WASHINGTON – As US doctors cut back on opioid painkillers, a new option for intractable pain is taking root: ketamine, a decades-old surgical drug that’s now a trendy psychedelic therapy.
Prescriptions for ketamine have soared in recent years, driven by for-profit clinics and telehealth services that offer the drug as a treatment for pain, depression, anxiety and other conditions.
Generic drugs can be bought cheaply and are prescribed by most doctors and some nurses, regardless of their training.
With limited research on its effectiveness against pain, some experts worry the US may repeat the mistakes that created the opioid crisis: overprescribing questionable drugs that carry significant safety and abuse risks.
“There are few options for pain and so there is a tendency to take the next thing that can make a difference,” said Dr. Padma Gulur, a Duke University pain specialist who is studying ketamine use. “A medical journal will publish some paper saying, ‘Oh, look, this is doing a good thing,’ and then there’s rampant off-label use, without necessarily the science behind it.”
When Gulur and his colleagues tracked 300 patients receiving ketamine at Duke, more than a third of them reported significant side effects that required professional attention, such as hallucinations, troubling thoughts and visual disturbances.
Ketamine also did not lead to lower rates of opioid prescriptions in the months after treatment, a common goal of therapy, according to Gulur. His research is being reviewed for publication in a medical journal.
Ketamine is used to treat depression and other issues.Denver Post via Getty Images Duke University pain specialist Dr. Padma Gulur and her colleagues tracked 300 patients who received ketamine. Right: A patient A patient has ketamine given through an IV bag for the treatment of depression in Chicago in 2018. AP; Tribune News Service via Getty Images
A PSYCHEDELIC EXPERIENCE
Ketamine was approved more than 50 years ago as a powerful anesthetic for patients undergoing surgery. At lower doses, it can produce a psychedelic, out-of-body experience, which made it a popular club drug in the 1990s. With recent use for pain, patients are increasingly facing similar effects.
Daniel Bass, of Southgate, Kentucky, found the visual disturbance “terrifying.” His doctor prescribed a four- to six-hour IV infusion of ketamine for pain associated with a rare bone and joint disorder. Sitting in an empty hospital room without stimulation or guidance about the drug’s psychological effects, Bass said she felt “like a lab rat.”
Still, he credits ketamine with reducing his pain during the year he received twice-monthly infusions.
“No matter how horrible the experience is, if it allows me to be more functional, I’m going to do it,” Bass said.
Ketamine targets a brain chemical transmitter called glutamate, which is thought to play a role in both pain and depression. It is not clear whether the psychedelic experience is part of the drug’s therapeutic effect, although some practitioners consider it important.
Brooklyn resident Philip Markle is pictured with a pack of ketamine pills at his home in January 2022. He said he had a long battle with depression and tried drugs, psychedelics like LSD, talk therapy since the age of 12 and more.AFP via Getty Images
“We want the patient to dissociate or feel detached from their pain, depression or anxiety,” says Dr. David Mahjoubi, owner of the Ketamine Healing Clinic in Los Angeles. “If they feel like they’re just sitting in a chair all the time, we’re actually giving them more.”
Mahjoubi’s practice is typical of a growing industry: He offers IV ketamine for alcohol addiction, chronic pain, anxiety and post-traumatic stress disorder.
Ketamine doses for those indications are well below those used for surgery, but Mahjoubi prefers higher doses for pain than for psychiatric conditions.
Patients pay cash because most insurance companies do not cover non-surgical use of ketamine, none of which is approved by the Food and Drug Administration. Mahjoubi’s background is in anesthesiology, not psychiatry or addiction.
Patients can pay extra for ketamine nasal spray and tablets to use between infusions. The formulation is also not FDA approved and is compounded by a specialty pharmacy.
Sending ketamine through the mail has become its own profitable business for telehealth services, such as MindBloom, which jumped into the space after regulators eased online prescription rules during COVID-19.
Pain experts who study ketamine say there is little evidence for that version.
“The literature for nasal and oral formulations is relatively sparse,” said Dr. Eric Schwenk of Thomas Jefferson University. “There’s not a lot of good evidence to guide you.”
