1/2 | New research published Tuesday in JAMA Network Open shows hundreds of clinics are using false and misleading statements in online ads to treat mental health conditions and pain. This indicates that they may be selling unapproved, off-label ketamine (an injectable short-acting anesthetic).Photo credit: Psychonaught/Wikimedia Commons
NEW YORK, Nov. 7 (UPI) — New research published Tuesday in JAMA Network Open shows hundreds of clinics are using false and misleading statements in online ads to treat mental health conditions and pain. This indicates that they may be selling approved ketamine, an injectable short-acting anesthetic.
Researchers at the University of Colorado Anschutz Medical Campus in Aurora and Johns Hopkins University in Baltimore found evidence of misrepresentations on clinic websites that they say misrepresent the drug's Food and Drug Administration approval status. ing.
“One advertiser falsely stated that ketamine was approved to treat depression, and three of the advertisers then falsely stated that ketamine was not addictive,” the study said. said Michael DiStefano, co-author of Anschutz Medical and assistant professor in the Skaggs School of Pharmacy and School of Pharmacy. Campus told UPI in a phone interview.
“The use of ketamine to treat a variety of mental health and pain conditions appears to be on the rise, and it is important to understand how this use is being promoted to potential patients and consumers,” DiStefano said. I wanted to,” he added.
According to the Drug Enforcement Administration, ketamine “has some degree of hallucinogenic effects; it distorts visual and auditory perception, making users feel isolated and out of control,” and “makes patients feel disconnected from their pain and environment.” “It makes you feel it.”
The researchers noted that the off-label treatments promoted by these clinics are expensive and typically require patients to pay out of pocket, while evidence of unapproved use is often not robust. They said it was important to transparently and accurately explain the potential risks and benefits of these treatments.
Not approved for mental health
Although the FDA has not approved ketamine for mental health conditions, it is sometimes used off-label for such purposes. The oral formulation is an unapproved drug that is frequently advertised as providing psychedelic experiences at home.
Researchers used six national ketamine databases to identify online direct-to-consumer ketamine advertisers with at least one clinic and website in Maryland.
They found 17 advertisers operating in 26 locations in Maryland promoting IV and ketamine-assisted therapy for a wide range of conditions, including depression, post-traumatic stress disorder, anxiety, and chronic pain. .
This ad revealed a number of misleading statements regarding treatment and safety.
Although the study focused on clinics in Maryland, DiStefano said the team's compilation of six directories on ketamine treatment suggests there are about 800 such clinics nationwide. said. Several companies send oral ketamine to customers by mail.
DiStefano added that researchers hope to conduct a national study with detailed analysis soon.
Dr. Michael Barnett, associate professor of health policy and management at Harvard University's T.H. Chan School of Public Health in Boston, told UPI that “it's not really surprising that misleading claims are being thrown around” in the form of online ads. Ta. Telephone interview.
big demand
The reasons for ketamine's alleged and unapproved use stem from a number of factors, including a huge demand for effective mental health treatment and a lack of supply of clinicians, Barnett said.
“There is a huge market opportunity for clinics that promote quick-acting treatments,” Barnett said. “Ketamine is being used off-label and is not currently used in mainstream psychiatry, creating an environment where these fringe clinics proliferate.”
Many practitioners are meeting with potential patients via Zoom and prescribing ketamine to take at home, Joseph Palamar, an associate professor of population health at New York University Langone Health in New York City, said in an email. told UPI.
Palamar published an analysis in JAMA Psychiatry in May, noting that ketamine seizures by law enforcement are on the rise.
“This suggests that the availability of illicit ketamine is increasing,” he said. “Further research is needed to determine whether the positive press coverage of these ketamine clinics encourages recreational use.”
Dr. Smita Das, a clinical associate professor and addiction psychiatrist at Stanford School of Medicine in Palo Alto, Calif., told UPI in a phone interview that a “surprising” number of clinics are offering various treatments without FDA approval. He said he promotes ketamine for symptoms. National practice guidelines.
Not a benign substance
“This is very alarming and ketamine is not a benign substance,” Das said. “It is important to treat it with the medical and psychiatric attention it deserves.”
Because of false claims, people with depression and other mental health conditions “may be denied access to the real, evidence-based treatments that we provide,” she says. . “We're excited about new treatments that help with mental health, and we'd like to see them incorporated into a set of evidence-based guidelines.”
Das added that “club drugs” commonly can cause nausea, drowsiness, hallucinations and increased blood pressure. In rare cases, it can cause paranoia and suicidal thoughts.
Other complications include vocal cord spasms, agitation, confusion, and negative effects on the bladder and kidneys, Dr. Chris Holstage, director of the Blue Ridge Poison Center at Virginia Health University in Charlottesville, told UPI in a phone interview. he said.
“Patients with mental health conditions are a vulnerable group and we as a society need to ensure they have access to appropriate treatment,” Holstage said.
Dr. Gerald Sanacola, a professor of psychiatry at Yale School of Medicine in New Haven, Conn., and director of the Yale Depression Research Program, told UPI in a phone interview that there is an FDA-approved version of ketamine, esketamine. It is sold as a nasal spray under the brand name Spravato and is used for two forms of major depressive disorder that are difficult to treat.
Spravato comes with very specific safety monitoring instructions, including a mandatory two-hour observation by a clinician after a patient takes the drug. Clinics that sell regular ketamine “are not necessarily adhering to the spirit of the safety regulations set forth by the FDA,” Sanacola said.
