As a clinician with almost two decades of clinical experience, I have garnered my share of stories (including my own personal failings) involving the informed consent process. My own naturopathic profession recently went through an extensive scope of practice modernization (Government of Ontario, 2015) and now has a very defined informed consent standard that members of the naturopathic profession must adhere to. Regrettably, and irrespective of current regulation, I have observed that some clinicians take for granted the consent process by assuming some version of “implied” consent from their patients. This has led to my interest in finding better ways in which to negotiate the treatments I am recommending to patients.
Pressures loom large, for instance, when an exhausted and overwhelmed parent wants something to control her “problem” child’s misbehaviour and defiant ways, or when a long-term (e.g., 10 or more years) medicated patient with a diagnosis of schizophrenia wants to get off antipsychotic medication, having read about natural alternatives on the internet. These examples will be used to facilitate important aspects of the informed consent process, which will hopefully highlight to our readership some fundamental ethical principles that ought to be considered when patients are being offered orthomolecular interventions.
Example 1 – “Problem” Child
Sheila brings her eleven-year-old son, Jacob, to the clinic because she heard that there are alternative treatments for attention deficit hyperactivity disorder (ADHD). Jacob was recently offered methylphenidate by his pediatrician. Sheila does not like the idea of putting her son on psychiatric medication, and would rather that Jacob be provided with some orthomolecular interventions to moderate his misbehaviour and oppositional ways, as well as to assuage his declining school performance.
In this example, the parent expressed concerns about the possible adverse effects from stimulant medication, and wants an alternative treatment to essentially provide similar therapeutic benefits but with less apparent risks. The child must also consent to whatever alternative treatment is being offered. There is no age of consent in the Province of Ontario, except that consenting patients must have the cognitive capacity to furnish or make balanced judgements about granting or withholding their consent. Without getting overly complex here, certainly a two-year-old would not have the cognitive capacity to make a balanced judgement, but an eleven-year-old (with his or her guardian’s assistance) would be much more capable of doing so.
There are several salient aspects to the informed consent process that require further elucidation. All clinicians have an obligation to discuss the risk, benefits, alternatives to any treatment being offered, and associated costs. However, if we look a little more deeply and use this example to highlight important aspects of the informed consent process, it seems imperative that clinicians offering orthomolecular interventions recognize the potential limitations of the treatments they are offering. This conforms to the principles of beneficence and nonmaleficence. Essentially, beneficence refers to actions taken for the benefit of the patient, and nonmaleficence refers to not harming the patient, or inflicting the least amount of harm in order to arrive at a beneficial outcome. Thus, it would be important to inform both the parent and patient that an actual orthomolecular alternative to stimulant medication does not exist, but that there are many evidenced-informed orthomolecular treatment options (e.g., Gordon, Rucklidge, Blampied, & Johnstone, 2015, and Kaplan, Hilbert, & Tsatsko, 2015) that possess fewer adverse effects than medication, and that can lessen symptoms of the mental disorder.
Additioanlly, it is possible that some clinicians offering orthomolecular treatments do not openly explain that sufficient time is needed before the orthomolecular treatments will demonstrate efficacy. Or, put somewhat differently, harm could result if the more expedient contemporary treatment in this case is avoided (i.e., stimulant medication) while waiting for the orthomolecular treatments to work. Certainly, the consequences to the patient could be significant if he is getting further behind in school, and having more conflicts with other students and teachers while waiting for the orthomolecular treatment to work.
It would be vital, therefore, that the treating clinician explicitly inform both the parent and patient that any orthomolecular treatment, or combination thereof, is not go- ing to work nearly as fast as that of stimulant medication. If time is of the essence, as it is in this example, then it might make more sense to offer orthomolecular treatments in combination with stimulant medication, and to consider tapering the medication (i.e., in collaboration with the prescribing physician) once there has been a sufficient period of stability and academic improvement. Finally, cost should be openly discussed, including the implications of agreeing to potentially more costly orthomolecular interventions, since many patients receive insurance reimbursement for prescribed medications, and not for recommended orthomolecular substances.
Example 2 – Long-term Patient with a Schizophrenia Diagnosis
Mark is 42 years of age and has been on atypical antipsychotic medication, including other psychiatric medications, for about 20 years. He was first diagnosed with schizophrenia while in University, never being able to complete his undergraduate degree as a result of the illness. While his symptoms have been minimal for many years and well-managed, he has not been functional enough to work a regular job. He receives government assistance and lives independently in the community. He spends most of his time watching television, surfing the net, and occasionally attends some meetup group for events like hiking or biking. He dislikes the adverse effects of the atypical antipsychotic medication, and is hoping he could substitute it with natural alternative treatments that he read about on the internet.
This is a situation I have encountered in clinical practice with some frequency. While this example contains many complicating factors, I will mention only the salient aspects that directly involve the informed consent process. The majority of orthomolecular treatments, at least from my perspective, are not meant to replace antipsychotic medication. Rather, they are meant to be given in combination with antipsychotic medication and/ or standard medical treatment. Most studies evaluating their efficacy have demonstrated benefits upon the symptoms of schizophrenia when given in combination with antipsychotic medication or standard medical treatment (e.g., Prousky, 2014, for a review of orthomolecular treatment options in schizophrenia). Only when clear and consistent progress has been observed, can the dose of antipsychotic medication or other standard treatments be potentially reduced, and rarely, eliminated altogether. This always requires collaboration from the patient’s treating psychiatrist or family physician. The clinician recommending orthomolecular treatment must be very explicit about managing expectations, and this is imperative especially when some patients (and/ or their family members) possess unrealistic expectations about the clinical expediency of orthomolecular treatments.
The ethical situations encountered by clinicians offering orthomolecular treatments do not differ significantly from those encountered by other health care practitioners. Undoubtedly, the informed consent process is vastly more complex than what I have discussed briefly in this editorial. However, the few principles highlighted – beneficence and nonmaleficence – as applied to these two patient examples demonstrate the need for clinicians to always keep the patient’s best interests in mind, while also limiting possible harms when orthomolecular treatments are competently recommended.
Caspi, O., Shalom, T., & Holexa, J. (2011). Informed Consent in Complementary and Alternative Medicine. Evidence-Based Complementary and Alternative Medicine, 2011, 1-7.
Gordon, H. A., Rucklidge, J. J., Blampied, N. M., & Johnstone, J. M. (2015). Clinically significant symptom reduction in children with attention- deficit/hyperactivity disorder treated with micronutrients: An open-label reversal design study. Journal of Child and Adolescent Psychopharmacology, 25(10), 783-798.
Government of Ontario, Ontario Regulation 168/15 made under the Naturopathy Act, 2007. (2015). Parts I-IV (Interpretation, Controlled Acts, Delegation, and Commencement). Retrieved from https://www.ontario.ca/laws/regulation/r15168
Kaplan, B. J., Hilbert, P., & Tsatsko, E. (2015). Micronutrient treatment for children with emotional and behavioral dysregulation: A case series. J Med Case Rep,9(1), 1-6.
Prousky,J.E.(2014).Theclinicaluseoforthomolecules in the treatment of schizophrenia: Critical reflections and commentary. J Orthomol Med, 29(4), 141-153.