Ethical questions in human clinical psychopharmacology: should the focus be on placebo administration?
Of all ethical issues in clinical trial designs, only placebo use is dealt with acrimony and unwarranted, rhetoric emphasis. Many misconceptions are biased and may hamper research in the mechanisms of healing and recovery if placebo is banned from clinical trials, as some influential ethicists propose. Current treatments in psychiatry are by no means optimal and may vary in their effect across studies, rendering difficult to find the best available therapeutic method with which to compare new drugs. Because drugs possess specific mechanisms, it is not possible to compare drugs with different mechanisms as to their relevance in the pathophysiology of a given disorder. Placebo acts through non-specific mechanisms and is the ideal control for any disorder whose pathophysiology is relatively unknown and its treatment is still suboptimal. Sticking to short-term patient benefit in a trial reflects an individualistically oriented thinking in contemporary ethics and is likely to limit further research and efforts to better understand the mechanisms of disease and drug action, but also those related to general body reactance and self-healing, which are enhanced by placebo administration. Because in history ethics are swinging between two opposed views, it is possible that in the near future, the balance will move towards communitarianism, which is more likely to better serve long-term patient needs. Ethicists should also consider some other aspects of human experimentation, such as the consistency of research lines and the trend to substitute older drugs with their metabolites or enantiomers.
Kotzalidis
Gd
G
Department of Psychiatry, Sant'Andrea Hospital, La Sapienza University, Rome, Italy. giorgio.kotzalidis@uniroma1.it
Pacchiarotti
I
I
Manfredi
G
G
Savoja
V
V
Torrent
C
C
Mazzarini
L
L
Tatarelli
C
C
Amann
B
B
Di Marzo
S
S
Sánchez-Moreno
J
J
Sani
G
G
Girardi
P
P
Colom
F
F
Vieta
E
E
D002986:Clinical Trials as Topic / Q000592:standards*; D004992:Ethics, Medical; D006801:Humans; D001523:Mental Disorders / Q000188:drug therapy*; D010506:Periodicals as Topic; D010919:Placebos / Q000592:standards*; D011600:Psychopharmacology / Q000941:ethics*; D011643:Publishing
D010919:Placebos