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Scope of Practice Concerns Lead to Hospital’s Temp Ban on CRNAs
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.
In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.
The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.
Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.
“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.
In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”
The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.
Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
CRNA Claims to Be in Charge
Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.
According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.
The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”
Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”
In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.
CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.
CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.
Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.
The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
Scope of Practice Confusion?
But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.
Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.
“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.
It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.
Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.
The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.
Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
Filling a Gap
Nurse anesthetists see things differently.
CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.
She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”
Most nurse anesthetists see themselves as independent practitioners.
Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.
Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.
The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.
Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.
“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”
There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.
Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.
“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”
A version of this article first appeared on Medscape.com.
Oncology Mergers Are on the Rise. How Can Independent Practices Survive?
When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.
Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.
But the oncologists at Alliance did not want to join Jefferson.
The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.
said Jeff Patton, MD, CEO of OneOncology, a management services organization.
A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.
“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”
Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
A Growing Trend
The latest data continue to show a clear trend: Consolidation in oncology is on the rise.
A 2024 study revealed that the pace of consolidation seems to be increasing.
The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.
While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.
“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.
Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.
Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.
Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.
Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.
The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.
The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.
Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.
“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.
Declining Medicare reimbursement has also hit independent practices hard.
Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
Less Access, Higher Costs, Worse Care?
Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.
“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.
Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.
Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.
In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.
Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
Navigating the Consolidation Trend
In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.
According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.
In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.
These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.
The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”
The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.
In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.
“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.
Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.
However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”
Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.
Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.
Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.
Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”
The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”
A version of this article first appeared on Medscape.com.
When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.
Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.
But the oncologists at Alliance did not want to join Jefferson.
The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.
said Jeff Patton, MD, CEO of OneOncology, a management services organization.
A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.
“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”
Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
A Growing Trend
The latest data continue to show a clear trend: Consolidation in oncology is on the rise.
A 2024 study revealed that the pace of consolidation seems to be increasing.
The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.
While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.
“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.
Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.
Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.
Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.
Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.
The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.
The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.
Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.
“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.
Declining Medicare reimbursement has also hit independent practices hard.
Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
Less Access, Higher Costs, Worse Care?
Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.
“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.
Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.
Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.
In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.
Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
Navigating the Consolidation Trend
In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.
According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.
In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.
These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.
The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”
The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.
In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.
“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.
Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.
However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”
Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.
Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.
Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.
Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”
The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”
A version of this article first appeared on Medscape.com.
When he completed his fellowship at Fox Chase Cancer Center in Philadelphia, Moshe Chasky, MD, joined a small five-person practice that rented space from the city’s Jefferson Hospital in Philadelphia. The arrangement seemed to work well for the hospital and the small practice, which remained independent.
Within 10 years, the hospital sought to buy the practice, Alliance Cancer Specialists.
But the oncologists at Alliance did not want to join Jefferson.
The hospital eventually entered into an exclusive agreement with its own medical group to provide inpatient oncology/hematology services at three Jefferson Health–Northeast hospitals and stripped Dr. Chasky and his colleagues of their privileges at those facilities, Medscape Medical News reported last year.
said Jeff Patton, MD, CEO of OneOncology, a management services organization.
A 2020 report from the Community Oncology Alliance (COA), for instance, tracked mergers, acquisitions, and closures in the community oncology setting and found the number of practices acquired by hospitals, known as vertical integration, nearly tripled from 2010 to 2020.
“Some hospitals are pretty predatory in their approach,” Dr. Patton said. If hospitals have their own oncology program, “they’ll employ the referring doctors and then discourage them or prevent them from referring patients to our independent practices that are not owned by the hospital.”
Still, in the face of growing pressure to join hospitals, some community oncology practices are finding ways to survive and maintain their independence.
A Growing Trend
The latest data continue to show a clear trend: Consolidation in oncology is on the rise.
A 2024 study revealed that the pace of consolidation seems to be increasing.
The analysis found that, between 2015 and 2022, the number of medical oncologists increased by 14% and the number of medical oncologists per practice increased by 40%, while the number of practices decreased by 18%.
While about 44% of practices remain independent, the percentage of medical oncologists working in practices with more than 25 clinicians has increased from 34% in 2015 to 44% in 2022. By 2022, the largest 102 practices in the United States employed more than 40% of all medical oncologists.
“The rate of consolidation seems to be rapid,” study coauthor Parsa Erfani, MD, an internal medicine resident at Brigham & Women’s Hospital, Boston, explained.
Consolidation appears to breed more consolidation. The researchers found, for instance, that markets with greater hospital consolidation and more hospital beds per capita were more likely to undergo consolidation in oncology.
Consolidation may be higher in these markets “because hospitals or health systems are buying up oncology practices or conversely because oncology practices are merging to compete more effectively with larger hospitals in the area,” Dr. Erfani told this news organization.
Mergers among independent practices, known as horizontal integration, have also been on the rise, according to the 2020 COA report. These mergers can help counter pressures from hospitals seeking to acquire community practices as well as prevent practices and their clinics from closing.
Although Dr. Erfani’s research wasn’t designed to determine the factors behind consolidation, he and his colleagues point to the Affordable Care Act (ACA) and the federal 340B Drug Pricing Program as potential drivers of this trend.
The ACA encouraged consolidation as a way to improve efficiency and created the need for ever-larger information systems to collect and report quality data. But these data collection and reporting requirements have become increasingly difficult for smaller practices to take on.
The 340B Program, however, may be a bigger contributing factor to consolidation. Created in 1992, the 340B Program allows qualifying hospitals and clinics that treat low-income and uninsured patients to buy outpatient prescription drugs at a 25%-50% discount.
Hospitals seeking to capitalize on the margins possible under the 340B Program will “buy all the referring physicians in a market so that the medical oncology group is left with little choice but to sell to the hospital,” said Dr. Patton.
“Those 340B dollars are worth a lot to hospitals,” said David A. Eagle, MD, a hematologist/oncologist with New York Cancer & Blood Specialists and past president of COA. The program “creates an appetite for nonprofit hospitals to want to grow their medical oncology programs,” he told this news organization.
Declining Medicare reimbursement has also hit independent practices hard.
Over the past 15 years, compared with inflation, physicians have gotten “a pay rate decrease from Medicare,” said Dr. Patton. Payers have followed that lead and tried to cut pay for clinicians, especially those who do not have market share, he said. Paying them less is “disingenuous knowing that our costs of providing care are going up,” he said.
Less Access, Higher Costs, Worse Care?
Many studies have demonstrated that, when hospitals become behemoths in a given market, healthcare costs go up.
“There are robust data showing that consolidation increases healthcare costs by reducing competition, including in oncology,” wrote Dr. Erfani and colleagues.
Oncology practices that are owned by hospitals bill facility fees for outpatient chemotherapy treatment, adding another layer of cost, the researchers explained, citing a 2019 Health Economics study.
Another analysis, published in 2020, found that hospital prices for the top 37 infused cancer drugs averaged 86% more per unit than the price charged by physician offices. Hospital outpatient departments charged even more, on average, for drugs — 128% more for nivolumab and 428% more for fluorouracil, for instance.
In their 2024 analysis, Dr. Erfani and colleagues also found that increased hospital market concentration was associated with worse quality of care, across all assessed patient satisfaction measures, and may result in worse access to care as well.
Overall, these consolidation “trends have important implications for cancer care cost, quality, and access,” the authors concluded.
Navigating the Consolidation Trend
In the face of mounting pressure to join hospitals, community oncology practices have typically relied on horizontal mergers to maintain their independence. An increasing number of practices, however, are now turning to another strategy: Management services organizations.
According to some oncologists, a core benefit of joining a management services organization is their community practices can maintain autonomy, hold on to referrals, and benefit from access to a wider network of peers and recently approved treatments such as chimeric antigen receptor T-cell therapies.
In these arrangements, the management company also provides business assistance to practices, including help with billing and collection, payer negotiations, supply chain issues, and credentialing, as well as recruiting, hiring, and marketing.
These management organizations, which include American Oncology Network, Integrated Oncology Network, OneOncology, and Verdi Oncology, are, however, backed by private equity. According to a 2022 report, private equity–backed management organizations have ramped up arrangements with community oncology practices over the past few years — a trend that has concerned some experts.
