Review

To be taken in small doses

Regulation of the Pharmaceutical Industry
eds. John Abraham and Helen Lawton Smith
Palgrave Macmillan, 2003. £55

This densely informative collection of studies addresses a huge and complicated topic. Its value and usefulness is as a resource; the editing juxtaposes a range of related topics but there is little coherence to the book as a whole. Thus it is hard to arrive at any general conclusions about how regulation might better serve the public interest; the introduction offers no guidance here either, merely summarising the chapter contents.

But the breadth of issues covered is impressive: the various authors cover the effects of European harmonisation, globalisation of the industry, the challenges posed by biotechnology, and relationships between governments, the state and the industry.

Many of the accounts are factual narratives, and none the less riveting for that – particularly Ollila and Hemminki’s chapter on the licensing of the Norplant contraceptive in Finland, and their 10-year struggle to get access to the relevant documentation and permission to publish their results.

There are common issues that arise in a range of these accounts – such as secrecy, transparency, accountability, authority and power – but it is left to the reader to make the connections. This lack of integration does weaken the impact of the book: the two excellent chapters discussing ethical regulations have no direct bearing on the work of other authors, despite their evident relevance.

It seems extraordinary that some chapters make no mention of the beneficiaries of pharmaceutical products; still, others do foreground users and public health in terms of population needs. Van Kammen’s chapter on users’ involvement in the regulation of contraceptive vaccines suggests that women’s health advocates have had a unique influence, and there is brief mention, too, of the impact that AIDS activists have had on the regulation of the industry and on product development.

The needs of poorer countries are also mentioned, in the context of how national essential drug policies challenge the globalised practices of the trans-national corporations.

There is much here to activate (if not surprise) the concerned reader: we learn, for instance, that in 37 per cent of 800 clinical drug trials audited in the UK, patients had given no prior consent to involvement; that there is significant under-reporting of adverse drug reactions by industry to regulators; and that despite general support for greater public access to information, 54 per cent of industry sources surveyed were opposed to US-style freedom of information. Plenty of work to do then, and this book provides an important source of information.