Concerns Raised Over False Claims in Direct-to-Consumer Online Marketing of Ketamine

Experts have raised concerns regarding online direct-to-consumer (DTC) advertising of subanesthetic ketamine, specifically the promotion of intravenous (IV) infusions and oral forms of ketamine for the treatment of mental health conditions.

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In a study published by JAMA Network Open, the authors noted that IV ketamine has not been approved by the FDA to treat mental health issues and is used off-label, whereas the oral forms of the drug are unapproved compounded formulations that are frequently promoted for recreational purposes.

“Oral formulations are compounded, unapproved drugs often advertised to induce a hallucinogenic experience at home,” the authors wrote.

The study noted that depending on context, online DTC promotion of prescription drugs is regulated by the FDA, Federal Trade Commission, and potentially other 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,” the authors wrote.

For the study, investigators analyzed online DTC advertising for off-label, unapproved ketamine with at least one clinic in the state of Maryland, as well as a website. For the cross-sectional study, the authors used a list of advertisers from six national ketamine clinic databases, which was supplemented by advertisers found via a geolocated Google search focused on Baltimore, Maryland.

The study authors documented advertiser websites by creating archived site-level directories for all component webpages. Investigators also included data on the types, costs, and uses for advertised ketamine services along with claims that address safety and regulatory status promoted by ketamine advertisers. Claims were deemed as false or misleading if they contradicted evidence gathered via a multidisciplinary review or from FDA statements.

The study ultimately included 17 advertisers across 26 individual locations in Maryland as of March 2023. The services most frequently promoted were IV infusions and ketamine-assisted therapy, while several advertisers promoted on-label use of esketamine.

The drug was offered across an variety of indications for mental health issues, such as depression, post-traumatic stress disorder (PTSD), and anxiety. Advertisers also promoted its use for conditions such as chronic pain, Lyme disease, substance use disorder, alcohol use disorder, and opioid withdrawal.

The cost per infusion ranged from $360-$2500, with the cost of consultations ranging from free-of-charge to $390. Further, seven of 17 advertisers did not disclose the potential for adverse effects, such as the risk of substance abuse associated with ketamine, with three advertisers going as far as issuing false claims that the drug is not addictive.

Further, one advertiser falsely claimed ketamine has been approved by the FDA to treat depression. In 2019, the FDA approved a variant of ketamine for PTSD, but no such approvals have been granted for depression.

Additionally, 10 of the advertisers did not reveal that the services they were promoting represented off-label use of ketamine, with three others who were promoting unapproved ketamine formulations failing to disclose its unapproved status.

“Our analysis of Maryland ketamine DTC advertising showed numerous misleading representations regarding treatment safety and efficacy,” the study authors wrote. “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. 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.”

Limitations of the study included that it only focused on advertisers in Maryland, which may not be representative of the entire United States. Other limitations were that the website information may not be reflective of all the information the sites were providing 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,” the authors concluded.

References

Crane MA, DiStefano MJ, Moore TJ. False or Misleading Claims in Online Direct-to-Consumer Ketamine Advertising in Maryland. JAMA Netw Open. 2023;6(11):e2342210. doi:10.1001/jamanetworkopen.2023.42210