Coma From Drugs

Nothing Unusual About Animal Tests
Two Men Remain in Coma From British Drugs
March 21, 2006

LONDON (AP) -- They were chosen because they were fit and healthy, but minutes after being injected with a test drug designed to combat leukemia and other diseases, the men went into convulsions as their internal organs began to fail.

Two men were still in a coma Tuesday and four others were seriously ill but improving after participating in the trial last week. The drug sent the men into vomiting fits; they removed their shirts in panic as their bodies seized up with pain.

Fresh questions are being asked about the safety of clinical trials and whether the tests draw vulnerable people with promises of pay. Parexel, one of the makers of the drug, paid eight men 2,330 pounds (US$4,092) each to participate, said Raste Khan, 23, one of two patients who had been given a placebo.

He described the gruesome scene in the hospital ward.

"It felt like we stepped into some sort of horror film," Khan told The Press. "The three other men in my ward started vomiting, then they began to fall in and out of consciousness. The person on my left was begging doctors to help him. I was really scared and was just waiting for it to start happening to me."

After taking the drug the men lapsed into comas as their organs failed, forcing doctors to put them on organ support machines, said Dr. Ganesh Suntharalingam, who was treating the men at Northwick Park hospital in London.

The Medicines and Healthcare products Regulatory Agency -- which authorized the trial -- said there was nothing unusual about the results of laboratory and animal tests on the drug or the methodology for the human trials provided by Waltham, Massachusetts-based Parexel and the other maker, TeGenero AG of Wuerzburg, Germany.

TeGenero's chief scientific officer, Thomas Hanke, said the drug TGN1412 -- designed for the treatment of autoimmune and inflammatory diseases and leukemia -- had been tested on rabbits and monkeys with no "drug-related adverse events."