The authors of a recent analysis in JAMA Internal Medicine explained that, although private equity involvement in physician practices may enable operational efficiencies, “critics point to potential conflicts of interest” and highlight concerns that patients “may face additional barriers to both accessibility and affordability of care.”
The difference, according to some oncologists, is their practices are not owned by the management services organization; instead, the practices enter contracts that outline the boundaries of the relationship and stipulate fees to the management organizations.
In 2020, Dr. Chasky’s practice, Alliance Cancer Specialists, joined The US Oncology Network, a management services organization wholly owned by McKesson. The organization provides the practice with capital and other resources, as well as access to the Sarah Cannon Research Institute, so patients can participate in clinical trials.
“We totally function as an independent practice,” said Dr. Chasky. “We make our own management decisions,” he said. For instance, if Alliance wants to hire a new clinician, US Oncology helps with the recruitment. “But at the end of the day, it’s our practice,” he said.
Davey Daniel, MD — whose community practice joined the management services organization OneOncology — has seen the benefits of being part of a larger network. For instance, bispecific therapies for leukemias, lymphomas, and multiple myeloma are typically administered at academic centers because of the risk for cytokine release syndrome.
However, physician leaders in the OneOncology network “came up with a playbook on how to do it safely” in the community setting, said Dr. Daniel. “It meant that we were adopting FDA newly approved therapies in a very short course.”
Being able to draw from a wider pool of expertise has had other advantages. Dr. Daniel can lean on pathologists and research scientists in the network for advice on targeted therapy use. “We’re actually bringing precision medicine expertise to the community,” Dr. Daniel said.
Dr. Chasky and Dr. Eagle, whose practice is also part of OneOncology, said that continuing to work in the community setting has allowed them greater flexibility.
Dr. Eagle explained that New York Cancer & Blood Specialists tries to offer patients an appointment within 2 days of a referral, and it allows walk-in visits.
Dr. Chasky leans into the flexibility by having staff stay late, when needed, to ensure that all patients are seen. “We’re there for our patients at all hours,” Dr. Chasky said, adding that often “you don’t have that flexibility when you work for a big hospital system.”
The bottom line is community oncology can still thrive, said Nick Ferreyros, managing director of COA, “as long as we have a healthy competitive ecosystem where [we] are valued and seen as an important part of our cancer care system.”
A version of this article first appeared on Medscape.com.
Tirzepatide Reduces Sleep Interruptions, Halting Almost Half of CPAP Use
ORLANDO, FLA. — The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40%-50% no longer needed to use a continuous positive airway pressure (CPAP) device, according to two new studies.
Tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 (GLP-1) receptor agonist, also lowered C-reactive protein levels and systolic blood pressure. And patients taking the medication lost 18%-20% of their body weight.
said lead author Atul Malhotra, MD, professor of medicine at the University of California, San Diego, and director of sleep medicine at UC San Diego Health.
The two double-blind, randomized, controlled trials in patients with obesity and moderate to severe OSA were conducted at 60 sites in nine countries. The results were presented at the American Diabetes Association (ADA) 84th Scientific Sessions and simultaneously published online in the New England Journal of Medicine.
OSA affects 1 billion people worldwide and 30 million American adults, many of whom are undiagnosed. Obesity is a common risk factor. According to the ADA, 40% of those with obesity have OSA and 70% of those with OSA have obesity.
CPAP is an effective and the most-used intervention for OSA, but many patients refuse to use the device, stop using it, or cannot use it. Should tirzepatide eventually gain Food and Drug Administration approval for OSA, it would be the first drug approved for the condition.
“This new drug treatment offers a more accessible alternative for individuals who cannot tolerate or adhere to existing therapies,” said Dr. Malhotra.
Huge Reduction in Episodes, Severity
For the two studies, patients were enrolled who had moderate to severe OSA, defined as more than 15 events per hour (using the apnea-hypopnea index [AHI]) and a body mass index of 30 kg/m2 or greater. Those not using a CPAP device were enrolled in study 1, and those using a CPAP device were enrolled in study 2.
Participants received either the maximum tolerated dose of tirzepatide (10 or 15 mg by once-weekly injection) or placebo for 1 year. In study 1, 114 individuals received tirzepatide and 120 received placebo. For study 2, 119 patients received tirzepatide and 114 received placebo. All participants received regular lifestyle counseling sessions about nutrition and were instructed to reduce food intake by 500 kcal/day and to engage in at least 150 min/week of physical activity.
Enrollment was limited to 70% men to ensure adequate representation of women.
At baseline, 65%-70% of participants had severe OSA, with more than 30 events/hour on the AHI scale and a mean of 51.5 events/hour.
By 1 year, patients taking tirzepatide had 27-30 fewer events/hour, compared with 4-6 fewer events/hour for those taking placebo.
Up to half of those who received tirzepatide in both trials had less than 5 events/hour or 5-14 AHI events/hour and an Epworth Sleepiness Scale score of 10 or less. Those thresholds “represent a level at which CPAP therapy may not be recommended,” wrote the authors.
Patients in the tirzepatide group also had a decrease in systolic blood pressure from baseline of 9.7 mm Hg in study 1 and 7.6 mm Hg in study 2 at week 48.
The most common adverse events were diarrhea, nausea, and vomiting, which occurred in approximately a quarter of patients taking tirzepatide. There were two adjudicated-confirmed cases of acute pancreatitis in those taking tirzepatide in study 2.
Patients who received tirzepatide also reported fewer daytime and nighttime disturbances, as measured using the Patient-Reported Outcomes Measurement Information System Short Form scale for Sleep-Related Impairment and Sleep Disturbance.
Tirzepatide Plus CPAP Are Best
Writing in an accompanying editorial, Sanjay R. Patel, MD, noted that, although clinical guidelines have recommended that weight loss strategies be incorporated as part of OSA treatment, “the integration of obesity management into the approaches to care for obstructive sleep apnea has lagged.”
As many as half of patients abandon CPAP therapy within 3 years, wrote Dr. Patel, who is professor of medicine and epidemiology at the University of Pittsburgh, Pittsburgh, Pennsylvania, and medical director of the UPMC Comprehensive Sleep Disorders program. “An effective medication to treat obesity is thus an obvious avenue to pursue.”
Dr. Patel noted the large reductions in the number of events on the AHI scale. He wrote that the improvement in systolic blood pressure “was substantially larger than effects seen with CPAP therapy alone and indicate that tirzepatide may be an attractive option for those patients who seek to reduce their cardiovascular risk.”
Dr. Patel raised concerns about whether patients outside of a trial would stick with therapy, noting studies have shown high rates of discontinuation of GLP-1 receptor agonists.
And, he wrote, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”
Commenting on the study during the presentation of the results, Louis Aronne, MD, said he believes the trials demonstrate “the treatment of obesity with tirzepatide plus CPAP is really the optimal treatment for obstructive sleep apnea and obesity-related cardiometabolic risks.” Dr. Aronne is the Sanford I. Weill professor of metabolic research at Weill Cornell Medical College, New York City.
Dr. Aronne added there is still much to learn. It is still not clear whether tirzepatide had an independent effect in the OSA trial — as has been seen in other studies where the drug clearly reduced cardiovascular risk — or whether the positive results were primarily caused by weight loss.
“I believe that over time we’ll see that this particular effect in sleep apnea is related to weight,” he said.
The study was supported by Eli Lilly. Dr. Malhotra has reported being a paid consultant for Lilly and ZOLL Medical and a cofounder of Healcisio.
A version of this article appeared on Medscape.com.
ORLANDO, FLA. — The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40%-50% no longer needed to use a continuous positive airway pressure (CPAP) device, according to two new studies.
Tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 (GLP-1) receptor agonist, also lowered C-reactive protein levels and systolic blood pressure. And patients taking the medication lost 18%-20% of their body weight.
said lead author Atul Malhotra, MD, professor of medicine at the University of California, San Diego, and director of sleep medicine at UC San Diego Health.
The two double-blind, randomized, controlled trials in patients with obesity and moderate to severe OSA were conducted at 60 sites in nine countries. The results were presented at the American Diabetes Association (ADA) 84th Scientific Sessions and simultaneously published online in the New England Journal of Medicine.
OSA affects 1 billion people worldwide and 30 million American adults, many of whom are undiagnosed. Obesity is a common risk factor. According to the ADA, 40% of those with obesity have OSA and 70% of those with OSA have obesity.
