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Drug Trial Goes Foul, Six Volunteers Critically Ill

by Medindia Content Team on March 15, 2006 at 7:27 PM
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Drug Trial Goes Foul, Six Volunteers Critically Ill

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LONDON - A drug trial in northwest London went horribly off course as six men who were participating in the trial are now battling for life at the emergency ward of the Northwick Park Hospital. Eight volunteers had taken part in the trial of a drug to treat conditions such as rheumatoid arthritis and leukemia.

Two of the volunteers were given a placebo and were healthy, but the other six who received the anti-inflammatory drug fell ill within hours of consuming it and suffered multiple-organ failure. The Medicines and Healthcare products Regulatory Agency
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(MHRA) has withdrawn permission for the trial and has issued an international alert to prevent the drug from being tested again. "Our immediate priority has been to ensure that no further patients are harmed. We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken," said Chief executive officer Professor Kent Woods, adding that the association's inspectors would visit the research unit and stay in touch with the police. Healthy volunteers can make up to £150 a day by taking part in clinical trials. Parexel, the company, which was conducting the trial, said it had followed all the requisite guidelines and such occurrences were pretty rare, "When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately. Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation," said Professor Herman Scholtz, from Parexel. "Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."
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