Prog. Neuro-PsychophaznncoZ. Vo1.3, pp.277-200, 1979. Pergamon Press Ltd. Printed in Great Britain

SOME El’HlCAL CONSIDERATIONS IN THE DEVELOPMENT OF PsYCHoPEiARMA COLOGICAL RESEARCH AND PRACI’ICE IN TEE

E.F.B. FORSTER

Department of Psychiatry, University of Ghana Medical School Accra, Ghana

Contents

Abstract 277 1. Introduction 277 2. Social setting and medical ethics. (Influence of religion and culture) 278 3. The place of the patient in psychopharmacological research 278 4. Dangers of proliferation of psychotropic drugs 278 5. Future growth of psychopharmacological research and practice 279

References 280

Abstract

1. The author sees this issue as philosophical with paradoxical moral overtones. Ethical questions may have an inhibiting effect on drug research.

2. The individual morals and professional ethics of physicians and researchers are seen as central to the conduct of psycho-pharmacotherapeutic research.

3. The effect on ethics of religion, culture and social setting is discussed. 4. Human subjects in drug research are discussed. 5. Control of the drug industry (research, quality control, distribution) is discussed and

supra national control advocated.

Key words: rights of human being, informed consent, religion/culture influence, medical ethics, drug trials, psychotropic drugs proliferation, clinical psychopharma- cology research

1. Introduction

Ethical considerations in the field of psychopharmacology takes US into realms of philoso- phical gymnastics and moral examination.

For quite some time now the medical profession has been plagued by problems demanding moral decisions on whether it is right or wrong for a practising doctor of medicine or a medical research worker to act in a certain way even though within himself, he may think in other ways. I am not thinking here of the problems of euthanasia, but rather of the paradoxes raised by psychopharmacological research and practice.

It is generally accepted that in order to establish the efficacy of a new drug we need controlled trials. In the same breath we hear the echo of an almost nullifying statement that it is amoral to examine the efficacy of treatment by any drug by trying it out on a human being. These paradoxical statements go on to state that it is unethical to apply treat- ment to any patient, the efficacy of which has not been scientifically established.

278 E. F. B. Forster

This state of affairs is rather confusing for the doctor or research worker contemplating a career in the study of psychopharmacology. It poses a challenge to his professional ethics, if he has any; and what he considers his professional responsibility. These are both moral issues and he has three ways of introspectively examining himself; whether what he has decided to do is right in his own mind’s eye, in the eyes of others, or whether it conforms to the norm observed in his society by his peers. The self-oriented, socially oriented and the idealized moral standards he employs in his philosophical gymnastics are in turn controlled by his religious beliefs and cultural practices.

2. Social Setting and Medical Ethics (Influence of religion and culture)

Most of our moral codes are derived from our religious beliefs and these influence the direction of our decision making when moral judgements have to be made, when super-ego guid- ance is called for to avoid moral anxiety. The kind of predicament in which the doctor or researcher finds himself is at times compounded by his own limited experience in the field of psychopharmacological research and practice. How does he decide what drugs he would study, and for what purpose? He is often misguided by motivation which turns out to be a mere enthu- siasm to help relieve a patient or patients whom he knew had not been relieved by other medica tions. He may be prompted, or even coerced into a premature utilization of the drug before all the various acceptable phases of study had been completed. On what basis would he make the decision to use the drug at this stage?

Some cultural practices accept, and other reject, the use of animals in drug studies and maintain that it is wrong to utilize dumb animals for this purpose and yet, except for the Christian Science believers who decline the use of all drugs, it is a universal practice to use drugs at times of illness.

3. The Place of the Patient in Psychopharmacological Research

There is no doubt that at some stage in the evolution of a therapeutic drug for humans that a human must be used as an experimental subject. In what phase of study would this be proper? Another question which comes to mind is whether it is ethical to utilize the intra-individual comparison method in drug trials.

One of the major problems in the use of the human subject for drug study is that of consent - “informed consent”. Many a research project has had a humanitarian bias as its foundation which on close scrutiny was a mere cloak to cover enthusiasm for drug trials. We should not lose sight of the individual in our efforts to assist him. His rights to self determination are inviolable and must be respected at all times in spite of the wish of society for scienti- fic progress. He should be informed of the purpose of the study and the benefits expected to be derived from the project. He should not be misled into entering the research design, which should be carefully explained to him, administration of the drug,

not omitting any risks that may be incumbent on the

rewards and risks. without the full realization of what he was entering into, the

In spite of all these provisos some people maintain that it is amoral and unethical to request any human being to make such a decision. drug trials,

It has been suggested that

prisoners. including psychopharmacological drugs should be carried out only on condemned

The rights of the human being are of extreme importance and of such high priority that it has been suggested that there should be legislation to control his involvement in drug trials. So far only West Germany (Drug Law, 1974; Hasskarl and Kleinsorge, 1974) has come out with such legislation, which though restrictive in parts, opens the way for universal legislation on this subject (Helmchen and Mhller-Oerlinghausen, 1976).