CPAP is an effective and the most-used intervention for OSA, but many patients refuse to use the device, stop using it, or cannot use it. Should tirzepatide eventually gain Food and Drug Administration approval for OSA, it would be the first drug approved for the condition.
“This new drug treatment offers a more accessible alternative for individuals who cannot tolerate or adhere to existing therapies,” said Dr. Malhotra.
Huge Reduction in Episodes, Severity
For the two studies, patients were enrolled who had moderate to severe OSA, defined as more than 15 events per hour (using the apnea-hypopnea index [AHI]) and a body mass index of 30 kg/m2 or greater. Those not using a CPAP device were enrolled in study 1, and those using a CPAP device were enrolled in study 2.
Participants received either the maximum tolerated dose of tirzepatide (10 or 15 mg by once-weekly injection) or placebo for 1 year. In study 1, 114 individuals received tirzepatide and 120 received placebo. For study 2, 119 patients received tirzepatide and 114 received placebo. All participants received regular lifestyle counseling sessions about nutrition and were instructed to reduce food intake by 500 kcal/day and to engage in at least 150 min/week of physical activity.
Enrollment was limited to 70% men to ensure adequate representation of women.
At baseline, 65%-70% of participants had severe OSA, with more than 30 events/hour on the AHI scale and a mean of 51.5 events/hour.
By 1 year, patients taking tirzepatide had 27-30 fewer events/hour, compared with 4-6 fewer events/hour for those taking placebo.
Up to half of those who received tirzepatide in both trials had less than 5 events/hour or 5-14 AHI events/hour and an Epworth Sleepiness Scale score of 10 or less. Those thresholds “represent a level at which CPAP therapy may not be recommended,” wrote the authors.
Patients in the tirzepatide group also had a decrease in systolic blood pressure from baseline of 9.7 mm Hg in study 1 and 7.6 mm Hg in study 2 at week 48.
The most common adverse events were diarrhea, nausea, and vomiting, which occurred in approximately a quarter of patients taking tirzepatide. There were two adjudicated-confirmed cases of acute pancreatitis in those taking tirzepatide in study 2.
Patients who received tirzepatide also reported fewer daytime and nighttime disturbances, as measured using the Patient-Reported Outcomes Measurement Information System Short Form scale for Sleep-Related Impairment and Sleep Disturbance.
Tirzepatide Plus CPAP Are Best
Writing in an accompanying editorial, Sanjay R. Patel, MD, noted that, although clinical guidelines have recommended that weight loss strategies be incorporated as part of OSA treatment, “the integration of obesity management into the approaches to care for obstructive sleep apnea has lagged.”
As many as half of patients abandon CPAP therapy within 3 years, wrote Dr. Patel, who is professor of medicine and epidemiology at the University of Pittsburgh, Pittsburgh, Pennsylvania, and medical director of the UPMC Comprehensive Sleep Disorders program. “An effective medication to treat obesity is thus an obvious avenue to pursue.”
Dr. Patel noted the large reductions in the number of events on the AHI scale. He wrote that the improvement in systolic blood pressure “was substantially larger than effects seen with CPAP therapy alone and indicate that tirzepatide may be an attractive option for those patients who seek to reduce their cardiovascular risk.”
Dr. Patel raised concerns about whether patients outside of a trial would stick with therapy, noting studies have shown high rates of discontinuation of GLP-1 receptor agonists.
And, he wrote, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”
Commenting on the study during the presentation of the results, Louis Aronne, MD, said he believes the trials demonstrate “the treatment of obesity with tirzepatide plus CPAP is really the optimal treatment for obstructive sleep apnea and obesity-related cardiometabolic risks.” Dr. Aronne is the Sanford I. Weill professor of metabolic research at Weill Cornell Medical College, New York City.
Dr. Aronne added there is still much to learn. It is still not clear whether tirzepatide had an independent effect in the OSA trial — as has been seen in other studies where the drug clearly reduced cardiovascular risk — or whether the positive results were primarily caused by weight loss.
“I believe that over time we’ll see that this particular effect in sleep apnea is related to weight,” he said.
The study was supported by Eli Lilly. Dr. Malhotra has reported being a paid consultant for Lilly and ZOLL Medical and a cofounder of Healcisio.
A version of this article appeared on Medscape.com.
ORLANDO, FLA. — The diabetes and weight loss drug tirzepatide (Mounjaro for type 2 diabetes; Zepbound for obesity) was so effective at reducing sleep disruptions in patients with obesity and obstructive sleep apnea (OSA) that 40%-50% no longer needed to use a continuous positive airway pressure (CPAP) device, according to two new studies.
Tirzepatide, a long-acting glucose-dependent insulinotropic polypeptide (GIP) receptor agonist and glucagon-like peptide 1 (GLP-1) receptor agonist, also lowered C-reactive protein levels and systolic blood pressure. And patients taking the medication lost 18%-20% of their body weight.
said lead author Atul Malhotra, MD, professor of medicine at the University of California, San Diego, and director of sleep medicine at UC San Diego Health.
The two double-blind, randomized, controlled trials in patients with obesity and moderate to severe OSA were conducted at 60 sites in nine countries. The results were presented at the American Diabetes Association (ADA) 84th Scientific Sessions and simultaneously published online in the New England Journal of Medicine.
OSA affects 1 billion people worldwide and 30 million American adults, many of whom are undiagnosed. Obesity is a common risk factor. According to the ADA, 40% of those with obesity have OSA and 70% of those with OSA have obesity.
CPAP is an effective and the most-used intervention for OSA, but many patients refuse to use the device, stop using it, or cannot use it. Should tirzepatide eventually gain Food and Drug Administration approval for OSA, it would be the first drug approved for the condition.
“This new drug treatment offers a more accessible alternative for individuals who cannot tolerate or adhere to existing therapies,” said Dr. Malhotra.
Huge Reduction in Episodes, Severity
For the two studies, patients were enrolled who had moderate to severe OSA, defined as more than 15 events per hour (using the apnea-hypopnea index [AHI]) and a body mass index of 30 kg/m2 or greater. Those not using a CPAP device were enrolled in study 1, and those using a CPAP device were enrolled in study 2.
Participants received either the maximum tolerated dose of tirzepatide (10 or 15 mg by once-weekly injection) or placebo for 1 year. In study 1, 114 individuals received tirzepatide and 120 received placebo. For study 2, 119 patients received tirzepatide and 114 received placebo. All participants received regular lifestyle counseling sessions about nutrition and were instructed to reduce food intake by 500 kcal/day and to engage in at least 150 min/week of physical activity.
Enrollment was limited to 70% men to ensure adequate representation of women.
At baseline, 65%-70% of participants had severe OSA, with more than 30 events/hour on the AHI scale and a mean of 51.5 events/hour.
By 1 year, patients taking tirzepatide had 27-30 fewer events/hour, compared with 4-6 fewer events/hour for those taking placebo.
Up to half of those who received tirzepatide in both trials had less than 5 events/hour or 5-14 AHI events/hour and an Epworth Sleepiness Scale score of 10 or less. Those thresholds “represent a level at which CPAP therapy may not be recommended,” wrote the authors.
Patients in the tirzepatide group also had a decrease in systolic blood pressure from baseline of 9.7 mm Hg in study 1 and 7.6 mm Hg in study 2 at week 48.
The most common adverse events were diarrhea, nausea, and vomiting, which occurred in approximately a quarter of patients taking tirzepatide. There were two adjudicated-confirmed cases of acute pancreatitis in those taking tirzepatide in study 2.
Patients who received tirzepatide also reported fewer daytime and nighttime disturbances, as measured using the Patient-Reported Outcomes Measurement Information System Short Form scale for Sleep-Related Impairment and Sleep Disturbance.
Tirzepatide Plus CPAP Are Best
Writing in an accompanying editorial, Sanjay R. Patel, MD, noted that, although clinical guidelines have recommended that weight loss strategies be incorporated as part of OSA treatment, “the integration of obesity management into the approaches to care for obstructive sleep apnea has lagged.”