Saline fluid flows through tubes that demonstrate how ketamine will be administered to patients at the Duke Specialty Infusion Center.AP
Demand for ketamine has sent prescriptions soaring more than 500% since 2017, according to Epic Research, which analyzed trends using a database of more than 125 million patients. Every year, pain is the No. 1 condition. 1 for whom ketamine was prescribed, although the depression had improved rapidly.
The prescription boom has led to a shortage of manufactured ketamine, boosting sales of compounded versions.
There is more evidence for the use of ketamine for depression than for pain. In 2019, the FDA approved a ketamine-related chemical developed by Johnson & Johnson for severe depression. The drug, Spravato, is subject to strict FDA safety regulations about where and how it can be administered by doctors.
Guidelines from the pain society note some evidence for the use of ketamine in complex regional pain, a chronic condition that usually affects the limbs. But experts found “weak or no evidence” for ketamine in many other conditions, including back pain, migraines, fibromyalgia and cancer pain.
Ketamine was approved more than 50 years ago as a powerful anesthetic for patients undergoing surgery. Denver Post via Getty Images
‘WEST WEST’ PRESCRIBING KETAMINE
While the science behind ketamine is murky, the business model is clear: Physicians can buy ketamine for less than $100 a bottle and charge $500 to $1,500 per infusion.
The recent boom has been fueled, in part, by venture capital investors. Another set of consulting businesses offers to help doctors set up new clinics.
A blog post from one, Ketamine Startup, lists “Five reasons you should open a ketamine clinic,” including: “You want to be your own boss” and “You want to control your money-making ability.”
The clinic faces growing competition from telehealth services such as MindBloom and Joyous, which connect potential patients with physicians who can remotely prescribe ketamine and deliver it by mail.
In May, federal regulators are slated to repeal a COVID-era policy that allowed online prescriptions of high-risk drugs like ketamine and opioids. But the Drug Enforcement Administration, facing a backlash against telehealth companies and physicians, agreed to extend the flexible approach until 2024.
Lock boxes are held to show where ketamine is placed when administered at the Duke Specialty Infusion Center.AP
The current landscape is a “wild west,” says Dr. Samuel Wilkinson, a Yale University psychiatrist who prescribes both Spravato and ketamine for depression. US physicians have “some latitude” to prescribe drugs for unapproved or off-label uses.
“There are good things about it and not so good things about it,” he said.
When used in high doses, ketamine can cause bladder damage, sometimes seen in people who use the drug recreationally. Much less is known about the neurological effects of long-term use. Ketamine is linked to brain abnormalities in rat studies, FDA regulators say.
Last month, the FDA warned doctors and patients against compounded versions of ketamine, including lozenges and pills, saying the agency does not regulate their contents and cannot guarantee their safety. The warning follows similar advice last year about the nasal spray version of ketamine.
But most compounding pharmacies are small operations, overseen by state officials, not the FDA.
In April, the Massachusetts board of pharmacy flagged an FDA warning to local pharmacies, but stated that state officials would take no action to stop “the continued compounding and production of ketamine nasal spray.”
The FDA also has little leverage over physicians who promote ketamine, even those who make exaggerated or misleading claims.
Drug makers are subject to strict FDA regulations in how they promote their drugs — with the need to balance risk and benefit information. The rule does not apply to doctors.
While the FDA has tried to regulate risky in-office procedures, such as unproven stem cell infusions, the agency has a mixed track record playing out in court.
Prescriptions for ketamine have soared in recent years, driven by for-profit clinics and telehealth services that offer the drug as a treatment for pain, depression, anxiety and other conditions. The Washington Post via Getty Images
For now, experts say it’s unlikely regulators will go beyond their latest warning about off-label ketamine.
“There’s an element of hitting and it’s basically outside of their regulatory purview,” said Dr. Caleb Alexander, drug safety researcher at Johns Hopkins University. “These clinics will represent another area that they will find difficult to manage and address.”
The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute Science and Education Media Group. AP is solely responsible for all content.
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