Report on drug trial disaster a whitewash, says lawyer

Ian Sample, science correspondent Friday December 8, 2006 The Guardian

Experts investigating a disastrous drug trial that nearly killed six healthy volunteers in March yesterday urged the government to impose strict measures to make future clinical trials safer. Professor Gordon Duff's expert scientific group presented 22 final recommendations to the government designed to spot potentially dangerous drugs before they enter trials and to minimise the risks to volunteers.

The group was set up by the health secretary, Patricia Hewitt, after the first human trials of TGN 1412, an experimental drug for leukaemia, multiple sclerosis and rheumatoid arthritis, at Northwick Park hospital, north London.
The six men who received the drug suffered a massive immune reaction which caused horrific swelling and widespread organ failure. One patient was described as looking like "the elephant man" after his head swelled up; another has since required surgery to remove fingers and toes, and all the volunteers have been told they face a heightened risk of cancer and immunological disorders in later life.

The catastrophe happened even though trials in animals suggested the drug was safe.

Martyn Day, a solicitor for four of the men, said his clients were dismayed at the report. "They feel it is simply the latest in a series of whitewashes," Mr Day said. "Despite four reports from the regulator, the MHRA [Medicines and Healthcare Products Regulatory Authority], and now Prof Duff, the finger of blame has been pointed at no one."

Solicitors for three other men in the trial, one of whom received a placebo, said an independent inquiry was still needed to ascertain the full facts that led to the drug being approved for human trials.

The report confirms that pre-clinical tests on the drug failed to predict a safe dose for humans, even though the regulatory requirements were met.

It recommends that independent expert scientific advice is sought before high-risk trials of novel medicines are allowed, and calls on firms, universities and hospitals to pool information from unpublished or abandoned trials that may have found evidence of adverse reactions to new drugs.

It also recommends that drugs being tested in humans for the first time are given to one volunteer at a time, in case there are ill-effects.

Some drugs should also be given slowly, by infusion instead of a one-off injection, the report adds.

TeGenero, the German firm that developed the drug, went bankrupt after the trial's failure. The men are now considering suing the research company Paraxel, which conducted the trial.

The MHRA has been accused of rubber stamping the application to test TGN 1412 on humans.

Yesterday the Department of Health said the MHRA had put in place procedures for assessing independent scientific advice. An expert advisory group to review applications for high-risk trials will be set up next year

http://www.guardian.co.uk/medicine/story/0,,1967182,00.html

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