UPDATE 3-British drug trial goes wrong, two critically ill
Wed Mar 15, 2006 10:05 AM ET
(Adds details, quotes)
By Kate Holton
LONDON, March 15 (Reuters) - Two men were critically ill in a British 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.
Police said they were working with the country's medicines watchdog to establish the circumstances.
The American company running the trial said they had operated within industry guidelines but a girlfriend of one of the volunteers said they had been told to pray for a miracle.
She said her boyfriend was swollen beyond recognition.
The drug, known as TGN 1412, was being developed for a German company to treat chronic inflammatory conditions and leukaemia.
A spokeswoman for the Northwick Park Hospital in London where they are being treated said they were doing all they could to help the men, whom she described as young.
Myfanwy Marshal, whose boyfriend took part in the trial, said she had been told her partner could die at any time.
"They just all went down like flies, all six of them," she told the BBC.
"The (doctors) can't give us a cure, they're talking to experts. The doctors were on the phone to experts all night (asking) what they can do.
"They've said to us 'we're in the dark, we don't know what to do. We don't know this drug.'"
She said 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.
All his internal organs had failed, she added.
Another man's head and neck had swollen to three times normal size, the Sun newspaper quoted a friend as saying.
EXHAUSTIVE INVESTIGATION
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.
"We will now undertake an exhaustive investigation to determine the cause and ensure all appropriate actions are taken," MHRA's Professor Kent Woods said in a statement, adding they were working with the Department of Health and London police.
A police spokeswoman said they were liaising with the watchdog to see how the investigation developed.
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.
British media reported the men were paid 2,000 pounds ($3,500) to take part. The trial was in the first phase, when healthy humans test the drug.
It was set up by U.S. drug research company Parexel International Corp. on behalf of German pharmaceutical company TeGenero AG.
Parexel said it had operated within regulatory guidelines |
