A Fraught New Frontier in Telehealth : Ketamine - The New York Times
Un (long) article passionnant. On retrouve un processus qui a créé la crise des opioides. Même si le danger de la kétamine n’est pas comparable, le pattern de comportement des autorités, comme des fabricants, des médecins et des patients est similaire. Et on retrouve toujours « l’excuse » des mauvais comportement avec un « bon » produit que les fabricants d’opioides, notamment les Sackler, ont utilisé très longtemps (avant qu’ils ne se mettent à fabriquer des produits pour sauver des overdoses, puis se déclarent en faillite pour ne pas payer d’amendes).
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 start-ups 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.
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.
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, 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-publicized promise of ketamine and the lesser-discussed risks.
“We know at a certain point you will get both the neurotoxic and the bladder-toxic effects — we just don’t know at what level,” said Dr. Gerard Sanacora, a psychiatrist and leading ketamine researcher at Yale University.
In the absence of data, some medical professionals said they were becoming more conservative in their prescribing because of anecdotes in published case reports or online forums.
Professional groups have developed informal guidelines that emphasize catching symptoms early, reducing the dose and spacing out treatments. But some at-home providers are pushing in the opposite direction, viewing ketamine as just another medicine to be taken regularly.
“I would be worried about chronic usage,” said Dr. Adam Howe, a urologist at Albany Medical Center who advises a group developing treatment guidance. Damage is avoidable with proper safeguards, he said, but “common sense would tell you, if you’re to use this every day for years on end, then at a certain point, you’re going to be damaging your bladder probably.”
The literature on addiction and abuse among medical users is also thin and inconclusive. Supporters point to studies indicating that patients on ketamine rarely, if ever, have those issues. Others note a pattern common in drug development: an initial overestimation of benefit, followed by more tempered results and recognition of previously undetected harm.
Production Is Booming
For years, mental health clinics have administered the F.D.A.-approved liquid form of ketamine that doctors also use to sedate patients in surgery. But at-home treatment created demand for a version that was less potent and easier to take — something not available from drugmakers.
Enter a uniquely positioned industry: compounding pharmacies.
These specialized companies operate in a murky regulatory space somewhere between a corner drugstore and a pharmaceutical manufacturer. They can produce variations of approved drugs but do not have to follow the same quality-control rules as drugmakers.
Most compounding pharmacies do not have to notify federal regulators when they learn of a patient experiencing a problem, and they are rarely, if ever, inspected by the F.D.A. In many cases, the agency may not even know they exist.
Companies that once served primarily local customers now ship their products across the country as the ketamine boom has presented an alluring opportunity.
“It’s become the new buzz in this space,” said Jeanine Sinanan-Singh, chief executive of Vitae Industries, which sells a machine that compounding pharmacies can use to produce doses at a faster clip than with other methods.
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, customizable 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’s 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 emojis. 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.
“Our algorithms use all of this information to tailor the protocol exactly to your brain and body’s needs,” Sharon Niv, co-founder and chief of customer experience, says in a video. In written responses to questions from The Times, the company said its general treatment approach “has been adapted and used by providers nationally and internationally” for more than five years and its internal data indicated that “this medicine is highly effective for both anxiety and depression.” It declined to provide details about how its technology works.
The company says lower doses translate to lower risk. Yet most of the eight Joyous patients who spoke with The Times said their doses reached the maximum the company would prescribe within weeks. Some providers who generally support at-home treatment expressed concern that taking ketamine every day, even at lower doses, could heighten the risk of tolerance, addiction and bladder problems.
“We believe that the patients who choose Joyous understand the risks and feel that the benefits outweigh the potential risks,” the company said, adding that nine out of every 10 patients “report feeling better overall.”
“We want to emphasize that Joyous is a public benefits corporation,” the company said, “meaning that we prioritize public goods over profits.”
The future of the ketamine boom depends largely on the actions of the federal government in the coming months. While states have some authority, the most important policy decision rests with the D.E.A. 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 D.E.A. 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.”
#Kétamine #Psychédéliques #Dépression #Abus #Pharmacie #Déontologie #Santé_publique