Police probe drug trial horror
2006-03-16 08:07
London - A German drug company said it has apologised to the families of six men who were in hospital on Thursday, two badly deformed and fighting for their lives, after a clinical trial in London went horribly wrong.
The Medicines and Healthcare products Regulatory Agency is currently investigating what went wrong with help from the Metropolitan police.
Thomas Hanke, chief scientific officer at TeGenero, also insisted that the trial to test a medicine for immunological diseases such as multiple sclerosis, rheumatoid arthritis and certain cancers had met regulatory standards.
But senior doctors told The Times newspaper that the test at a research unit operated by United States company Parexel International had failed to conform to best medical practices.
Two of the six patients were critically ill and the other four remained in serious condition in the intensive-care unit of Northwick Park Hospital, an official at the north-west London hospital said.
Writhing in pain
The men, who had all been healthy, were admitted on Wednesday evening after suddenly falling ill while taking part in the drug trial at the independent research unit in the hospital compound.
Doctor Hanke said TeGenero was "devastated" at the "shocking developments" in the testing of its drug, which the firm identified as TGN1412.
Asked by reporters whether the company had apologised to the men's families, he replied: "Yes."
Hanke also said the drug had shown no adverse side-effects previously and the testing had been done to regulatory standards.
The Times said senior doctors were concerned that all six victims had been given the experimental drug at the same time.
The newspaper said this went against guidance in "The Textbook of Pharmaceutical Medicine", which advises that such practices can be "very difficult to manage" and "put subjects at unnecessary risk."
Two other men also participated in the clinical trial - all eight men were paid volunteers - but escaped unscathed after being given a placebo.
One of the survivors, Raste Khan, 23, described the horror that befell six of his fellow human guinea pigs.
"First they began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode," Khan told The Sun tabloid on Thursday.
"After that they started fainting, vomiting and writhing around in their beds," he recalled.
Trainee plumber Ryan Wilson, 21, suffered heart, lung and kidney failure.
"His head had swollen to nearly three times its normal size. His neck was the same. It was wider than his head and his skin had turned a dark purple," Brown said.
Myfanwy Marshall, 35, tearfully said her boyfriend, a 28-year-old barman whose name has not been revealed, looked like the "Elephant Man".
"It's completely messed up their vital organs."
- AFP