WASHINGTON – As American doctors reduce their use of opioid painkillers, a new option for hard-to-treat pain is taking hold: ketamine, the decades-old surgical drug that is now a trendy psychedelic therapy.
Ketamine prescriptions have skyrocketed in recent years, fueled by for-profit clinics and telehealth services that offer the drug as a treatment for pain, depression, anxiety and other conditions.
The generic drug can be purchased at a low price and prescribed by most doctors and some nurses, regardless of their training.
With limited research on its effectiveness against pain, some experts fear that the United States may be repeating the mistakes that led to the opioid crisis: overprescribing a questionable drug that carries significant safety and abuse risks.
“There’s a shortage of options for pain and so there’s a tendency to just go with the next thing that might make the difference,” said Dr. Padma Gulur, a pain specialist at Duke University who is studying the use of ketamine. “A medical journal will publish some articles saying, ‘Oh, look, this is doing good things,’ and then there’s rampant use for off-label uses, 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, worrying thoughts, and visual disturbances.
Ketamine also did not result in lower rates of opioid prescribing in the months after treatment, a common goal of the therapy, according to Gulur. Her research is under review for publication in a medical journal.
Ketamine is used to treat depression and other problems. Denver Post via Getty Images Dr. Padma Gulur, a pain specialist at Duke University, and her colleagues have followed 300 patients receiving ketamine. Right: A patient A patient is administered ketamine through an intravenous bag for the treatment of depression in Chicago in 2018. AP; Tribune News Service via Getty Images
PSYCHEDELIC EXPERIENCE
Ketamine was approved more than 50 years ago as a powerful anesthetic for patients undergoing surgery. At lower doses, it can produce psychedelic out-of-body experiences, which made it a popular club drug in the 1990s. With its recent adoption for pain, patients are increasingly experiencing those same effects.
Daniel Bass, of Southgate, Kentucky, found the visual disturbances “horrible.” His doctors prescribed four- to six-hour intravenous infusions of ketamine for pain related to a rare bone and joint disorder. Sitting in a bare hospital room, with no stimulation or guidance about the psychological effects of the drug, Bass says he felt “like a lab rat.”
Still, he credits ketamine for reducing his pain during the year he received twice-monthly infusions.
“No matter how horrible an experience is, if it allows me to be more functional, I will do it,” Bass said.
Ketamine targets a brain chemical messenger called glutamate, which is thought to play a role in both pain and depression. It is unclear whether the psychedelic experience is part of the drug’s therapeutic effect, although some professionals consider it essential.
Brooklyn resident Philip Markle poses with a package of ketamine pills at his home in January 2022. He said he faced a long struggle with depression and tried medications, psychedelics such as LSD, psychotherapy from the age of 12 and more.AFP via Getty Images
“We want patients to dissociate or feel separated from their pain, depression or anxiety,” said Dr. David Mahjoubi, owner of Ketamine Healing Clinic in Los Angeles. “If they feel like they’re sitting in the chair all the time, we give them more.”
Mahjoubi’s practice is typical of the burgeoning industry: He offers intravenous ketamine for alcohol addiction, chronic pain, anxiety and post-traumatic stress disorder.
Doses of ketamine for those indications are well below those used for surgery, but Mahjoubi prefers higher doses for pain than psychiatric conditions.
Patients pay cash because most insurers do not cover nonsurgical uses of ketamine, none of which are approved by the Food and Drug Administration. Mahjoubi’s background is in anesthesiology, not psychiatry or addictions.
Patients may pay more for nasal sprays and ketamine tablets to use between infusions. These formulations are also not approved by the FDA and are prepared by specialty pharmacies.
Mailing ketamine has become a profitable business for telehealth services, such as MindBloom, which jumped into the space after regulators relaxed online prescribing rules during COVID-19.
Pain specialists who study ketamine say there is little evidence for those versions.
