Hundreds of clinics may be using false and misleading statements in online advertising to sell off-label and unapproved ketamine -– an injectable, short-acting anesthetic -- to treat mental health conditions and pain, a new study published Tuesday in JAMA Network Open indicates.
Photo by Psychonaught/Wikimedia Commons
NEW YORK, Nov. 7 (UPI) -- Hundreds of clinics may be using false and misleading statements in online advertising to sell off-label and unapproved ketamine -- an injectable, short-acting anesthetic -- to treat mental health conditions and pain, a new study published Tuesday in JAMA Network Open indicates.
The researchers -- at University of Colorado Anschutz Medical Campus in Aurora and Johns Hopkins University in Baltimore -- found evidence of false statements on the clinics' websites, which they say misrepresent the drug's Food and Drug Administration approval status.
"One advertiser falsely stated that ketamine was approved to treat depression, and then three falsely stated that ketamine was nonaddictive," Michael DiStefano, co-author of the study and an assistant professor in the Skaggs School of Pharmacy and Pharmaceutical Sciences on the Anschutz Medical Campus, told UPI in a telephone interview.
DiStefano added that "the use of ketamine to treat a variety of mental health and pain conditions seems to be growing, and we wanted to understand how this use is being advertised to potential patients and consumers."
Related
NEW YORK, Nov. 7 (UPI) -- Hundreds of clinics may be using false and misleading statements in online advertising to sell off-label and unapproved ketamine -- an injectable, short-acting anesthetic -- to treat mental health conditions and pain, a new study published Tuesday in JAMA Network Open indicates.
The researchers -- at University of Colorado Anschutz Medical Campus in Aurora and Johns Hopkins University in Baltimore -- found evidence of false statements on the clinics' websites, which they say misrepresent the drug's Food and Drug Administration approval status.
"One advertiser falsely stated that ketamine was approved to treat depression, and then three falsely stated that ketamine was nonaddictive," Michael DiStefano, co-author of the study and an assistant professor in the Skaggs School of Pharmacy and Pharmaceutical Sciences on the Anschutz Medical Campus, told UPI in a telephone interview.
DiStefano added that "the use of ketamine to treat a variety of mental health and pain conditions seems to be growing, and we wanted to understand how this use is being advertised to potential patients and consumers."
Related
Surgery patients with depression show improvements with ketamine, placebo
FDA warns of risks of compounded ketamine
Trial supports ketamine nasal spray for treatment-resistant depression
Ketamine "has some hallucinogenic effects. It distorts perceptions of sight and sound and makes the user feel disconnected and not in control," and "it makes patients feel detached from their pain and environment," according to the Drug Enforcement Administration.
Off-label treatments advertised by these clinics are costly and patients typically must pay out of pocket, while the evidence for unapproved uses often isn't robust, the researchers noted. Being transparent and accurate in explaining the potential risks and benefits of these treatments is important, they said.
Not approved for mental health
The FDA has not approved ketamine for any mental health condition, but it is sometimes used off-label for such purposes. Oral formulations are unapproved drugs frequently advertised to produce a hallucinogenic experience at home.
Researchers identified online direct-to-consumer ketamine advertisers with at least one clinic in Maryland and a website by using six national ketamine databases.
They found 17 advertisers operating across 26 locations in Maryland that promoted infusions or ketamine assisted therapy for a wide range of conditions including depression, post-traumatic stress disorder, anxiety and chronic pain.
The advertising uncovered many misleading representations regarding treatment and safety.
Although the study centered on clinics in Maryland, DiStefano said the research team's compilation of the six directories for ketamine treatment suggests that about 800 such clinics exist across the country. Several companies will send customers oral ketamine through the mail.
DiStefano added that the researchers hope to carry out a national survey with an expanded analysis soon.
"It is not too surprising that there are misleading claims floating around" in the form of online advertisements, Dr. Michael Barnett, an associate professor of health policy and management at the Harvard T.H. Chan School of Public Health in Boston, told UPI in a telephone interview.
Large demand
The reasons for the claims and unapproved uses of ketamine stem from a number of factors, including enormous demand for effective mental health treatment and an inadequate supply of clinicians, Barnett said.
"There is a big market opportunity for clinics advertising a quick fix," Barnett said. "Because ketamine is being used off-label and it's not really in mainstream psychiatry right now, that's an environment where you can have these fringe clinics proliferate."
Joseph Palamar, an associate professor of population health at NYU Langone Health in New York City, told UPI via email that many practitioners meet with potential patients on Zoom and prescribe ketamine to take at home.
Palamar published an analysis in JAMA Psychiatry in May, noting that law enforcement seizures of ketamine are rising.
"This suggests that availability of illicit ketamine has been increasing," he said. "We need more research to determine whether all of the positive coverage of these ketamine clinics is encouraging recreational use."
Dr. Smita Das, a clinical associate professor and an addiction psychiatrist at Stanford Medicine in Palo Alto, Calif., told UPI in a telephone interview that a "staggering" number of clinics have been advertising ketamine for a variety of conditions without FDA approval or national practice guidelines.
Not a benign substance
"This is very concerning, and ketamine is not a benign substance," Das said. "Both from a medical and psychiatric perspective, it's important to treat it with the care that it deserves."
Because of false claims, people with depression or other mental health conditions "may forgo the actual evidence-based treatments that we have," she said. "I'm hopeful for new treatments that can help with mental health, but I would want them to be part of an evidence-based set of guidelines."
