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Drug test 'like Russian Roulette'
QUICKVOTEYOUR E-MAIL ALERTSLONDON, England (CNN) -- A man who took part in trial tests of a new drug that left six people in serious condition said the experience was "like Russian Roulette." Raste Khan, one of eight people who volunteered for the London trial, said he watched in horror as six other people became violently ill within minutes of receiving the drug. "This one man was yelling 'doctor, my head hurts, my back hurts. I need help, I can't breathe.' He was just shouting and rambling to himself," said Khan, one of two men given a placebo. "Everyone was continuously vomiting," Khan said in an interview broadcast Thursday on Sky News. "It was like Russian Roulette -- two of us got away and were lucky." One victim, whose head and neck were reported to have increased to three times normal size, was later described by a friend as resembling "the Elephant Man." The six men remain in serious condition in Northwick Park Hospital in north London. Two of them are listed in critical condition, the hospital said. They were admitted late Monday to the intensive care unit from an independent medical research unit at Northwick Park Hospital. The men were paid to take part in a routine drug trial for TGN-1412, designed by German biopharmaceutical company TeGenero to treat autoimmune and inflammatory conditions, as well as leukemia. "The four who are seriously unwell are continuing to show signs of improvement but it is still early," according to the statement from Ganesh Suntharalingham, the director of critical care at London's Northwick Park Hospital. "The other two men remain critical and it could be a while until they show significant change." Marion Flanagan said she thinks the doctors are not sure how to treat her son and the other five patients. "They don't know what to give them or what to do with them," she said. Freak show figureMyfanwy Marshall said her 28-year-old "young, fit, healthy, gorgeous" boyfriend now resembled a 45-year-old heart attack patient. "His face is bloated out, like elephant man," she said, referring to freak show figure in Victorian Britain whose head ballooned outwards until his skull was wider than his waist. "They're recycling his blood trying to clean it out, it's affected every organ." The hospital statement said some of the physical effects, like the swelling described by Marshall, were temporary side effects of getting the patients the fluid they need to survive. "This is distressing for relatives to see, but it does go away on recovery and it has no long-term effects," the statement said. The publicly traded, U.S.-based company Parexel ran the trial and many other trials on behalf of drug companies. Parexel said it followed all the procedures for drug trials established in Britain. Health authorities have suspended the drug trial and have alerted hospitals around the world to make sure no one else is taking the drug. An attorney for the trial participants urged the drug companies to provide her clients and the medical staff taking care of them all relevant information "to make decisions about their treatment." "So far as my clients are concerned, what they need to know is a great deal more information about what was involved in this trial and what went wrong and how it was allowed to go wrong," Ann Alexander said. Alexander also asked for a formal apology from Parexel and TeGenero. "I haven't seen anything in writing from them, I haven't heard the words 'I am sorry' being used," she said. "I know that both of the companies have expressed the view, and they used the word 'devastated,' I think we're all devastated." Tom Edwards, 21, said he decided not to participate in the test because the literature he was given did not fully explain the effects of the drug. "I went through and read ... the consent form they got me to sign while rushing me," he said. "It didn't really explain it fully in there, so when I tried to contact them, there was no answer and no return of my message so I just left it at that and decided not to pursue it." Dr. Thomas Hanke, TeGenero's chief scientific officer, said Wednesday that TGN1412 had not caused any problems in previous testing. Later, when asked by reporters if the company had apologized, he replied "yes." Khan said he and the other volunteers were paid about £2,000 ($3,500) to participate in the trial, which was in the first phase of testing on healthy humans. The UK medicines watchdog -- the Medicines and Healthcare products Regulatory Agency (MHRA) -- immediately started an investigation. Professor Kent Woods, Chief Executive Officer at MHRA, told the UK Press Association: "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." Copyright 2006 CNN. All rights reserved.This material may not be published, broadcast, rewritten, or redistributed. Associated Press contributed to this report. 
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