Placebo and the helsinki declaration — What to do?

The Helsinki Declaration is the ‘gold standard’ — a directive, not a law, on how to conduct controlled studies in humans in conformity with ethical principles. In spite of many discussions about their unsuitability some articles have remained unchanged in the most recent (sixth) revision of the Declaration. The demand to use “the best treatment” excludes use of placebo in the control group and presents an obstacle to the scientific evaluation of a number of drugs and treatments in general. The use of placebo is justified whenever its use does not cause irreversible damage or considerable suffering to the well informed patient. It must be, is, and will be used in the controlled clinical trials of treatments of a great number of diseases especially those which have a tendency to spontaneous improvement, even healing, or have a pronounced psychological component An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Placebo in the investigation of psychotropic drugs,especially antidepressants

The paper presents major ethical, legal and methodological problems related to the use of placebo in mental disorders, especially in depression. It is pointed out that although authoritative groups of experts and numerous publications in the field of psychopharmacology indicate advisability of the double blind design with placebo in clinical trials of antidepressants, in recent years there have been more and more voices questioning legitimacy of this method. Objections of an ethical nature are raised, and reliability of this approach is put into doubt from the methodological viewpoint. These issues are discussed in more detail in the paper. Available alternative solutions should be implemented in psychotropic drug studies. The author shares these objections and doubts of an ethical nature, and believes that the placebo procedure is not a necessity in clinical trials of antidepressants. An earlier version of this paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Sham surgery: An ethical analysis

Surgical clinical trials have seldom used a "sham" or placebo surgical procedure as a control, owing to ethical concerns. Recently, several ethical commentators have argued that sham surgery is either inherently or presumptively unethical. In this article I contend that these arguments are mistaken, and that there are no sound ethical reasons for an absolute prohibition of sham surgery in clinical trials. Reflecting on three cases of sham surgery, especially on the recently reported results of a sham-controlled trial of arthroscopic surgery for arthritis of the knee, I present an ethical analysis that focuses on the methodological rationale for use of sham surgery, risk-benefit assessment, and informed consent.     

Searching for the facts in the clinical setting with couples

This paper describes a research proposal to examine whether or not the underlying analytic concepts behind the couple psychoanalytic psychotherapy model used at the Tavistock Marital Studies Institute in London are sufficiently coherent, both conceptually and clinically, to be used as the basis for a system of audit which respects the unique data produced in analytic psychotherapy. This 'psychoanalytic' system of audit is one which is characterized particularly by the use of the therapists' subjectivity, rather than attempts to be objective and gather data through such things as random controlled trials or generic outcome questionnaires. The paper describes the approach to the subject and the mix of qualitative and quantitative methods used. As the Tavistock Marital Studies Institute has a history of contact with Jungian analysts from the Society of Analytical Psychology, Jungian concepts are included in the model. The research is part of a professional doctorate in couple psychoanalytic psychotherapy at the Tavistock Marital Studies Institute in conjunction with the University of East London, entitled 'Conceptualizing audit in Couple Psychoanalytic Psychotherapy'.     

Patient Expectations of Benefit from Phase I Clinical Trials: Linguistic Considerations in Diagnosing a Therapeutic Misconception

The ethical treatment of cancer patientsparticipating in clinical trials requiresthat patients are well-informed about thepotential benefits and risks associated withparticipation. When patients enrolled in phaseI clinical trials report that their chance ofbenefit is very high, this is often taken as evidence of a failure of the informed consent process. We argue, however, that some simple themes from the philosophy of language may make such a conclusion less certain. First, the patient may receive conflicting statements from multiple speakers about the expected outcome of the trial. Patients may be reporting the message they like best. Second, there is a potential problem of multivocality. Expressions of uncertainty of the frequency type(e.g., ``On average, 5 out of every 100 patientswill benefit') can be confused with expressionsof uncertainty of the belief type (e.g.,``The chance that I will benefit is about80%'). Patients may be informed using frequency-type statements and respond using belief-type statements. Third, each speech episode involving the investigator and the patient regarding outcomes may subservemultiple speech acts, some of which may beindirect. For example, a patient reporting ahigh expected benefit may be reporting a beliefabout the future, reassuring family members,and/or attempting to improve his or her outcome by apublic assertion of optimism. These sources oflinguistic confusion should be considered injudging whether the patient's reported expectation isgrounds for a bioethical concern that there hasbeen a failure in the informed consent process.     

Games in Clinical Genetic Counseling Supervision

Games are defined as ongoing series of complementary ulterior transactions that are superficially plausible but have a concealed motivation to maximize pay-offs and minimize penalties for the initiator. While some games are harmless and part of socialization, others are destructive. Destructive game-playing in clinical supervision, in which game-playing (initiated by either supervisors or students) interferes with a student's realization of internship goals, has been documented in some allied healthcare professions but has not yet been studied in genetic counseling. Genetic counselors and clinical supervisors of genetic counseling students were anonymously surveyed regarding their experiences with destructive game-playing. Results show that such games do occur in genetic counseling clinical supervision. Some games are the same or similar to ones previously described in other health-care professions; others may be unique to genetic counseling. The purpose of this paper is to document these games as a first step to facilitating dialogue, understanding and awareness of them.     

The use of moral dilemmas for teaching agricultural engineers

Agricultural engineers’ jobs are especially related to sustainability and earth life issues. They usually work with plants or animals, and the aim of their work is often linked to producing food to allow people to improve their quality of life. Taking into account this dual function, the moral requirements of their day-to-day professional practice are arguably greater than those of other professions. Agricultural engineers can develop their ability to live up to this professional responsibility by receiving ethical training during their university studies, not only by taking courses specifically devoted to ethics, but also by having to deal with moral questions that are integrated into their technical courses through a program of Ethics Across the Curriculum (EAC). The authors feel that a suitable pedagogical technique for achieving this goal is the use of moral dilemmas, following Kohlberg’s theory of levels of morality (1981), with the final objective of attaining a post-conventional level. This paper examines the possibilities and limitations of using moral dilemmas as a pedagogical technique for training agricultural engineers. The cases, discussions, and evaluation used in the Agricultural Engineering Department of the Technical University of Valencia (Spain) are also presented. An earlier version of this paper was presented at the 2005 conference, Ethics and Social Responsibility in Engineering and Technology, Linking Workplace Ethics and Education, co-hosted by Gonzaga University and Loyola Marymount University, Los Angeles, CA, USA, 9–10 June 2005.     

The concept of quality in clinical research

Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000. An earlier version of the paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.