'The therapeutic nightmare', by John Abraham and Julie Sheppard. Price £14.95. London: Earthscan Publications Ltd, 1999.
This book comprises nigh on 150 pages of a polemic against the pharmaceutical industry and drug regulatory authorities and their employees in the United Kingdom and the United States in general, and the former Upjohn Company and triazolam (Halcion) in particular. Do not expect to find within its pages an accurate or objective assessment of the process of pharmaceutical regulation over the past 10 years.
Co-written by a professor of sociology and a "head of communications" (whose qualifications to co-author a book on this technical topic are not deemed of sufficient importance to publish), a constant theme is the "big bad pharmaceutical industry and government regulators". No allowance or mention is made of the positive contribution that new medicines have brought over the past 30 years or the cost-effectiveness of most pharmaceutical treatments in comparison to other more labour-intensive forms of health care and disease management. That would spoil the argument.
The book was begun in 1993 and has a publication date of 1999. Major changes in the legislation governing the pharmaceutical industry began in Europe in 1965. These were consolidated in 1993 with the creation of the European Agency for the Evaluation of Medicinal Products (EMEA) and an enhanced role in all EU member states for the main EU regulatory body for human medicines, the Committee for Proprietary Medicinal Products (CPMP). Despite this, the EMEA is not mentioned at all in the book, and there are only four cursory references to the CPMP, completely overlooking its pivotal role in the decisions made regarding drug regulation in all 15 EU member states, including the UK. The CPMP is also involved in all aspects of pharmacovigilance in the EU and to overlook its role completely is one of the book's major flaws.
I do not recommend that this book should not be read. To do so is of interest to learn how others sometimes perceive our industry. However, I would strongly caution anyone against relying on its technical content or objectivity. The latter, in particular, is notable by its absence.
Reviewer - Robin Harman
Robin Harman is a freelance pharmaceutical and regulatory consultant based in Farnham, Surrey