Six British men critically ill in clinical test of German drug
15 March 2006, LONDON - Six British men who fell ill after participating in a clinical trial to test a new anti-inflammatory drug were in critical condition in a London hospital Wednesday, the health authorities said.
15 March 2006
LONDON - Six British men who fell ill after participating in a clinical trial to test a new anti-inflammatory drug were in critical condition in a London hospital Wednesday, the health authorities said.
Parexel, the clinical research company running the trial with the German-produced drug, TGN1412, aimed to treat conditions such as rheumatoid arthritis and leukaemia, said Wednesday it operated within the regulatory guidelines.
Professor Hermann Scholtz, from Parexel, said: "Such an adverse drug reaction occurs extremely rarely and this is an unfortunate and unusual situation."
According to the BBC, quoting relatives of the trial participants, one of the men had suffered multiple organ failure. Some of the remaining cases are said to be life-threatening in a North London hospital.
British Health Secretary Patricia Hewitt said Wednesday: "It is a shocking event."
She would now await the results of an investigation by the Medicines and Healthcare products Regulatory Agency (MHRA) which has withdrawn authorisation for the trial.
An international warning has also gone out to prevent it being tested abroad.
The drug is made by the pharmaceutical TeGenero AG, based in Würzburg, Germany, where it was also due to be tested.
TeGenero's chief executive, Benedikte Harz, said in a statement: "These events were completely unexpected and do not reflect the result we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers."
However, a girlfriend of one of the participants said Wednesday she could "barely recognize" her boyfriend after he started the trial.
"He looked like the Elephant Man," Myfanwy Marshall told the BBC.
Her boyfriend had felt ill 80 or 90 minutes after being given an oral or injected dose on Monday.
"He is like a shell of who he is. His chest is puffed out. He is already a big kind of guy but his face is out here, like the Elephant Man, it's completely puffed," she said.
Marshall, a nurse, said: "This is a drug they have never tested on humans before so they don't know what they are dealing with. It's completely messed up their vital organs."
Subject: German news