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UK drug trial victims face uncertain futures

"When I came around from the sedation, most of the doctors had a shocked look on their faces and said, `You're lucky to be here.'"

Ryan Wilson, clinical trial victim

Lawyers acting for the six volunteers who suffered multiple organ failure during the trial of a new drug last month fear the men may not get full compensation because the company accepting liability for the injuries was underinsured.

Martyn Day, solicitor for four of the men, said the German pharmaceutical company TeGenero, which created the drug TGN1412, had insurance of only £2 million (US$3.5 million) for the trial but the liability for damages and losses suffered by the men may be much bigger.

The revelation came as the full extent of the injuries suffered by one of the men emerged.

Ryan Wilson, 20, the man who suffered the most severe effects of the drug, said he would lose some of his fingers and toes and would be in hospital for another six months.

Wilson has defied the expectation of doctors treating him at Northwick Park hospital in north London -- he survived heart, kidney and liver failure, pneumonia and septicemia in the days after receiving the dose of TGN1412.

But his hands and feet are swollen and rotten.

"Now they're waiting for my body to heal itself. I'm told it's like frostbite and my fingers will just fall off," he told the News of the World newspaper.

"From what I've been told, I'm not supposed to be here. When I came around from the sedation, most of the doctors had a shocked look on their faces and said, `You're lucky to be here,'" he said.

He said he only took part in the trials, for which the volunteers were paid £2,000, to buy driving lessons and a holiday and the only side effects he was warned of were headaches and nausea.

The long-term prognosis of all six men is uncertain but they have been warned they may have suffered serious damage to their immune systems.

The consent form the men were asked to sign showed that TeGenero was aware the drug might seriously damage the immune system. It warned of the possibility of a "cytokine release", a massive immune system reaction.

"The consent form which each of the clients signed said that TeGenero would pay compensation as a matter of course. Now we find that in fact there may well not be enough money for the men to be paid what they need," Day said.

Richard Powell, an expert in clinical immunology, said £2 million was unlikely to be enough to compensate the men for the long-term effects to their health. He said they could develop auto-immune disorders, in which the body attacks itself by mistake, the very type of condition the drug was being developed to treat. A second risk was that the men's immune systems could be permanently compromised, making them prone to infections or even tumors.

Senior TeGenero executives said on Sunday that the company agreed, before the start of the trial, to compensate the volunteers in the event of any injury, according to Association of the British Pharmaceutical Industry guidelines.
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