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Last Updated: Tuesday, 13 March 2007, 00:15 GMT
Moving on from drug trial horror
By Clare Murphy
BBC News

Gloved hand holds a syringe
New rules were issued after last year's drug trial disaster
Rob may be at risk of developing a series of diseases after taking part in a disastrous drug trial a year ago, but he says he feels quite upbeat.

"I could worry about it," says the 32-year-old.

"But I've made a promise to myself that I won't let it get the better of me.

"A year ago I could barely walk. Now I go to the gym. I've got a personal trainer. I'm feeling pretty positive."

Rob was one of six trial participants at an independent site at Northwick Park Hospital who suffered organ failure after being injected with a drug which sent their immune systems into overdrive.

On the anniversary of one of Britain's most disastrous drug trials, his lawyer is holding talks with the company involved, aimed at thrashing out a compensation deal.

So far, each man has received 10,000 as an interim payment from an insurance fund.

The pot still contains about 2m, but this is not enough, lawyer Martyn Day argues, to cover the future health problems - including contracting cancer - his clients may suffer.

Parexel, the US clinical research group which conducted the trial, has yet to come up with "a sausage" in compensation, he says.

The company denies it was negligent. It did not itself develop TGN 1412, designed to treat multiple sclerosis, leukaemia and arthritis, but carried out the trial on behalf of a German firm which has now filed for insolvency.

The worst affected of the group was 20-year-old Ryan Wilson. His fingertips and toes have been amputated, and he says he will never achieve his ambition of becoming a plumber.

Rob says his case against the company is in part about seeking compensation for the future.

"I could have two kids and a wife. I don't want to be a burden on them if I fall ill," he says.

But for him, it is also equally about getting his own back.

"They need to be punished. And the thing is, they can afford it."

Changing procedures

In December, an expert group set up by the Department of Health issued 22 recommendations on how mistakes made at Northwick Park could be avoided in the future.

A year ago I could barely walk. Now I go to the gym
Rob
The recommendations included calls for independent expert advice to be sought before high risk studies go ahead, as well as ensuring the provision of adequate medical back-up at suitable units.

Observers say in any event trial practitioners were keen to learn the lessons of Northwick Park. Changes in the size of doses, and the intervals in between, were implemented in the immediate aftermath of the incident, before any new regulations were drawn up.

The Medicine and Healthcare products regulator (MHRA), which was accused of being too lax in its decision to approve the TGN 1412 trial in the first place, says it wholeheartedly supports the recommendations and that many have already been implemented.

Ryan Wilson's hands
Trainee plumber Ryan Wilson was the worst affected by the trial
But it concedes problems with one of the key points of the report: the need to collect information about adverse reactions from unpublished clinical studies, making such data available to all before they embark on their own trial.

This has proven difficult at a number of levels.

For one, it requires a level of international co-operation that takes time to establish.

"We have already raised these issues with the relevant European Commission authorities who will normally act on behalf of all member states in taking the lead on issues with an international dimension," said the MHRA in a statement.

"We will continue to press for the commission to take action to prioritise their implementation."

But drug companies are also in competition with each other, and insiders say it can be difficult to strike a balance between sharing useful safety information and allowing competitors insight into business activity.

Good publicity

In any event, last year's high profile drug trial disaster does not appear to have deterred volunteers.

Richard Ley, spokesperson for the Association of the British Pharmaceutical industry (ABPI) says exact figures are hard to come by, but if anything there has been positive impact on the number of people signing up to take part in trials.

"People were perhaps not aware of the money available, and the coverage at the time made clear that these trials were actually very safe," he says.

Rob still feels that being a drugs trial volunteer is "gallant".

"I think it's a great thing to do for society," he says.

"Just watch out who you're doing it for. They're not all Marie Curie."




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