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Britain Halts Drug Test as Participants Fall Ill

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From the Associated Press

British regulators Wednesday ordered the immediate suspension of trials of a drug to treat autoimmune diseases and leukemia after six men participating in the tests were hospitalized with severe adverse reactions.

Two of the men were in critical condition and four were in serious condition but showing signs of improvement, a hospital official said.

“The drug, which is untested and therefore unused by doctors, has caused an inflammatory response which affects some organs of the body,” said Ganesh Suntharalingam, clinical director of intensive care at Northwick Park Hospital, where the men were admitted.

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The names of the six men were not released. But one woman said her boyfriend, a 28-year-old London bar manager, was among them.

“They just keep saying he’s very, very sick and we are doing all we can,” Myfanwy Marshall told the BBC. “He needs a miracle, those were their words.”

Marshall told the BBC her boyfriend had decided to participate in the trial for the money -- about $3,500 -- to pay bills.

The Medicines and Healthcare Products Regulatory Agency, which ordered the tests suspended, said the six men were the only people given the drug in a small trial. Two other subjects received placebos.

“These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies, which enabled us to progress investigations into human volunteers,” said Dr. Benedikte Hatz, chief executive of the German pharmaceutical firm, TeGenero of Wuerzburg, that developed the drug.

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