· Volunteers were testing treatment for arthritis
· US company says adverse reaction is 'extremely rare'
Sarah Boseley, health editor
Wednesday March 15, 2006
Six men were in intensive care in a north London hospital last night after a pharmaceutical company's trial went wrong. Regulatory authorities have suspended the drug trial and are investigating in collaboration with the police.
The six were healthy volunteers, paid to take part in the earliest stage of human testing of a potential new medicine for inflammatory diseases such as rheumatoid arthritis and leukaemia. The volunteers were needed to establish whether there were any side effects or obvious problems with the drug before it was tested on people who have the conditions.
But on Monday, the first day of the trial, the Medicines and Healthcare Products Regulatory Authority (MHRA) said yesterday all six men became ill at the commercially run clinical trials unit at Northwick Park hospital, Harrow. One of the men reportedly had extreme breathing difficulties within three hours of taking the drug and his family was told his legs had turned purple, according to the Sun newspaper.
Two other men at the unit were enrolled in the trial but had been given a placebo and are unaffected.
Because the unit was in the hospital building, the sick men were rapidly given medical help and transferred to intensive care that evening. A spokeswoman for the MHRA said it was "very concerning" but "almost unheard of". The drug company, the German firm Te Genero, had submitted the results from animal safety tests, as it must do under the regulations, to get permission to run a trial on human beings. There had been no irregularities in the animal tests, the MHRA said. Investigators at the site will be looking at whether human error played a part in the incident, whether the product was contaminated or something went wrong with its storage.
The hospital said last night the men were seriously ill. "Although they were not part of an NHS trial, we were able to admit the patients very quickly to critical care and our full team has been treating them," said Ganesh Suntharalingam, clinical director of intensive care. "They are in a serious condition and receiving close monitoring and appropriate treatment. Their families are very concerned and we are keeping them closely informed."
The hospital emphasised that the clinical trials unit was a separate entity and that none of its doctors had anything to do with it. "It is run by an independent company and they are responsible for the trials," a hospital spokesman said.
The unit is run by the US company Parexel which contracts with drug companies to recruit patients and run trials all over the world. In a statement last night it said the volunteers had "an unexpected drug reaction" and that its staff had given them the right dosage.
"Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation," said Herman Scholtz, head of Parexel International Clinical Pharmacology. "We have a high-quality medical team in our Northwick Park unit. Since our unit is located within the hospital, we have immediate access to world-class medical care and we did everything possible to get the patients treated as quickly as possible."
The firm had operated entirely within clinical and research guidelines, he said. Parexel has run a 36-bed unit at Northwick Park since 1991. It advertises predominantly for healthy young men. Volunteers are told they must not have used any other medication or recreational drugs.