CONSENSUS IS BUILDING ON STEM-CELL THERAPIES
Provider registry program and set of ground rules would further research, say Dr. Fabio Rossi and Dr. Judy Illes.
On Sept. 26, a small group representing scientific communities from Canada and the U.S., as well as the government, gathered in Vancouver to identify common values in the arena of stem-cell therapies, and agree on principles to move forward.
This historic moment recognized that patients who seek health solutions to their chronic, unmet medical needs deserve our attention and collaborative efforts. It demonstrated that a meeting of minds between researchers, clinicians, ethicists, entrepreneurs and other stakeholders is possible in this highly contentious space.
We unanimously upheld the duty of providers to act in the best interests of their patients and support the overriding first principle of “do no harm.” We agreed that stem cells hold tremendous promise. We discussed the different levels of risk that different stem-cell therapies carry, and agreed they should not necessarily all be held to the same regulatory standards.
We agreed that the level of risk is low when stem cells are harvested from a person and then promptly re-injected into a specific part of their own body. By contrast, uses of cells taken from an embryo or fetus, or expanded outside of the patient, carry far higher risk. These procedures are human experimentation and belong in a medical setting with ethics oversight and monitoring at a level not available at private clinics.
We agreed that quality control is vital. Knowledge and oversight about what is injected into people is severely lacking. Transparency about what conditions are being treated and why, and reporting on negative as well as positive outcomes is essential. Potential patients also need be told of the risks so they have realistic expectations.
Conflicts of interest must be disclosed. Advertising must be honest. Stem-cell treatments may be beneficial in certain diseases, especially those in which out-of-control inflammation such as osteoarthritis is involved. But to advertise them as a panacea for essentially everything is irresponsible. Errors of omission are as harmful to patients and public trust as overt errors of commission.
We did not agree on everything. We did not agree on whether access to effective stem-cell interventions ought to be a right, or how to resolve tensions between medical and financial imperatives. We did not agree on the extent to which the published research literature supports the efficacy of stem-cell injections. This is an issue that affects multiple fields in science. There are good papers and bad papers and some of the latter can be found in even the most reputable medical journals.
The discussion was not limited to medical issues. We debated the consequences of preventing interventions from being offered in Canada, as onerous regulations may push demand and economic gain to out-of-country destinations and away from regulatory scrutiny. However, we reflected on the possibility that Canada could find itself in a leadership role and enjoy, rather than forgo, the benefits of innovation on this landscape guided by a collaborative framework for the private sector that emphasizes efficacy and responsibility.
What is the call to action? How can we take advantage of opportunity to learn from the troves of patients who are being treated with stem-cell therapies below the radar of the health-care system?
We collectively propose the formation of a stem-cell provider registry program, in which those who enrol certify that they will adhere to the fundamental medical and ethical principles and values we describe. The registry would likely have to focus on the most common treatments, for example musculoskeletal health as a start.
To participate, clinics will have to further require that patients provide an informed consent to share their treatment and followup data for research purposes. These data could be linked to administrative databases that exist in all provinces to provide followup on safety and effectiveness. In this way we could learn if someone who, for example, received stem cells in the knee, has reduced use of painkillers and prolonged time before they need surgery. Large numbers are required for such studies to generate reliable results, but may be readily available with the willingness of clinics to contribute.
No doubt, the devil is in the details. Questions remain. What will constitute control data? What is the latitude for off-label work? What pathways or obstacles does the patent regime offer? Funding will be needed to set up and maintain the registry, and private clinics will have to come on board. Some, as evidenced by the meeting we held at UBC, are prepared to do so. If enforcement is not realistic, self-regulation by clinics will be necessary.
Patients can play an important role by scrutinizing the clinics they are considering for therapy, ensuring the clinic is a member of the registry, and fulfilling test requirements and standardized reports of outcomes over time.
Finally, the continuing interest and active involvement of Health Canada in the discussion will help to ensure the shared vision, goals and methods we propose here see the light of day for the benefit of all stakeholders in this potentially groundbreaking Canadian-led stem-cell collaborative initiative.
We discussed the different levels of risk that different stem-cell therapies carry, and agreed they should not necessarily all be held to the same regulatory standards.