False or Misleading Claims in Online Direct-to-Consumer Ketamine Advertising in Maryland

Introduction Online direct-to-consumer (DTC) advertisements for prescription drugs, depending on context, are variously regulated by the US Food and Drug Administration, the Federal Trade Commission, and/or state consumer protection statutes. Specific requirements vary in rigor, and existing guidelines focus on manufacturers, distributers, and packers of prescription drugs-designations that do not appear to include clinics and telemedicine platforms that provide access to prescription drugs.(1,2) One market of concern in this gray area of advertising relates to subanesthetic ketamine.(1-3) Advertisers may promote intravenous infusions and/or oral formulations, depicted as an emerging treatment for mental health conditions.(1,2) Intravenous ketamine is not FDA approved to treat any mental health condition and is used off-label for this purpose. Oral formulations are compounded, unapproved drugs often advertised to induce a hallucinogenic experience at home. In this study, we evaluated online DTC advertising of off-label and unapproved ketamine in Maryland. Methods For this cross-sectional study, we identified online DTC ketamine advertisers with at least 1 clinic in Maryland and a website. We identified advertisers from 6 national ketamine clinic databases (eTable 1 in Supplement 1). We supplemented this list with advertisers identified through a geolocated Google search centered in Baltimore, Maryland. Advertiser websites were documented by creating archived site-level directories of all component webpages, excluding blogs. Two researchers (M.A.C. and M.J.D.) extracted information in March 2023 on types, costs, and uses of advertised ketamine services as well as claims regarding safety and regulatory status promulgated by ketamine advertisers. Website analysis methods are detailed in the eMethods in Supplement (1). Claims were determined to be false or misleading if they contradicted evidence accumulated through a multidisciplinary review or contradicted FDA statements (eTable 2 in Supplement 1).(4)We followed the STROBE reporting guidelines. This work was performed to brief Maryland regulators. This study used data from publicly available websites. In accordance with 45 CFR 46, we did not submit the study to an institutional review board for approval because it did not involve human participants. Results We identified 17 advertisers operating in Maryland across 26 individual locations as of March 2023. Advertisers most frequently promoted infusions (n = 13) or ketamine-assisted therapy (n = 9), with several advertisers also providing on-label use of esketamine (n = 6). Ketamine was offered for a wide range of potential indications, including depression (n = 17), posttraumatic stress disorder (n = 17), anxiety (n = 14), and chronic pain (n = 13). Less common indications advertised included Lyme disease, substance use disorder, alcohol use disorder, and opioid withdrawal. Published cost per infusion varied widely (range, $360-$2500), as did services publicized by specific advertisers. Consultations were often free but could cost up to $390 (Table 1). Table 2 summarizes risk disclosures and claims about ketamine's regulatory status. Seven of the 17 advertisers failed to disclose any potential adverse effects, including risk of abuse associated with use of ketamine. Three advertisers falsely stated that ketamine was nonaddictive. One advertiser falsely stated that ketamine was FDA approved to treat depression. Ten advertisers did not disclose that their advertised services represent off-label use of ketamine, and all 3 advertisers offering unapproved ketamine formulations failed to disclose this unapproved status. Discussion Our analysis of Maryland ketamine DTC advertising showed numerous misleading representations regarding treatment safety and efficacy. Ketamine is not the only example of this type of advertising; a secret shopper study on DTC platforms providing testosterone therapy uncovered prevalent guideline-discordant care.(5) Despite potential benefits of ketamine in treating select mental health conditions, well-founded concerns have been raised regarding similarities with opioid prescribing and the risk of widespread misuse.(6) This work has limitations. Our sample included only Maryland advertisers, which may not represent the entire country. Furthermore, information on websites may not reflect all information provided to patients. Despite these limitations, our findings point to a concerning regulatory environment that may not adequately protect consumers and holds substantial potential for patient harm.