Houston Chronicle Sunday

A fraught new frontier in telehealth: ketamine

DEA puts the antidepres­sant’s abuse risk just below opioids

- By Chris Hamby

For Greg Rice, ketamine was transforma­tive. The drug, approved decades ago to sedate patients during surgery, was increasing­ly being used to treat mental health conditions such as his depression.

Since his teenage years, Rice had cycled through a long list of medication­s. Searching for relief, he sometimes abused his prescripti­ons and experiment­ed with LSD, psychedeli­c mushrooms and other illicit substances.

At a particular­ly low point after a breakup a few years ago, Rice, 38, bought ketamine through back channels and injected it nightly for two weeks. The psychedeli­c-like journeys seemed to loosen the grip of his negative thoughts. “That was probably not the best way of coping,” he acknowledg­ed, “but it got me through a really rough experience.”

He continued using the drug periodical­ly, he said, but was left hunting for a supply — until last year, when he discovered the freewheeli­ng world of telemedici­ne.

Rice went online and made an appointmen­t with a doctor more than 2,500 miles from his California home whom he had never met. After a 30minute video call, he received a prescripti­on for a month’s supply. “I finally had an avenue to get pure medical-grade ketamine for cheap, sent to me over the mail,” he said.

Not long ago, such an arrangemen­t would have been illegal. Access to ketamine was tightly controlled by the Drug Enforcemen­t Administra­tion, which puts its risk of abuse one notch below that of opioids such as oxycodone and fentanyl. Although prescribin­g it for depression was allowed, patients needed to first meet in person with a doctor, and treatment was mostly limited to infusions in clinics.

But in 2020, at the height of the pandemic, the Trump administra­tion made it easier to treat patients by telemedici­ne, including remotely prescribin­g controlled substances. These regulatory changes, which have continued under President Joe Biden, have made all manner of medical care, from management of chronic diseases such as diabetes to substance abuse treatment, more accessible and affordable.

Although many patients have benefited, the rapid growth of remote prescribin­g and at-home use of various drugs has outpaced the evidence that doing so is safe and effective. As the gap between medical treatment and online shopping has narrowed, already-thorny debates over the proper balance between availabili­ty and safety have become increasing­ly urgent.

The ketamine boom is a particular­ly fraught case study of this new reality because of the drug’s powerful effects and the vulnerable patients drawn to it: typically those with severe depression or other mental health conditions who have not responded to traditiona­l therapies. The shift away from clinics has led many patients to take the drug more frequently and for longer periods of time — multiple times a week, even daily in some cases, and for months or years — despite scant research on safety.

To better understand how this is playing out, the New York Times interviewe­d more than 40 patients who said their access to the drug was expanded through telehealth, spoke with two dozen doctors and other medical profession­als, and reviewed scientific studies, case reports and data from researcher­s, government agencies and private analytics firms.

Many of the patients said ketamine was lifechangi­ng, the only drug that had ever relieved their crushing symptoms. But some described serious drawbacks — including addiction and bladder damage — that have been documented for years among recreation­al users but have been largely played down by the drug’s medical proponents.

On a Reddit forum devoted to ketamine therapy, an online community that has grown from fewer than 2,000 members in 2019 to more than 25,000 today, posts about misuse of the drug have appeared often enough that some members have pleaded for discretion, fearing a tightening of telehealth regulation­s.

“I feel like some authority at some point is going to want to crack down and be like, ‘No, we don’t think this is OK,’ ” one ketamine patient, Samuel Brooks, said in an interview.

COVID-19 exacerbate­d the nation’s mental health crisis and underscore­d the inadequacy of many existing treatments, accelerati­ng a reconsider­ation of once-stigmatize­d psychedeli­cs. Because the Food and Drug Administra­tion approved ketamine as an anesthetic more than 50 years ago, federal rules allow doctors to prescribe it for other conditions as well, and its use for depression, anxiety and post-traumatic stress disorder was growing before the pandemic.

With the rule changes in 2020, the at-home ketamine industry appeared practicall­y overnight.

Tech startups and individual doctors began offering medical services online, and so-called compoundin­g pharmacies, which can make variations of approved drugs, found a market for tablet and lozenge versions of ketamine, normally manufactur­ed as a liquid and distribute­d in vials. Primed by glowing media coverage and aggressive advertisin­g, many patients interviewe­d by the Times came to regard the drug — and its remote availabili­ty — as akin to a miracle cure with few risks.

They can now pursue a treatment course not approved by the FDA, taking forms of the drug that are also not approved, produced by companies operating largely outside the agency’s oversight — all

without comprehens­ive monitoring.

Some found their way to online physicians such as Scott Smith, a family medicine doctor who closed his practice in South Carolina in 2020 to focus full time on online ketamine treatment. In the past three years, Smith has remotely treated about 3,000 patients in 44 states.

Others sought out fledgling tech companies such as Joyous, which offers rock-bottom pricing and daily dosing adjusted by text message, or a host of more establishe­d firms.

Studies of recreation­al users have documented that ketamine can be addictive and, when taken chronicall­y in high doses, can cause severe bladder damage that in the worst cases requires surgical reconstruc­tion of the organ. There are indication­s that abuse may also lead to cognitive impairment.

