The Rise of Ketamine in Pain Management Amid Opioid Prescription Decline: Concerns Over Research and Regulation

by Joshua Brown
ketamine pain treatment

With the curtailment of opioid prescriptions, U.S. healthcare providers are increasingly turning to an alternative for managing severe pain: ketamine. This substance, once primarily used in surgery and known for its psychedelic properties, is now being prescribed widely, even with scant research on its efficacy and regulatory oversight.

The surge in ketamine prescriptions is fueled by profit-driven clinics and telemedicine services that are aggressively marketing it for a range of issues, including pain, depression, and anxiety. The drug’s cost-effectiveness and the ability for it to be prescribed by a broad spectrum of medical professionals, regardless of their specialization, are contributing factors to its growing use.

The lack of substantial evidence regarding ketamine’s effectiveness in pain treatment is causing concern among experts who fear a repeat of the overprescribing practices that ignited the opioid epidemic. Dr. Padma Gulur from Duke University, who is investigating the use of ketamine, noted the eagerness to adopt new treatments without robust scientific backing.

In a study involving 300 patients at Duke who were administered ketamine, over one-third experienced severe side effects necessitating medical intervention, including hallucinations and visual disturbances. Furthermore, ketamine did not significantly reduce opioid prescriptions post-treatment, challenging the notion that it could be a viable alternative to traditional painkillers.

Despite these concerns, the allure of ketamine’s psychedelic effects at lower doses, reminiscent of its notoriety as a party drug in the past, is undeniably playing a role in its present-day use for pain management.

Daniel Bass’s experience with ketamine was unsettling; despite the distressing visual side effects he encountered during his treatments for a rare disorder, he acknowledges the drug’s effectiveness in alleviating his pain.

Ketamine’s action on the brain neurotransmitter glutamate is thought to influence both pain and depressive symptoms, yet it is unclear whether the psychedelic experiences it induces are integral to its therapeutic impact.

Dr. David Mahjoubi of the Ketamine Healing Clinic in Los Angeles asserts that the dissociative experiences are key to the treatment’s success for conditions like chronic pain and mental health disorders. His clinic is one of many cash-based operations that cater to various conditions, often outside FDA-approved indications.

The industry has seen a dramatic increase in prescriptions, with pain being the primary indication, although depression prescriptions are also on the rise. This boom has led to shortages and increased sales of compounded ketamine, which lacks FDA approval and rigorous safety data.

The FDA has only approved a ketamine-related treatment for severe depression, subject to stringent regulations. However, most insurance companies do not cover off-label uses of ketamine, resulting in a thriving cash market for the drug.

Experts have expressed concern over the robust “wild west” marketplace that has emerged, driven in part by venture capital and consultancy firms guiding physicians to start ketamine clinics. These services, like MindBloom and Joyous, are capitalizing on relaxed online prescribing rules instituted during the pandemic, now extended through 2024 despite federal intentions to revert to pre-COVID policies.

The FDA has warned against the compounded formulations of ketamine, highlighting the potential dangers and the lack of regulatory control over their quality. However, state boards like that in Massachusetts may not enforce federal recommendations, leaving a gap in oversight.

While the FDA rigorously regulates pharmaceutical companies, these standards do not apply to individual prescribers, leaving a wide berth for potential abuse or misrepresentation. Efforts by the FDA to regulate office-based high-risk drug use have seen mixed success in the courts.

As it stands, the expectation of increased regulation of off-label ketamine use appears low, with agencies likely to continue issuing warnings rather than taking direct action against providers.

For further information, you can follow Matthew Perrone on Twitter: @AP_FDAwriter

The health and science coverage by The Big Big News is supported by the Howard Hughes Medical Institute’s Department of Science and Educational Media. The content herein is exclusively the responsibility of The AP.

Frequently Asked Questions (FAQs) about ketamine pain treatment

What has led to the increase in ketamine prescriptions for pain treatment?

The scaling back of opioid painkiller use by U.S. doctors has contributed to the rise of ketamine as a new option for treating persistent pain. With its low cost and the ability for most healthcare providers to prescribe it, the drug has seen a significant surge in prescriptions, especially from for-profit clinics and telehealth services.

Are there concerns regarding the use of ketamine for pain management?

Yes, there are concerns. Given the limited research on ketamine’s effectiveness for pain and its potential safety and abuse risks, some experts worry the U.S. may be inadvertently repeating the same mistakes that led to the opioid crisis by overprescribing a drug without solid scientific backing.

What are the potential side effects of ketamine when used for pain?

In a study tracking 300 patients at Duke receiving ketamine, more than a third experienced significant side effects requiring medical attention, including hallucinations, troubling thoughts, and visual disturbances.

Does ketamine reduce opioid prescribing rates?

Ketamine did not show a decrease in opioid prescribing rates post-treatment in a study conducted by Dr. Padma Gulur. This finding challenges the common goal of such therapies to reduce reliance on opioids.

What is the ‘wild west’ of ketamine prescribing?

This term refers to the current unregulated and booming industry of ketamine prescribing, driven by factors such as the profit model of charging high prices for low-cost vials of ketamine, competition from telehealth services, and a lack of stringent federal regulation on off-label drug use.

How does the FDA regulate the use of ketamine for non-surgical purposes?

The FDA has approved a ketamine-related chemical for severe depression under strict safety guidelines but has not approved other non-surgical uses of ketamine, such as for pain or mental health conditions. The FDA has warned against compounded forms of ketamine due to safety concerns.

More about ketamine pain treatment

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GaryT November 7, 2023 - 2:21 pm

so now ketamine is in the mail? that’s convenient, or really concerning, not sure which…

DaveKicks November 7, 2023 - 2:52 pm

The bit about ‘wild west’ of prescribing, so true… these clinics popping up everywhere it’s like anyone with a medical degree and a room can start pushing ketamine

Mike Sutherland November 7, 2023 - 6:10 pm

interesting article but theres a lot of focus on the risks and not much on how it can actually help people in pain, feels a bit one-sided?

Julia_Hrtz November 8, 2023 - 11:04 am

i’m no expert but isnt ketamine kinda serious stuff to be using for pain management, feels like were going down a slippery slope with this one

SamanthaB November 8, 2023 - 11:43 am

have they even considered the long term effects? we dont want another opioid crisis on our hands


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