A prolific telehealth prescriber of sublingual ketamine, Scott William Smith, MD, has shut down his practice as of Wednesday after losing his ability to prescribe controlled substances. The closure drew an outpouring of frustration from abruptly cut-off patients, as well as questions about the long-term feasibility of online access to controlled substances.
According to an email to Smith's patients that was and verified , the Drug Enforcement Administration (DEA) has suspended Smith's controlled substance license and instructed him to close his practice.
"My privileges to prescribe controlled substances have been suspended until further notice," Smith wrote in the email. "I am in quite a bit of a shock about this."
His website now reads, "Please contact us through the patient portal for records transfer and assistance for referral to providers in you area due to the closing of our practice." The reason for the suspension and closure is still unclear, and Smith did not respond to multiple requests for comment from ľֱ in time for publication.
Smith was licensed in at least 45 states, according to a previous , and had built an active patient pool of over 3,000, largely on Reddit where he posted as u/KetamineDrSmith in a subreddit where patients went to exchange information on ketamine treatment. He was based in South Carolina.
He told the Washington Post that access to the drug was critical for his patients: "I'm like a medic running around on the battlefield taking care of wounded people, and ketamine helps the people I'm taking care of."
According to information from his website and gathered from online accounts, the treatment model was similar to that of other telehealth platforms: patients would see Smith for an initial video intake and have follow-up appointments with his staff, which included licensed therapists, nurse practitioners, and "ketamine coaches." Patients took the sublingual troches themselves at home, without medical supervision. The treatment cost $250 a month, not counting the ketamine.
An easing of restrictions during the COVID-19 public health emergency (PHE) in the U.S. allowed Smith and others to see patients and prescribe controlled substances via video visit and gave rise to the success of a number of online platforms like MindBloom and Nue Life. The end of the PHE prompted a set of proposed DEA rule changes, including going back to requiring an in-person visit to prescribe controlled substances. The deadline for the start of the rule, however, was to November 11, 2023, with an extra year for those with pre-existing telehealth relationships.
A nasal spray derivative of ketamine known as esketamine (Spravato) is FDA approved for the treatment of treatment-resistant depression and related symptoms. Other forms of ketamine, a sedative that has traditionally been used around operations as an analgesic or anesthetic, are increasingly being prescribed off-label. These include tablets, troches, and infusions. According to Smith's website, patients would get their monthly prescriptions of sublingual ketamine troches through local compounding pharmacies.
Ketamine's reputation as a party drug, in addition to its side effects, and a lack of randomized, controlled trials to establish its safety and effectiveness for long-term use have drawn skepticism, including from clinicians concerned that widespread off-label prescribing for home use, without supervision, has jumped ahead of the available research.
"There's very minimal data to support the use of at-home ketamine," said Gerard Sanacora, PhD, MD, professor of psychiatry and director of the Yale Depression Research Program in New Haven, Connecticut, who has treated patients with ketamine and written about its role in treating mood disorders. "The flip side is, it's incredibly expensive to get quality data. So it's difficult."
But ketamine's potential for side effects and abuse have been well established. Sanacora pointed to the risk of bladder injury, bladder disease, potential neurotoxic effects, and dependence. "It's not risk-free at all, so how you balance the potential benefits of access versus potential harms is really difficult," he said.
Members of the subreddit for medical professionals, r/medicine, put their criticism of prescribers like Smith in stronger terms. "These sketchy ketamine clinics are going to ruin a promising treatment," wrote one commenter who identified as a hospitalist.
Another identifying as an emergency medicine physician wrote, "If you market yourself as only prescribing one thing (ketamine, testosterone, Adderall, etc) then you're not a doctor, you're a drug dealer."
But patients who say they depend on it for lifesaving care feel otherwise. Immediately following the news of Smith's practice closing, panicked patients flocked to Reddit to air their grievances, voice their support for Smith, and ask for advice.
"Dr Smith and his team saved me from suicide. I don't know what I'm going to do without him and his team," one Reddit user wrote in the subreddit r/TherapeuticKetamine, a sentiment that appeared many times on the thread. Another wrote: "DEA has blood on their hands. No warning whatsoever. I wish we could sue them."
Another wrote: "Absolutely heartbreaking. My routine feels like the only thing keeping me going these days after losing both of my parents in the last 6 months; I am positively beside myself." Yet another argued that "beyond obvious therapeutic value, services like smith's provide a safe supply. Regardless of your reason for using drugs, harm is greatly reduced when purity is ensured by a doc."
The DEA did not respond in time for publication to a request for comment on the reason for suspension of Smith's prescribing privilege. For now, patients are turning to other online providers.
"There are some unscrupulous people doing things that are clearly not in the patient's best interest," said Sanacora. "But I think there are a lot of providers out there that really think they're doing what is in the patient's best interest, but are likely to be acting with very limited data."