4. Dangers of Proliferation of Psychotropic Drugs

Some of the inherent dangers of psychopharmacological research and practice are the unbridled proliferation of psychotropic drugs on the market, due to a se%ous competition

Ethical considerations in psychopharmacological research and practice 279

amongst manufacturers for control of the world market. Consequently, varying standards of quality and purity of product have entered the scene. This statement is not true only of psychopharmacological drugs. It is difficult to have an umbrella type international standards board to superintend the work of national boards to bring some order and system into the chaotic state of affairs now existing. There is a lack of international quality control.

As a result of this lack of an international standard of drug control, it was alleged (BBC, 1976) that there had been an unscrupulous release of low standard and poor quality drugs on the African continent by some drug manufacturers. These drugs were said to have been unaccep- table in other countries whose drug standard boards rejected them. Again the supply of these rejects to Africa was done on a humanitarian basis. This sort of criminal exploitation of patients is one of the outcomes of the uncontrolled growth in the production of psychopharma- cological drugs.

There is a possibility or risk of major cut-backs of industrial participation in psycho- pharmacological research if too much interference in the running of their affairs occurs. This would be a disaster because much of the progress made in the development of peychopharma- cological research has been spearheaded by the major drug houses. It is to their insatiable desire for improvement in drug quality, because of financial benefits to themselves, that we owe so much of our knowledge and use of drugs.

5. Future Growth of Psychopharmacological Research and Practice

There is no doubt that psychopharmacological research and practice will continue to grow and to contribute in a much more generous manner in the areas of mental health extension services. We all welcome this growth but hope that in the future there will be more order and meaning in the progress of the science, and not just advancement that is uncharted, on a rudderless ship.

We would like to see a systematic and rigid control of the production, distribution and marketing of psychopharmacological products. In addition to national systems of the control of production it would not be invidious for the World Health Organization to institute some system by which such a control would be globally feasible. In such a case, there should be clear and unambiguous rules to govern the production and dissemination of these products, derived from international consensus to govern research practices. Owing to the high cost of drugs today it is no wonder than many countries are embarking on their own drug manufacture. This is all the more reason why it should be treated as a matter of priority to have an inter- national consensus for the control of drug use.

We need to intensify continuing education in the study of various facets of psychopharma- cology by creating more training centres in this discipline. This is necessary because at the undergraduate level of medical education only a very small portion of this comparatively new discipline is taught to the students. Since these are the future doctors on whom the propagation of the discipline would rely, it is mandatory that adequate opportunities be pro- vided for the study of psychopharmacology, especially in departments of psychiatry of medical schools. I consider this the most appropriate place in a medical school’s curriculum for the study of psychopharmacology as it would offer the continuing education envisaged, not only to the undergraduate students, but also would offer opportunities for in-depth study to post-

graduate students and general practitioners interested in mental health services. ‘During the course of this continuing education, there would be ample opportunities to expose students and others to the problems of the ethical considerations of psychopharmacology. This should aim at raising the ethical standards to an internationally accepted level, build up confidence in the ability to make sound value judgements on ethical issues and develop a sound motivation for research, based on “growth motives”. In the process of this continuing education we should not lose sight of the negative consequences of psychopharmacological drugs or else ethical standards will be askew.

In determi.ning the legal rules envisaged in the control and direction of psychopharmacolo- gical research and practice in future, the World Health Organization has a very important and difficult part to play. I would consider it the responsibility of this body to collect, examine and abstract useful materials from sources all over the world, that are relevant to psychopharmacological research and practice, examine their ethical implications and make

280 E. F. B. Forster

recommendations in order to arrive at a reasonable acceptable consensus for governments to follow. I would expect the abstraction to contain recommendations for a shift of responsi- bilities for ethical matters in drug research and practice to Governments and pharmaceutical companies.

The World Health Organization would then be in a sound position to guide the establishment of acceptable standards of drug production and quality control, monitor the use of these drugs in research and practice and thereby encourage the exercise of high ethical considera- tions in the use of pyschopharmacological drugs for whatever purpose.

References

BBC/British Broadcasting Corporation (1976). Commentary on quality of drugs in Africa. DRUG LAW (1974) . Plans for a law which will rearrange the drug law. Entwurf eines Gesetzes

zur Neuordnung des Arzneimittelrechts. Pharm. Ind. 36: l-60. HASSKARL, H. and RLEINSORGE, H. (1974). The testing ofDrugs, the Drug Law. Arzneimittel-

prufung, Arzneimittelrecht. G. Fisher, Stuttgart. HELMCHEN, H. and MULLER-OERLINGHAUSEN, B. (1976). Ethical and legal implications of investi

gations into the efficacy of psychiatric treatments. Psychopharmacol. Bull. 12: 5-11. -

Inquiries and reprint requests should be addressed to:

Dr. E.F.B. Forster Department of Psychiatry, University of Ghana Medical School P.O. Box 4236, Accra, Ghana