As many as half of patients abandon CPAP therapy within 3 years, wrote Dr. Patel, who is professor of medicine and epidemiology at the University of Pittsburgh, Pittsburgh, Pennsylvania, and medical director of the UPMC Comprehensive Sleep Disorders program. “An effective medication to treat obesity is thus an obvious avenue to pursue.”
Dr. Patel noted the large reductions in the number of events on the AHI scale. He wrote that the improvement in systolic blood pressure “was substantially larger than effects seen with CPAP therapy alone and indicate that tirzepatide may be an attractive option for those patients who seek to reduce their cardiovascular risk.”
Dr. Patel raised concerns about whether patients outside of a trial would stick with therapy, noting studies have shown high rates of discontinuation of GLP-1 receptor agonists.
And, he wrote, “racial disparities in the use of GLP-1 receptor agonists among patients with diabetes arouse concern that the addition of tirzepatide as a treatment option for obstructive sleep apnea without directly addressing policies relative to coverage of care will only further exacerbate already pervasive disparities in clinical care for obstructive sleep apnea.”
Commenting on the study during the presentation of the results, Louis Aronne, MD, said he believes the trials demonstrate “the treatment of obesity with tirzepatide plus CPAP is really the optimal treatment for obstructive sleep apnea and obesity-related cardiometabolic risks.” Dr. Aronne is the Sanford I. Weill professor of metabolic research at Weill Cornell Medical College, New York City.
Dr. Aronne added there is still much to learn. It is still not clear whether tirzepatide had an independent effect in the OSA trial — as has been seen in other studies where the drug clearly reduced cardiovascular risk — or whether the positive results were primarily caused by weight loss.
“I believe that over time we’ll see that this particular effect in sleep apnea is related to weight,” he said.
The study was supported by Eli Lilly. Dr. Malhotra has reported being a paid consultant for Lilly and ZOLL Medical and a cofounder of Healcisio.
A version of this article appeared on Medscape.com.
FROM ADA 2024
A New Psychotherapeutic ‘Gold Standard’ for Chronic Pain?
, the current psychotherapeutic gold standard, a new study suggested.
Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.
The study is one of only a few to directly compare EAET with CBT.
“Most people with chronic pain don’t consider psychotherapy at all,” said study investigator Brandon C. Yarns, MD, a staff psychiatrist at the VA Greater Los Angeles Healthcare System, and clinical professor of health sciences at the Department of Psychiatry and Biobehavioral Sciences, UCLA Health.
Although patients were allowed to continue medication for pain and other comorbidities during the study, those who received EAET “had larger improvements in pain, depression, and anxiety,” Dr. Yarns said. “That suggests that the effect was due to the EAET.”
The findings were published online in JAMA Network Open.
‘Gold Standard’
EAET was first used in the early 2010s. In the therapy, patients are asked to recall a difficult or traumatic memory, engage in experiencing how the related emotions feel in the body, express those feelings in words, and release or let them go. They are taught that the brain’s perception of pain is strongly influenced by the evasion of grief, fear, rage, or guilt, Dr. Yarns said.
This contrasts with CBT — considered the current gold standard for chronic pain — which teaches patients to improve the ability to tolerate pain though guided imagery, muscle relaxation, and other exercises and to adapt their thinking to change how they think about pain.
Although prior studies suggested EAET is effective in reducing pain in fibromyalgia and chronic musculoskeletal, pelvic, and head pain, most included primarily younger, female patients.
The research is the “first full-scale evaluation of EAET, to our knowledge, in a medically or psychiatrically complex, racially and ethnically diverse, older sample comprising predominantly men,” investigators wrote.
The trial enrolled 126 veterans (92% men; 55% Black or African American) aged 60-95 years with at least 3 months of musculoskeletal pain. More than two thirds of patients had a psychiatric diagnosis, with about one third having posttraumatic stress disorder (PTSD). Almost all had back pain, and many had pain in multiple locations.
All services were delivered in-person at the US Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles. Half underwent CBT, while the other half received EAET.
Each patient had one 90-minute individual session and eight additional 90-minute group sessions.
Patients were asked to rate their pain using a 0-10 scale in the Brief Pain Inventory (BPI) before starting treatment, at the end of the nine sessions (at week 10), and 6 months after the sessions ended. Baseline BPI score for both groups was a mean of around 6.
Post treatment, people in the EAET versus CBT group had a mean two-point reduction versus 0.60 reduction, respectively, on the BPI scale. A clinically significant reduction in pain — defined as ≥ 30% decrease — was reported in 63% of EAET patients versus 17% of CBT patients (odds ratio [OR], 21.54; P < .001).
At 6 months, the mean reduction was 1.2 for the EAET group compared with 0.25 for the CBT group, and 40% of the EAET group reported a clinically significant reduction in pain.
A little more than a third (35%) of veterans receiving EAET reported at least a 50% reduction in pain at 10 weeks compared with 7% of those receiving CBT. At 6 months, 16% of the EAET arm reported a halving of their pain.
EAET was also superior to CBT in reducing anxiety, depression, and PTSD symptoms at the 10-week mark.
More Work Needed
In an accompanying editorial, Matthias Karst, MD, PhD, a clinician with the Pain Clinic, Hannover Medical School, in Hannover, Germany, noted that EAET’s effects “are significantly superior to those of CBT in almost all dimensions, even after 6 months.”
EAET “assigns a special place to the integration of the body into the emotional experience,” he wrote.
The study demonstrated that “the evocation and expression of emotions is superior to the mere cognitive discussion of these emotions in therapy of patients with chronic pain.”
Commenting on the findings, Traci J. Speed, MD, PhD, assistant professor of psychiatry and behavioral sciences and an attending psychiatrist of the Johns Hopkins Pain Treatment Program at Johns Hopkins University, Baltimore, called the study “ground-breaking” because it showed effectiveness in people with high rates of PTSD, anxiety, and depression.
“It is a little bit surprising how impressive the study outcomes are in terms of maintaining the effects at the end of the treatment and sustaining some of the effects on pain sensitivity even at the 6-month follow-up,” said Dr. Speed, who was not part of the study.
However, she continued, “I don’t think it changes the current standard of practice yet. CBT has decades of research and evidence that it is effective for chronic pain and that will I think continue to be the standard of care.”
Although EAET is in its infancy, chronic pain experts are interested in learning more about the therapy, Dr. Speed added.
“It blends well with the current techniques and extends the current gold standard treatment approaches,” she said. “We are starting to really appreciate the role that emotions play in pain sensitivity.”
Both Dr. Karst and Dr. Speed noted that more study is needed to determine the sustainability of treatment effects.
Dr. Yarns agreed. “We need more research on what the appropriate dose is and perhaps how one might go about personalizing that for the patient,” he said.
The study was funded by a career development award to Dr. Yarns from the VA Clinical Science Research and Development Service. Dr. Yarns reported receiving grants from the US Department of Veterans Affairs during the study. Other authors’ disclosures are in the original article. Dr. Speed reported no conflicts.
A version of this article appeared on Medscape.com.
, the current psychotherapeutic gold standard, a new study suggested.
Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.
The study is one of only a few to directly compare EAET with CBT.
“Most people with chronic pain don’t consider psychotherapy at all,” said study investigator Brandon C. Yarns, MD, a staff psychiatrist at the VA Greater Los Angeles Healthcare System, and clinical professor of health sciences at the Department of Psychiatry and Biobehavioral Sciences, UCLA Health.
Although patients were allowed to continue medication for pain and other comorbidities during the study, those who received EAET “had larger improvements in pain, depression, and anxiety,” Dr. Yarns said. “That suggests that the effect was due to the EAET.”
The findings were published online in JAMA Network Open.
‘Gold Standard’
EAET was first used in the early 2010s. In the therapy, patients are asked to recall a difficult or traumatic memory, engage in experiencing how the related emotions feel in the body, express those feelings in words, and release or let them go. They are taught that the brain’s perception of pain is strongly influenced by the evasion of grief, fear, rage, or guilt, Dr. Yarns said.
This contrasts with CBT — considered the current gold standard for chronic pain — which teaches patients to improve the ability to tolerate pain though guided imagery, muscle relaxation, and other exercises and to adapt their thinking to change how they think about pain.
Although prior studies suggested EAET is effective in reducing pain in fibromyalgia and chronic musculoskeletal, pelvic, and head pain, most included primarily younger, female patients.
