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Ketamine ushers in fraught new frontier

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, Mr 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.

A man poses for a photo with a ketamine pill pack at his home in the Brooklyn borough of New York. AFP

At a particularly low point after a breakup a few years ago, Mr 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.

Mr Rice went online and made an appointment with a doctor more than 4,000 kilometres from his California home whom he had never met. After a 30-minute 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 the 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 life-changing, 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.

TELEHEALTH KETAMINE 2 KEITH NEGLEY/NEW YORK TIMES

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-stigmatised psychedelics.

Because the Food and Drug Administration approved ketamine as an anaesthetic 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.

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

TELEHEALTH KETAMINE 3 KEITH NEGLEY/NEW YORK TIMES

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, Dr Smith has remotely treated about 3,000 patients in 44 states, and has been featured in The Washington Post and on social media sites such as YouTube and Reddit.

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 — popularly known as K or Special K, with a reputation as a club drug — 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 Mr 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 hands-off.”

A Trip With Risks

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

TELEHEALTH KETAMINE 4 KEITH NEGLEY/NEW YORK TIMES

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, including a Tennessee cybersecurity manager and a former Pennsylvania factory worker, 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 — a Utah data analyst, a California bartender and a Pennsylvania internet entrepreneur — 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-publicised 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 milligrammes on a daily basis,” Dr Smith, the online physician from South Carolina, said of bladder damage. “We’re treating most people with 200 milligrammes every three days. We haven’t seen anybody that’s had that problem.”

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Still, two of Dr Smith’s former patients said in interviews that they experienced serious issues that required care from a urologist. Both said they did not tell Dr Smith because they felt addicted to the drug and wanted to continue their prescriptions, which they were misusing.

Daily 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.

KEITH NEGLEY/NEW YORK TIMES

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 is the new kid on the at-home ketamine block, a reflection of where market forces and scant regulation have taken the fledgling industry. The company has sought to distinguish itself by promoting its tech-driven, customisable treatment plans, but the real draw for many patients is its pricing.

“I signed up for Joyous, if we’re being honest, just because of the price,” said Francisco Llauger, who, like Mr Curl, found in-clinic treatments effective but too expensive.

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 self-care, 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”. The company’s co-founder and chief medical officer, Dr Bobbi Leben, has a physical rehabilitation and pain management practice in the Florida Keys, and Joyous is not her first foray into telehealth entrepreneurship.

Archived versions of the website for a company called Everyone’s MD identify Dr Leben as a co-founder and offer treatments including ketamine, generic Viagra and hemp cream for pain. Joyous said she “was involved in the initial discussion” about the company but “was not involved in the launch” and now had no affiliation with the firm.

Joyous patients typically receive ketamine from SmartScript, a compounding pharmacy in Wisconsin, records show, that is managed by Dr Leben’s husband, Daniel. In its written responses, Joyous said that patients were free to choose where their prescription was filled.

As Joyous’ customer base has grown, so have complaints. Messages to the company’s support line go unreturned for days, multiple patients said. Mr Curl, who initially praised Joyous in an interview in November, expressed exasperation last month: “They don’t respond to your comments anymore, and I figure, what’s the point?”

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. The DEA declined to comment on its plans.

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.

Mr Curl said he hoped that his and other patients’ negative experiences would not ruin the at-home 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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