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This is an archive article published on March 17, 2006

Row over drug trial backfiring

Four men who became seriously ill in a drug test are improving, but two others remain in critical condition, doctors said on Thursday.

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Four men who became seriously ill in a drug test are improving, but two others remain in critical condition, doctors said on Thursday.

8220;The four who are seriously unwell are continuing to show signs of improvement but it is still early days,8221; said Ganesh Suntharalingham, clinical director of intensive care at Northwick Park Hospital. 8220;The other two men remain critical and it could be a while until they show significant change.8221;

Suntharalingham said the extreme swelling reported by relatives of the stricken men may have no lasting effect. 8220;Some of the features of what is happening are in common with other disorders we see in intensive care. One example is that these patients sometimes need a lot of fluid, and one result of that is severe but temporary swelling,8221; he said.

Raste Khan8212;one of two men given a placebo in the trial8212;said the six had been stricken within a few minutes of receiving the drug. 8220;Everyone was continuously vomiting,8221; said Khan .

The six men had been given does of TGN1412, a monoclonal antibody developed by TeGenero AG of Wuerzburg, Germany, for treatment of autoimmune and inflammatory diseases and leukemia.

Dr Thomas Hanke, TeGenero8217;s chief scientific officer, said on Wednesday that TGN1412 had not caused any problems in previous testing.

Khan said the reaction set in quickly. 8220;Roughly maybe a few minutes after the final person had been given the drug, the first person who had been given started to kind of shake, he took his top off, looked like he was kind of burning up,8221; said Khan in an interview. 8220;Obviously, I assume he had a headache because he was rubbing his head.8221;

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Khan said most of the patients were 8220;moaning and groaning,8221; and only one said 8220;what hurt.8221; He was saying, 8216;My head hurts.8217;He was going, 8216;Doctor, my head!8217; 8216;My back!8217; 8216;Doctor, I need help! I want help! I can8217;t breathe!8217;

8220;I feel guilty because I was the lucky one,8217; Khan added, 8220;whereas other people obviously were not so lucky.8221;

 

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