The use of placebo according to the laste version of the Declaration of Helsinki. Discussión between two ethical positions
2017
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.
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