“The literature on nasal and oral formulations is quite sparse,” said Dr. Eric Schwenk of Thomas Jefferson University. “There’s just not a lot of solid evidence that can guide us.”
A saline liquid runs through a tube demonstrating how ketamine would be administered to a patient at the Duke Specialty Infusion Center.AP
Demand for ketamine has caused prescriptions to skyrocket more than 500% since 2017, according to Epic Research, which analyzed the trend using a database of more than 125 million patients. Each year, pain was the number one condition for which ketamine was prescribed, although depression has increased rapidly.
The rise in prescriptions has led to shortages of manufactured ketamine, boosting sales of compounded versions.
There is more evidence for the use of ketamine against depression than for pain. In 2019, the FDA approved a ketamine-related chemical developed by Johnson & Johnson for major depression. The drug, Spravato, is subject to strict FDA safety rules about where and how doctors can administer it.
Pain society guidelines point to some evidence for the use of ketamine in complex regional pain, a chronic condition that typically affects the extremities. But experts found “weak or no evidence” for ketamine in many more 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 Mail via Getty Images
THE ‘WILD WEST’ OF KETAMINE PRESCRIPTION
While the science behind ketamine is confusing, the business model is clear: Doctors can buy ketamine for less than $100 a vial and charge between $500 and $1,500 per infusion.
The recent boom has been fueled, in part, by venture capital investors. Another set of consulting companies is offering to help doctors create new clinics.
A blog post by one, Ketamine Startup, lists “Five Reasons Why You Should Open a Ketamine Clinic,” including: “You want to be your own boss” and “You want to take control of your ability to make money.”
Clinics face increasing competition from telehealth services like MindBloom and Joyous, which connect potential patients with doctors who can prescribe ketamine remotely and deliver it by mail.
In May, federal regulators planned to reverse a COVID-era policy that allowed online prescribing of high-risk drugs like ketamine and opioids. But the DEA, faced with backlash from telehealth companies and doctors, agreed to extend the flexible approach through 2024.
A lock box is kept to show where ketamine is placed while it is administered at the Duke Specialty Infusion Center.AP
The current landscape is a “wild west,” said Dr. Samuel Wilkinson, a psychiatrist at Yale University who prescribes both Spravato and ketamine for depression. American doctors have “quite a bit of leeway” to prescribe drugs for unapproved or unauthorized uses.
“There’s good things about it and there’s not so good things about it,” he said.
When used in high doses, ketamine can cause bladder damage, which is sometimes seen in people who use the drug recreationally. Much less is known about the neurological effects of long-term use. Ketamine was linked to brain abnormalities in studies with rats, FDA regulators say.
Last month, the FDA warned doctors and patients against compounded versions of ketamine, including lozenges and lozenges, saying the agency does not regulate their contents and cannot guarantee their safety. The warning followed a similar notice last year about nasal spray versions of ketamine.
But most compounding pharmacies are small operations, overseen by state officials, not the FDA.
In April, the Massachusetts Board of Pharmacy noted the FDA’s warning to local pharmacies but said state officials would take no action to stop “the continued preparation and dispensing of ketamine nasal spray.”
Likewise, the FDA has little influence over doctors who promote ketamine, even those who make exaggerated or misleading claims.
Drug manufacturers are subject to strict FDA regulation of how they promote their drugs, with requirements to balance information about risks and benefits. Those rules don’t apply to doctors.
Even when the FDA has tried to regulate risky in-office procedures, such as unproven stem cell infusions, the agency has had a mixed record of prevailing in court.
Ketamine prescriptions have skyrocketed in recent years, fueled 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 regulators are unlikely to go beyond their recent warnings about unauthorized ketamine.
“There’s a whack-a-mole element and it’s essentially beyond their regulatory purview,” said Dr. Caleb Alexander, a drug safety researcher at Johns Hopkins University. “These clinics would represent another front that would be difficult to manage and address.”
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Scientific and Educational Media Group. The AP is solely responsible for all content.
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