The randomized clinical trial is a scientific method for solving clinical problems. The method is typically employed before a new type of treatment is offered on a major scale in order to safeguard patients against a less curative therapy. Especially with regard to cancer treatment, randomized studies are conducted in increasing numbers. However, there remains a considerable discrepancy between the actual number of patients entered in randomized trials and the eligible number available. The demand of obtaining informed consent is a major reason for not entering patients into randomized studies. The critical item is whether information about randomization as a method for allocation should be disclosed to the patient. The doctor feels embarrassed not to be able to advise and support the patient in decision making about treatment and finds his or her role as the caring doctor replaced by the roulette. The requirement to seek informed consent has increased the rate of denial to participate in randomized trials from a few percent, up to about 50% or even higher.
After many years of disregard, the use of psychedelic drugs in psychiatric treatment has re-emerged in recent years. The prospect that psychedelics may again be integrated into mainstream psychiatry has aroused interest in long-forgotten research and experience from the previous phase of psychedelic therapy, which lasted from the late 1940s to the 1970s. This article will discuss one large-scale psychedelic therapy programme at Modum Bad Nervesanatorium, a psychiatric clinic which treated 379 inpatients with psychedelic drugs during the years 1961-76. The psychiatrists there initially regarded the psychedelic treatment as efficacious and without serious negative reactions, but reports of long-term harm have since surfaced. This article discusses how insights from Modum Bad might benefit the new generation of psychedelic treatment efforts.
One hundred and fourteen in- and out-patients from a department of internal medicine were interviewed, on the basis of a questionnaire with the following key questions: 1) Their attitudes to medical trials with man as the subject. 2) Their emphasis on informed consent. 3) Their attitudes to inclusion of patients not being able to give informed consent. 4) Their attitudes to tentative participation in 4 concrete projects. In all, 98% considered doctors' and patients' collaboration on new therapeutical methods both necessary and desirable. Eighty-eight per cent considered information of patients participating in trials a prerequisite. Eighty-six per cent accepted participation in scientific trials based on the guarantee of the doctors responsible. Of these 86%, 58% felt that a scientific-ethical committee's accept of the project implied an extra element of security. Seventy-five per cent replied that patients not being able to give informed consent themselves could be included in scientific trials. The majority, 77%, added that patients' relatives would then have to accept, 20% that such trials could be based on the participating doctors' responsibility, and only 2% that such a responsibility was to place on scientific-ethical committees. In the 4 concrete projects, answers followed a uniform trend: full information of patients was demanded by approximately 80%, and acceptance of participation resting with responsible doctors in more than 80%. Less than half of these 80% felt that evaluation by a scientific-ethical committee would add to patients' security.
Dr. Kenneth Rothman, a critic of the use of placebos in clinical trials, recently discussed the issue with Health Canada employees. Some researchers insist this is not a black-and-white issue, and that in some cases patients who receive a placebo are the lucky ones.
