Clinical trial safety committees: the devil's spoonBMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7229.244 (Published 22 January 2000) Cite this as: BMJ 2000;320:244
- J R Hampton, professor of cardiology (John.Hampton@nottingham.ac.uk)
- Division of Cardiovascular Medicine, Queen's Medical Centre, Nottingham, NG7 2UH
- Correspondence to: J R Hampton
- Accepted 1 November 1999
He who sups with the devil needs a long spoon. To cast the pharmaceutical industry in the role of the devil may seem a little unfair, but the British Biotech affair has shown all too clearly that there are times when the industry must be kept at arm's length from the development of its own drugs. This paper describes briefly the problems which beset British Biotech—reports of which have generally been confined to the financial pages of the daily press—and emphasises the need for the medical profession to recognise that the relation between drug development and patient care will always be an uneasy one.
British Biotech was (and still is) one of the new breed of companies based on high technology, “hype,” and promise. Its market capitalisation—with a share price based solely on drugs under development—increased so much that the company nearly gained entry to the FTSE 100 index. When the director of clinical research, Dr Andrew Millar, told the principal shareholders that the clinical trials of two of their drugs were not going as well as the directors had claimed, he was dismissed and the share price collapsed. Millar was then sued by the company for breach of confidentiality. After nearly two years of legal wrangling British Biotech backed down and compensated him. The company's wrists were slapped by the Stock Exchange council—which is apparently what passes as “self regulation” in the City—and the story was over.
But all this need never have happened, and would not have done, had the two clinical trials in question been watched over by a data monitoring and safety committee. Although most companies and academics involved with clinical trials take the importance of data monitoring and safety committees as read, the British Biotech story is worth telling for the benefit of those who …