Ketamine Clinics Misleading Consumers About Side Effects, Suggests Study
An analysis of Maryland ketamine advertisers has suggested that their websites are awash with false and misleading claims.
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An analysis of Maryland ketamine advertisers has suggested that their websites and marketing materials are awash with false and misleading claims about the drug’s addictiveness, side effects and approval status.
The review was published in a research letter in JAMA Network Open.
Dr. Michael DiStefano, a study co-author and assistant professor in the Department of Clinical Pharmacy at the University of Colorado Anschutz Medical Campus, said that the marketing materials used by direct-to-consumer advertisers may create “unrealistic expectations” for potential clients.
Ketamine: legal but unapproved
Ketamine has been used as an anesthetic drug in human and animal medicine for decades. It has been swept up in the search for rapid-acting antidepressant molecules and a variant of the compound, Janssen’s drug Spravato®, has been approved by the US Food and Drug Administration (FDA) for treatment-resistant depression. Generic ketamine has also been the subject of numerous clinical trials as an antidepressant but is importantly not approved by the FDA for any psychiatric use. Instead, the drug is used off-label by physicians for this purpose, alongside a long list of other conditions, including everything from chronic pain, to opioid withdrawal and even Lyme disease.
DiStefano’s study reviewed the websites of 17 ketamine advertisers across 26 locations in Maryland. The providers offered a battery of potential ketamine procedures, including infusions, intramuscular injections and oral or intranasal administrations of the drug. Of these 17, 10 failed to mention that the ketamine treatment they offer is an off-label procedure. “[Patients] will also likely spend a substantial amount out-of-pocket to access these treatments, as off-label or experimental treatments are not often covered by insurance,” says DiStefano. These bills could potentially be vast: the cost per infusion varied from $360 to $2500 at some clinics.
One clinic even falsely claimed that their ketamine treatment was FDA-approved.
The team also looked at the list of side effects and risks disclosed by the ketamine providers in their promotional materials. Outside of the clinic or operating room, ketamine has a second life as a party drug and is addictive. DiStefano’s analysis showed that 7 of 17 providers failed to mention the drug’s potential for misuse or addiction in their promotional materials, while 9 didn’t warn consumers that there would be a risk from driving after taking the drug. A trio of providers even falsely stated that ketamine was non-addictive on their website.
The high cost of these treatments means abuse at the clinics themselves is unlikely, but that same financial barrier means patients could potentially be driven to take the drug illicitly, although there is limited evidence of this happening in practice. This isn’t the only risk, says DiStefano, “There are concerns other than addiction, such as effects on cognition, from repeated dosing with ketamine. More research is needed to understand these potential long-term effects.”
The authors note that as the clinics and advertisers featured in the study don’t manufacture, pack or distribute the ketamine they administer, an FDA loophole leaves them outside the agency’s regulatory remit. This is an oversight that should be rectified as soon as possible, says DiStefano: “The FDA's regulatory authority could be clarified or updated to apply to consumer advertising by any business entity that sells prescription drugs.”
Reference: 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