Evelyn Jiang: Stem Cell Tourism: Balancing Hope and Harm
With its potential to treat a wide range of debilitating diseases and injuries, stem cell therapy has captured the interest of the medical community and patients alike. However, most stem cell applications are still in their infancy and have yet to demonstrate clinical benefits. Within the US, the stringent FDA regulatory framework limits the availability of stem cell therapies that have not undergone rigorous clinical testing and approval processes. This framework is necessary to ensure the safety and efficacy of stem cell therapies for patients but also means that the development and approval of new stem cell therapies can be a lengthy and expensive process. In the interim, the provision of unproven stem cell interventions has developed into an unregulated global industry: desperate patients who are promised medical benefits beyond what the scientific literature can substantiate pay large sums of money to private clinics in countries with less rigorous regulations, such as Mexico and Thailand. This form of medical travel is called "stem cell tourism" and has been criticized for numerous ethical, legal, and health concerns. As reckless policies may drive patients away from clinical researchers, promote illegal activity, and tramp on other forms of medical travel, it is critical to strike a balance between recognizing the hope that stem cell treatments can offer and the harm that unproven treatments can cause. Thus, effective solutions can be devised only by understanding the nuances and challenges of this industry.
A booming industry
The use of stem cells as a treatment option dates to the 1950s with the discovery that bone marrow transplants could help treat certain types of blood cancer. This led to further research into the potential use of stem cells to treat other conditions, from Parkinson's disease to spinal cord injuries, but for many treatments, the literature is limited to small observational studies. As of 2023, the only stem cell-based treatment approved in the US by the Food and Drug Administration (FDA) is hematopoietic stem cell transplantation for patients with cancers and disorders affecting the blood and immune system (CERB). The possible consequences of receiving unapproved stem cell treatments cannot be understated. Infection, donor rejection, and tumorigenesis are common complications, with spinal meningitis and brain tumors listed as two commonly reported adverse outcomes from fetal-derived neural stem cells in Chinese and Russian clinics (Bauer et al.). It is speculated that more adverse outcomes are under-reported (Bauer et al.).
With many patients turning to stem cell tourism once they have exhausted all approved medical options in their home country, the demand for stem cell therapies continues to soar despite a blatant lack of scientific justification and continuing education efforts. In 2022, the global stem cell therapy market was estimated to be worth $5.14 billion, and it is poised to reach $6.45 billion by 2027 (The Business Research Company). The leading countries in the international stem cell tourism market—the US, China, India, Thailand, and Mexico—attract patients seeking stem cell therapies for a variety of reasons, including innovation, lower cost, lax regulations, and greater availability (Murdoch and Scott). Although some countries have implemented regulations to reduce stem cell tourism, there is no harmonized international regulatory scheme. This legal divergence between countries enables clinics to continue evading regulatory oversight. For example, in Japan, if early phase trials for regenerative therapies show promise of safety and efficacy, clinics are allowed to advertise them for up to seven years without ever demonstrating the effectiveness of the treatment (Murdoch and Scott).
The influence of media attention and advertising in the growth of the stem cell industry cannot be ignored. Media reports often sensationalize preliminary scientific findings and cases while underestimating the risks associated with unproven treatments. Furthermore, digital marketing has allowed clinics to reach patients worldwide and promote their services using flashy persuasive advertising, and celebrity endorsement. For example, Gordie Howe, a Canadian hockey player who received unapproved stem cell treatments in Mexico, was known as an active spokesperson for the industry during his lifetime, earning the nickname "Mr. Stem Cell” (Chan). Advertisements for commercial stem cell clinics often encourage patients to take their fate into their own hands whilst portraying standard clinical medicine as lacking imagination and innovation, appealing enormously to the hopes and needs of chronically ill patients. This narrative is mainly one-sided: clinics have been known to change name and location quickly if there is any attempt at "name and shame," detrimental effects on a patient's condition are often challenging to prove, and patients are often embarrassed to admit having paid a large sum of money for unsuccessful treatment. Companies and clinics also utilize the deeper connection between the mythos of regenerative medicine and the cultural obsession with escaping death and decay to promote their procedures. Overall, advertising and media coverage enables clinics offering unproven stem cell treatments to exploit vulnerable "last option" patient populations.
Financial consequences
The financial risks of these uninsured procedures for patients are evident, as most stem cell treatments cost $10,000 to $50,000, excluding travel expenses and follow-up care (Cona). The full extent of the financial consequences of unregulated stem cell tourism cannot be described by only the sticker price of these procedures. As many stem cell clinics are based in low- and middle-income countries (LMICs), patients often incur travel-related illnesses and treatment-related complications and infections that require complex and expensive treatment in their home country. This is significant not only for patients but also for public health programs, private insurance companies, and hospitals. The financial and socioeconomic consequences are particularly damaging in countries like Canada, where healthcare is publicly funded.
