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.
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Speaking of unproven therapies; But is there any mention in any of Tim Caulfield’s opinion attacks on non Allopathic Medicine of the FACTUAL Federal Court convictions and 10’s of BILLIONS of dollars in fines levied against the Big Pharma companies for such items,as, ” medical larceny,” ” manipulation of MD’s,” ” deliberately lying about the efficacy and safety,” of the drugs they sell, How about the BILLIONS of dollars in current litigation against Drug Companies by Provinces and States for deliberately creating the Opioid Crisis. Any mention that conventional medicine kills so many people, it has it’s own term, ” IATROGENISIS, John Hopkins University Study reports ” Medical errors are the third-leading cause of death in America
2018/02/22 › medical-errors-third-leading-cause-of…
The third-leading cause of death in US most doctors don’t want you to know about. A recent Johns Hopkins study claims more than 250,000 people in the U.S. die every year from medical errors. Other reviewed studies the numbers to be as high as 440,000.”
How many have been killed by Homaeopathy ? 0, that’s ZERO reported to date. How many patients died in Homeopathy Hospitals during the Great Fl Epidemic, less than 1 %, by officia government records; how many died in Conventional Allopathic/ MD principled hospitals 37.3%.
I believe in oversight controlled medicine. I also believe strongly in the efficacy of non Allopathic Medical Practice. I am totally convinced after decades of research that the danger of Homaeopathy , Naturopathy, Osteopathy, Chiropractic, Herbology, Midwifery, and a host of other medical arts, is the lost profits they cause, Big Medicine, a subsidiary of Big Pharma, to fear.
I am glad you published this opinion. I would wish it could be a directive. Canada’s approval processes in many areas from airplanes to drugs and foodstuffs often follow FDA USA leadership and also apply the principle of buyer beware, even in medical procedures. When there are problems the regulators expect the consumer or the doctors for example in medical procedures to report these problems that then are forwarded to the private enterprises that made or applied these products and procedures. It’s like putting the fox in charge of the hen house. Can it be any different? Maybe not as scientific evidence is very expensive and time consuming. But maybe on an international scale it could be done? Which begs the question for increased global standardisation and science based approval processes.
Locally and among my friends enthusiasm for stem cell therapy for osteoarthritis is boundless. At $2500 a pop it is not much more than a car repair job, and the clients line up for the treatment because it gives them hope by the lay-priests of medicine who like to play God for the right price.
Thank you again for your professional stance, it is reassuring to see ethical people stand up and speak up.
I have had USTC in April 2017 and booster treatments in April 2018. I have osteoarthritis from my neck to my toes. The pain was 9 to 10. I felt like my left great toe was stepping on a spike with every step My mobility and flexibility was greatly reduced. Without a handrail, I was unable to navigate stairs up or down. I was told that I needed to have my right knee replaced and I should come back when I could not manage any more. To me, that was not an option because I heel with keloid and scar tissue. Needless to say, I was preparing to leave my bungalow. I asked the doctor who was treating me with prolotherapy and PRP if I would be a candidate for USTC and I was prepared to go to the USA for the treatment to get some relief. (prior to Health Canada approval in Canada). He told me to wait because they were just waiting for this approval. The results have been incredible! My pain is about 1-2 now. I can go up and down stains without pulling myself up, my mobility and strength have improved significantly. I am no longer thinking about leaving my home, I volunteer at 1 or 2 places every day, I participate in social activities almost every day, I garden, I look after my home and I have quality life again. I have paid a lot to improve my health because health care funding is completely missing or inadequate for arthritis treatments. Some people do not fit in the narrow box of acceptable treatment. Please don’t deny access and hope when there are no viable options for some of us.
Really disappointing,as a taxpayer, to hear a professional try to stop freedom of information.
It is very clear to most of the public how narrow the medical practice has become with confining too many treatment options to the sale of pharmaceuticals. There is a great deal of unbiased science published in the medical journals for alternative treatments of many medical conditions that is being either not learned by this profession or ignored in favour of the antiquated status quo. It is costly to our systems to spend 10 minutes assessing patient needs and then limiting treatments to drugs, diet and exercise. Let’s start seeing the kind of medicine that we are paying for, which is thoughtful and open to options. Let’s widen the knowledge base and perspectives in this medical field to achieve what we are paying for, which is to cure patients, not just put a bandaid on and give out prescriptions that are often times causing more harm than good. Let’s take the hierarchy and politics out of medicine and start “doing no harm”. Let’s also start respecting patients. Doctors do not have a license to judge the patients that are paying their wages and prevent them from seeking to understand their options. Perhaps if they spent more time getting to know their patients, they might also learn to communicate with them about options. The doctor patient relationship should be a collaborative one, not a dictatorship. It’s time the medical profession becomes accountable to the people it is paid by to serve, not to its own organizations.
Great comment and I agree. I feel the same way but over time I have learned that the problem is not the “doctors” and “colleges”. Most people go into medicine with a genuine interest to heal people. Somewhere in the course of training, this ideal gets shattered. There are many factors, and yes I truly believe pharmaceutical industries are one of the factors to blame. Take for instance this entire issue we are now facing with narcotic addictions. 10-20 years ago Pfizer actually made false claims which were printed into medical education booklets about Pain Management. I still have a copy of one of these books that we used during our pain education week. Now the truth comes out that this industry knew of the dangers of oxycontin addiction but was lying to the physicians and public to increase their profits. If you take any really popular drug or treatment approach (Lipitor or heart disease management through lowering fats for instance) and you look at the actual published studies that support the medication or strategty you start to see that a lot of what we push on people is based on maybe 1 or 2 actual studies from 30 years ago, which some are actually now having trouble replicating. We sort of accepted the results and pharma kept saying “yes this is safe”. Now thanks to the internet, we can find research from other countries that are questioning some of the validity of our practices.
However, the main problem is the fact that in Canada we have purely public health care. Sure, we can all get care “for free” (i.e. from our taxes), but because of this focus on making sure we are all equal, we all get to attend affordable Mickey Mouse clinics as the government cannot possibly pay for us to have the option to go to the most advanced treatments, and likelwise cannot afford to have physicians spend more than 10 minutes per patient. There is no focus on good outcomes when the patient is not paying out of pocket, the focus is on pushing the patient through the system as fast as possible to make room for the next patient, all the while doctors love this because they charge fee for service (i.e. get paid for 6 assessments per hour instead of 1-2 with adequate time for each). I think there is value in having private options. Private business will need to provide results for clients in order to gain a reputation and attract more clients. People also have the right to spend their money in whichever way they want, and if they want to try a treatment that regular docs find “controversial”, that’s their right. Not sure if these authors are aware, but MDs make mistakes and MDs do not know everything. For the record, I know a couple of individuals who did the stem cell thing for OA pain in their joints and have excellent results over a year later (props for reducing dependence on pain meds for these folks). It might not work on everyone, but it does for some.