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Drug trial victims go to court to find out what medical files really say
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03 June 2008
The legal action is the latest twist in a two-year battle by the human guinea pigs to obtain millions of pounds in compensation.
Lawyers acting for the six drugs trialists have accused Northwick Park Hospital in Harrow of blocking the release of the data ahead of publication of the findings in a prestigious medical journal.
They will begin High Court proceedings today to force disclosure of tests carried out on the men to monitor their long-term health.
The hospital denies withholding the data but says it will take "some months" to make it available given its "current format".
It is understood the tests show the men are in a worse state than originally thought and are still to return to "normal" health. One, Ryan Wilson, 22, from Highbury, has had to have all his toes amputated and the tips of several of his fingers removed. He is in line to receive a £2 million payout.
The other five men have suffered less serious injuries but fear the injection of the experimental pharmaceutical drug TGN 1412 makes them susceptible to diseases such as cancer. Their compensation is much harder to calculate because it is not clear what effect TGN 1412 will have on them in years to come.
The Northwick Park data is critical in securing them payouts worth several hundred thousand pounds each from the American company Parexel, which administered the drug at its private clinic on the hospital site.
The men suffered organ failure following the tests on 13 March 2006 and their lives were saved by medical staff at Northwick Park. One man's head swelled so severely he was dubbed the "Elephant Man".
Martyn Day, of the law firm Leigh Day & Co, said today: "It is totally outrageous. We want the raw data and the hospital is withholding its release. This is about our clients, whose lives have been at risk, and their best interests. The hospital appears to be more interested in producing the data for a medical journal." One of the guinea pigs told the Standard he was appalled at the delay.
Rob, 33, a part-time actor from west London, who does not wish his surname to be made public, said: "I just want the data released so we can move on. We put trust in medical experts thinking that they know what's best for our health and peace of mind... [so] it's very disappointing."
Northwick Park said in a statement that Dr Nicki Panoskaltsis, who has tested the men regularly over more than two years, was planning to publish a paper but that his findings are "currently incomplete", making it "inappropriate to provide at this stage". It denied withholding "any medical data" relating to the TGN 1412 trial.
In a letter to the men's lawyers, Northwick Park claims that given the men have already waited more than two years, a further delay of a few weeks or months is " comparatively minor". Sally Ashkenazi, the lawyer acting for the hospital, wrote: "You have failed to provide any cogent reason why the disclosure of this data is currently of such an urgent nature." Ms Ashkenazi suggested Dr Panoskaltsis's analysis of the test results could take between four and 12 weeks but added: "We would not wish to be held to that time frame as it relies upon factors beyond our control."
But lawyers acting for the men say there is renewed urgency because a special hearing last month - which would likely have led to a payout - was postponed when Dr Panoskaltsis's research came to light on the eve of the case.
The case has been complicated by the inadequate insurance cover provided by the German company TeGenero, which invented TGN 1412 and which was declared insolvent following the drugs trial disaster. Its insurance was limited to £2 million and Parexel, which ran the trial, had until now been reluctant to make up the difference.
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