STEM CELL CLAIMS ARE AHEAD OF THE SCIENCE
Interventions to treat neuropathy still require proper clinical trials, Kristine Chapman and Judy Illes say.
March was a busy time for advertisements for natural products, miracle cures and untested treatments for different health conditions in The Vancouver Sun. Early in the month, when many of us in neurology were focused on Brain Awareness Week, promoting brain health, debating medical aid in dying for the mentally ill and mature minors, and discussing the role of neuroscience in the courtroom, others were pursuing a learning-and-luring experience for people suffering from peripheral neuropathy.
The many-day, full-page ad campaign invited British Columbians to attend seminars at hotels for the purpose of recruiting them to a U.S. chiropractor-run clinic to have “stem cell therapy” treatment for peripheral neuropathy.
The text boasted: “Extremely high clinical success rates. Treatment is safe, effective, and requires NO SURGERY.”
Neuropathy, a result of damage to the nerves outside of the brain and spinal cord, often causes numbness, tingling, weakness and burning pain in the feet and hands. Peripheral nerve disorders affect 2.4 per cent of Canadians.
More than half of all people with diabetes have some form of neuropathy. Treatments focus on addressing the underlying cause and managing symptoms.
While some products for which health claims are made may have no effect or are simply innocuous, we are concerned the recent ads for stem cell therapy misled and exploited patients who are physically and emotionally vulnerable from their pain, and put them in harm’s way.
Surgery is almost never required in the treatment of peripheral neuropathy. At present, neurologists use immune modulating therapy for the small minority of neuropathies caused by the body’s immune system attacking its own nerves, such as Guillian Barre Syndrome.
But even in those cases, stem cell interventions have not been demonstrated to be effective and would not be used in Canada, let alone for common neuropathies such as diabetic neuropathy or hereditary neuropathy.
Depending on the type of stem cells and approach used, there are risks related to the procedure and marrow ablation beforehand. In addition, there are long-term risks of stem cell therapy such as graft versus host disease, and possible malignant transformation.
Although mesenchymal stem cell therapy is thought to be relatively safe, many questions about the potential risks have yet to be answered.
We are not just protecting our turf in expressing our opinion here, an accusation levied against many conducting research in the neurological sciences and practicing neurology at the time that the eventually debunked CCSVI “liberation” procedure was being advanced for multiple sclerosis a few years ago. Worthless treatments divert funds that could be used for valuable medical research.
Stem cell therapy holds promise in some areas and outstanding basic science research continues, but until properly conducted human trials are completed, it is not ready for routine use for peripheral neuropathies, or for stroke recovery, spinal cord injury, or anti-aging therapy for which stem cell procedures locally and abroad are also often advertised.
In the U.S., the FDA has recently announced a policy framework for the development and oversight of stem cell therapies in an effort to crack down on use of stem cells for unapproved therapies. The International Society for Stem Cell Research has noted the new measures from the FDA are an important step toward consumer protection. Canadian law obliges tolerance for members of regulated health professions who sell patients bogus remedies like chelation for coronary artery disease, body fluid supernatants for osteoarthritis, and homeopathy-based vaccines. Remarkably, this practice occurs against the backdrop of the Canadian prohibition against direct-to-consumer advertising for prescription drugs for which clinical trials have actually been conducted and efficacy proven. There is a paradoxical madness to this.
What can patients and consumers do in the face of advertisement for ineffective and potentially dangerous treatments? Consumer Reports suggests patients should be aware of hype and expensive fees, skeptical of offers of dramatic improvement or cures, and ask about results of carefully conducted human studies.
Patients should note that clinical trials do not promote therapy using flashy advertisements. They should not settle for testimonials couched as evidence.
We are not the first to raise ire about dubious practices that purport to promote health and well-being, nor is it the first time we express our opinion on the subject. Nonetheless, we keep the warnings alive here, and the pressure on for action.
Open debate is healthy, but when harm and risk overshadow the safety and benefit for our patients and research participants, oversight and regulation are urgently needed.
Although mesenchymal stem cell therapy is thought to be relatively safe, many questions about the potential risks have yet to be answered.
KRISTINE CHAPMAN AND JUDY ILES
Kristine Chapman is associate professor of neurology at the University of B.C. and director of the Vancouver Hospital Neuromuscular Disease Unit; Judy Illes is a UBC professor of neurology and director of Neuroethics Canada.