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Six hospitalized in drug test gone wrong

Two men were critically ill in a British hospital and four others serious in intensive care after suffering violent reactions to a new drug they took as part of a clinical trial.
/ Source: Reuters

Two men in intensive care after taking part in a clinical trial remain critically ill and are unlikely to make any early improvement, their doctor said on Thursday.

Six men were taken ill during the trial in London to test a drug designed to treat chronic inflammatory conditions and leukaemia. Four are in serious condition but have shown signs of improvement.

“The two men remain critical and it could be a while until they show significant change,” said Northwick Park Hospital’s Clinical Director of Intensive Care, Ganesh Suntharalingham.

“The four who are seriously unwell are continuing to show signs of improvement but it is still early days,” he added in a statement.

Relatives and friends of the two men have said the volunteers’ features have become severely swollen. One man was described as looking like the “Elephant Man” — a freak show figure in Victorian Britain whose head ballooned outwards until his skull was wider than his waist.

The hospital said patients in intensive care often needed a lot of fluid which could result in severe swelling and said this could reduce as they recover.

Suntharalingham said the six men could make a full recovery but added it was too early to make predictions. He said he did now know what had caused the violent reaction.

The trial was being run by U.S. drug research company Parexel International Corp. on behalf of German pharmaceutical company TeGenero AG.

They were testing a new antibody therapy known as TGN 1412.

British media reported the men were paid $3,500 to take part. The trial was in the first phase, when healthy humans test the drug.

Parexel said it had operated within regulatory guidelines and that such adverse reactions were extremely rare.

Shocking developments
Thomas Hanke, chief scientific officer of the German firm, said in a statement the new medicine had shown no safety problems in laboratory trials.

He said they were “shocked” by the developments and, asked by reporters whether the company had apologised, he replied “yes.” Parexel said it had operated within regulatory guidelines.

On Thursday, one of two men given a harmless placebo, told Sky News how he had watched in horror as the six around him collapsed.

Raste Khan said the volunteers were writhing in agony, continually vomiting and screaming about the pain in their heads. He said they became ill minutes after taking the drug.

“This one man was yelling ‘doctor, my head hurts, my back hurts. I need help, I can’t breathe.’ He was just shouting and rambling to himself,” he said.

“It was like Russian Roulette — two of us got away and were lucky.”

A girlfriend of another volunteer said they had been told to pray for a miracle.

Professor Karol Sikora, of Imperial College School of Medicine at Hammersmith Hospital in London, said antibody therapies target specific proteins on the surface of cells. They have been used extensively to treat cancer.

“This is a very unusual situation and at this stage it is difficult to work out what is going on with the six men volunteers,” he said.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has said it is working with police and the Department of Health to investigate what went wrong.