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Victim of Arthritis Drug Trial Horror in UK to Receive Two Million Pounds as Compensation After Two Years

by Medindia Content Team on  April 16, 2008 at 1:19 PM Drug News   - G J E 4
Victim of Arthritis Drug Trial Horror in UK to Receive Two Million Pounds as Compensation After Two Years
One of the six victims of an arthritis drug trial that turned into a catastrophe in the UK is set to receive a huge compensation two years later.
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Ryan Wilson, 22, has had all his toes amputated and the tips of several fingers removed following the "Elephant Man" drug trial. His injuries have wrecked his career as a plumber and left him unable to work.

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Wilson's battle for compensation goes to an independent hearing next month when the American company Parexel that conducted the trials is expected to offer just over £2million.

The six men who took the experimental pharmaceutical drug TGN 1412 suffered multiple organ failure. The drug had been designed to treat conditions such as rheumatoid arthritis, leukaemia and multiple sclerosis, and the London trial was the first test on humans.

Wilson suffered by far the most serious physical injuries, although the other five human "guinea pigs" are also set to receive several hundred thousand pounds each following the trial at Parexel's clinic at Northwick Park Hospital on 13 March 2006.

The head of one of the men swelled so severely he was dubbed the "Elephant Man" by his girlfriend after she visited him in hospital, while others fear long-term health risks such as cancer.

A catastrophic over-stimulation of the immune system might have caused the horrific reactions, it was then said.

TGN 1412 had shown "exquisite and unique ex vivo and in vivo T lymphocyte activating capacity and great therapeutic potential", its German manufacturer TeGenero had said then in its defence. In plain English it meant that in tests in culture dishes, using human cells, and in animals, it had performed as they had hoped.

Once a drug candidate completes animal trials successfully, it enters human trials. These usually consist of three phases, each phase involving increasing numbers of people.

Phase 1 trials are small, using only a handful of healthy volunteers. The purpose is to establish safety, and to assess what the most effective dose of the drug may be.

It was at this early stage that TGN 1412 demonstrated powerful and unexpected effects on the immune systems of the six healthy volunteers who took it. Phase 1 trials very seldom come up with shocks as profound as this, as the animal tests are designed to weed out any drugs likely to show toxic effects.

Phase 1 trials confer no benefits on those who take part in them. Sometimes volunteers are recruited among the altruistic, who simply want to help. But in this case, the volunteers were found through the website of Parexel, an international company based in Massachusetts and with offices in 36 countries around the world.

Parexel employs more than 5,000 people in a range of services to the drug industry, including the conduct of clinical trials.

TeGenero was a tiny company, with only 15 employees, so was not equipped to do its own Phase 1 trial, and hence Parexel took up the job.

Confidential documents obtained by The Sunday Times and Channel 4's Dispatches programme revealed that the drug had been administered on average 15 times more quickly to the volunteers than to monkeys in earlier safety studies.

Parexel is accused of failing to stagger the injections, which would have led to just one of the men falling ill rather than all six, and failing to offer the proper treatment once the men began to feel ill.

Instead of being given a massive dose of steroids, the men were initially given painkillers.

Wilson's lawyer Auriana Griffiths said Tuesday: "We are hopeful the case will finally settle. The case for damages will be assessed independently next month. I just hope for everybody's sake we can now wrap things up as quickly as possible.

"As to the size of Ryan's claim I cannot comment. It is confidential."

Sources have suggested that Parexel has indicated after two years of negotiation a willingness to compensate the men and that it is offering around £2 million to Wilson.

But its refusal to offer a settlement earlier or to accept any blame for what went wrong has angered the men - who were each paid £2,000 to test TGN1412.

Griffiths, a medical negligence partner at law firm Irwin Mitchell, said: "It has absolutely destroyed Ryan's life.

"He lost all his toes and the tops of some of his fingers. He cannot walk unaided and because the skin won't heal properly on his left foot he still cannot have prosthetics fitted."

She said that last month Wilson underwent yet another operation to mend broken skin.

She also regretted, "Our clients are particularly frustrated that there has been no admission of liability from Parexel.

"They have said they are sorry for what has happened but that is not the same thing. They have never accepted responsibility for what has happened in terms of the setting up of the trial.

"We have obtained evidence that is supportive of allegations of negligence in terms of their running of the trial."

The case has been made complicated by inadequate insurance cover obtained by the now defunct TeGenero. It went into liquidation after the disaster.

Its insurance was limited to £2million while Parexel has been reluctant until now to make up the difference.

Source: Medindia
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