The Committee on the Ethics of Cell & Gene Therapy (ECGT) of the International Society for Cell & Gene Therapy (ISCT) has issued a position paper on direct-to-consumer marketing of unproven and unapproved cell-based, cell-derived, and gene-based therapies/ interventions (collectively known as carrier genetic tests, or CGTs) (Ikonomou et al. 2023). The paper includes information on multi-national consumer protection resources related to both proven and unproven CGTs. It states:
The sheer volume of direct-to-consumer businesses offering unproven CGTs and the exploitation of regulatory ambiguity and/or loopholes have resulted in a global marketplace with widespread patient exploitation. Further reasons exacerbating this problem are the inability of understaffed regulatory agencies to perform rigorous and extensive inspections of such businesses and take enforcement actions, the absence of global regulatory convergence, and transnational travel (also known as medical tourism) of patients seeking unproven CGTs.
The paper identifies frequent features of unproven CGTs, many of which are common in the marketing of other dubious therapies. Among them are unclear scientific rationales, lack of appropriate evidence, inadequate disclosures to patients to enable proper informed consent, use of patient testimonials and celebrity endorsements, and claims that a single treatment approach can help patients with many different and unrelated conditions.