Recent research has shown that clinics offering unproven stem cell therapies (USCTs) are now widespread in both the United States and Canada. These clinics are offering treatments for everything from orthopedic problems to sexual enhancement to complex neurological, immunological, cardiovascular and respiratory diseases. A simple Google search reveals dozens of clinics in Canada advertising autologous stem cell therapies, which involve removing bone marrow or fat tissue, isolating stem cells within that tissue, and then reinjecting those cells into various parts of the same person’s body.
This is a serious problem. We know that very few stem cell therapies have been proven safe and effective, and that unproven ones can cause serious harm, including physical injury, financial loss, and the erosion of public trust.
USCTs are often wrongly presented as routine. In fact, for most ailments, the use of stem cells as a therapy remains, at best, experimental. Moreover, few clinics publish the methods used to purify and prepare cells and in some cases do not share the cell types being used, raising questions regarding standardization and quality control.
In several jurisdictions across the world, action has recently been taken to curb the spread of USCTs. In the United States, the FDA has a working group to pursue “unscrupulous” clinics, the U.S. Department of Justice has initiated lawsuits to shut down clinics in Florida and California, and the state of California has passed a law requiring clinics offering USCTs to note that they are not approved by the FDA. In Australia, new regulations prohibit advertising or offering most therapies involving human stem cells without approval from the Department of Health.
Yet few efforts to curb the spread of USCTs have taken place in Canada. Health Canada officials have told the CBC that all cell therapies, including USCTs like those we described above, are considered “drugs,” meaning that “distribution and use of these products would require authorization by Health Canada” under the Food and Drugs Act.
However, legal academics have pointed out that Health Canada regulations technically have a gap which has been exploited by some clinics to allow USCTs to be offered without approval. “Minimally manipulated autologous cell therapies for homologous use,” which are therapies where a person’s cells are extracted, not significantly altered, then reinjected into other areas of their body, are not currently covered under the wording of the regulations. Policymakers should close this loophole to ensure comprehensive and consistent oversight of this field. Regardless, it seems clear that at least some clinics—depending on what their therapies entail and how significantly they alter cells—are offering USCTs in breach of federal regulations.
Provincial self-regulating colleges of physicians and surgeons control medical doctors’ ability to offer USCTs. Policies and standards requiring that doctors maintain evidence-based practices exist for every provincial college (e.g. Ontario, Quebec, British Columbia) as well as in the Canadian Medical Association’s Code of Ethics and Professionalism.
Interestingly, four provinces—Ontario, Manitoba, Alberta and British Columbia—have legislation directing that colleges should not find members guilty of unprofessional conduct or of incompetence solely for using a therapy that is “non-traditional” or “departs from the prevailing medical practice,” unless it can be shown that the therapy is of greater risk to a patient’s health or safety than the prevailing practices. But the idea that doctors should be allowed to offer evidence-free therapies is, from a legal perspective, absurd. Doctors must meet a clear legal standard of care —that of a “prudent and diligent doctor in the same circumstances.” And physicians are still required to adhere to their other professional obligations, which include recommending “evidence-informed treatment options” and ensuring that all marketing is factual and supported by evidence.
In addition, if the “non-traditional” practice exemption did excuse physicians from requiring evidence, it would gut the entire purpose of self-regulation. Health professions are meant to use their expertise—which, one would assume, includes knowledge of the available clinical evidence—to ensure their members behave in a manner that accords with the best interest of the public. Allowing misleading marketing and the provision of unproven and potentially harmful therapies clearly conflicts with this core mandate.
Provincial college disciplinary decisions also reinforce the rule that medical doctors must have an evidence-based practice (e.g. colleges have ruled against a doctor inappropriately diagnosing allergies/“sensitivities” and using unproven/unnecessary injections as treatments; and against a doctor using discredited methods like reflexology to treat psychological conditions). The Discipline Committee of the College of Physicians and Surgeons of Ontario held in 2009, for example, that a doctor can commit professional misconduct by advertising and offering a procedure that is “not proven to be effective or have any lasting effect,” even if it is “unlikely to cause any real harm” (in this case, a penile enhancement procedure).
Other cases confirm that the scientific evidence in support of a procedure is key to determining whether it is appropriate (e.g. two cases of doctors found to have committed professional misconduct for, among other things, misrepresenting the effectiveness of and using unproven allergy testing). The controversial or unproven nature of an intervention must be explained to patients, and some provincial colleges’ policies state that unproven or non-standard interventions should only be used in the context of a scientific trial (see: Quebec, Prince Edward Island). Additionally, failing to disclose to patients that one uses unconventional or alternative interventions constitutes misconduct.
There are strong arguments under college policy and disciplinary tribunal precedent for prohibiting members from offering USCTs,or at least, stopping members from using misinformation in marketing material. Purveyors of USCTs seem to have been able to function and grow their practices because existing rules have not been applied. It is important that this behaviour be curtailed before it spreads further and exposes more patients to potential harm. If colleges choose not to act, civil lawsuits initiated by patients who have been harmed or misled by clinics offering USCTs may help set further legal precedent and encourage enforcement action.
The current international climate of increased enforcement efforts against USCTs presents an opportunity for Canadian medical colleges to release clear standards of practice prohibiting doctors from offering and marketing USCTs, and to notify all doctors offering them to cease and desist. The time to act is now.