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PLACEBO: ITS ACTION AND PLACE IN HEALTH RESEARCH TODAY


L. Hirszfeld Memorial International Bioethical Conference

PLACEBO: ITS ACTION AND PLACE IN HEALTH RESEARCH TODAY

Warsaw, 12th and 13th April 2003


Under the auspices of the Secretary General of the Council of Europe, Mr Walter Schwimmer / Sous le patronage de Monsieur Walter Schwimmer, Secretaire General du Conseil de l'Europe
and the Minister of Health

 

 

In the recent years, there has been a growing concern about the reliability of basic and health-oriented research. Some of these issues were addressed and discussed during the recent international conference on conflict of interest, as described in:

http://www.iitd.pan.wroc.pl/en/Events/Conferences/coi.html

One of the most important topics in applied science, and which has recently been the subject of much controversy, is the use of appropriate controls in clinical research. In fact, the efficacy of new medicines can be established in clinical trials where placebo has been used as a control. This placebo orthodoxy was recently challenged by changes in the Declaration of Helsinki, especially in the wording of its section 29:

The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, where no proven prophylactic, diagnostic or therapeutic method exists.

This change arose from concerns that patients could be disadvantaged or exploited, especially in less-developed countries. However, the wording seems to rule out many trials where such prophylactic, diagnostic and therapeutic methods exist. Therefore, advocates of placebo controls argue for scientific validity, while advocates of active controls argue for minimizing risks.

Furthermore, the mechanism of placebo action remains obscure, and the issue is further complicated by recent findings (widely publicized by the press) that in the treatment of depression the use of placebo can be superior to that of standard drugs. Recently described nocebo phenomenon (side effects of placebo treatment) seems to be very interesting, and will be presented by Prof.Barsky (JAMA 2002 Feb 6;287(5):622-7).

Obviously, such a situation poses great medical, ethical, social and economic challenges.

In view of the above considerations, it is of paramount importance to achieve some consensus on the status of placebo versus the "best treatment" or "no treatment" options in health research. It should be emphasized that the problem is multifaceted and has not only ethical, but also economic and social dimensions.

Therefore, it could be expected that the conference will be a very important event on the international bioethical arena, in that it will:

  1. allow an updating of current views and positions on the applicability of placebo in various aspects of health research;
  2. offer an important international forum meant to reach a consensus regarding the ethical use of placebo, i.e. a strategy which should assure optimal protection of research subjects while maintaining the scientific validity of the research process;
  3. set forth scientifically and ethically sound guidelines which could be used in health research internationally.



Conference schedule


Saturday, April 12

9.00 - 9:30 OPENING
Dr Rainer Gerold, Director, Directorate C: Science and Society, European Commission, Brussels, Belgium
9.35 - 10.00 Dr Randy Smoak, Jr., Chair of Council, World Medical Association, Past President, The American Medical Association - How the world was changed by placebos
10.00 - 10.25 Dr Barbara Rhode, Head, Ethics in Research & Science, European Commission, Brussels, Belgium - Ethics in research: Striving for common ground within the cultural diversity in Europe
10.25 - 10.50 Dr Peteris Zilgalvis, Bioethics Division, Council of Europe - Placebo use in biomedical research: how is it addressed in the Convention of Human Rights and Biomedicine and its draft Protocol on Biomedical Research
10.50 - 11.15 Prof.Juhana E. Idanpaan-Heikkila, M.D., Ph.D., Secretary General, Council for International Organizations of Medical Sciences - The CIOMS views on the use of placebo in clinical trials
11.15 - 11.30 COFFEE BREAK
11.30 - 11.55 Prof. Francis P. Crawley, Secretary General European Forum for Good Clinical Practice, Belgium - A history of the debate on the Declaration of Helsinki's stance on placebos: scientific pride and the desire of ethics
11.55 - 12.20 Dr Robert Temple, Associate Director for Medical Policy, FDA, USA - Problem of active control trials
12.20 - 12.45 Jeremy Sugarman, M.D. M.P.H., M.A., Director, Center for the Study of Medical Ethics and Humanities, Professor of Medicine & Philosophy, Duke University Medical Center, USA - Data, Rhetoric, and the Ethics of Placebo-Controlled Trials
12.45 - 13.10 Nikola Biller-Andorno M.D., Ph.D. University of Gottingen, Germany - The use of the placebo effect in clinical medicine – ethical blunder or ethical imperative?
13.10 - 13.35 Prof. Ernst A.Singer, Chairman, Ethics Committee, University of Vienna, Austria - The necessity and the value of placebo
13.35 - 14.30 LUNCH
14.30 - 14.55 Dr. Olivier Chassany, M.D., Ph.D., Direction de la Politique Medicale de l’Assistance Publique, Hopitaux de Paris, France - Why the restriction of placebo use may hinder clinical research
14.55 - 15.20 Prof. Jan Joerden, Prorector, University Viadrina, Frankfurt/Oder, Germany - Placebo and informed consent
15.20 - 15.45 Prof.Jacek Splawinski, The Drug Institute, Warsaw, Poland - Clinical trials: active control vs placebo - what is ethical?
15.45 - 16.10 Prof.Bozidar Vrhovac, Chairman, Committee for Ethics and Deontology, Medical Chamber, Croatia - Placebo and Helsinki Declaration - what to do?
16.10 - 16.25 COFFEE BREAK
16.25 - 16.50 Dr Joanne Box, Medical Research Council, U.K. - Placebo and MRC - and the consumer's perspective
16.50 - 17.15 Dr Patricia Huston, The Health Canada Project Director - Public consultations in Canada on the appropriate use of placebos
17.15 - 17.40 Prof. Franz Porzsolt, University of Ulm, Germany - Economic implications of placebo effect
19.00 Welcome reception


Sunday, April 13

9.00 - 9.25 Arthur J.Barsky, M.D., Professor of Psychiatry, Harvard Medical School, USA - The nocebo phenomenon and its implications in clinical practice
9.25 - 9.50 Prof. Stanisław Pużyński, National Consultant in Psychiatry, Institute of Psychiatry & Neurology, Poland - Placebo in the investigation of psychtropic drugs, especially antidepressants
9.50 - 10.15 Raul de la Fuente-Fernandez, M.D., University of British Columbia, Vancouver, Canada - The biochemical bases of the placebo effect
10.15 - 10.40 Prof. Thomas R. Weihrauch, Senior Vice President, Global Medical Strategy & Relations, Bayer AG, Germany - Placebo treatment is effective differently in different diseases – but is it also harmless?
10.40 - 10.55 COFFEE BREAK
10.55 - 11.20 Franklin G. Miller, Ph.D., Department of Clinical Bioethics, National Institutes of Health – The ethics of placebo surgery
11.20 - 11.45 Prof.Josef Glasa, M.D., Institute of Medical Ethics, Bratislava, Slovakia - Placebo - controlled trials: possible problems from Central & East - European perspective
11.45 - 12.10 Prof. P.Zaborowski, Dr Adam Gorski, Poland - Informed Consent and the use of placebo in Poland: Legal and Ethical aspects
12.10 - 12.35 Prof.Vladimir A. Gheorghiu (Justus-Liebig University, Giessen, Germany), Dr Romuald Polczyk (Jagiellonian University, Cracow, Poland) - The “instrumental” placebo effect
12.35 - 13.00 Dr Bohdan Wasilewski, Chairman, Department of Psychosomatics, Sexuology and Pathology of Intepersonal Relations, Medical Centre for Postgraduate Education, Poland - Homeopathic medicines as placebo alternatives?
13.00 LUNCH