German drugs firm apologises to victims' families

16th March 2006, Comments 0 comments

16 March 2006, LONDON - Doctors fighting to save the lives of six men who fell seriously ill after a clinical drugs trial in Britain said Thursday they were dealing with a "unique" set of symptoms.

16 March 2006

LONDON - Doctors fighting to save the lives of six men who fell seriously ill after a clinical drugs trial in Britain said Thursday they were dealing with a "unique" set of symptoms.

Of the six volunteers, who were given the German-produced anti-inflammatory drug TGN1412, two remained in critical condition, a spokesman for Northwick Park Hospital in Harrow, north London, said Thursday.

"The exact sequence of what's happening here is unique," said Dr Ganesh Suntharalingam, clinical director of the intensive care unit Thursday.

Meanwhile, the British government moved to reassure the public, saying in a statement that the events that had occurred during the drugs trials were "wholly unexpected."

The German company TeGenero, manufacturer of TGN1412, has offered an apology to the families of the six victims, which include a man from New Zealand.

But a spokeswoman for TeGenero has insisted that the developments did "not reflect" results from initial laboratory studies and animal tests with TGN1412.

The six trial volunteers, aged between 18 and 40, fell ill within hours of being injected with the drug Monday.

One of the trial participants, who was given a placebo, Thursday described what happened.

"They went down like dominoes," 23-year-old Raste Khan told the Sun newspaper.

"They began tearing their shirts off complaining of fever, then some screamed out that their heads felt like they were going to explode," said Khan.

Parexel, the US clinical research company which conducted the trials at Northwick Park Hospital, said it had followed all regulatory guidelines.

But Ann Alexander, British lawyer for the families, said Thursday there had been a "lack of consistency and some misinformation" in what her clients were told ahead of participation in the trials.

She referred to information that an animal had died in tests with the drug, used to treat rheumatoid arthritis, leukaemia and multiple sclerosis.

TGN1412 is described as a new-generation drug aimed at activating the body's own immune system.

Britain's health watchdog MHRA has launched an investigation into the scandal, while an international warning has gone out to prevent trials being carried out in other countries.

Professor David Eisenberg, from University College London, said Thursday the trials had prompted the "most unusual and unique consequences."

Speaking at Northwick Park Hospital, Dr Suntharalingam said Thursday he had never had to deal with a case quite like this before.

The men suffered inflammation which had subsequently affected other parts of their body, including their internal organs. "We do not know exactly what triggered the reaction", he said.

The patients were being treated with anti-inflammatory drugs such as steroids.

"Some of the features such as the need for a large amount of fluid and unstable organs are things that happen with other disorders but the exact sequence of what's happening here is unique," said the doctor.

"There is an inflammatory process going on that seems to have been triggered by something. That process started to affect other parts of the body so we have two jobs to do, one is to try to treat the inflammation and the other is to deal with the consequences of it," he said.

Dr Suntharalingam refused to comment on reports that one patient's head had swollen to three times its normal size but said: "This sort of condition does require fluid and that does cause swelling.

"That swelling does go away on recovery but it's very distressing for the families to see. It is one aspect of intensive care that gets better as the patients get better," he added.

But he said it was far too early to say whether that would be the case.

DPA

Subject: German news

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