The Case Against Randomized Controlled Trials – An Initial Foray Existential Psychoanalysis: Is It Art, Science or Self Healing Miracle?
Joe Tarantolo, M.D., Psychiatrist
“… the tyranny of randomized controlled experiments…” (David Brooks, New York Times, October 8, 2018)
“… Science Without Humanity…” is 1 of the 7 deadly sins of Mahatma Gandhi
“Most clinical research is not useful.” (John Ioannides, MD - https://www.youtube.com/watch?v=Uok-7NPFn4k)
“… it is essential that psychoanalysis be situated as an existing practice within the art of science… a controlled randomized comparison study has not been conducted…” (Dr. Aida Alayarian, J.A.S.P.E.R. International, 2018 Vol 2, Issue 1)
When in confusion about good and evil, it is often helpful to turn to Nazi atrocities for clarification. Although the Third Reich did not/has not cornered the market on “bad,” they were expert and like many clever evil doers they sucked in those with an insecure hold on their own morals. They did many heinous “experiments” but the most famous was the Dachau hypothermia experiments. Robert L. Berger, MD examined these experiments (see “Nazi Science – the Dachau Hypothermia Experiments, NEJM, 1990, Vol 322:1435-1440.) The experiments were directed by Sigmund Rascher, a deadbeat Nazi with no experience in scientific research who wanted to impress Himmler. The debate has been: given the unethical malice of the experiments – at least 80 of the 300 “volunteers” died – should the data be used anyway in the hope that they, the data, at least might contribute to scientific knowledge? Allegedly Dr. Rascher wanted to find the best way to re-warm soldiers and pilots who were subjected to cold water i.e. sinking ships, crashed airplanes. In sum (I’d rather not give details of the sickening experiments) Dr. Berger demonstrates the scientific uselessness of these experiments: “…critical shortcomings in scientific content and credibility… without an orderly experimental protocol… with inadequate methods and an erratic execution… riddled with inconsistencies… data falsification and… fabrication… [unsupportable] conclusions… a consistent pattern of dishonesty and deception… all the ingredients of a scientific fraud…”
But, there is a problem here for me. There is the implication that if Rascher had not been a medical nincompoop, had been a serious intellectual, had adhered to coherent scientific protocol, maybe then the data would pass muster, putting aside the obvious ethical lapses – clearly these were not “volunteers” fully informed about risk! My contention is that science without humanity is not only a “sin” but it is useless. As David Cohen and David Jacobs point out, Randomized Controlled Trials (RCT) of antidepressants are “clinically and scientifically irrelevant” (see Cohen & Jacobs (2010). Randomized Controlled Trials of Antidepressants: Clinically and Scientifically Irrelevant, The Institute of Mind and Behavior, Inc., 31:1,2, pp. 1-22; & Jacobs & Cohen (2010). The Make-Believe World of Antidepressant Randomized Controlled Trials — An Afterword to Cohen and Jacobs. The Institute of Mind and Behavior, Inc., 31:1,2, pp. 23-36).
I believe this goes for all RCTs.
PLACEBO IS A BASTARDIZATION OF SELF HEALING
Cohen and Jacob's critique, however, focuses on the design of the studies, the capriciousness of the medical diagnostic category model, and the toxicities of drugs. They also make clear that the RCT model tries to “stamp out high placebo rates rather than reveal their clinical implication.” (p 1) Let me say more about this because here is where my bias is most pronounced. The premise of the RCT method is if you completely fool/trick the subjects (e.g., in the antidepressant drug experiments), then the experiment is worthwhile, i.e., the subject does not know if they got the real drug or the sugar pill. Of course there is a relatively easy way to do that. Simply use an active placebo rather than sugar pill. Big Pharma will not do this because efficacy of the drug disappears when using an active placebo. Fooling and tricking the subjects, in my estimation, is not ethical, even if you tell the subjects in advance that they will not be told whether they are getting the real thing. There is some evidence, by the way, that placebos often work even when the subject is told that they are receiving a placebo (personal communication, Irving Kirsch, ISEPP Conference, Toronto, 2018). Evidently some people find the ritual of taking a pill beneficial.
So what exactly does a placebo activate? I would say self-healing or better yet, inter-self healing. My position then is that using placebo with its implication of trickery is unethical. Placebo is a bastardization, I believe, of the biological mystery of self-healing. I have often opined that my patients get better in the waiting room. The decision to take on their suffering in and of itself has healing power: the will to live, a hope that past traumas can be tamed, that honest dialogue with an expert all promote healing, self-acceptance and self-care, social integration, building self resiliency. I recently attended a Harvard course on Psychiatry and Neuroscience with more that a dozen psychiatrist and neurologists wedded to the medical model. It was not my cup of tea. They did not attempt to define either consciousness or will, for example, and repeatedly made associations of brain connection with behavior and mood. Cogently one presenter said, “In the brain everything is connected to everything,” indeed! But one truth that we all shared was that a principle “side effect” of antidepressants was “apathy.” So if you maintain an existential philosophy, as I do, this is the killing power of drug treatment. Without the will we don’t heal. The higher power is not the drug or the analyst or a god but rather the biological miracle of self-healing promoted by inter-self dialogue. Some call it psychoanalysis.