KEY POINTS:
The worst effects of a disastrous drug trial that left six human volunteers fighting for their lives would have been avoided by taking simple precautionary measures, an expert committee has concluded.
The volunteers, all men in their twenties, almost died in the trial of the new biological drug
TGN1412, carried out in a private testing facility at Northwick Park Hospital last March.
All six experienced severe reactions within minutes of receiving the drug, including fever, swelling and vomiting, and were transferred to intensive care where they were put on life support.
One was described as looking like the "elephant man" when his face swelled and another lost his toes and some of his fingers.
The final report of an expert committee appointed by Health Secretary, Patricia Hewitt, to examine trials of new drugs in the wake of the Northwick Park incident said closer scrutiny of novel biological agents and extra precautions over their testing were necessary to minimise risks.
Although new drugs had brought great benefits to millions of patients, the safety of those in whom they were first tested must be paramount, it said.
Among 22 recommendations, it says drugs given as infusions should be administered more slowly, over hours rather than minutes, and to each volunteer in turn rather than altogether, so the test could be stopped as soon as an adverse reaction became apparent.
Professor Gordon Duff, chairman of the group and professor of molecular medicine at Sheffield University said that although risks could never be eliminated the "tragic incident" at Northwick Park would have been avoided if the measures had been in place.
"We believe quite firmly it wouldn't have happened.
The dose calculation would have been lower, the drug would have been given sequentially with a gap between each volunteer and it would have been given more slowly.
One person might have been affected but more mildly," he said.
The disaster happened because animal tests with the drug on Macaque monkeys had shown no adverse effects even at doses 500 times higher.
But the report revealed that new scientific tests on blood samples carried out in the laboratory by the National Institute for Biological Standards and Control had shown the potential of the drug to cause a "cytokine storm" - an overwhelming inflammatory response - that was not revealed by the animal tests.
Professor Stephen Inglis, who led the research at the institute, said the new tests had taken months to develop and had not been used before.
They were not available to the manufacturers of TGN1412.
Details would be published in a scientific journal and, if their effectiveness was proven, could be incorporated in future trials.
"If the test had been around [at the time of the TGN1412 trial] at least it would have rung alarm bells.
There might have been a dose adjustment," Professor Inglis said.
Andy Burnham, health minister pledged to make "every effort" to improve regulation of trials and sharing of information both in the UK and abroad.
An expert advisory body will be established in the New Year to assess clinical studies of high-risk substances.
"We believe that implementing the wide-ranging and comprehensive recommendations made in this report will make a significant contribution to the safety of clinical trials of high risk substances in the future." But Martyn Day, solicitor for four of the TGN 1412 trial patients said his clients were "very disappointed" with the report.
"They feel it is simply the latest in a series of whitewashes.
The Duff report has done a good job at looking at the lessons to be learned but it does nothing in terms of helping my clients understand the detail of exactly what happened and what went wrong."
- INDEPENDENT
