Kirstin R.W. Matthews, “Promoted Yet Unproven: How State Laws Expand Access to Unchecked Stem Cell Interventions” (Houston: Rice University's Baker Institute for Public Policy, May 13, 2024), https://doi.org/10.25613/A10Z-D563.
Tens of thousands of clinics market stem cells and regenerative medicine products to patients, leading many to believe that these interventions cure patients. However, this hype hides the truth — as most stem cell interventions (SCIs) have not been proven to work and be safe by the U.S. Food and Drug Administration (FDA). Researchers have also found that these interventions are emotionally, physically, and financially harmful. Patients have suffered severe side effects from stem cell procedures done incorrectly, and many do not understand that SCIs are experimental and unproven treatments.
Further, these interventions can cost thousands of dollars for each treatment, as multiple rounds are often required with patients returning for several visits. Because these SCIs are experimental, the burden falls on the patient to pay, since health insurance will not cover them. Despite this negative data, several U.S. states — Texas, North Carolina, Mississippi, and Utah — passed legislation that not only permits the marketing of unproven SCIs, but also promotes the use of experimental SCIs for individuals with terminal or chronic diseases.
State-based SCI medical freedom laws are largely based on “Right-to-Try” (RTT) legislation that provides terminally ill patients access to experimental treatments. Since 2014, RTT laws passed in more than 40 U.S. states and were enacted into federal law in 2018 by former President Donald Trump. While the FDA already has an expanded access program that permits the use of interventions under investigation, RTT laws circumvent this system by working directly with manufacturers to avoid FDA requirements, specifically informed consent approval by patients. The RTT process also relies heavily on physician’s ability to identify appropriate experimental treatment options with limited information about the associated risks and effectiveness of these interventions. Furthermore, RTT laws do not provide access to experimental treatments. They only provide patients with the right to ask.
New state experimental SCI laws expand on these existing RTT laws. In addition to allowing experimental treatment access for terminally ill patients, they explicitly permit unproven SCIs to severe chronically ill patients excluded in RTT laws — the definition of “severe chronic disease” is left open to interpretation, covering anything from obesity to multiple sclerosis. Moreover, experimental SCI laws not only permit but also promote the marketing and use of unproven SCI, putting patient’s health and lives at risk while providing little protection to patients harmed by these procedures.
In the recent publication, “US State Laws on Medical Freedom and Investigational Stem Cell Procedures: A Call to Focus on State-Based Legislation,” I collaborated with Zubin Master, Baker Institute nonresident scholar and Wake Forest University associate professor, and former Rice University student Samantha J. Lowe to analyze state experimental SCI laws’ expansion, dissemination, and impact on public health.[i] Our data suggest that these state policies can be harmful to patients – physically, financially, and emotionally.
Based on our findings, we recommend that scientific and medical societies form a broad coalition to address state-based policies promoting unproven SCIs. Scientific and medical societies are uniquely poised to advocate against these state-based policies, as they have built-in expertise within their memberships on stem cells as well as state politics. However, individual organizations may have limited resource, which may lower their ability to advocate in all 50 states on their own. The establishment of a broader coalition and allocation of resources would alleviate this issue and begin to address state-based experimental SCI laws and their effects on patient safety and health.
[1] Kirstin R.W. Matthews, Samantha J. Lowe, and Zubin Master, “US State Laws on Medical Freedom and Investigational Stem Cell Procedures: A Call to Focus on State-Based Legislation,” Cytotherapy 26, no. 4 (April 2024): 404–09, https://doi.org/10.1016/j.jcyt.2024.01.002.
