Medical Doctors, Unproven Treatments, and Professional Standards
If there’s one group that you’d expect would take a dim view of physician provision of unproven or ineffective treatments, it’s the regulatory colleges that determine medical standards of practice. And that’s why it’s concerning and surprising the College of Physicians and Surgeons of Ontario (CPSO) has published the following draft policy paper, Non-Allopathic (Non-Conventional) Therapies in Medical Practice. The policy as written is unclear with respect to physician expectations. It also appears to significantly diminish the requirement for physicians to provide medical care and advice based on established scientific standards.
To start, let’s look at the CPSO’s role. From their own description:
Doctors in Ontario have been granted a degree of authority for self-regulation under provincial law. The College of Physicians and Surgeons of Ontario is the body that regulates the practice of medicine to protect and serve the public interest. This system of self-regulation is based on the premise that the College must act first and foremost in the interest of the public. All doctors in Ontario must be members of the College in order to practise medicine.
Now let’s take a look at the policy, and its congruence to the CPSO’s role. There’s already been a strong reaction online. Both The Committee for the Advancement of Scientific Skepticism (CASS), as well as Dr. David Gorski, at the Science-Based Medicine Blog have posted detailed analyses. Each identifies multiple shortcomings in the policy that put the public interest into question. Here are some additional thoughts on the policy itself [PDF].
The first observation is the language of the document, starting with the title: “Non-Allopathic”. The term “allopathic” is pejorative, created by Samuel Hahnemann, the inventor of homeopathy. Hahnemann attempted to position homeopathy as a separate and more effective form of medicine, compared to conventional medical practices. Given homeopathy is an elaborate placebo system, homeopathy probably was safer than medical practice at the time, which was still based around the idea of the four humors. Happily, germ theory emerged, and ideas of humors disappeared, as did any elements of vitalism in medicine, as it embraced a scientific model based on objective observations and careful evaluation. Alternative medicine practices that are not based on science have largely never progressed from vitalistic roots. The term allopathy remains a derisive term among alternative practitioners for science-base medicine practice. From the National Coalition Against Health Fraud:
Although medicine never accepted the label of allopathy, nonmedical practitioners such as chiropractors, homeopaths, and naturopaths regularly misrepresent physicians as “allopaths.” This is usually done in order to make differences between their practice guilds appear based upon conflicting philosophies rather than ideology versus science. Opponents of medicine claim that they treat the underlying causes of disease, while MDs treat only the symptoms. Further, they claim that medicine suppresses the symptoms, thus interfering with the body’s inherent healing processes. A close examination reveals that this line of reasoning is only clever rhetoric.
The CPSO policy goes to great pains to elevate “non-allopathic” to the same level as “allopathic” medicine. In practice and in fact, conventional or “allopathic” medicine is based on empirical evidence and rooted in a scientific understanding of the illness. Medical practices that are non-allopathic are not-based on these principles. The draft policy reluctantly admits this, at line 52:
Non-Allopathic Therapies (Non-Conventional Therapies): refers to a broad range of procedures or treatments that are not commonly used in allopathic medicine; this includes those referred to as complementary or alternative. Non-allopathic therapies tend to differ from allopathic medicine in terms of diagnostic techniques, theories of illness and disease, and treatment paradigms. The categorization of specific therapies as non-allopathic is fluid: as clinical evidence regarding efficacy is accumulated, certain non-allopathic therapies may gain broad acceptance and thus be accepted in allopathic medicine. [emphasis added]
Interpretation: Alternative treatments and diagnostics are not accepted as “allopathic” medicine because clinical evidence is lacking. When clinical evidence emerge to demonstrate the non-allopathic therapies are in fact effective, they become accepted as part of medical practice. In short: Effective treatments is “medicine”. Ineffective or unproven treatments are not medicine, and are “non-allopathic”.
