Ruth Macklin. Double standards in medical research in developing countries. Published in the series ‘Cambridge Law, Medicine and Ethics’. Cambridge, U K: Cambridge University Press. 2004. 280 pages. Paperback. Price not stated. ISBN 0 521541700

Dr Ruth Macklin is well known to readers of this journal. She is a Professor of Bioethics at Albert Einstein College of Medicine, New York. Her recent visit to Mumbai evoked considerable enthusiasm among the few working in the field here.

In this book she explores ethical controversies surrounding medical research in developing countries. Characteristically she focuses on exploitation of subjects in these countries by multinational companies employing double standards in clinical studies.She also questions whether the fruits of such studies will be made available to poor patients in the countries where they were carried out. Her conclusion – double standards in medical research to the disadvantage of subjects and patients in poor countries are unacceptable – will strike many sympathetic chords.

At the beginning of the first chapter she highlights an important controversy. Are multinational companies justified in carrying out research on drugs in poor countries when such studies can be carried out in developed countries? Is it fair to use the poor as guinea pigs merely because such studies will cost less and they can be completed rapidly since large numbers of subjects are available? Arguments pro and con are discussed. ‘Exploitation of the poor’ is juxtaposed against raising the standards of medical research in poor countries.

She enunciates fundamental principles. I refer to two. i) There can be no justification for conducting research in a developing country when the same research could not ethically be conducted in the United States or Europe. ii) Since the burdens of serving as research subjects fall upon the developing countries, the population in those countries…deserves the same type of benefits that flow to the wealthier or insured populations in countries that sponsor research.

I found the section “Which countries are “developing?” (pages 9 – 12) amusing. Obviously, feathers are ruffled when the simple, age-old terms poor and rich are used!

Dr Macklin correctly points out: “Moral development is a concept conspicuously absent from international discourse, despite frequent allusions to the related, yet different, concept of human rights.”

In separate sections, Dr. Macklin discusses ethical standards in research; justice in research and the allied topic of avoiding exploitation; the provision of safeguards against exploitation whilst maintaining high standards; making drugs affordable, especially in the countries in which research has been carried out on them; and generally upholding human rights. In the final chapter she focuses on the need for a single standard, worldwide. Each chapter provides food for deep thought.

In her concluding remarks, she states: ‘The purpose of biomedical research is to contribute to scientific knowledge that can be used to provide better clinical care and introduce better public health measures for all people, not just the inhabitants of wealthy countries, or the wealthy inhabitants of poor countries.’ This book goes a long way in arousing consciousness on present inequities that come in the way of reaching this goal.

This book deserves careful study by health administrators, researchers, and leaders in the pharmaceutical industry and human rights activists.