Drug trial victim may lose fingers and toes
A man who fell into a coma in London last month during a clinical trial of TeGenero’s monoclonal antibody TGN1412 has said he may lose parts of his fingers and toes, the UK’s News of the World newspaper reported on Sunday.
“I’m told it’s like frostbite and my fingers will just fall off,” Ryan Wilson told the newspaper in an interview.
Photographs in the newspaper showed Wilson in bed at Northwick Park Hospital, in northwest London, where the trial took place, with his blackened feet and hands.
Wilson, 20, from London, was the most seriously ill of six men whose heads and bodies swelled up following injections of TGN1412 in March. He said he may well need to stay in hospital for six more months as his condition is monitored.
“The doctors say they don’t want to take my fingers off because that’s messier than if the body sorts itself out, “ he told the newspaper. “So if the fingers fall off they’ll actually heal better.
“They’re waiting for pink flesh to move further up the feet, but the tips of most of my toes are basically dead. So at the very least I’ll lose them.”
GANGRENE
Wilson was among the volunteers to have been given the TGN1412, created by the German biotech group TeGenero, by the contract research company Parexel.
Wilson said he took part in the trial, which paid ?2,000, to fund driving lessons and a holiday.
He suffered heart, liver and kidney failure, pneumonia, septicaemia, and was ventilated on oxygen. Doctors then tried to save him from dry gangrene.
“When I woke up in intensive care after almost three weeks unconscious, I only realised how serious my injuries were when I saw my hands and feet were black,” he told the News of the World.
The other five volunteers have all been released from hospital after suffering less severe symptoms.
TeGenero has said the men’s reactions were “completely unexpected” and did not reflect the results obtained from earlier laboratory studies.
In an interim report on the case earlier this month, the UK’s Medicines and HealthCare Products Regulatory Agency (MHRA) concluded that there was no evidence of problems with the quality of the test drug and no contamination or dosage errors.
It found there were no obvious errors in the testing procedure but said in future first-in-man trials of similar drugs would not be authorised without expert advice.
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