Autumn Books

Science, Politics, and the Pharmaceutical Industry: Controversy and Bias in Drug Regulation

BMJ 1995; 311 doi: (Published 21 October 1995) Cite this as: BMJ 1995;311:1101
  1. Joe Collier

    John Abraham UCL Press, pounds sterling12.95, pp 308 ISBN 1 85728 200 0

    John Abraham's book on the relationship between the regulators and the pharmaceutical industry is a classic. For years there have been suspicions, and even allegations, that all too often those responsible for regulating the licensing and marketing of drugs have favoured the interests of manufacturers rather than those of the consumer. Hard data were often sparse—in the United Kingdom not least because of the excessive secrecy surrounding licensing.

    Sometimes the special relationship was obvious; what other explanation could there be for the way the Department of Health (now the Medicines Control Agency) abrogated responsibility for controlling drug promotion to the pharmaceutical industry itself? Usually the relationship was more clandestine, with British observers often left to gather evidence from snippets dropped from the regulator's table. Often phones buzzed as consumerists analysed the wording of a press release from the Department of Health, a reply to a question in parliament, an interview with a minister, an inconsistency in a data sheet, a leak from a working party or (and of particular value) some braggadocio from the Association of the British Pharmaceutical Industry. In the analysis often what was not said was as important as what was.

    Now, with the publication of Science, Politics and the Pharmaceutical Industry, Abraham has shown many of us up as amateurs. By systematically comparing licensing episodes relating to Opren, Feldene, Zomax, Naprosyn, and Suprol in the United States and in the United Kingdom, by taking advantage of the greater access to information in the USA, by scouring the literature and badgering the authorities, he shows convincingly that, when options present, regulators in both countries favour the industry. Moreover he demonstrates that such bias is as old as regulation itself. Much of the bias is the result of the industry's lobbying skills, but there is also structural bias (if the bulk of government's advisers are close to the industry their collective opinion will tend to favour the industry), and what Adamson argues is the politicisation of science. Indeed, it is his chapter on science as an agent of politics that I found the most stimulating.

    I have no doubt that some of the conclusions reached in the book will be wrong. I also predict that the regulators will complain that they are misrepresented and anyway the examples are out of date and now all is well. Ultimately, however, the most convincing reassurance will come when the excesses of secrecy are lifted and consumers are allowed to judge for themselves. Until that day suspicion will continue.—JOE COLLIER, reader in clinical pharmacology, St George's Hospital Medical School, London


    A cyclist pedals past a neem tree in New Delhi. Oil from the tree is used in a wide range of products from toothpaste to contraceptives, and has long been used by Indians for medical purposes. The extraction process that produces the oil from the tree's seeds has become controversial because an American company, W R Grace & Co,patented the process, even though critics say that Indians have been extracting the oil in much the same way for centuries.

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