THIS disaster will not only endanger the life of the volunteers but will also cost the pharmaceutical company concerned tens, probably hundreds, of millions of pounds and undermine the credibility of the industry itself.

Unfortunately, anti-inflammatory drugs designed to treat patients with rheumatic diseases have displayed unexpected but sinister adverse affects when released for general use.

Britain’s lead in haematology and the care of people with malignant blood disorders has been achieved only through co-operation between doctors, volunteers and patients, governed by the current system of clinical trials. This system ensures that drugs are tested in the laboratory and on animals as well as on healthy human beings before being given first to patients in the hospital system and then more generally.

All drugs are approved by the Medicines and Healthcare products Regulatory Agency, the British drug safety authority, and a similar European authority, and will not be widely used until endorsed by the National Institute for Health and Clinical Excellence, which not only has to determine that the drugs are clinically safe and efficacious but also cost-effective.

No drug that puts six out of eight volunteers in intensive care in the first comparatively few hours of treatment could be acceptable but, even as the inquiries take place, we should not forget that the pharmaceutical arch villain thalidomide is now a life-prolonging, sometimes life-saving, anti-cancer drug and that aspirin would never have been approved for clinical use if the present trial system of judging drug safety was around when it was first manufactured.

To introduce a drug to the market costs an estimated £300 million. To reach the stage where it is being given to volunteers, much of the research will have already been completed.

But despite the financial loss to an individual company, nothing is as important as maintaining patients’ faith in the pharmaceutical industry.

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