The state of California and its top medical regulator remain mired in a go-slow posture on the regulation of “snake oil” stem cell clinics that are currently riding the COVID-19 crisis to peddle dubious treatments to desperate patients.
The marketing surge by the clinics has drawn increased attention nationally, including in prestigious scientific journals such as Cell Stem Cell whose usual fare deals with such things as “Stem Cell Hierarchy in Colorectal Cancer.”
The quotes around “stem cell treatments” are deliberate. No guarantee exists that the treatments actually include stem cells.
But one article published earlier this month was titled: “Preying on Public Fears and Anxieties in a Pandemic: Businesses Selling Unproven and Unlicensed ‘Stem Cell Treatments’ for COVID-19.”
Leigh Turner, an associate professor of bioethics at the University of Minnesota, authored the piece. He said, “In the midst of a global public health emergency, some businesses are taking advantage of widespread fears by marketing purported stem cell treatments for Covid-19.
“Such businesses target prospective clients with misleading claims, expose patients to potentially risky stem cell-based products, and undermine efforts to develop evidence-based treatments for Covid-19.”
Nearly two years ago, California’s State Medical Board said it was going to tackle the problem of the rogue clinics. But to this date little has occurred. State legislation to develop regulations was also sidelined.
The California stem cell agency has also pushed for tighter regulation and partnered to help pass the law for disclosure notices.
The California Stem Cell Report queried the medical board earlier this month concerning the status of its effort and whether regulations had been drafted and when a draft would be ready. In response, the board last week released the following statement:
“The board is continuing to work toward the goal of providing recommendations on stem cell and regenerative therapies and developing some guidelines that California physicians and patients can follow that will include a sample informed consent document and educational materials for the public to present to the board for review and final approval.
“In the meantime, pursuant to Business and Professions Code section 684, healthcare practitioners providing stem cell therapy not approved by the Food and Drug Administration (FDA) and who have not obtained approval or clearance for an investigational new drug or device exemption from the FDA for the use of human cells, tissues, or cellular or tissue-based products, must provide notice to their patients indicating the lack of FDA approval, and encouraging their patients to consult with their primary care physician before treatment. Individuals concerned about a physician’s stem cell practice should file a complaint with the Board for review and appropriate action.”
The issues with the clinics has drawn attention in the Los Angeles Times from Pulitzer Prize-winning columnist Michael Hiltzik, who wrote recently, “The proliferation of stem cell clinics selling untested and unlicensed therapies has been a public health crisis for years. The Covid-19 pandemic will only deepen the crisis as clinics add the coronavirus to their menu of treatment claims.”
The California stem cell agency has also pushed for tighter regulation and partnered to help pass the law for disclosure notices concerning lack of FDA approval. For patients considering stem cell treatments, the agency has posted as rundown on issues concerning the treatments or clinical trials.
Editor’s Note: David Jensen is a retired newsman who has followed the affairs of the $3 billion California stem cell agency since 2005 via his blog, the California Stem Cell Report. He has published more than 4,000 items on California stem cell matters.