Healthy Skepticism Library item: 12910

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Publication type: report

Wemos Foundation
A Bitter Pill
Amsterdam: Wemos Foundation 2008 Jan
http://www.somo.nl/html/paginas/pdf/A_Bitter_Pill.pdf

Abstract:

In this information booklet, the Wemos Foundation describes the risks involved when carrying out clinical drug trials on the inhabitants of developing countries, and puts forward concrete proposals for the improved protection of these vulnerable test subjects.

Preface

For many decades those working in the fields of medical ethics and health law have devoted considerable attention to the question of research into the effects of new drugs on human beings. Many countries, including all members of the European Union and the United States, have put in place extensive legislation to protect ‘test patients’, for the most part people suffering from an illness and who are given the new drug as part of an experimental treatment. At the heart of all these legislative frameworks is the requirement that such patients must have given their prior, voluntary and informed consent, and may not under any circumstances be exposed to harm. This issue continues to warrant our watchfulness and concern; in practical terms it means that every clinical
trial ought to be subjected to the scrutiny of an ethical review committee. For many years Wemos has closely examined the clinical drug trials that are carried out in developing countries by Western pharmaceutical companies. To my mind it is self-evident that these trials ought to be subject to the same ethical regulation framework as they are in the West. We must continue to discuss with politicians, policymakers and the pharmaceutical industry: are the relevant standards and regulations being adhered to? Which bodies monitor compliance? And is their supervision adequate to the task? Of course, clinical drug trials everywhere are necessarily accompanied by a certain level of risk to the participants. However, in my view we are faced with a serious problem. The West has such a voracious appetite for new and improved drugs that it sometimes seems justified to make these available at any cost. It would be mistaken to claim that the pharmaceutical industry alone is responsible for this; the matter concerns us all.

One principle, however, does apply everywhere and in all cases: the ancient Hippocratic injunction to ‘do no harm’. This does not mean that nothing will ever turn out unfavourably, but it clearly means that we must always do our best to prevent harm. And we must continue to urge each other to do the same, as is the case in this document.

Dr. Heleen Dupuis
Professor of Medical Ethics and member of the Dutch Upper Chamber of the States General