Original URL: http://www.theregister.co.uk/2006/03/15/drug_trial/

UK drugs trial hospitalises six

Intensive care for 'seriously ill' men

By Lester Haines

Posted in Science, 15th March 2006 16:21 GMT

Six drug trial volunteers who were given an anti-inflammatory drug at a private research unit based at London's Northwick Park Hospital are in intensive care after suffering a "reaction", the BBC reports.

The six were given TGN1412 - "designed to treat conditions such as rheumatoid arthritis and leukaemia" - on Monday. Within hours they were hospitalised after suffering "an inflammatory response which affects some organs of the body", as Northwick's intensive care director Ganesh Suntharalingam put it.

Suntharalingam explained that two of the men were in a critical condition, while the remainder were "serious but showing some signs of improvement".

The girlfriend of one of the men described her 28-year-old boyfriend's face as so swollen he "looks like the Elephant Man". Myfanwy Marshall told the BBC: "His friends cannot even face seeing him. I have to stay there because I'm looking beyond all the wires and the puffiness. This is not leukaemia, this is not pneumonia, this is not something they know how to deal with."

Parexel, the firm behind the trial, said it had followed guidelines and that such cases were extremely rare. The company's Professor Herman Scholtz said: "When the adverse drug reaction occurred, the Parexel clinical pharmacology medical team responded swiftly to stop the study procedures immediately."

The drug's German-based manufacturer, TeGenero, said the reactions were "completely unexpected and did not reflect results from initial laboratory studies".

The Medicines and Healthcare products Regulatory Agency (MHRA), meanwhile, immediately withdrew the trial's authorisation and issued an international warning against testing. Its inspectors have visited the unit and are consulting the local health authority, Department of Health and police with regard to the matter.

According to the BBC, the drug had already been tested on animals and cleared for human trials. ®