Analyzing State-Based Legislation Surrounding Medical Freedom, Stem Cell Procedures

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Given the severity of terminal and chronic diseases, the regulatory agencies that are responsible for verifying that novel biotherapeutics are as safe and effective as possible often find themselves under pressure to provide quick public access to these products, noted the authors of an analysis published in Cytotherapy.¹ Some could make the argument that the stem cell intervention (SCI) market is a prime example, a sector in which there over 2,700 clinics in the United States, and tens of thousands more across the globe.

The industry has been described as having “insufficient evidence of safety and efficacy of the interventions, unqualified clinicians practicing outside their scope of training, and misinformation promulgated primarily by clinics to augment sales.”

Despite the lack of evidence, countries overseas have attempted to accelerate public access to these novel therapies, with advocates pushing for medical freedom and right-to-try (RTT) experimental interventions via ways that promote deregulation; to many, autologous stem cells belong to that specific individual who can use them as they see fit, such as for treatment purposes.

The authors of the commentary set out to examine state SCI medical freedom laws in the United States that authorize the market expansion of unproven SCIs beyond just the investigational context. The authors argue that SCI medical freedom laws often undercut federal authority when it comes to managing the safety and efficacy of biologics prior to marketing; spread distrust in the scientific and medical community; and increase access to SCIs that could potentially hurt patients.

The authors noted that the development of RTT laws dates back to the Goldwater Institute, a free-market think tank. When it came to the creation of state SCI medical freedom laws, the 2018 Medical Freedom Act was heavily responsible and was powered by the American Legislative Exchange Council (ALEC). The nonpartisan industry-sponsored group has responsibilities that include organizing state legislators, developing model bills, and offering a forum to discuss state-level policymaking. In more recent years, many of its members have been believed to be associated with the Republican Party, according to the authors.

Under the ALEC Medical Freedom Act, patients with terminal or severe chronic diseases have access to investigational SCIs. While RTT laws state that the investigational drug/device needs to have passed Phase I trials, the ALEC Medical Freedom Act only asks that an intervention be “under investigation in a clinical trial and being administered to human participants in that trial.” The SCIs also need to be provided by a licensed physician who is approved by an institutional review board (IRB) that records treatments and sends a yearly report to the state's medical board.

Multiple states have ended up passing SCI medical freedom laws, including Texas, North Carolina, and Mississippi. In 2015, the state legislature passed a RTT law, and an SCI medical freedom law in 2017 with an update two years later. In fact, the SCI medical freedom law, House Bill (HB) 810 (2017), was the inspiration that set the wheels in motion for the ALEC Medical Freedom Act. For North Carolina and Mississippi, these states’ SCI medical freedom laws were also inspired by the Medical Freedom Act but had one main addition: informed consent details. Mississippi even imposed restrictions on the cell types that were allowed.

Overall, the investigators noted that “the creation of the ALEC Medical Freedom Act has encouraged interest in state-based SCI-promoting laws nationwide. These bills and laws have largely gone unnoticed or unmentioned by scientific societies. Although SCI medical freedom laws may vary in terms of patient eligibility, IRB requirements and physician protections, all promote the commercial expansion of unproven SCIs outside of an investigational setting.

“As a result, state-based SCI medical freedom laws undermine the FDA's regulatory authority, promote medical misinformation among patients and limit repercussions for exploitative business practices. …societies should increase their state-level policy advocacy efforts by developing a coalition where they can pool resources and promote dismantling of state-based SCI medical freedom laws.”

Reference

1. Matthews KRM, Lowe SJ, Master Z. US state laws on medical freedom and investigational stem cell procedures: a call to focus on state-based legislation. Cytotherapy. February 3, 2024. doi: https://doi.org/10.1016/j.jcyt.2024.01.002