In this context, the policy advice to physicians is baffling. Consider this statement, at line 128:
The College supports patient choice in setting treatment goals and in making health care decisions, and has no intention or interest in depriving patients of non-allopathic therapies that are safe and effective.
The policy excerpt above indicated how alternative (non-allopathic) treatments become deemed medicine: There needs to be evidence to substantiate them. By the policy’s own definition, treatments and interventions that are deemed “non-allopathic” are not backed by clinical evidence. In the absence of evidence, how are these therapies also deemed “safe and effective”?
The policy is full of confusing verbiage – consistently striving to give legitimacy and equivalency to “non-allopathic” treatments and practices while acknowledging that they are not backed by clinical evidence of efficacy. Consider this statement, at line 128:
When providing non-allopathic therapies, physicians are expected to demonstrate the same commitment to clinical excellence and ethical practice, as they would when providing allopathic care.
This statement is hard to believe, given the responsibility of CPSO to serve the public interest. The policy acknowledges that “non-allopathic” treatments are not backed by clinical evidence. Therefore how can physicians providing them be demonstrating the same commitment to clinical excellence and ethical practice, compared to a physician that provided therapies that are backed by good clinical evidence?
It continues, at line 160:
If physicians also form a non-allopathic diagnosis, such diagnosis must be objectively justifiable, based on the clinical assessment conducted and other relevant information available to the physician. A demonstrable and reasonable connection, supported by sound clinical judgement must exist between the condition or symptoms for which the patient is seeking care, and the non-allopathic diagnosis reached. [emphasis added]
Again, how can a “non-allopathic” diagnosis be objectively justifiable when by definition these treatments and diagnoses are not accepted medical practices, because they lack clinical evidence? Objectively justifiable means just that – based on objective evidence, and grounded in facts.
And there’s more, around line 185, in the section Therapeutic Options:
Reasonable expectations of efficacy must be supported by sound evidence. The type of evidence required will depend on the nature of the therapeutic option in
question, including, the risks posed to patients, and the cost of the therapy. Those options that pose greater risks than a comparable allopathic treatment or that will impose a financial burden, based on the patient’s socio-economic status, must be supported by evidence obtained through a randomized clinical trial that has been
Once again, the policy is contradictory. Non-allopathic treatments are not backed by clinical evidence by the policy’s own definition in line 58. Given the lack of evidence demonstrating efficacy, how is it possible to evaluate the relative risk of treatment compared to treatments backed by scientific evidence?
Another curious section is at line 247:
Where physicians are unfamiliar with the non-allopathic therapy in question, they must indicate as much to the patient, and explain that they are consequently unable to comment on the matter. Physicians may wish to consider whether they can assist patients in obtaining information. This may involve suggesting potential resources, or referring patients to other practitioners.
Again, given the definition, this section gives strange advice. It’s the physician’s responsibility to understand the evidence base and provide treatments and therapies that are science-based and backed by good clinical evidence. Non-allopathic therapies are by definition either unproven, or proven ineffective. A physican providing ethical care should indicate that any non-allopathic treatment is either unproven, or proven ineffective. It is not in the patient’s interest to provide no comment, or to refer a patient to a regulatory college (as the policy suggests) of a alternative medicine practice be it naturopathy, homeopathy, acupuncture, or any other alternative therapy. The physician’s responsibility to know the evidence base. Non-allopathic treatments that have been shown to work are by definition, medicine. If the non-allopathic treatment is homeopathy, it’s not necessary to know more about the “remedy” in question – homeopathy has no therapeutic effects, and physicians should not be restricted from saying so.
I could probably identify a dozen more questionable sections in the policy. Rather than suggest further wording changes, I’ll recommend that the CPSO just adopt the policy of the College of Physicians & Surgeons of British Columbia, which is far more clear with respect to physician expectations. It uses plain language, is concise, and puts the onus of responsibility squarely onto physicians to provide science-based medicine. I’ll quote it in its entirety [PDF]:
The last few years have seen an enormous surge in interest in complementary and alternative therapies, and considerable confusion exists among physicians as to how to respond to this interest. The reasons for this phenomenon are complex and include patient dissatisfaction with available treatment and patient mistrust of scientific medicine.