The research is the “first full-scale evaluation of EAET, to our knowledge, in a medically or psychiatrically complex, racially and ethnically diverse, older sample comprising predominantly men,” investigators wrote.
The trial enrolled 126 veterans (92% men; 55% Black or African American) aged 60-95 years with at least 3 months of musculoskeletal pain. More than two thirds of patients had a psychiatric diagnosis, with about one third having posttraumatic stress disorder (PTSD). Almost all had back pain, and many had pain in multiple locations.
All services were delivered in-person at the US Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles. Half underwent CBT, while the other half received EAET.
Each patient had one 90-minute individual session and eight additional 90-minute group sessions.
Patients were asked to rate their pain using a 0-10 scale in the Brief Pain Inventory (BPI) before starting treatment, at the end of the nine sessions (at week 10), and 6 months after the sessions ended. Baseline BPI score for both groups was a mean of around 6.
Post treatment, people in the EAET versus CBT group had a mean two-point reduction versus 0.60 reduction, respectively, on the BPI scale. A clinically significant reduction in pain — defined as ≥ 30% decrease — was reported in 63% of EAET patients versus 17% of CBT patients (odds ratio [OR], 21.54; P < .001).
At 6 months, the mean reduction was 1.2 for the EAET group compared with 0.25 for the CBT group, and 40% of the EAET group reported a clinically significant reduction in pain.
A little more than a third (35%) of veterans receiving EAET reported at least a 50% reduction in pain at 10 weeks compared with 7% of those receiving CBT. At 6 months, 16% of the EAET arm reported a halving of their pain.
EAET was also superior to CBT in reducing anxiety, depression, and PTSD symptoms at the 10-week mark.
More Work Needed
In an accompanying editorial, Matthias Karst, MD, PhD, a clinician with the Pain Clinic, Hannover Medical School, in Hannover, Germany, noted that EAET’s effects “are significantly superior to those of CBT in almost all dimensions, even after 6 months.”
EAET “assigns a special place to the integration of the body into the emotional experience,” he wrote.
The study demonstrated that “the evocation and expression of emotions is superior to the mere cognitive discussion of these emotions in therapy of patients with chronic pain.”
Commenting on the findings, Traci J. Speed, MD, PhD, assistant professor of psychiatry and behavioral sciences and an attending psychiatrist of the Johns Hopkins Pain Treatment Program at Johns Hopkins University, Baltimore, called the study “ground-breaking” because it showed effectiveness in people with high rates of PTSD, anxiety, and depression.
“It is a little bit surprising how impressive the study outcomes are in terms of maintaining the effects at the end of the treatment and sustaining some of the effects on pain sensitivity even at the 6-month follow-up,” said Dr. Speed, who was not part of the study.
However, she continued, “I don’t think it changes the current standard of practice yet. CBT has decades of research and evidence that it is effective for chronic pain and that will I think continue to be the standard of care.”
Although EAET is in its infancy, chronic pain experts are interested in learning more about the therapy, Dr. Speed added.
“It blends well with the current techniques and extends the current gold standard treatment approaches,” she said. “We are starting to really appreciate the role that emotions play in pain sensitivity.”
Both Dr. Karst and Dr. Speed noted that more study is needed to determine the sustainability of treatment effects.
Dr. Yarns agreed. “We need more research on what the appropriate dose is and perhaps how one might go about personalizing that for the patient,” he said.
The study was funded by a career development award to Dr. Yarns from the VA Clinical Science Research and Development Service. Dr. Yarns reported receiving grants from the US Department of Veterans Affairs during the study. Other authors’ disclosures are in the original article. Dr. Speed reported no conflicts.
A version of this article appeared on Medscape.com.
, the current psychotherapeutic gold standard, a new study suggested.
Two thirds of the patients who received EAET reported at least a 30% reduction in pain compared with 17% of those who received CBT. The randomized clinical trial also showed that individuals with depression and anxiety responded more favorably to EAET, a novel finding.
The study is one of only a few to directly compare EAET with CBT.
“Most people with chronic pain don’t consider psychotherapy at all,” said study investigator Brandon C. Yarns, MD, a staff psychiatrist at the VA Greater Los Angeles Healthcare System, and clinical professor of health sciences at the Department of Psychiatry and Biobehavioral Sciences, UCLA Health.
Although patients were allowed to continue medication for pain and other comorbidities during the study, those who received EAET “had larger improvements in pain, depression, and anxiety,” Dr. Yarns said. “That suggests that the effect was due to the EAET.”
The findings were published online in JAMA Network Open.
‘Gold Standard’
EAET was first used in the early 2010s. In the therapy, patients are asked to recall a difficult or traumatic memory, engage in experiencing how the related emotions feel in the body, express those feelings in words, and release or let them go. They are taught that the brain’s perception of pain is strongly influenced by the evasion of grief, fear, rage, or guilt, Dr. Yarns said.
This contrasts with CBT — considered the current gold standard for chronic pain — which teaches patients to improve the ability to tolerate pain though guided imagery, muscle relaxation, and other exercises and to adapt their thinking to change how they think about pain.
Although prior studies suggested EAET is effective in reducing pain in fibromyalgia and chronic musculoskeletal, pelvic, and head pain, most included primarily younger, female patients.
The research is the “first full-scale evaluation of EAET, to our knowledge, in a medically or psychiatrically complex, racially and ethnically diverse, older sample comprising predominantly men,” investigators wrote.
The trial enrolled 126 veterans (92% men; 55% Black or African American) aged 60-95 years with at least 3 months of musculoskeletal pain. More than two thirds of patients had a psychiatric diagnosis, with about one third having posttraumatic stress disorder (PTSD). Almost all had back pain, and many had pain in multiple locations.
All services were delivered in-person at the US Department of Veterans Affairs Greater Los Angeles Healthcare System, Los Angeles. Half underwent CBT, while the other half received EAET.
Each patient had one 90-minute individual session and eight additional 90-minute group sessions.
Patients were asked to rate their pain using a 0-10 scale in the Brief Pain Inventory (BPI) before starting treatment, at the end of the nine sessions (at week 10), and 6 months after the sessions ended. Baseline BPI score for both groups was a mean of around 6.
Post treatment, people in the EAET versus CBT group had a mean two-point reduction versus 0.60 reduction, respectively, on the BPI scale. A clinically significant reduction in pain — defined as ≥ 30% decrease — was reported in 63% of EAET patients versus 17% of CBT patients (odds ratio [OR], 21.54; P < .001).
At 6 months, the mean reduction was 1.2 for the EAET group compared with 0.25 for the CBT group, and 40% of the EAET group reported a clinically significant reduction in pain.
A little more than a third (35%) of veterans receiving EAET reported at least a 50% reduction in pain at 10 weeks compared with 7% of those receiving CBT. At 6 months, 16% of the EAET arm reported a halving of their pain.
EAET was also superior to CBT in reducing anxiety, depression, and PTSD symptoms at the 10-week mark.
More Work Needed
In an accompanying editorial, Matthias Karst, MD, PhD, a clinician with the Pain Clinic, Hannover Medical School, in Hannover, Germany, noted that EAET’s effects “are significantly superior to those of CBT in almost all dimensions, even after 6 months.”
EAET “assigns a special place to the integration of the body into the emotional experience,” he wrote.
The study demonstrated that “the evocation and expression of emotions is superior to the mere cognitive discussion of these emotions in therapy of patients with chronic pain.”
Commenting on the findings, Traci J. Speed, MD, PhD, assistant professor of psychiatry and behavioral sciences and an attending psychiatrist of the Johns Hopkins Pain Treatment Program at Johns Hopkins University, Baltimore, called the study “ground-breaking” because it showed effectiveness in people with high rates of PTSD, anxiety, and depression.
“It is a little bit surprising how impressive the study outcomes are in terms of maintaining the effects at the end of the treatment and sustaining some of the effects on pain sensitivity even at the 6-month follow-up,” said Dr. Speed, who was not part of the study.
However, she continued, “I don’t think it changes the current standard of practice yet. CBT has decades of research and evidence that it is effective for chronic pain and that will I think continue to be the standard of care.”
Although EAET is in its infancy, chronic pain experts are interested in learning more about the therapy, Dr. Speed added.
