Where Oversight Increases

The lack of ketamine clinic oversight contrasts sharply with Janssen’s Spravato oversight. Janssen patented the isolation of one of the molecules in ketamine, esketamine. The FDA approved the brand-name drug for treatment-resistant depression in 2019 and later for major depressive disorder with acute suicidal ideation. Ketamine is a generic drug that has never been approved for indications other than as an anesthetic.

Spravato is distributed by suppliers under one of the FDA’s most stringent risk assessment and mitigation strategy systems. The agency typically uses REMS for higher-risk drugs that don’t have much real data, as it learns more about the treatment’s safety and use in clinical practice.

For each patient receiving Spravato, providers must submit a form to the registry and must follow a long list of other requirements and criteria.

In June 2020, the nonprofit mental health center in Denver opened up Spravato therapy to a small number of patients. Medicare and Medicaid, which cover most patients, reimburse the drug, often costing thousands of dollars a month of treatment. Meanwhile, ketamine costs a fraction of that price.

The clinic administers Spravato nasal spray to patients and blocks a two-hour window to monitor them. Patients received treatment twice a week for 4 weeks and then once in 4 weeks.

But providers spend more time on administrative tasks and receive lower reimbursement for monitoring patients.

“Just looking at all the guidelines the FDA has come up with for Spravato, there’s a bit of concern that there are a lot of clinics out there that offer IV ketamine, and I don’t know how much background or what kind of medical history they’re taking people,” said a nurse practitioner at Denver Mental Health. said Dennis Hosier, who is also director of Adult Integrated Nursing and Nursing Services.

The FDA can do something about ketamine, but not to the extent they can with new drugs. It has the ability to issue drug safety alerts, or apply black box warnings, but has so far not done so.

She said all the work Hosier and the center did for their clinic paid off. Most patients go from suicidal thoughts every day to infrequent suicidal thoughts. Hosier remembers a patient recounting watching an episode of “Friends.”

“She recalled that she thought it was funny, she laughed out loud, and she couldn’t remember the last time she would laugh about something,” Hosier said. “I think how sad that is, and I take it for granted that this woman hasn’t been able to do it for years. That’s why I think it’s one of the things I’m very excited to talk about.”

Drug safety experts argue that for all the good stories about patients getting better with Spravato, there’s still a critical system that produces hard data beyond anecdotal measures to measure whether its benefits outweigh the risks.

If the FDA determines that Spravato needs this rigorous monitoring system, so does ketamine, said Thomas Moore, a faculty member at the Johns Hopkins Center for Drug Safety and Effectiveness.

“It’s one thing to say that physicians need to be flexible in using their judgment to prescribe drugs that may help patients in some way beyond FDA-approved indications,” Moore said. “And then it’s a whole other thing to build businesses to advertise and recruit patients for treatments that obviously don’t have the safety precautions the FDA requires for nearly identical products.”