These blows come as the Drug Enforcement Administration continues to operate. make rules This would place new restrictions on how medical professionals can use telemedicine to prescribe highly regulated drugs like ketamine.
Ketamine is used for anesthesia In hospitals for decades and illegally as a club drug. In recent years, it has shown promise as a treatment for depression, where conventional antidepressants have been ineffective.
In 2019, the FDA approved Spravato, a nasal spray that is a derivative of ketamine. strict rules Regulating the use of Spravat has led many people to seek other ways to obtain the drug that are legal but not FDA-approved. A growing number of clinics are offering IV drips, and some medical institutions are prescribing tablets that can be taken at home.
The rapid expansion of ketamine from medical settings to patients' homes has led to a growing debate among ketamine providers, who see it as an important tool to combat mental illness but disagree about how it should be used. ing.
The nonprofit American Association of Ketamine Physicians, Psychotherapists, and Practitioners issued a statement after ketamine use was banned: “This is a clear and unified message for ketamine physicians and the broader medical community based on real-world data and medical science.'' This is a wake-up call to erect guardrails.” implicated in Perry's death. The group pledged to create guidelines for using ketamine at home.
Many medical professionals consider ketamine to be safer than opioids with less potential for abuse. However, the FDA has not established dosing guidelines for ketamine when used for psychiatric disorders, raising safety concerns such as abuse, increased blood pressure, and bladder problems. The FDA says using the drug at home without a health care provider present increases the risk.
Despite such warnings, there is considerable excitement about the prospect of ketamine and other drugs with psychedelic properties for treating mental health disorders. Just two weeks after the FDA warning, psychedelic drug-focused venture firm Beckley Waves acquired telemedicine ketamine company Nue Life for undisclosed terms. Nue Life was valued at $103 million in 2022, according to data provider Pitchbook. The service said rival Mindbloom was worth an estimated $230 million in 2021.
According to , Nue Life has provided home ketamine therapy to more than 10,000 patients in 23 states. Transaction announcement. “Through Nue Life, we are able to provide affordable access to safe, legal ketamine therapy,” said Daniel Love, co-founder of Beckley Waves, adding that the company takes risks seriously and follows safety protocols. He added that he is working on strengthening it.
One of the major disagreements among ketamine practitioners is where and how patients receive treatment. One camp argues 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 can reduce depression. , claims it can provide more affordable relief from anxiety and post-traumatic stress disorder.
Each approach has tradeoffs. On-site trained therapists can help patients avoid the mind-altering effects of drugs and ensure physical safety, but it can be expensive. For some people, signing up for virtual services may be more accessible, but they won't provide the same level of support as an in-person experience.
Raquel Bennett, a ketamine expert and founder of the Kriya Institute, falls into the former camp and sees ketamine as a tool for self-discovery. “The goal of ethical ketamine treatment is not to make patients dependent on ketamine forever,” she said, adding that if prescribers don't help patients learn new emotional skills, “it creates a ketamine addiction.” He may be complicit in this,” he added.
A spokesperson for Mindbloom said that Mindbloom has “helped thousands of people overcome depression and anxiety,” and that its protocol “ensures that the treatment is effective and safe.” It includes extensive safeguards to ensure that
Mindbloom, Nue Life and other startups are taking advantage of a waiver from the federal government's requirement that prescribers assess patients in person before treating them with DEA-regulated drugs to help improve home delivery during the pandemic. The debate over the use of ketamine intensified. This means doctors can prescribe ketamine to patients from their computers, often allowing them to treat people in multiple states.
In March, the DEA proposed a rule Manage how healthcare professionals use telemedicine to prescribe controlled substances (drugs considered to have varying degrees of abuse potential). For drugs classified as ketamine, doctors can prescribe a 30-day supply through a telemedicine visit, but after that they must see the patient in person to continue treatment.
That sparked an avalanche of backlash from patients and health care providers who have turned to telemedicine to administer medications ranging from Adderall to benzodiazepines. Many people say ketamine saved their lives. DEA received more than 38,000 comments Regarding the proposed telemedicine rule and related rules regarding buprenorphine.
“We believe this is one of the highest numbers of comments we have received in the history of the DEA,” the agency's administrator, Ann Milgram, said at the September hearing.
Not all proponents of expanding access to telemedicine think ketamine should be part of it. At a hearing in September, Talkiatry's chief medical officer, Georgia Gaveras, pointed out that patients using Sprabat would need to be monitored by a medical professional and exempted ketamine from telemedicine rules. I suggested that.
According to the event, “We also believe that there are very significant diversion risks to home-prescribing substances that may have significant benefits for depression, and that they should be further regulated. “I will.” transcript.
Some drug companies are betting on improvements to generic ketamine, which is currently prescribed off-label.
Adam Kaplin saw firsthand the power of ketamine while overseeing the clinical trials that led to the approval of Spravat, but he also saw the inconvenience and cost of FDA-required monitoring. He said events like Perry's death show that “giving patients access to this at home is a very potentially dangerous practice.”
Kaplin, now chief scientific officer at Mira Pharmaceuticals, is aiming to develop a ketamine derivative with fewer side effects. The goal, he said, is to develop a drug that even the FDA approves as safe for patients to take at home.