“It blends well with the current techniques and extends the current gold standard treatment approaches,” she said. “We are starting to really appreciate the role that emotions play in pain sensitivity.”
Both Dr. Karst and Dr. Speed noted that more study is needed to determine the sustainability of treatment effects.
Dr. Yarns agreed. “We need more research on what the appropriate dose is and perhaps how one might go about personalizing that for the patient,” he said.
The study was funded by a career development award to Dr. Yarns from the VA Clinical Science Research and Development Service. Dr. Yarns reported receiving grants from the US Department of Veterans Affairs during the study. Other authors’ disclosures are in the original article. Dr. Speed reported no conflicts.
A version of this article appeared on Medscape.com.
Doctors Endorsing Products on X May Not Disclose Company Ties
Lead author Aaron Mitchell, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told this news organization that he and his colleagues undertook the study in part to see whether physicians were adhering to professional and industry guidelines regarding marketing communications.
The team reviewed posts by physicians on X during 2022, looking for key words that might indicate that the posts were intended as endorsements of a product. The researchers then delved into the Centers for Medicare and Medicaid Services Open Payments database to see how many of those identified as having endorsed a product were paid by the manufacturers.
What Dr. Mitchell found concerned him, he said.
Overall, the researchers identified 28 physician endorsers who received a total of $1.4 million from sponsors in 2022. Among these, 26 physicians (93%) received payments from the product’s manufacturer, totaling $713,976, and 24 physicians (86%) accepted payments related to the endorsed drug or device, totaling $492,098.
While most did disclose that the posts were sponsored — by adding the word “sponsored” or using #sponsored — nine physicians did not.
Although 28 physician endorsers represent a “small fraction” of the overall number of physicians who use X, each endorsement was ultimately posted dozens, if not hundreds of times, said Dr. Mitchell. In fact, he said he saw the same particular endorsement post every time he opened his X app for months.
Overall, Dr. Mitchell noted that it’s less about the fact that the endorsements are occurring on social media and more that there are these paid endorsements taking place at all.
Among the physician specialties promoting a product, urologists and oncologists dominated. Almost one third were urologists, and 57% were oncologists — six medical oncologists, six radiation oncologists, and four gynecologic oncologists. Of the remaining three physicians, two were internists and one was a pulmonary and critical care medicine specialist.
The authors tracked posts from physicians and industry accounts. Many of the posts on industry accounts were physician testimonials, usually videos. Almost half — 8 of 17 — of those testimonials did not disclose that the doctor was being paid by the manufacturer. In another case, a physician did not disclose that they were paid to endorse a white paper.
Fifteen promotional posts were for a Boston Scientific product, followed by six for GlaxoSmithKline, two for Eisai, two for Exelixis, and one each for AstraZeneca, Novartis, and Pfizer.
In general, Dr. Mitchell said, industry guidelines suggest that manufacturer-paid speakers or consultants should have well-regarded expertise in the area they are being asked to weigh in on, but most physician endorsers in the study were not key opinion leaders or experts.
The authors examined the paid endorsers’ H-index — a measure of academic productivity provided by Scopus. Overall, 19 of the 28 physicians had an H-index below 20, which is considered less accomplished, and 14 had no published research related to the endorsed product.
Ten received payments from manufacturers for research purposes, and only one received research payments related to the endorsed product ($224,577).
“Physicians’ participation in industry marketing raises questions regarding professionalism and their responsibilities as patient advocates,” the JAMA authors wrote.
The study was supported by grants from the National Cancer Institute. Dr. Mitchell reported no relevant financial relationships. Coauthors Samer Al Hadidi, MD, reported receiving personal fees from Pfizer, Sanofi, and Janssen during the conduct of the study, and Timothy S. Anderson, MD, reported receiving grants from the National Institute on Aging, the American Heart Association, and the American College of Cardiology, and receiving consulting fees from the American Medical Student Association. Dr. Anderson is also an associate editor of JAMA Internal Medicine.
A version of this article appeared on Medscape.com.
Lead author Aaron Mitchell, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told this news organization that he and his colleagues undertook the study in part to see whether physicians were adhering to professional and industry guidelines regarding marketing communications.
The team reviewed posts by physicians on X during 2022, looking for key words that might indicate that the posts were intended as endorsements of a product. The researchers then delved into the Centers for Medicare and Medicaid Services Open Payments database to see how many of those identified as having endorsed a product were paid by the manufacturers.
What Dr. Mitchell found concerned him, he said.
Overall, the researchers identified 28 physician endorsers who received a total of $1.4 million from sponsors in 2022. Among these, 26 physicians (93%) received payments from the product’s manufacturer, totaling $713,976, and 24 physicians (86%) accepted payments related to the endorsed drug or device, totaling $492,098.
While most did disclose that the posts were sponsored — by adding the word “sponsored” or using #sponsored — nine physicians did not.
Although 28 physician endorsers represent a “small fraction” of the overall number of physicians who use X, each endorsement was ultimately posted dozens, if not hundreds of times, said Dr. Mitchell. In fact, he said he saw the same particular endorsement post every time he opened his X app for months.
Overall, Dr. Mitchell noted that it’s less about the fact that the endorsements are occurring on social media and more that there are these paid endorsements taking place at all.
Among the physician specialties promoting a product, urologists and oncologists dominated. Almost one third were urologists, and 57% were oncologists — six medical oncologists, six radiation oncologists, and four gynecologic oncologists. Of the remaining three physicians, two were internists and one was a pulmonary and critical care medicine specialist.
The authors tracked posts from physicians and industry accounts. Many of the posts on industry accounts were physician testimonials, usually videos. Almost half — 8 of 17 — of those testimonials did not disclose that the doctor was being paid by the manufacturer. In another case, a physician did not disclose that they were paid to endorse a white paper.
Fifteen promotional posts were for a Boston Scientific product, followed by six for GlaxoSmithKline, two for Eisai, two for Exelixis, and one each for AstraZeneca, Novartis, and Pfizer.
In general, Dr. Mitchell said, industry guidelines suggest that manufacturer-paid speakers or consultants should have well-regarded expertise in the area they are being asked to weigh in on, but most physician endorsers in the study were not key opinion leaders or experts.
The authors examined the paid endorsers’ H-index — a measure of academic productivity provided by Scopus. Overall, 19 of the 28 physicians had an H-index below 20, which is considered less accomplished, and 14 had no published research related to the endorsed product.
Ten received payments from manufacturers for research purposes, and only one received research payments related to the endorsed product ($224,577).
“Physicians’ participation in industry marketing raises questions regarding professionalism and their responsibilities as patient advocates,” the JAMA authors wrote.
The study was supported by grants from the National Cancer Institute. Dr. Mitchell reported no relevant financial relationships. Coauthors Samer Al Hadidi, MD, reported receiving personal fees from Pfizer, Sanofi, and Janssen during the conduct of the study, and Timothy S. Anderson, MD, reported receiving grants from the National Institute on Aging, the American Heart Association, and the American College of Cardiology, and receiving consulting fees from the American Medical Student Association. Dr. Anderson is also an associate editor of JAMA Internal Medicine.
A version of this article appeared on Medscape.com.
Lead author Aaron Mitchell, MD, MPH, a medical oncologist at Memorial Sloan Kettering Cancer Center in New York City, told this news organization that he and his colleagues undertook the study in part to see whether physicians were adhering to professional and industry guidelines regarding marketing communications.
The team reviewed posts by physicians on X during 2022, looking for key words that might indicate that the posts were intended as endorsements of a product. The researchers then delved into the Centers for Medicare and Medicaid Services Open Payments database to see how many of those identified as having endorsed a product were paid by the manufacturers.
What Dr. Mitchell found concerned him, he said.
Overall, the researchers identified 28 physician endorsers who received a total of $1.4 million from sponsors in 2022. Among these, 26 physicians (93%) received payments from the product’s manufacturer, totaling $713,976, and 24 physicians (86%) accepted payments related to the endorsed drug or device, totaling $492,098.
While most did disclose that the posts were sponsored — by adding the word “sponsored” or using #sponsored — nine physicians did not.
Although 28 physician endorsers represent a “small fraction” of the overall number of physicians who use X, each endorsement was ultimately posted dozens, if not hundreds of times, said Dr. Mitchell. In fact, he said he saw the same particular endorsement post every time he opened his X app for months.
