Tag: legal

Smith is part of a wave of doctors and telehealth start-ups capitalizing on the pandemic-inspired federal public health emergency declaration, which waived a requirement for health-care providers to see patients in person to prescribe controlled substances. The waiver has enabled Smith to build a national ketamine practice from his home outside Charleston — and fueled a boom among telehealth companies that have raised millions from investors.

As the urgency around covid-19 subsides, many expect the waiver to expire this spring. Companies are lobbying to extend it, and patients are bracing for a disruption to purely virtual care.

“I would not have wanted to do this if I had to go to a clinic,” said Steve, a Chicago resident who works in public relations and who spoke on the condition that his last name be withheld because of the stigma around the drug. Ketamine has helped his bipolar disorder more than any other medication, he said, and he wants to continue taking it through a service called Mindbloom, which connected a Post reporter with him. “It’s just not going to happen, if that regulation changes.”

Ketamine for depression: What it feels like and who it can help

The Drug Enforcement Administration in 2020 temporarily waived the requirement that prescribers meet patients in person before treating them with several classes of drugs, from opioids to certain treatments for depression. A DEA spokesperson said the agency is working on regulations to allow this permanently, but declined to provide details or a timeline.

At least eight companies have begun providing ketamine by telehealth since the start of the pandemic. Between just Smith and two of the better known companies, Nue Life and Mindbloom, more than 10,000 patients have been treated at home. Virtual ketamine start-ups say they’re making the treatment vastly more accessible and improving patients’ lives. But many psychiatrists — including those who believe in ketamine’s promise for treating mental illness — worry that having patients taking it outside a doctor’s direct supervision is a step too far, too soon.

Smith, who thinks the federal waiver should be made permanent, is unbothered by critics who question the wisdom of mailing ketamine to patients at home. “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,” he said.

Ketamine has long been used in hospitals for anesthesia and abused recreationally for its mind-altering properties. But in recent years, it’s shown promise for delivering rapid relief to patients with mental health conditions who’ve tried conventional antidepressants without success.

Nothing seemed to treat their depression. Then they tried ketamine.

The FDA approved a nasal spray derived from ketamine, Spravato, in 2019 to treat severe depression. But that approval came with strict guardrails to ensure patient safety, a nod to known side effects such as altered consciousness and increases in blood pressure.

The FDA requires that patients be monitored by health-care professionals for two hours after they take Spravato, in addition to mandating certain steps for clinics and pharmacies.

Those safety measures may have an unintended consequence, some ketamine scholars say: Rather than go through the extensive FDA requirements, more patients and doctors may turn to what is known as “off-label” ketamine, ordering the generic variety the FDA has approved for anesthesia to instead treat depression. Ketamine clinics have opened up across the nation to provide the generic version through an IV infusion.

Now, with the federal waiver of requirements to treat patients in person, more health-care professionals — and venture capital-backed start-ups — are prescribing ketamine in the form of dissolving tablets that patients can take at home.

The growing use of off-label ketamine outside direct medical supervision has aroused concern among some psychiatrists who worry there isn’t enough evidence to show it’s safe.

“I’m very concerned about treatments that deviate too far from the standard recommendations given by the FDA,” said Gerard Sanacora, director of the Yale Depression Research Program who led a team that pioneered ketamine to treat depression. “I really do believe that it is one of the major advances of psychiatry in the past half-century,” he said of ketamine, “but we have to be very careful to continue to develop this responsibly.”

“I understand the concern,” said Juan Pablo Cappello, chief executive of Miami-based Nue Life, launched in 2021 to provide virtual ketamine therapy. “But what I really spend my time thinking about is suffering that’s going on today and how to alleviate it,” he said.

Among telehealth ketamine companies, the details vary but the model is similar: Patients meet with a doctor virtually to determine whether ketamine therapy is appropriate. If so, a provider orders generic ketamine lozenges from a pharmacy. The patient is mailed a dose, with instructions to have a “sitter” present while they take the ketamine and how to follow up after the experience. Prescribing practitioners work with patients to adjust the dose and monitor their symptoms.

The telehealth model allows ketamine providers to offer the treatment at a lower cost than infusion clinics, which can run hundreds of dollars per session.

How to know if it’s depression or just ‘normal’ sadness

“At-home ketamine has increased accessibility for those who may not have access to ketamine clinics due to physical location, cost and time commitments,” Ryan Magnussen, chief executive of ketamine provider Wondermed, said in a statement.

Beyond pitching their affordability, telehealth providers are trying to translate their patients’ experiences into scientifically rigorous proof that ketamine is safe and effective to take at home. Company websites highlight research findings alongside images of blissful-looking people in warm hues, though the scientific claims at times lack context.

Nue Life, for instance, cites an American Psychiatric Association publication that ketamine’s effects are “rapid and robust” without mentioning another passage in the same paper: “we strongly advise against the prescription of at-home self-administration of ketamine.” The association still maintains this view.

Wondermed proclaims that “over 90{35112b74ca1a6bc4decb6697edde3f9edcc1b44915f2ccb9995df8df6b4364bc}” of patients see an improvement in anxiety and depression — but that is among those who have reported on their well-being, and some 40 percent have not.

Mindbloom similarly touts that 89 percent of its clients report improvement for these conditions, but that figure comes from a study where more than half of participants didn’t report any follow-up data.

