2000, volume 16, issue 2


Placebo w badaniach leków psychotropowych

Adam Bilikiewicz
Farmakoterapia w Psychiatrii i Neurologii, 2000, 2, 114-121

On the basis of literature data and own longstanding experience, the author discusses the role of placebo in clinical evaluation of psychotropic drugs. He points out the ethical and legal aspects of the double blind, placebo controlled trials, and suggests that this procedure should be strongly limited in psychiatry. In his opinion, patients with mandatory requirements for active therapy should be excluded from placebo trials. He is also critical of the requirement for a "wash-out" period.


Problem placebo w badaniach klinicznych leków przeciwdepresyjnych

Stanisław Pużyński
Farmakoterapia w Psychiatrii i Neurologii, 2000, 2, 122-131

The author analyses ethical concerns about the double blind, placebo controlled trials in development of new antidepressants. He concludes that the placebo procedure is not a necessary condition for methodological correctness of clinical trials and should not be applied to sick people.


Komisja Bioetyki wobec badania nowych leków psychotropowych (z perspektywy badacza)

Jerzy Matysiakiewicz, Robert Pudlo, Piotr Gorczyca
Farmakoterapia w Psychiatrii i Neurologii, 2000, 2, 154-160

Authors describe 4-years experiences with the new drugs investigations. After the short presentation of the GCP rules some problems concerned obtaining the agreement of the Independent Ethics Committee are described and discussed with the special stress on ethically dubious placebo comparison.


Ethics and pharmacotherapy

Zbigniew Szawarski
Farmakoterapia w Psychiatrii i Neurologii, 2000, 2, 173-191

Most clinical problems can be boiled down to the following practical syllogism: "If a patient has a condition p, then he should be treated with q, r, or t or whatever combination of them. The patient X has the condition p. Therefore, the patient X should be treated with q, or r, or t, or whatever combination of them". It is evident that the conclusion of this syllogism is a result of two different kinds of knowledge: first, medical knowledge understood as general and universal knowledge of health, disease, and treatment which is contained in standard medical textbooks and which, according to the present fashion, is called evidence based medicine; and second, clinical knowledge which is specific knowledge of a particular patient in terms of his unique narrative identity. (Recently, this kind of knowledge has been named narrative based medicine.) Acquisition and application of medical and clinical knowledge are governed by ethical rules. The basic rules of human subject research ethics are presented and discussed. I conclude that even a perfect evidence based medical knowledge is not enough to make a sound clinical judgement. Because every human individual may have a specific reaction to a drug, each treatment is always experimentation on the human being and basic rules of human experimentation must be applied. One of the fundamental rules of clinical experiment is respect for moral autonomy of the patient which is reflected in the moral, legal, and clinical doctrine of informed consent; another, the principle of an acceptable risk-benefit balance. Both principles are examined in the context of psychiatric treatment.


Prawno-karne i cywilno-prawne skutki zakresu informacji o objawach ubocznych leku psychotropowego. Studium przypadku

Błażej Kolasiński, Jerzy Pobocha, G. Wośko
Farmakoterapia w Psychiatrii i Neurologii, 2000, 2, 192-202

Authors of work; public prosecutor and psychiatry expert and forensic doctor describe the case of suicide of depressive patient treated with fluoxetine. On the grounds of the evidence of criminal proceedings began towards the psychiatrist, who recommended this drug, the authors discuss the problems: the range and forms of information about the drug, "information" error in the course of pharmacotherapy which may be effective with criminal and civil responsibility of the physician.