David vs. Goliath: California’s Stem Cell Program Demonizes Small Clinics
/By A. Rahman Ford, PNN Columnist
In a recent article published in Stem Cells Translational Medicine, officials with the California Institute for Regenerative Medicine (CIRM) call for nationally uniform standards for stem cell products to facilitate the ”responsible delivery of regenerative medicine.”
Some of their recommendations are reasonable. However, CIRM’s insistence upon uniformity and their demonization of small stem cell clinics in a contrived narrative is sophomoric, disingenuous and counterproductive.
CIRM was created in 2004 when California voters passed Proposition 71, the California Stem Cell Research and Cures Initiative. Supporters of Prop 71 lamented how the federal government had failed to provide adequate funding for stem cell research, so the state needed to step in and provide $295 million in bonds to advance stem cell treatments to patients with unmet medical needs.
CIRM is currently at a financial crossroads. To date, CIRM has funded over 1,000 research, training and community engagement projects. However, with its initial funding almost gone, it is now seeking an additional $5.5 billion through a ballot initiative. While CIRM has been strong in research, no CIRM-funded trial has won FDA approval. According to Nature, CIRM has funded 55 clinical trials but only one therapy is likely to hit the market any time soon.
Indeed, a 2018 San Francisco Chronicle investigation found that CIRM’s achievements “fall far short of what Prop. 71’s promoters promised.” Furthermore, “the bulk of CIRM grants have gone to basic research, training programs and building new laboratories, not to clinical trials testing the kind of potential cures and therapies the billions of dollars were supposed to deliver.”
Thus, while it’s noteworthy that CIRM-funded scientists have published over 330 scholarly articles in some of the top academic journals, practical results remain negligible to non-existent.
Promises Laid Upon False Premises
California’s scientific and physical infrastructure has benefited greatly from CIRM, but sick and disabled Californians have not. The fact that CIRM’s accomplishments have been so minimal makes their claims about acting in “the best interest of the patient” all the more curious.
Lead author Geoffrey Lomax, PhD, a Program Manager at CIRM, and colleagues argue that clinics offering stem cell treatments are in need of increased regulatory oversight. Toward that end, they recommend a new policy framework with technical, organizational and ethical benchmarks aimed at developing a standard of care for the stem cell industry. It pledges adherence to the FDA clinical trial process and chastises clinics for flaunting long-established rules for drug approval.
“There are documented examples of unproven stem cell interventions causing harm to patients. In the majority of examples, the intervention deviates from the norms of responsible medical practice. Numerous authoritative bodies have raised concerns over the potential for medical and financial harm to result from these practices,” Lomax wrote.
Generally speaking, some of their recommendations make sense. For example, they recommend that doctors, nurses and technicians providing stem cell treatments possess specialized training and expertise. They also recommend that providers educate and evaluate patents throughout the treatment process. Finally, the authors support the creation of a stem cell registry to facilitate the reporting of adverse events resulting from stem cell treatments.
However, these common-sense recommendations are overlaid by a rigid, forced adherence to an anachronistic model of medical treatment. This model is the FDA clinical trial process, which treats a patient’s own stem cells as “drugs.” That is unfortunate, because stem cell therapies are revolutionary, paradigm-shifting and defy old conceptions about drugs and medicine.
Perhaps the most glaring sin is CIRM’s demonization of small clinics offering stem cell treatments. These clinics are producing the real-world results that CIRM has not. This “us vs. them” approach occludes truth and impedes progress to the detriment of those most in need. It is unnecessary to diminish the value of others’ efforts to bolster or justify one’s own. Cooperation, not contrived competition, is in the best interest of patients.
Furthermore, forced uniformity in stem cell policy standards may not be the answer. Let us not forget that it was the state of California in 1996 that led the way on medical marijuana, amidst a cacophony of marijuana opponents who decried the potential for a “wild west” of rogue marijuana dispensaries that would prey upon desperate patients.
Now, years later, we see that none of those calamities materialized. For CIRM to now use the same argument and same invective toward stem cell clinics seems disingenuous and hypocritical.
Lomax fails to see that from the patient perspective the narrative is not “heroic” CIRM vs. the “villain” clinics, but more of a story of the “Goliath” CIRM vs. the “David” clinics. We all know how that story turned out.
A. Rahman Ford, PhD, is a lawyer and research professional. He is a graduate of Rutgers University and the Howard University School of Law, where he served as Editor-in-Chief of the Howard Law Journal. Rahman lives with chronic inflammation in his digestive tract and is unable to eat solid food. He has received stem cell treatment in China.
