, men aged 28-49, began taking
   the drug on January 7, but symptoms only began appearing this week.

   Cases of early-stage clinical trials going badly wrong are rare but not
   unknown. In 2006, six healthy volunteers given an experimental drug in
   London ended up in intensive care. One was described as looking like
   "the elephant man" after his head ballooned in size. Another lost his
   fingertips and toes.

   In the initial or "phase 1" stage of clinical testing, a drug is given
   to healthy volunteers to see how it is handled by the body, and what is
   the right dose to give to patients.

   "Undertaking Phase 1 studies is highly specialist work," said Daniel
   Hawcutt, a lecturer in clinical pharmacology at Britain's University of
   Liverpool.

   Medicines then go into larger phase 2 and phase 3 trials to assess
   their effectiveness and safety before they are finally approved for
   sale.

   Europe has strict regulations governing the conduct of clinical trials,
   with phase 1 tests subject to particular scrutiny. However, Ben
   Whalley, a professor of neuropharmacology at the University of Reading,
   said these could only minimize risks, not eliminate them.

   "There is an inherent risk in exposing people to any new compound,"
   Whalley said.
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   ously-ill/3147572.html

References

   1. http://www.voanews.com/content/reu-drug-trial-france-volunteers-seriously-ill/3147572.html