Das added that the "club drug" can commonly cause nausea, drowsiness, hallucinations and increased blood pressure. On rare occasions, it also can incite paranoia and thoughts of suicide.
Other complications include vocal cord spasms, agitation and confusion, as well as adverse effects on the bladder and kidneys, Dr. Chris Holstege, director of the University of Virginia Health's Blue Ridge Poison Center in Charlottesville, told UPI in a telephone interview.
"Patients who have mental health conditions are a vulnerable population, and we need to as a society assure that they are getting appropriate treatments," Holstege said.
Dr. Gerard Sanacora, a professor of psychiatry and director of the Yale Depression Research Program at the Yale School of Medicine in New Haven, Conn., told UPI in a telephone interview that there is an FDA-approved version of ketamine -- esketamine, which is sold as a nasal spray under the brand name Spravato and used for two challenging-to-treat forms of major depressive disorder.
Spravato comes with very specific safety monitoring instructions, including a mandatory two hours of observation by a clinician after a patient takes the drug. The clinics marketing regular ketamine, Sanacora said, "are not always abiding by spirit of the safety regulations the FDA put in place."
FDA warns of risks of compounded ketamine
Trial supports ketamine nasal spray for treatment-resistant depression
Ketamine "has some hallucinogenic effects. It distorts perceptions of sight and sound and makes the user feel disconnected and not in control," and "it makes patients feel detached from their pain and environment," according to the Drug Enforcement Administration.
Off-label treatments advertised by these clinics are costly and patients typically must pay out of pocket, while the evidence for unapproved uses often isn't robust, the researchers noted. Being transparent and accurate in explaining the potential risks and benefits of these treatments is important, they said.
Not approved for mental health
The FDA has not approved ketamine for any mental health condition, but it is sometimes used off-label for such purposes. Oral formulations are unapproved drugs frequently advertised to produce a hallucinogenic experience at home.
Researchers identified online direct-to-consumer ketamine advertisers with at least one clinic in Maryland and a website by using six national ketamine databases.
They found 17 advertisers operating across 26 locations in Maryland that promoted infusions or ketamine assisted therapy for a wide range of conditions including depression, post-traumatic stress disorder, anxiety and chronic pain.
The advertising uncovered many misleading representations regarding treatment and safety.
Although the study centered on clinics in Maryland, DiStefano said the research team's compilation of the six directories for ketamine treatment suggests that about 800 such clinics exist across the country. Several companies will send customers oral ketamine through the mail.
DiStefano added that the researchers hope to carry out a national survey with an expanded analysis soon.
"It is not too surprising that there are misleading claims floating around" in the form of online advertisements, Dr. Michael Barnett, an associate professor of health policy and management at the Harvard T.H. Chan School of Public Health in Boston, told UPI in a telephone interview.
Large demand
The reasons for the claims and unapproved uses of ketamine stem from a number of factors, including enormous demand for effective mental health treatment and an inadequate supply of clinicians, Barnett said.
"There is a big market opportunity for clinics advertising a quick fix," Barnett said. "Because ketamine is being used off-label and it's not really in mainstream psychiatry right now, that's an environment where you can have these fringe clinics proliferate."
Joseph Palamar, an associate professor of population health at NYU Langone Health in New York City, told UPI via email that many practitioners meet with potential patients on Zoom and prescribe ketamine to take at home.
Palamar published an analysis in JAMA Psychiatry in May, noting that law enforcement seizures of ketamine are rising.
"This suggests that availability of illicit ketamine has been increasing," he said. "We need more research to determine whether all of the positive coverage of these ketamine clinics is encouraging recreational use."
Dr. Smita Das, a clinical associate professor and an addiction psychiatrist at Stanford Medicine in Palo Alto, Calif., told UPI in a telephone interview that a "staggering" number of clinics have been advertising ketamine for a variety of conditions without FDA approval or national practice guidelines.
Not a benign substance
"This is very concerning, and ketamine is not a benign substance," Das said. "Both from a medical and psychiatric perspective, it's important to treat it with the care that it deserves."
Because of false claims, people with depression or other mental health conditions "may forgo the actual evidence-based treatments that we have," she said. "I'm hopeful for new treatments that can help with mental health, but I would want them to be part of an evidence-based set of guidelines."
Das added that the "club drug" can commonly cause nausea, drowsiness, hallucinations and increased blood pressure. On rare occasions, it also can incite paranoia and thoughts of suicide.
Other complications include vocal cord spasms, agitation and confusion, as well as adverse effects on the bladder and kidneys, Dr. Chris Holstege, director of the University of Virginia Health's Blue Ridge Poison Center in Charlottesville, told UPI in a telephone interview.
"Patients who have mental health conditions are a vulnerable population, and we need to as a society assure that they are getting appropriate treatments," Holstege said.
Dr. Gerard Sanacora, a professor of psychiatry and director of the Yale Depression Research Program at the Yale School of Medicine in New Haven, Conn., told UPI in a telephone interview that there is an FDA-approved version of ketamine -- esketamine, which is sold as a nasal spray under the brand name Spravato and used for two challenging-to-treat forms of major depressive disorder.
Spravato comes with very specific safety monitoring instructions, including a mandatory two hours of observation by a clinician after a patient takes the drug. The clinics marketing regular ketamine, Sanacora said, "are not always abiding by spirit of the safety regulations the FDA put in place."
No comments:
Post a Comment