Patients question physicians about herbal preparations and other unconventional treatments and expect reasonable answers based on the physician’s interest and knowledge. Physicians must be aware of their patients’ use of such therapies, and should ask about alternative remedies in the same way that they ask about non‐prescription drugs. Both types of treatment can produce direct toxicity, or interactions with prescription medications or other accepted treatments.
Problems arise because even after the most diligent search for available information about complementary and alternative treatments, a physician may remain relatively ignorant about unknown or untested preparations. It is this lack of knowledge about risk and benefit that makes unorthodox treatment so difficult for physicians and their patients. The popular notion that herbal remedies are always safe – because they are deemed to be natural – is not true.
Complementary and alternative therapies differ from conventional medicines because they are generally unproven. When an alternative treatment undergoes rigorous testing, for example in a controlled and randomized trial, then the results dictate whether the alternative treatment becomes conventional treatment, whether the unorthodox becomes accepted, and whether the unproven becomes proven. Assertions, speculations, and testimonials do not substitute for scientific evidence.
Physicians who consider using complementary and alternative methods should recall that, although some untested remedies may be harmless, the absence of good evidence about a given herbal or other agent makes recommendation of that treatment unethical. The optimal environment for the use of an unorthodox therapy is within a clinical trial designed to establish the therapy’s safety and efficacy.
In formulating any treatment plan, the physician must consider the relative risks and benefits of any potential therapy, and choose that course most likely to restore the patient to good health. Although the patient is always an active participant in this process, it is the conscientious application of the experience and knowledge of the physician that is essential in determining the patient’s best interest.
It follows that the patient’s preference cannot be sufficient grounds to select a given treatment, and the physician must be careful in advising patients who are considering or using complementary or alternative therapies, and especially careful in promoting or recommending such therapies.
With these precepts in mind, the ethical physician
- Must carry out appropriate and conventional examinations and investigations in order to establish a diagnosis and basis for treatment.
- Must employ a rigorous medical approach before offering any unorthodox therapy. The use of an effective and proven therapy must not be delayed or supplanted by the choice of a complementary or alternative treatment.
- Must not expose the patient to any degree of risk from a complementary or alternative therapy of no proven benefit.
- Must not misrepresent the safety or efficacy of any therapy or procedure, whether conventional or unconventional.
- Must counsel the patient, to the best of his or her ability and knowledge, about the risks and benefits of any procedure, so that the patient can give informed consent.
- Must not exploit the emotions, vulnerability, or finances of a patient for personal gain or gratification.
- Must not associate with, or refer patients to, alternative practitioners who recommend unproven over proven therapies. By doing so, the physician assumes a degree of responsibility for the outcome of the treatment.
- Must respect the autonomy of the patient in choosing from available treatment options. If the patient’s choice of a complementary or alternative therapy has made it impossible for the physician to discharge his or her ethical responsibilities, it is acceptable for the physician to terminate the physician‐patient relationship.
Physicians are advised to consult with the College about any questions that arise concerning complementary and alternative therapies because these considerations can be difficult and sometimes ambiguous. Careful review by one’s colleagues can prevent problems for both patient and physician.
The CPSO’s proposed policy is almost 3000 words, and is a confusing, contradictory mess that raises numerous questions about how the public interest is being served. In contrast, in under 700 words, the CPSBC outline a clear, concise, understandable policy on exactly the same issue. And that’s because British Columbia’s regulator is prepared to call “non-allopathic” products and therapies for what they are: unproven. When that’s acknowledged, the appropriate physician behaviors are obvious: British Columbia’s physicians are told that recommending therapies in the absence of good evidence is unethical. In British Columbia, the standard is clear and puts the public interest first. Why should that standard be any different in Ontario?
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