Thursday, December 07, 2006
Staff and agencies
Thursday December 7, 2006
An advisory body is to be established to assess high-risk drug trials, meeting one of 22 recommendations made today by experts who investigated a trial that left six men seriously ill in March.
However, a lawyer for some of the victims of the trial at Northwick Park hospital, north London, said his clients felt the report by the panel of scientists was yet another "whitewash".
The panel, set up by the health secretary Patricia Hewitt, made the recommendations to tighten procedures after volunteers who were given an experimental drug suffered organ failure.
Led by Professor Gordon Duff, the group recommended that the government's medicines watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), should take additional advice from independent experts when deciding whether to approve trials. It also advocated the introduction of measures intended to ensure danger signs were not missed in the run-up to future trials.
The Department of Health later said an expert advisory body would be established in the New Year to assess clinical studies of high-risk substances. The pharmaceutical industry's own guidelines on the conduct of patient trials were also being revised.
The MHRA has been accused of being too lax in its decision to approve the trial of the drug TGN 1412, which left one of the six volunteers looking like "the elephant man" after his head swelled up. Another volunteer lost parts of his fingers and toes through a reaction similar to frost bite.
TGN 1412, developed by the German biotechnology company TeGenero, was designed to treat rheumatoid arthritis, leukaemia and multiple sclerosis.
It was meant to subtly "re-tune" the immune system, but instead the trial in March provoked an adverse immune reaction.
Prof Duff said he was confident the recommendations, if adopted, would make another such tragedy unlikely.
"With any first exposure to any new medicine there is always some risk involved, even if it may be small," he said. "The important thing is to minimise that risk and manage that risk in the most appropriate ways. I think our 22 recommendations speak to these topics and if they are taken up, future clinical trials will be safer."
Martyn Day, the solicitor for four of the six victims, said his clients were "very disappointed" with the report.
"They feel it is simply the latest in a series of whitewashes," he said. "Following the terrible events of March 13 they have looked for three things to happen: an in-depth review of what exactly happened and what went wrong, an analysis of the lessons to be learnt to ensure that this never happens again to ensure what they went through is never repeated, and finally, to ensure their futures are secure financially if any of the very worrying forecasts come true.
"The Duff report has done a good job at looking at the lessons to be learnt but it does nothing in terms of helping my clients understand the detail of exactly what happened and what went wrong."
Mr Day said his clients planned to sue Parexel, the drug company that administered the trial, unless it promised them financial help to cope with any illness arising from the trial.
He added: "What is terribly disappointing about today's report is that it helps my clients not one jot. They are basically left to have the fight with Parexel alone. Depressing as this is for them, my clients are determined to continue, to get justice for what they have been put through."
Key elements of the report focus on the need for independent scientific advice before high-risk trials get the go-ahead, and the sharing of safety-related information. It also calls for data from unpublished or abandoned clinical trials which may have discovered adverse reactions to be shared freely and kept on a database.
The DoH said measures had been taken to improve the sharing of information between the MHRA and research ethics committees, which vet trial applications at a local level.
The Association of the British Pharmaceutical Industry said its guidelines for drug companies on the conduct of clinical trials were being revised following the recommendations.
However no mention was made of the sharing of possibly sensitive information about experimental drug agents.