FDA warning and Matthew Perry’s death dims ketamine’s glow

Federal health authorities are stepping up their investigation into the drug ketamine for treating mental health disorders, as the mind-altering compound grows in popularity despite a lack of regulatory approval for such use. .

The Food and Drug Administration warned in October about the dangers of using home pharmacy-made ketamine, citing the case of a patient whose breathing slowed to a dangerous level after taking a large dose outside of a care facility. health Then the autopsy of actor Matthew Perry, released on December 15, concluded that a high dose of ketamine led to his death in October, an event that, although rare, gave rise to a dark side of the anesthetic. which can also be abused recreationally.

These knocks come as the Drug Enforcement Administration continues to work on a rule that will set new limits on how health care professionals can use telemedicine to prescribe strictly controlled drugs like ketamine.

Ketamine has been used for anesthesia in hospitals for decades and illicitly as a club drug. In more recent years, it has shown promise as a salve for depression when conventional antidepressants have failed.

The FDA approved a derivative of ketamine, the nasal spray Spravato, in 2019. But the strict rules governing the use of Spravato have led many people to seek other ways of obtaining the drug that are legal but not FDA approved. Clinics have emerged to provide infusions, while some providers prescribe a tablet that can be taken at home.

Ketamine’s rapid spread outside of health care settings and into patients’ homes has heightened the debate among ketamine providers who see the drug as a critical tool for combating mental illness but disagree. -according to how it should be used.

It’s a wake-up call for ketamine practitioners and the broader medical community to put clear and unified guardrails in place guided by real-world data and medicine, said the nonprofit American Society of Ketamine Physicians, Psychotherapists, and Practitioners after ketamine was implicated in Perry’s death. The group pledged to create guidelines for the use of ketamine at home.

Many practitioners consider ketamine to be safe, with less potential for abuse than opioids. The FDA, however, has not established dosing guidelines for ketamine when used for a psychiatric condition, and the agency has flagged safety concerns that include abuse, increased blood pressure and bladder problems. Adding to the risk, the FDA says, is using the drug at home without a health care provider.

Despite such alarms, there is great excitement about the prospects for ketamine and other drugs with psychedelic properties to treat mental health disorders. Nearly two weeks after the FDA warning, Beckley Waves, a venture firm focused on psychedelics, bought telehealth ketamine firm Nue Life for undisclosed terms. Nue Life will be worth $103 million in 2022, according to data provider PitchBook. Mindbloom, a rival company, has an estimated value of $230 million in 2021, according to the service.

Nue Life has provided at-home ketamine therapy to more than 10,000 patients in 23 states, according to the deal announcement. Daniel Love, co-founder of Beckley Waves, said through Nue Life, we can provide affordable access to safe and legal ketamine therapy, adding that the company takes the risks seriously and is committed to strengthening protocols in safety.

This doctor is prescribing ketamine to thousands online. Everything is legal.

A major divide among ketamine practitioners is how and where patients receive treatment. One camp asserts that the drug is safest and most effective when used in the presence of a trained therapist, while others argue that allowing patients to use it at home may provide more affordable relief from depression, anxiety and post-traumatic stress disorder.

Each approach has trade-offs. A trained on-site therapist can help a patient navigate the mind-altering effects of drugs and ensure physical safety, but that can be costly. Signing up for a virtual service may be more accessible for some, though it doesn’t come with the same level of support as an in-person experience.

Raquel Bennett, a ketamine specialist and founder of the Kriya Institute, belongs to the former camp, seeing ketamine as a tool of self-discovery. The goal of ethical ketamine treatment is not to have clients become dependent on ketamine forever, he said, adding that if prescribers don’t help patients learn new emotional skills, they can contribute to creating ketamine addiction.

A spokesperson for Mindbloom said it has helped thousands of people overcome depression and anxiety, and that its protocols include extensive safeguards to ensure the treatment is effective and safe.

The debate over the use of ketamine at home has intensified during the pandemic, as Mindbloom, Nue Life and other start-ups have capitalized on a federal waiver of a requirement that prescribers screen patients when personally before treating them with DEA-regulated drugs. This means doctors can prescribe ketamine to patients from their computers, often treating people in multiple states.

In March, the DEA proposed a rule to govern how health care professionals use telehealth to prescribe controlled substance drugs that are considered to have varying degrees of potential for abuse. For drugs in the ketamines classification, a doctor can prescribe a 30-day supply via a telehealth visit but must see a patient in person after that for treatment to continue.

That prompted an avalanche of pushback from patients and providers who relied on telehealth for controlled drugs from Adderall to benzodiazepines. Many have said that ketamine has been a lifesaver for them. DEA received more than 38,000 comments on its proposed telemedicine rule and a related rule for buprenorphine.

We believe that is among the highest number of comments we have gotten in the history of the DEA, Anne Milgram, the agency’s administrator, said in a September listening session.

Not everyone in favor of expanded access to telehealth thinks ketamine should be part of it. At a September listening session, Georgia Gaveras, Talkiatry’s chief medical officer, suggested that ketamine be exempt from the telehealth rule, pointing out that patients using Spravato would need to be monitored by a health care professional.

We also believe that prescribing at home a substance that has great promise for depression also has a tremendous risk of diversion, and we believe that it should be taken care of, he said, according to a transcript of the event.

Some pharmaceutical firms are betting that they can improve the generic ketamine prescribed off-label today.

Adam Kaplin witnessed the power of ketamine while overseeing the clinical trials that led to Spravato’s approval, but also saw the hassle and expense that comes with FDA-required monitoring. Events like Perry’s death, he said, show it’s a potentially dangerous practice to give patients access to it at home.

Kaplin, now chief scientific officer of Mira Pharmaceuticals, aimed to develop a derivative of ketamine with fewer side effects. The goal, he said, was to create a drug that even the FDA would endorse as safe for patients to take at home.

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