Inquiry into drug trial that became a nightmare

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Indy Lifestyle Online

Investigators yesterday launched an inquiry into the clinical trial that left six healthy young men in intensive care, as scientists voiced fears the incident could prove disastrous for attempts to develop cures for major diseases.

Two of the men were "critical", battling for their lives, while four others remained in a "serious" but improving condition at Northwick Park hospital in north London. The girlfriend of one man said she had been told he "needs a miracle" to survive.

The six were rushed to intensive care with multiple organ failure on Monday night after being given doses of TGN1412 ­ an antibody-based treatment for chronic inflammatory conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis.

Myfanwy Marshall said her 28-year-old boyfriend looked "like the Elephant Man" after his body swelled alarmingly 90 minutes after taking the drug. "They haven't got a cure. This is a drug they have never tested on humans before so they don't know what they are dealing with. It's completely messed up their vital organs," she said. "They are saying he could be lying there in six months."

One victim was named as trainee plumber Ryan Flanagan, 21, of Highbury, north London. His family were told he could not breathe unaided, and his head and neck had swollen to three times their normal size.

Raste Khan, one of two men taking a placebo who was unharmed, said his co-subjects "went down like dominoes". He told The Sun: " First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were about to explode. After that they started fainting, vomiting and writhing."

The men, who were offered £2,000 to take part, were recruited by the US company Parexel, for the trial in its 36-bed unit on the Northwick Park hospital campus. They reportedly signed a contract warning that side-effects in rats and mice included "increased urine volume, decreased faeces, redness of the skin". Dogs experienced "increased heart rate and decreased blood pressure". German manufacturers TeGenero AG last night apologised to the men's families. Thomas Hanke, chief scientific officer, said the firm was "devastated" at the "shocking developments" in the testing of a new medicine which had previously showed no safety problems. Inspectors from the Medicines and Healthcare Regulatory Authority (MHRA) began an investigation into the incident, which scientists said was unprecedented. They removed samples of the drug used by Parexel and are in contact with Scotland Yard. The investigation will examine whether the incident occurred because of human error, contamination of the manufacturing process or a "freak of nature", said a spokeswoman for the MHRA.

A global alert was issued and a trial of the same drug, which had been approved but not started in Germany, was suspended.

Companies involved in testing new medicines were bracing for a collapse in volunteers. Around 300 safety trials, known as phase 1 trials, in which drugs are tested for the first time on humans, are run each year in the UK. They require several thousand human guinea pigs who are paid an average of £150 a day, according to the MHRA.

The MHRA said companies wishing to test a drug on humans had to apply for authorisation, under new rules introduced in May 2004. "Parexel would have provided us with information on the drug [known by the code TGN1412, made by TeGenero AG, based in Wurzburg, Germany] showing three to four years research including laboratory tests, tissue tests and trials on animals," a spokeswoman said.

'Something made me suspicious about the trial'

A former student described yesterday how he nearly took part in the Parexel trial but dropped out of it.

Tom Edwards, 21, said: ''I feel pretty lucky but I feel bad for the people who have done it, it is not like me to turn down £1,100 for lying on my back but I was not comfortable with doing it.''

Mr Edwards, of Oxford, wanted to do the trial to help pay off his student debt.

He had done a drugs trial in Cardiff before, for which he was paid £1,400, and went to Northwick Park last month for screening. They ran a medical check to clear him for the trial, handed him some papers and a consent form.

But he felt rushed. ''Something told me to be suspicious about it even though I did not know why I should,'' he said. ''It seemed a bit haphazard.''