Palmira Granados Moreno

Placebo Rules and the Promotion of Negligent Medical Practice

	Within the great innovation we are facing, we see innovation in many fields. Like everything new, there is a conflicted response to it; excitement for one, but at the same time, there is concerning about the appropriateness of the resulting product, about its efficacy and reach as well as about its legality. One of these fields in which this conflict takes place is the medical practice/research field.
	In the medical field, thus, even though society in general has benefited from the health improvements due to the medical research and innovation, there is also a debate addressing the ethical implications of supporting the use of placebo as a research tool. The authors of the article “CIOMS' Placebo Rule and the Promotion of Negligent Medical Practice” address one side of the controversy behind Placebo Treatments.
	The authors of the article address primarily, the legal consequences of the incongruence among some provisions within the World Medical Association's Declaration of Helsinki, and within the Council of International Organization of Medical Sciences' International Ethical Guidelines for Biomedical Research Involving Human Subjects (CIOMS Guidelines;) and between these Guidelines and Declaration and well-established national legal standards. I agree with them that physicians must favour compliance with their national standards regarding duty of care over compliance with the Guidelines or Declaration. (may provide when) They conclude that “Researchers, IRB members, institutions and sponsors should realize that the CIOMS Guidelines and the note of clarification in the Helsinki Declaration do not remove the reality of potential legal liability resulting from a violation of duty of care, which reflects well-established ethical obligations of physicians.” (p.167); however, even though the authors mention some ethical issues about the use of placebo with which I agree, in my opinion, these ethical implications thereof could be analyzed a little more deeply.
	The ethical implications should start by mentioning the legally accepted duty of care owed by the physician to his or her patients. This duty of care comes from the Hippocratic oath physicians take when they commit themselves to the medical professional activity, to protect the life, health, privacy and dignity of the patient. It relates to the fiduciary nature of the relationship between the physician and the patient in which imposes “higher duties of loyalty, good faith, and avoidance of a conflict of duty and self-interest.” Because of this duty of care physicians are not allowed to cause any conscious harm to his or her patient, or to endanger his or her health or life, otherwise, besides of having ethical flaws, they could be facing legal responsibilities for breaching legal standards of care such as in Canada, Belgium, Switzerland and South Africa, as the authors mentioned. 
	With this in mind, we take the concept of placebo. Placebo “is a medical treatment (operation, therapy, chemical solution, pill, etc.), which is administered as if it were a therapy, but which has no therapeutic value other than the placebo effect.” According to the CIOMS Guidelines it is acceptable to use placebo 1. when there is no established intervention method, 2. when, even though there is an established intervention method, it does not yield reliable results and there is no chance that the use of placebo would irreversibly harm or add serious risk to the patient/subject of research, and 3. when there is an established effective intervention method, but withholding it would only cause temporary discomfort or delay in relief symptoms. 
	Now then, the first ethical implication of using placebo in those terms and conditions is that, since placebo is a research device, in a research field, by definition of the “research” qualification, it does not provide certainty about the results. I do not believe that there is certainty about the non-risky and non-harmful qualifications of the consequences of using placebo instead of the “established effective intervention method” in a prophylactic, diagnostic or therapeutic situation. Therefore, this practice may end up doing severe harm to the patient's health, and in most grave cases, life, instead of simple “temporary reversible harm”. An  example of this conflict would be the blindness caused by the lack of a proper treatment in a diabetic patient under a placebo practice.
	I would apply the same criteria to the Helsinki declaration when it provides  that placebos can be used when the efficacy or safety of a prophylactic, diagnostic or therapeutic method is being determined or when a minor condition of an existent prophylactic, diagnostic or therapeutic method is being investigated and there is no chance the patient/subject will suffer an irreversible harm.
	The second ethical implication is about the difference between relationships. Supporters of placebo's use say that the relationship between the physician and the patient (medical relationship) is different from the relationship between the researcher and the subject (research relationship). Apparently, these people maintain that in the first relationship, there is a duty of care owed to the patient aimed to the patient's well-being by using the best standard therapy. In the second relationship, they seem to believe that the duty of care owed to the patient must be balanced with the potential benefits to medical research that the clinical trial may yield. In this matter, I would agree with the authors of the article that the physician does not play a different role in the second relationship, he or she does not stop dealing with human health and human life, their Hippocratic oath is not being paused. However, not only do not I think that the duty of care gets diminished in the second relationship, but on the contrary, I maintain that there should be a higher standard of care with respect to patients/subjects involved in medical research because they are consciously being put in risk.
	However, since I do support medical innovation, and I do realize that in order to have medical improvements and innovations targeted to human well-being, all those have to be tested in the subjects they are targeted to, I support clinical trials, but with some specifications. I propose that a differentiation has to be done between healing diseases and dealing with the symptoms. 
	Hence, on one hand, I would propose that the corresponding regulation provides that when the physician/researcher is trying to remedy the disease, clinical trial is accepted in only two situations: when there is no established effective medicine or treatment and when even though there is one, the research is targeted to test a new drug or treatment, not to test the efficiency of existing drugs comparing them with a “substance containing no medication”. Thus, the policy in the second case will be to prescribe to the members of one group the best medicine or treatment available, and to the members of the other group the new medicine or treatment that is suppose to improve the available one, or at least, as the earlier version of the Declaration of Helsinki and the authors themselves stipulates, “be as favorable as standard therapy”. On the other hand, I would propose to establish that clinical trials using placebo should only be accepted when the physician/researcher is dealing with the symptoms of the disease (not with the cause of it) and there is no medication available to deal with them. It is important to point out that in both cases should be required to keep an strict observation of the development of the treatment in order to avoid any complication thereof, and obviously the proper and informed consent to participate in the research.  
	The purpose of this proposed regulation is to assure that the standard of care is never diminished. Under this perfectly differentiated model, which I considered the authors' presentation missed, every patient has the right to be provided with the highest standard of care, and still, there is room for innovation.