Understanding the bioethical issues and challenges
Ethical concerns are inherent in stem cell tourism. Stem cell clinics in lax countries like Mexico, India, and Thailand use aggressive marketing strategies and make exaggerated claims about efficacy without providing adequate information about the risks associated with unproven treatments. These strategies often target emotionally and financially vulnerable patient populations, who may feel compelled to undergo unconventional treatments. Clinics often prioritize profit over well-being, charging exorbitant fees, and may repeatedly subject patients to unnecessary and costly procedures with little regard for their health.
Many believe that patients should be able to access unproven stem cell therapies based on their right to autonomy. This has led to the Right to Try Act (RTT) in the US, which allows terminally ill patients who have exhausted government-approved options and cannot enroll in clinical trials to access experimental treatments that have not yet received final FDA approval (Agarwal and Saltz). Supporters of the RTT argue that for patients who have exhausted treatment options, unapproved therapy treatments provide more hope than taking no action. However, liberal access to experimental therapies can lead to therapeutic misestimation, the tendency of patients and their loved ones to overestimate the benefits of and underestimate the risks of treatment. This can ultimately increase the burden of suffering and undermine patient autonomy and consent. In addition, there is a concern that liberal access to experimental therapies under the RTT could also harm the progress of clinical trials. If a patient who has additional preconditions receives an experimental therapy and experiences negative side effects or adverse events, it could ruin the clinical trials of the treatment. This is because the patient may not have met the criteria to participate in the clinical trial and may not have been a representative sample of the broader population that the treatment is intended for. As a result, premature approval of an experimental therapy under the RIT could end clinical trials of drugs too early and prevent researchers from obtaining the necessary data to make informed decisions about the safety and efficacy of the treatment.
Due to limited clinical data, lack of standardization, and the general complexity of the field, it is often challenging for physicians to communicate adequate information to patients regarding alternative stem cell therapies. Informed consent is an ethical obligation and a legal requirement that promotes patient autonomy; clinicians have a responsibility to provide patients with all relevant information to make informed decisions regarding their care. Hence, informed consent is not fully feasible.
Possible policy and regulatory actions
Medical travel encompasses many different practices, and demonizing stem cell tourism gives the risk of limiting other efforts for such travel. Often, patients travel to other countries because treatments are too expensive for patients in their native countries. It is also common for patients to travel if the treatments are banned for political or religious reasons. The efforts to enforce regulatory solutions surrounding stem cell tourism should therefore be targeted at the providers of such unproven therapies rather than the patients. Several policy and regulatory actions that can be taken to address stem cell tourism include stricter regulation of clinics, improved clinical trials, the creation of a global accreditation system, and a greater emphasis on physician competence.
Governments can increase regulatory oversight of stem cell clinics by including stricter license requirements, having mandatory reporting of stem cell treatment-related adverse events, and increasing penalties for noncompliance by clinicians. National authorities should also enforce penalties for clinics that make false claims about the services they provide, which can be done through various legal measures such as common law fraud and consumer fraud. It is essential that these regulatory schemes are harmonized to reduce the number of clinics that relocate to less-regulated jurisdictions. This will require collaboration and an increase in international public awareness.
Governments can also increase funding for clinical trials of stem cell therapies to help identify therapies that are safe and effective to reduce the demand for unproven therapies.
The establishment of a global accreditation system by a major organization such as the World Health Organization or Joint Commission International would also help with the standardization of medical information and services across the world. This system could involve the creation of review boards consisting of clinicians, scientists, technologists, and product quality experts. They would operate off comprehensive standards for cellular therapies based on published medical evidence. In this spirit, the International Society for Stem Cell Research (ISSCR) has already developed guidelines to promote rigor and transparency in stem cell practice (International Society for Stem Cell Research). They have openly condemned the use of unproven stem cell therapies and fraudulent stem cell clinics, instead recommending patients only to undergo treatments registered with the FDA or European Medicines Agency. They have also provided suggestions and guidelines for proper informed consent concerning stem cell treatments and guidebooks for patients to navigate various treatment options.
A greater emphasis on physician competence is also necessary. Instruction in regenerative medicine should be included in undergraduate and postgraduate medical curricula to help provide practitioners with the knowledge and skills to address patient queries and ensure patients receive accurate and unbiased information about these treatments.
Stem cell therapy holds great promise for treating a variety of medical conditions, but it also presents significant ethical and regulatory challenges. The rise of stem cell tourism and the proliferation of unproven and potentially harmful therapies highlights the need for robust policies and regulations to protect patients from exploitation and harm. Proper informed consent and patient education are crucial components of any policy to ensure patients have access to accurate and reliable information about the benefits and risks of stem cell therapy. Developing harmonized regulatory schemes across countries is also essential to prevent clinics from evading regulatory oversight by relocating their operations to less-regulated jurisdictions. Ultimately, prioritizing patient well-being over profit is critical to ensuring that stem cell therapy can fulfill its potential as a safe and effective medical treatment.
Evelyn Jiang is a first year at Yale University in Morse College
Citations
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