Resumen de The use of placebo according to the laste version of the Declaration of Helsinki. Discussión between two ethical positions
Fabrizio Liborio, Pablo Requena Meana
In October 2013, at Fortaleza (Brazil), during the 64 th General As- sembly of the World Medical Association (W MA ), the latest version of the Declaration of Helsinki (DoH) was approved, a key docu- ment in the ethics of experimentation on human beings, which in 2014 celebrated its 50 th anniversary. Among the major controver- sy, the use of placebo in scientific research certainly stands, es- pecially in cases where effective drugs are already available for the pathologies object of experimentation. The fundamental ques- tion concerns the ethical adequacy of and circumstantial conditio- ns according to which placebo can be offered to patients who are part of the control group of a research trial on a new drug, when an effective treatment for that disease already exists and is utili- zed with some benefit. Our contribution offers a careful examina- tion of the two great ethical-scientific approaches to this question, even in the light of the latest update of the D O H. The first great approach, whose main authors are F.G. Miller and H. Brody, de- fends an extensive use of placebo focusing on the distinction bet- ween medical ethics and experimental ethics. The other great approach, of which B. Freedman, C. Weijer and S. Garattini are prominent representatives, does not see a distinction between re- search and medicine because of the obligation of the physician to always offer the best standard of care, therefore, this approach li- mits the use of placebo to a few cases. Thus, we have tried to show the following propositions.
1 . The problematic nature of the Declaration, even in its latest update. On one hand, it promotes the principle of beneficence, specifying that the patients involved in trials should be treated the same way as ordinary patients (art.
4), and on the other hand it legitimates P CT in the case of «con- vincing and scientifically sound methodological reasons» (Art. 33).
2 . The scarce consideration given to the D O H, or its wide and per- missive interpretation regarding the use of placebo, by the two pharmaceutical agencies the American Food and Drug Adminis- tration (F DA ) and the European Medicines Agency (E MA ). 3. Our preference for the position of the limited use of placebo, both for scientific reasons and because it reflects more the ethical tradition of the therapeutic obligation to provide treatment and the non-dis- posability principle of the person. 4 . The unacceptability, from the theoretical point of view of the D O H, of the point in question – un- doubtedly closer to the position of the limited use of placebo – which in practice results in being easily vulnerable to economic and ethical pressures, far from the spirit of beneficence that for 50 years has characterized and distinguished the D O H.