Overall, Dr. Mitchell noted that it’s less about the fact that the endorsements are occurring on social media and more that there are these paid endorsements taking place at all.
Among the physician specialties promoting a product, urologists and oncologists dominated. Almost one third were urologists, and 57% were oncologists — six medical oncologists, six radiation oncologists, and four gynecologic oncologists. Of the remaining three physicians, two were internists and one was a pulmonary and critical care medicine specialist.
The authors tracked posts from physicians and industry accounts. Many of the posts on industry accounts were physician testimonials, usually videos. Almost half — 8 of 17 — of those testimonials did not disclose that the doctor was being paid by the manufacturer. In another case, a physician did not disclose that they were paid to endorse a white paper.
Fifteen promotional posts were for a Boston Scientific product, followed by six for GlaxoSmithKline, two for Eisai, two for Exelixis, and one each for AstraZeneca, Novartis, and Pfizer.
In general, Dr. Mitchell said, industry guidelines suggest that manufacturer-paid speakers or consultants should have well-regarded expertise in the area they are being asked to weigh in on, but most physician endorsers in the study were not key opinion leaders or experts.
The authors examined the paid endorsers’ H-index — a measure of academic productivity provided by Scopus. Overall, 19 of the 28 physicians had an H-index below 20, which is considered less accomplished, and 14 had no published research related to the endorsed product.
Ten received payments from manufacturers for research purposes, and only one received research payments related to the endorsed product ($224,577).
“Physicians’ participation in industry marketing raises questions regarding professionalism and their responsibilities as patient advocates,” the JAMA authors wrote.
The study was supported by grants from the National Cancer Institute. Dr. Mitchell reported no relevant financial relationships. Coauthors Samer Al Hadidi, MD, reported receiving personal fees from Pfizer, Sanofi, and Janssen during the conduct of the study, and Timothy S. Anderson, MD, reported receiving grants from the National Institute on Aging, the American Heart Association, and the American College of Cardiology, and receiving consulting fees from the American Medical Student Association. Dr. Anderson is also an associate editor of JAMA Internal Medicine.
A version of this article appeared on Medscape.com.
FDA Approves Nonstimulant Liquid Onyda XR for ADHD
, drug manufacturer Tris Pharma announced in a statement.
The drug is the first approved liquid nonstimulant ADHD medication. The once-daily extended-release oral suspension, with nighttime dosing, can be used alone or as an adjunctive therapy to FDA-approved stimulant medications in pediatric patients 6 years of age or older.
“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” Ann Childress, MD, a psychiatrist and president of the Las Vegas–based Center for Psychiatry and Behavioral Medicine, said in the release.
“The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control,” she added.
The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.
Onyda XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine.
The medication can cause dose-related decreases in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies with the extended-release tablets, somnolence and sedation were commonly reported adverse reactions. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular block, especially in patients taking other sympatholytic drugs, the company noted.
Onyda XR should be available in pharmacies in the second half of 2024.
A version of this article appeared on Medscape.com.
, drug manufacturer Tris Pharma announced in a statement.
The drug is the first approved liquid nonstimulant ADHD medication. The once-daily extended-release oral suspension, with nighttime dosing, can be used alone or as an adjunctive therapy to FDA-approved stimulant medications in pediatric patients 6 years of age or older.
“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” Ann Childress, MD, a psychiatrist and president of the Las Vegas–based Center for Psychiatry and Behavioral Medicine, said in the release.
“The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control,” she added.
The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.
Onyda XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine.
The medication can cause dose-related decreases in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies with the extended-release tablets, somnolence and sedation were commonly reported adverse reactions. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular block, especially in patients taking other sympatholytic drugs, the company noted.
Onyda XR should be available in pharmacies in the second half of 2024.
A version of this article appeared on Medscape.com.
, drug manufacturer Tris Pharma announced in a statement.
The drug is the first approved liquid nonstimulant ADHD medication. The once-daily extended-release oral suspension, with nighttime dosing, can be used alone or as an adjunctive therapy to FDA-approved stimulant medications in pediatric patients 6 years of age or older.
“People with ADHD require a range of therapeutic options that are designed for their individual needs, because not every medication or type of therapy works for every patient,” Ann Childress, MD, a psychiatrist and president of the Las Vegas–based Center for Psychiatry and Behavioral Medicine, said in the release.
“The approval of Onyda XR, the only liquid non-stimulant ADHD medication, with nighttime dosing that shifts the release profile, is a convenient option for patients needing better ADHD control,” she added.
The approval was based on “adequate and well-controlled studies” of the company’s extended-release tablets.
Onyda XR is contraindicated in patients with a history of a hypersensitivity reaction to clonidine.
The medication can cause dose-related decreases in blood pressure and heart rate. Vital signs should be monitored frequently in at-risk patients. In studies with the extended-release tablets, somnolence and sedation were commonly reported adverse reactions. The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular block, especially in patients taking other sympatholytic drugs, the company noted.
Onyda XR should be available in pharmacies in the second half of 2024.
A version of this article appeared on Medscape.com.
Is Mental Illness ‘Transmissible’?
Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.
The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.
The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.
At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.
“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”
The results were published online on May 22 in JAMA Psychiatry.
Few Data
Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.
“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.
Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.
Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.
Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.
The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
Dose-Response Relationship
Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.
The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.
The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.
“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.
The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.
Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.
The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.
Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.
The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
New Direction for Treatment?
Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.
Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.
However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.
“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”
The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.
The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.
The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.
The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.
At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.
“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”
The results were published online on May 22 in JAMA Psychiatry.
Few Data
Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.
“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.
Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.
Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.
Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.
The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
Dose-Response Relationship
Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.
The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.
The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.
“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.
The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.
Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.
The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.
Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.
The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
New Direction for Treatment?
Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.
Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.
However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.
“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”
The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.
The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
Teens with classmates who have a mental illness have a significantly greater risk for a psychiatric diagnosis later in life, even after controlling for parents’ mental health history and other factors, a new study suggested.
The research provides new evidence that adolescents within a specific peer network may possibly “transmit” mental disorders such as depression and anxiety to each other, the investigators noted.
The study is said to the be the largest to date on the topic, including data on more than 700,000 ninth graders in Finland who were followed for up to 18 years.
At least one expert noted that the numbers are higher than he would have expected, but the investigators were quick to caution the study doesn’t prove having a classmate with a mental illness leads to later psychiatric diagnosis among peers.
“The associations observed in the study are not necessarily causal,” lead investigator Jussi Alho, PhD, a postdoctoral researcher at the University of Helsinki, Finland, told this news organization. “The study did not investigate the mechanisms that explain the observed associations.”
The results were published online on May 22 in JAMA Psychiatry.
Few Data
Previous studies have reported a clustering of mood symptoms, eating disorders, and other psychiatric illnesses among adolescent and adult social networks. But most involve self-selected peer groups.
“Investigating the transmission of mental disorders is especially important in childhood and adolescence,” the authors noted. “Yet, despite a few survey studies reporting that adolescents may experience increased mental health symptoms when exposed to friends or peers with mental health problems, large-scale studies on the potential peer influences of mental disorders in youth are lacking,” the authors wrote.
Researchers used a database of 713,809 students in the ninth grade, about half boys and half girls. All were born between January 1, 1985, and December 31, 1997. About 47,000 were excluded as they had a mental disorder diagnosis before the study began.
Some 666,000 students in 860 schools were followed from ninth grade until the first diagnosed mental disorder, death, emigration, or the end of the study in 2019. Median follow-up was 11.4 years.
Diagnoses were gathered from Finnish registries for inpatient, outpatient, and primary care and included ICD-9 and ICD-10 diagnoses for substance misuse disorders, schizophrenia spectrum disorders, mood disorders, anxiety disorders, eating disorders, emotional and social-functioning disorders, and hyperkinetic and conduct disorders.
The authors adjusted for sex, birth year, school and ninth-grade class size, area-level urbanicity, area-level morbidity, area-level education, area-level employment rate, parental educational level, and parental mental health, with a random intercept per school.
Dose-Response Relationship
Overall, a quarter (167,227) of the students were diagnosed with a mental disorder.
