Where oversight increased
The lack of ketamine clinic oversight stands in stark contrast to regulation of Janssen Pharmaceuticals’ Spravato. Janssen received a patent by isolating esketamine, a molecule found in ketamine. The FDA approved the branded drug in 2019 for treatment-resistant depression and later for major depressive disorder with acute suicidal ideation. Ketamine is a generic drug and has never been approved for an indication other than as an anesthetic.
Spravato is distributed by providers under one of the strictest Risk Evaluation and Mitigation Strategies systems from the FDA. The agency usually uses REMS for drugs that have higher risk profiles and don’t have much real-world data as it learns more about the treatment’s safety and use in clinical practice.
For every patient who receives Spravato, providers must submit forms to a registry, and must follow a long list of other requirements and standards.
In June 2020, not-for-profit Mental Health Center of Denver opened up Spravato treatment to a small number of patients. Medicare and Medicaid, which cover the majority of their patients, reimburse for the drug, which usually costs thousands of dollars for a month of treatment. Meanwhile, ketamine costs a fraction of that price.
The clinic administers the Spravato nose spray to patients and blocks a two-hour window to monitor them. Patients receive treatment twice a week for four weeks, and then one treatment over four weeks.
But providers spend more time on administrative work and receive lower reimbursement for monitoring patients.
“Just looking at all the guidelines that the FDA has put forth for the Spravato, it’s a little concerning that there are many clinics that are just out there giving IV ketamine infusions, and I don’t know how much of a background or what kind of medical history they’re taking on folks,” said Denise Hosier, a nurse practitioner and director of adult integrated care and nursing services at Mental Health Center of Denver.
The FDA could take some action on ketamine, though not to the extent they can with a new drug. It has the ability to issue drug safety alerts, or apply a black box warning, but to date has not done so.
All the work Hosier and the center have put into their clinic has paid off, she said. Most of the patients go from thinking about suicide every day to not often. Hosier remembers a patient who recounted watching a “Friends” episode.
“She recalled that she found it enjoyable, she laughed out loud and she could not recall the last time that she’d laugh at something,” Hosier said. “I thought about how sad that was, the things that I would take for granted, this woman hadn’t been able to do for years. That’s why I think it is one of the things that I get super excited to talk about.”
Drug safety experts argue that for all the good stories of patients getting better with Spravato, there’s still a crucial system in place that will produce hard data beyond anecdotes to weigh whether its benefits trump the risks.
And if the FDA determined that Spravato needed that kind of rigorous monitoring system, so does ketamine, according to Thomas Moore, a faculty associate at Johns Hopkins’ Center for Drug Safety and Effectiveness.
“It’s one thing to say that physicians need flexibility to use their judgment to prescribe drugs that may be somewhat outside the FDA-approved indications to help patients,” Moore said. “And then entirely another thing to set up businesses to openly advertise and recruit patients to take treatments that clearly do not have the safety precautions that the FDA has required for a virtually identical product.”