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To: A.J. Mullen who wrote (4590)	3/15/2006 9:38:00 AM
From: Sam Citron	Respond to of 7143

Drug trial goes wrong, two critically ill Wed Mar 15, 2006 12:19 PM GMT By Kate Holton LONDON (Reuters) - Two men were critically ill in a hospital on Wednesday and four others serious in intensive care after suffering violent reactions to a new drug they took as part of a clinical trial. The drug is being developed for a German company to treat chronic inflammatory conditions and leukaemia, a medicines watchdog said. The Sun said the head and neck of one of the men had swollen to three times normal size. It quoted a friend as saying the 21-year-old man was a student and had taken part in the trial to make money after seeing an advert on the Internet. The girlfriend of another volunteer told the BBC her partner looked like the "Elephant Man" -- a freak show figure in Victorian Britain whose head ballooned outwards until his skull was wider than his waist. She said all his internal organs had failed. The Medicines and Healthcare products Regulatory Agency (MHRA) said eight healthy men took part in the trial, two of whom were given a placebo, or dummy drug. The six who took the real drug all fell ill. A spokeswoman for the Northwick Park Hospital in northwest London where they are being treated said the six are all young men. Two were critically ill, while four were seriously ill but had shown signs of improving. Richard Ley, spokesman for the Association of the British Pharmaceutical Industry (ABPI), said he had never heard of anything like it before. "This is an absolutely exceptional occurrence. I cannot remember anything comparable," he added. The media reported the men were paid 2,000 pounds to take part. The trial was in the first phase, when healthy humans test the drug. "There are several possibilities as to what might have gone wrong," MHRA Chief Executive Officer Kent Woods told BBC radio. "We've had inspectors on site since yesterday trying to clarify what exactly the event was that caused this disaster." "Has there been some manufacturing problem? Has there been some issue of contamination? Has there been a dosing error or is this indeed some completely unanticipated side effect of the drug in humans, which is specific to humans?" The trial was set up by U.S. drug research company Parexel International Corp. on behalf of German pharmaceutical company TeGenero AG. The ABPI's Ley said it was now very common for clinical trials to be conducted in different parts of the world at the same time. He said "tens of thousands of people, if not more" took part in clinical trials in Britain each year. Parexel described the incident as "unfortunate and unusual," adding that it assumed the volunteers had suffered an adverse reaction to the drug, known as TGN 1412. "Such an adverse drug reaction occurs extremely rarely," said Professor Herman Scholtz, head of Parexel International Clinical Pharmacology, in a statement. As soon as the men fell ill, the MHRA suspended the trial and notified other European regulatory bodies about it.