Healthy Skepticism Library item: 7055

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Publication type: Journal Article

Day M.
Duff's report calls for changes in way drugs are tested.
BMJ 2006 Dec 16; 333:(7581):1240
http://www.bmj.com/cgi/content/full/333/7581/1240-a

Abstract:

Experts have called for major changes to the way new drugs are tested to avoid a repeat of the disastrous Northwick Park Hospital study that almost killed six volunteers.

The panel, set up by health secretary Patricia Hewitt and led by Gordon Duff, professor of molecular medicine at Sheffield University, investigated the incident in which all six recipients of the immune modulating drug TGN1412 had multiorgan failure at the private research wing of the Northwick Park Hospital, north London, in March this year.

In the light of events, the report makes 22 recommendations for pre-phase I, “first-to-human” trials using new drugs or drugs that alter the immune system.

It calls for independent expert advice to be sought before such high risk studies are allowed. It also calls on firms, universities, and hospitals to pool information from unpublished or abandoned trials that may provide clues about adverse reactions to new drugs.

The report also recommends that when drugs are tested in humans for the first time they be given to one volunteer at a time, in case there are rapid ill effects. Some drugs should also be given slowly, by infusion instead of a one-off injection, the report adds.

But while observers were still perusing the report, some campaigners were already dismissing it as a whitewash.

Martyn Day, the solicitor for four of the six victims, said his clients were “very disappointed” with the report.

He said: “They feel it is simply the latest in a series of whitewashes. Despite four reports from the regulator, the MHRA [Medicines and Healthcare Products Regulatory Agency], and now Professor Duff, the finger of blame has been pointed at no-one.

“The 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.”

Others were less critical of the report. Ann Alexander of Irwin Mitchell, the law firm representing Ryan Wilson and Mohamed Abdelhady, the two men most seriously injured in the TGN1412 trial, largely welcomed the findings.

Of particular importance, she said, was the report’s acknowledgement that the TGN1412 study had not considered what constituted a safe dose for use in humans-and had not been required to under current law.

“Going forward, it is now critical that the 22 recommendations made by the committee are implemented urgently to ensure the safety, rights and wellbeing of volunteers taking part in future clinical trials,” she said.

Evan Harris, Liberal Democrat science spokesman said: “While I have every sympathy for the men who suffered in the TGN1412 trial, I don’t think the litigants or their lawyers have a good case when they claim there has been a cover up.

“This thorough report makes some helpful recommendations for the future and is correct to conclude that there was no negligence in this case.”

The volunteers are launching a multimillion pound damages claim against Parexel, the research company that conducted the trial.

The worst affected of the volunteers, Ryan Wilson, had to have fingers and toes amputated.

The Association of the British Pharmaceutical Industry said that its guidelines on the procedures of clinical trials were being revised.