Despite the incomplete data, the study is a point of pride for Mindbloom. Dylan Beynon, Mindbloom’s chief executive and a ketamine patient himself, said it is the largest-ever peer-reviewed study on ketamine therapy, showing that 63 percent of 1,247 patients had a clinically significant improvement in their anxiety and depression and fewer than 5 percent reported side effects.

The study had significant limitations. It didn’t compare ketamine treatment with a control group receiving a placebo, the gold standard for gauging a drug’s safety and impact.

Sanacora, the ketamine specialist at Yale, objected to the conclusions of the Mindbloom study, which described ketamine by telehealth as “safe and effective.” In a letter to the journal that published the study, he and a colleague wrote, “We think the authors’ conclusions go well beyond the data.”

Mindbloom said the study was open about its limitations. “It’s also important to understand how well a treatment works for people in the real world,” the company said in a statement attributed to Thomas Hull, the paper’s lead author.

The company CEOs uniformly believe that telemedicine is here to stay but are preparing for the expiration of the federal waiver, including making plans to open physical clinics.

Mindbloom, one of the more established ketamine telehealth firms, reports operating in 35 states and Washington, D.C. But even that reach doesn’t match one doctor in South Carolina.

As a doctor working in an emergency room in the early 1990s, Scott Smith knew ketamine as a drug he used to sedate patients. His understanding began to shift with the experience of his wife, who after suffering from depression tried ketamine infusions.

“I had lost the person I had married,” he said. After her ketamine treatment, “I got my college girlfriend back. That was a life-changing event.”

Smith describes himself as a “person who gets obsessed with things.” He took up quilting after watching “Project Runway” and acquired five sewing machines. When he got into gardening, he threw himself into researching plants that could thrive in his completely shaded yard. He bought a fixer-upper house and did the electrical and plumbing work himself, he said. Ketamine is his latest fixation.

Smith closed his brick-and-mortar family practice during the pandemic to focus on ketamine by telemedicine, where patient demand was higher. People began reaching out to him on Reddit, where he posts under the handle KetamineDrSmith, to see if he could treat them.

With the federal public health emergency declaration, he could. It just took getting licensed in states where patients lived, he said. He went all in, obtaining licenses in 45 states in addition to South Carolina, according to a Washington Post review of state licensing databases. His Louisiana license expired in May. In July, an Alabama law required telehealth providers to meet patients in person to prescribe a controlled substance like ketamine.

Initially, “it was like building a bridge while you’re driving across it,” Smith said. Catherine Smith, his wife and medical assistant, added, “We’re really saving more lives than we ever did in our primary care practice.”

Smith estimates that about 5 percent of patients who come to him aren’t good candidates for ketamine therapy, and he declines to treat them. Occasionally, younger patients will ask for a prescription simply because they want to try the drug.

“They think it’s like an internet service,” he said, “like there’s a drive-through window at McDonald’s for ketamine.” Smith only treats patients for a legitimate medical purpose, he said, usually for depression, anxiety or post-traumatic stress disorder.

His patients generally pay $250 a month, which includes a supply of ketamine — 10 tablets at a time — and follow-up visits with a nurse practitioner, medical assistant or other members of his eight-person practice. More than half respond well, he said, and he will prescribe ketamine for six months and then encourage them to stop taking it.

Ketamine doesn’t carry the same risk of addiction or overdose as opioids, but side effects can range from unpleasant, disorienting sensations — what some might call a “bad trip” — to being temporarily immobilized.

“So if somebody took a dose of ketamine that was way too high and their house caught on fire, they wouldn’t be able to leave the house,” Smith said.

At first, Smith scheduled virtual appointments with patients in the evening and would stay by his computer for 90 minutes. “It was so incredibly uneventful and such a poor use of my time,” he said. “If a competent adult has somebody to sit with them, that’s adequate.”

By taking ketamine orally, patients absorb less of the drug, and more slowly, than they do when it is administered through an IV. Smith believes this reduces the risk of side effects, citing the Mindbloom study and another study by Nue Life.

Because he doesn’t physically watch patients take ketamine, Smith acknowledges it is possible for them to use the drug inappropriately — taking multiple doses at once to get a high, for instance, or selling the ketamine to others. Still, he says, he has ways of holding patients accountable, such as having them do a “pill count’ on screen to see if they are taking the doses as directed.

“This is a part of my job I take very seriously,” he said. “I can have my medical license taken away. I can be fined, can do jail time for continuing to treat people” who are abusing ketamine, he said. Of some 3,000 patients, he said there have only been two who wanted to abuse the drug, and he stopped prescribing and arranged follow-up care for them.

Smith knows his practice is controversial but isn’t concerned. “What is the risk versus benefit, is the question society needs to ask,” he said. Rather than returning to pre-pandemic regulations where he would have to consult patients in person, Smith says the key to making ketamine therapy safer is for the DEA to create a registry and closely monitor the drug’s prescribers.

“Put everybody under a microscope,” he said.

But should the waiver that has allowed him to practice nationally expire, he has a plan: hit the road.

“I would buy an RV,” he said, comparing the prospect of meeting his virtual patients to reunions with people he’s come to know through internet games. “Nothing would thrill me more than to meet these people in person,” he said.