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Catastrophic Elephant Man Drug Trial Victims Injected Recklessly

by Medindia Content Team on  September 26, 2006 at 4:40 PM Drug News   - G J E 4
Catastrophic Elephant Man Drug Trial Victims Injected Recklessly
Experts allege that victims of the terrible 'Elephant Man' clinical trial were given the test drug injections at a 'reckless' rate.
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The drug, a monoclonal antibody was TGN 1412 that is supposed to fight leukaemia, multiple sclerosis and rheumatoid arthritis. Confidential documents have revealed that the victims had been injected 15 times faster than when given to monkeys in animal studies.

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Scientists claim that this 'reckless' mistake probably explained the disastrous reaction to the drug that has left volunteers fighting for their lives.

The six young men who has volunteered for the trial were all fit and healthy before signing up for the March trial at Northwick Park Hospital in North-West London. After the injection they suffered a host of side-effects, including pain, vomiting and organ failure.

Bar manager Mohamed 'Nino' Abdelhady, 28, had his head swollen up and was described as 'the Elephant Man' by his partner Myfanwy Marshall.

Trainee plumber Ryan Wilson, 20, suffered heart, liver and kidney failure, pneumonia and blood poisoning and remained n a coma for three weeks.

While in coma, he suffered a frostbite-like reaction and eventually lost parts of his fingers and had his toes amputated.

The trial volunteers are launching a multimillion pound damages claim against Parexel, the private research firm which undertook the trial. The victims are now at a risk of contracting cancer and other chronic and incurable diseases such as multiple sclerosis.

An investigation by the Medicines and Healthcare products Regulatory Agency, concluded that no discrepancies existed in the making and testing of the drug but rather was blamed on unpredictable effects of the drug in the human body.

However documents obtained by the Channel 4 program Dispatches has revealed that the speed at which the drug was given could be to blame.

According to them Mr Wilson was given the drug in just four minutes. The others were injected or infused with the solution over periods ranging from three to six minutes. On the other hand monkeys used in earlier experiments were slowly infused with the drug over an hour.

Professor Terry Hamblin, a Southampton University expert on monoclonal antibodies, said: 'When you give an antibody, the quicker you put it in, the more likely you are to get a reaction.

'I usually give it over about six hours. If you give it in less than an hour you get horrific reactions.

'To quickly infuse it over three to six minutes in six individuals I think is reckless.'

Dr David Glover, former chief medical officer of drug developer Cambridge Antibody Technology, said: 'The drug was given too quickly.'

A spokesman at MHRA, which had signaled the go ahead for the human trial after examining the results of animal experiments, said the men were given doses 500 times lower than those used in animals and that said similar drugs have been given to people in the past at a faster rate without any problems.



Source: Medindia
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