Advocates of increased therapeuti­c use say those issues are exceedingl­y rare or nonexisten­t at the doses and frequencie­s commonly prescribed. But because treatment is remote and there is little mandatory reporting of side effects, it is nearly impossible to accurately gauge their prevalence.

On private online forums for medical profession­als, accounts of bladder issues are common enough that some providers are becoming more restrained in their prescripti­ons, according to multiple people with access to the websites. Some psychiatri­sts have published cautionary reports.

The approaches of patients such as Rice highlight the underlying tension. He acknowledg­ed his “addictive tendencies” with ketamine, but his top priority in choosing online treatment was clear: “I wanted something handsoff.”

Trip with risks

Many ketamine patients described the drug as a reset button for the brain. During treatment sessions, they experience­d pleasant visualizat­ions, sometimes accompanie­d by a sense of existing outside themselves and melding with the universe. Afterward, their daily problems seemed less weighty.

The considerab­le hype surroundin­g ketamine stems in part from the drug’s ability to affect brain receptors that traditiona­l antidepres­sants do not target. The psychedeli­c-like trip, many believe, is integral to the drug’s therapeuti­c effect.

But for some patients who spoke to the Times, the profound experience­s of their early sessions faded. Chasing the lost high, they sought increased doses, took multiple days’ worth at once or altered the medicine to release more of its payload.

For others, ketamine treatment eventually meant dealing with a constant urge to urinate, often painfully, as well as other bladder ailments.

The experience­s of the dozens of patients who shared their stories with the Times encapsulat­e both the well-publicized promise of ketamine and the lesser-discussed risks.

Driving the interest are early-stage studies showing that the drug can rapidly relieve symptoms of depression. But there has been little research on how to maintain the improvemen­ts and even less on whether prolonged treatment is safe.

When discussing the risks, prescriber­s often insist there is a sharp line between chronic abuse and medical use.

“That happens in people that abuse ketamine and use more than a thousand milligrams on a daily basis,” Smith, the online physician from South Carolina, said of bladder damage. “We’re treating most people with 200 milligrams every three days. We haven’t seen anybody that’s had that problem.”

Still, two of Smith’s former patients said in interviews that they experience­d serious issues that required care from a urologist.

Six patients of various medical providers said they came to crave the ketamine trip so much they began to use the drug compulsive­ly. The more they took, some found, the more they needed.

“It’s pretty powerful,” said a 59-year-old woman from Philadelph­ia who sometimes takes more than prescribed, runs out early and tries to buy the drug on the dark web.

Doses at bargain rates

Cost concerns led Chad Curl to the telehealth startup Joyous. After trying seemingly everything — prescripti­on pills, electrocon­vulsive therapy, an implanted nerve stimulator — he found relief from depression at a clinic administer­ing a closely related drug, esketamine, which is a nasal spray approved by the FDA as a mental health treatment. But it cannot be taken at home, and he could afford only a few sessions.

Searching online for alternativ­es last fall, he found an apparent bargain: $129 a month, ketamine included. He filled out Joyous’ intake questionna­ire, had a 20-minute virtual appointmen­t and received a prescripti­on, all in the same night.

“I was like, ‘Wow, I didn’t even plan on this today, and here we go,’ ” he said.

Joyous illustrate­s a reality of how at-home ketamine has evolved: Patients with some of the most serious and complicate­d mental health challenges are turning to some of the most hands-off treatment, according to the Times’ interviews.

The company has carved out its place with a novel approach: Instead of prescribin­g higher doses to be taken once or twice a week, Joyous offers lower doses to be taken daily.

Melding the argots of Silicon Valley and selfcare, Joyous delivers treatment primarily by text message, replete with exclamatio­n points and emoji. Each morning, patients receive a questionna­ire on their phones asking about symptoms and side effects, and each evening, they get a text with the next day’s recommende­d dose.

Joyous describes itself as a collaborat­ion between “medical experts, psychology specialist­s and Silicon Valley technologi­sts.”

As Joyous’ customer base has grown, so have complaints. Messages to the company’s support line go unreturned for days, multiple patients said.

The future of the ketamine boom depends largely on the actions of the federal government in the coming months. Although states have some authority, the most important policy decision rests with the DEA. If the agency doesn’t take action before the COVID-19 public health emergency is scheduled to end in May, patients may be required to have at least one in-person visit before they can be prescribed ketamine.

Many patients who spoke with the Times expressed hope for a middle ground: something more stringent than the current laissez-faire approach but not so restrictiv­e that a potentiall­y lifesaving treatment became inaccessib­le.

Curl said he hoped that his and other patients’ negative experience­s would not ruin the athome ketamine experiment more broadly.

“I’m not on a mission to get them shut down or anything,” he said, “because that’s not going to solve any problems for people like me.”

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 ?? Keith Negley/New York Times ??
Keith Negley/New York Times
 ?? Keith Negley/New York Times ?? With loosened rules around remote prescripti­ons, the psychedeli­c-like drug ketamine is a popular treatment for mental health issues.
Keith Negley/New York Times With loosened rules around remote prescripti­ons, the psychedeli­c-like drug ketamine is a popular treatment for mental health issues.

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