Men Hospitalized After Bad Reaction to Drug Trial A clinical drug trial has left two men critically ill in a British hospital, and four others in intensive care. They suffered violent reactions to the new medication. The drug was being developed by a German company as a treatment for chronic inflammatory conditions and leukemia. The American company running the trial said they had operated within industry guidelines.
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Men Hospitalized After Bad Reaction to Drug Trial

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Men Hospitalized After Bad Reaction to Drug Trial

Men Hospitalized After Bad Reaction to Drug Trial

Men Hospitalized After Bad Reaction to Drug Trial

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A clinical drug trial has left two men critically ill in a British hospital, and four others in intensive care. They suffered violent reactions to the new medication. The drug was being developed by a German company as a treatment for chronic inflammatory conditions and leukemia. The American company running the trial said they had operated within industry guidelines.

RENEE MONTAGNE, host:

Two British men are in critical condition in a London Hospital and four others are in intensive care after a drug trial went terribly wrong. The six men suffered violent reactions to a drug developed by a German company to treat autoimmune diseases and leukemia.

NPR's Rob Gifford reports from London.

ROB GIFFORD reporting:

It was supposed to be just another clinical drug test, of the type that's carried out on a daily basis in hospitals around the world. Eight healthy young men presented themselves on Monday, for a trial of the new drug. Each was being paid about $3,500 for taking part. The drug is an anti-inflammatory that its makers hoped would become a treatment for diseases like leukemia and rheumatism.

Six of the men were injected with the drug. Two were given a placebo. The six, very rapidly, developed an extreme reaction. The two given the placebo did not.

The girlfriend of one of the stricken men, Myfanwy Marshal, got a call at three o'clock Tuesday morning telling her to go immediately to the hospital. She says she was completely shocked by what had happened to her fit, 28-year-old boyfriend.

Ms. MYFANWY MARSHAL (Girlfriend of U.K. Drug Trial Victim): And I walked in and he's looking puffed up like the Elephant Man and he looks like a 45-year-old man. He's had a cardiac arrest. He's got all the things all over his chest. His lungs were going up and down, thanks to a machine. His blood is being pumped in and out, being recycled and being cleaned out. His lungs, his heart, his kidneys are being supported, his liver, all these vital organs have just been attacked by this drug.

GIFFORD: Experts stress that it is still not clear what caused the problem. The main issue now is that because it's the first ever trial on human beings, there's no knowledge of how to deal with the adverse reactions. Doctors are having to deal with it on the basis of the symptoms.

The company running the drug trial said it had operated within industry guidelines. The drug maker is a German company called TeGenero. Thomas Hanke is its chief scientific officer.

Dr. THOMAS HANKE (Chief Scientific Officer, TeGenero): Our first concern right now is for the patients and the families and that they get all treatment possible. We're confident in the excellent treatments at this hospital and have made ourselves available to answer any questions from the doctors about the drug. Investigation must proceed as quickly as possible into these shocking developments and the testing of the new medicine, which showed no signs of any safety problems in previous testing.

GIFFORD: TeGenero is working 'round the clock with doctors at Northwick Park Hospital to try to help the six stricken men. Meanwhile, doctors and analysts have been quick to point out that despite the terrible results of Monday's test, it is very unusual for such adverse reactions to occur.

Sheena McCormack works for the British Medical Research Council.

Ms. SHEENA McCORMACK (British Medical Research Council): It's unprecedented. I've certainly never heard of this in my time. It's extraordinarily unusual because of the very intense program of preclinical, prehuman safety testing that goes on. So that happens in the lab, then it happens in small animals, in at least two species.

GIFFORD: The families of the men affected have gathered at the hospital, waiting for news of their loved ones. An announcement on the condition of the six men is expected later today.

Rob Gifford, NPR News, London.

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