Articles

Neuro Ethics Canada – A Discussion to Advance Cell Therapy in Canada

NE-Canada
Pictured from Left to Right: Dr. Jonathan Brock, Dr. Elliot Lander, and Dr. Martin Braun

Summary: After an outspoken “bio-ethicist” published a report on the number of “unregulated” stem cell clinics in Canada, Dr. Elliot Lander traveled in Vancouver to sit down with CSN Affiliates Dr. Martin Braun and Dr. Jonathan Brock as well as a team of scientists and representatives from Health Canada to discuss the benefits of cell therapy and how to appropriately advance these new therapies.  

Last week, as an outspoken bio-ethicist decried the number of “unproven stem cell clinics” popping up in Canada, Dr. Elliot Lander joined Dr. Martin Braun and Dr. Jonathan Brock of the Vancouver Stem Cell Treatment Centre for a roundtable discussion at Neuroethics Canada. Neuroethics Canada brought together some of the country’s leaders in stem cell research/clinical applications and regulators from Health Canada to discuss the current landscape surrounding cell therapy in Canada.

While the meeting’s attendees didn’t agree on everything, it was generally noted that the registry employed by Cell Surgical Network should be used by Health Canada and was the most responsible way forward in this new era of medicine.

Hopefully, Health Canada will soon adopt a national cell therapy registry, as has been done in Japan. Cell Surgical Network continues to work with many regulatory bodies around the world, including the FDA, to pave the way forward for responsible use and expanded access of cell therapy.

A Consensus On How To Move Forward On Stem Cells, which details the meeting was published in the Vancouver Sunby Fabio Rossi, MD, PhD and Judy Illes, CM, PhD from the University of British Columbia.

[for original article: click here]

Original Article: https://stemcellrevolution.com/csn-affiliate-news/neuroethics-canada/

Vancouver Sun (October 10, 2018)
Dr. Fabio Rossi and Dr. Judy Illes: A consensus is building on how to move forward on stem cells

[for the original article: click here]

Excerpt: On Sept. 26, a small group representing both these 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 over-riding 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 that 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 that are 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 today. 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 that 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.

On Sept. 26, a small group representing both these 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 over-riding 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 that 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 that are 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 today. 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 that 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 forego, 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 that 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.

Dr. Fabio Rossi is a professor of medical genetics and scientific director of BCRegMed and the University of B.C. Dr. Judy Illes is Canada Research Chair in Neuroethics, a professor of neurology and director of Neuroethics Canada at UBC’s faculty of medicine.

Original Article from Vancouver Sun (updated on: October 10, 2018): https://vancouversun.com/opinion/op-ed/dr-fabio-rossi-and-dr-judy-illes-a-consensus-is-building-on-how-to-move-forward-on-stem-cells

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