Drug trial may lead to amputations

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LONDON (AP) – A 20-year-old man who suffered severe reactions during a drug trial run by a Waltham, Mass.-based company told a British Sunday tabloid that he will lose parts of his fingers and toes.

Ryan Wilson, from London, and five other healthy volunteers took part in a clinical trial last month for TGN1412, a drug being tested for treatment of leukemia and autoimmune and inflammatory diseases.

“I’m definitely going to lose bits of my fingers and toes. And they say I could be in here for another six months,” he told the News of the World.

“I’m told it’s like frostbite and my fingers will just fall off,” he was quoted as saying.

Large parts of Wilson’s hands and feet have turned black, where flesh has died, pictures published in the newspaper reveal.

Wilson and the five others were each paid the equivalent of about $3,500 for taking part in the trial, but suffered convulsions and organ failure minutes after being administered the test drug. All the other volunteers have been released from hospital.

“I had heart failure, kidney failure, pneumonia, septicemia and liver failure and was ventilated on 99 percent oxygen,” Wilson told the newspaper.

The student, who said doctors told him that he defied their expectations by surviving, plans to sue to the drug makers TeGenero AG of Wuerzburg, Germany, as well as Parexel International, based in Waltham, which conducted the trials.

In an interim report, investigators said they found no evidence of product contamination or the use of improper practices in the trial. Britain’s Medicines and Healthcare products Regulatory Agency are continuing their investigation, and have name a panel of experts to make recommendations on how drugs like this can be safely developed in the future.

TeGenero initially said there had been no “drug-related adverse events” in tests on animals, but later acknowledged the drug had left monkeys with swollen glands.

About 350 similar phase one clinical trials on humans are conducted every year in Britain – tests which will continue pending further investigation.

AP-ES-04-15-06 1922EDT

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