The risk of being diagnosed with any mental disorder was 3% higher during the entire follow-up period (hazard ratio [HR], 1.03; 95% CI, 1.02-1.04). Risk was highest in the first year of follow-up (HR, 1.13; 95% CI, 1.08-1.18) and then rose again in years 4 and 5, when the risk was 5% higher with one diagnosed classmate and 10% higher with more than one diagnosed classmate.
The risk was significantly increased for mood, anxiety, and eating disorders in each follow-up time window. Investigators also noted a dose-response relationship: The more classmates with a psychiatric illness, the greater the risk for later mental illness.
“These findings suggest that mental disorders may be transmitted within adolescent peer networks,” the authors wrote.
The researchers chose to describe the spread of mental disorders among peer classmates as “transmission” in part because it has been previously used in the literature, Dr. Alho said.
Alho said the researchers also believe that transmission is an accurate term to describe the potential mechanisms by which mental disorders may spread.
The authors hypothesized that more students might be diagnosed when disorders are normalized, through increased awareness and receptivity to diagnosis and treatment.
Conversely, the rate of disorders might also have increased — especially in the first year of follow-up — if there were no students in the peer network who had been diagnosed, the authors added. Without an example, it might discourage a student to seek help.
The authors also noted that it’s “conceivable that long-term exposure to a depressive individual could lead to gradual development of depressive symptoms through the well-established neural mechanisms of emotional contagion.”
New Direction for Treatment?
Commenting on the findings, Madhukar H. Trivedi, MD, the Betty Jo Hay Distinguished Chair in Mental Health at UT Southwestern Medical School, Dallas, said that the theory that having classmates with psychiatric illness could normalize these conditions has merit.
Once someone is diagnosed or receives treatment, “their peers kind of get implicit permission to be able to then express their own symptoms or express their own problems, which they may have been hiding or not recognized,” he said.
However, Dr. Trivedi disagreed with the authors’ suggestion that the rate of disorders might also have increased if no classmates had received a psychiatric diagnosis, noting that it was unlikely that a student would not have been exposed to depression, anxiety, or another mood disorder — through a peer or family member — given how common those illnesses are.
“The numbers are slightly higher than I would have expected,” Dr. Trivedi said, adding that peer influence having that type of impact “is something that has not been shown before.”
The study is notable for its use of comprehensive registries, which helped solidify the data integrity, Trivedi said, and the results offer some potential new directions for treatment, such as adding peer support. That has been found useful in adult treatment but has been less utilized with adolescents, he said.
The study was funded by the European Union and the Academy of Finland. The authors reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
First US Adult ADHD Guidelines Finally on the Way?
The first US clinical guidelines to diagnose and treat attention-deficit/hyperactivity disorder (ADHD) in adults are expected to be released this fall, providing patients, clinicians, insurers, and policymakers with a long overdue and much-needed standardized framework.
The initiative comes under the auspices of the American Professional Society of ADHD and Related Disorders (APSARD). David Goodman, MD, a member of the APSARD guidelines executive committee and assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine in Baltimore, Maryland, noted that the US lags behind several other nations, including Canada, the United Kingdom, Australia, and New Zealand who already have guidelines in place.
Dr. Goodman would not go into any detail as to why the country has been so slow off the mark but told this news organization that in part it has been due to a lack of specific funding. In addition, he said, “adult psychiatry abdicated responsibility for ADHD in adults.”
The American Psychiatric Association (APA) would not comment, although a spokesperson said two of its members are working with APSARD on the guidelines.
Estimates show that there are 10-11 million American adults (4.4%) with ADHD, making it the second most common psychiatric disorder in adults.
Surveys show that mental health professionals, including psychiatrists, report a lack of familiarity with ADHD in adults, said Margaret Sibley, PhD, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine in Seattle and chair of the APSARD guidelines diagnostic and screening committee.
Many don’t consider an ADHD diagnosis in adults “because they were always trained to conceptualize it as something that’s relevant only in childhood,” Dr. Sibley told this new organization. However, research shows that people with ADHD do not outgrow the disorder.
“ADHD itself is still present and has unique problems associated with it in adults,” Dr. Sibley said.
Filling the Leadership Gap
Laurie Kulikosky, CEO of the advocacy group CHADD, said that the organization views the development of guidelines “as a huge step forward in the ability for more people to understand ADHD, particularly on the adult side.”
Oren Mason, MD, a primary care physician who specializes in ADHD at his Grand Rapids, Michigan-based practice, said “there hasn’t been a single specialty that has taken lead responsibility in adult ADHD,” which has contributed to the lag in guideline development.
In addition, Dr. Mason said, “trying to come up with adult guidelines even 5 or 10 years ago wouldn’t have yielded nearly as robust a set of guidelines because it’s taken awhile to have the evidence base to be able to make a few pronouncements really confidently.”
Not only has the evidence base grown but so has telehealth, especially during the height of the COVID-19 pandemic. That led to concerns that ADHD was not rigorously evaluated and that stimulants were prescribed too easily, said Dr. Goodman.
Several telehealth providers came under federal scrutiny, with the DEA accusing Cerebral’s pharmacy of dispensing stimulants for nonmedical reasons. The agency said that some 72,000 prescriptions for controlled substances, mostly stimulants, were written between 2020 and 2022.
APSARD felt it was time to act, said Dr. Goodman.
“We could not allow entrepreneurs who felt there was a business opportunity here to, under the auspices of advocating for mental health, increase the distribution of potentially addictive medications in the community,” he said
Ensuring Psychiatrist Buy-In
Development of the APSARD guidelines is led by Thomas Spencer, MD, a retired associate professor of psychiatry at Harvard Medical School, and Frances Rudnick Levin, MD, the Kennedy-Leavy Professor of Psychiatry at Columbia University, both of whom have decades of experience and clinical work in adults with ADHD.
Dr. Goodman is joined on the executive committee by Lenard Adler, MD (NYU Grossman School of Medicine), and Stephen Faraone, PhD (SUNY Upstate Medical University), along with 30 others who have expertise in psychiatry, psychology, primary care, and other health professions.
To participate in the development of the guidelines, experts had to agree to disengage from any potential conflicts and devote themselves — unpaid — to the process, said Dr. Goodman. The goal is to head off any charges of conflicts or biases, he said.
Three subcommittees — diagnosis and assessment, medical treatment, and nonmedical treatment — will review the literature, grade the evidence base, and use the Delphi consensus method to write the draft guidelines.
The draft will go out to the public and to medical specialties for comment, which will be considered for inclusion in the final publication, said Dr. Goodman.
The guidelines panel has been working closely with the APA and following the APA guideline development process in an effort to get buy-in from psychiatrists, he said.
Critical Educational Tool
“Doctors are often surprised to hear that there are no guidelines for adult ADHD in the US,” said Ann Childress, MD, APSARD president, when the group announced its effort in 2023. “Whether diagnosis and treatment are provided in office or online, the standard of care should be the same throughout the country,” she said.
Guidelines will “reduce mythology and error or at least when we run into mythology and error we can say no, there’s a giant consensus with hundreds of experts that disagree with that and so if you want to counter that you better bring some heavy machinery, you can’t just throw out an opinion and leave it unsupported,” said Dr. Mason.
Dr. Sibley said that, although there are no good data, anecdotally it appears many clinicians rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM) when treating adults with ADHD.
The DSM “tells people what they should do but it doesn’t exactly tell them what’s the best way to do it,” she said, adding that often physicians follow what they learned from whoever they were trained by.
“Some people have been trained by people who are well versed in best practices and so they might be doing things that we would say have a research support to them, and other people might be doing things based on people who developed their own opinions about the best way to diagnose ADHD based on lived experience which may or may not be best practices,” Dr. Sibley said.
Her subcommittee aims to offer guidance on screening “that will be helpful in primary care, in terms of what are the most efficient ways to do it” and to help with accuracy, she said. Currently, there are likely some clinicians who are making too liberal a diagnosis and others who are making too conservative a diagnosis, she said.
With so many clinicians — especially in primary care — having a lack of experience, the guidelines could increase “the ability for more different kinds of providers to help,” said Dr. Kulikosky.
Guidelines should also provide a template for ongoing education, especially for clinicians who have never received any training in ADHD.
Dr. Goodman said it is increasingly likely that primary care physicians will be writing more prescriptions for ADHD medications than psychiatrists. “If that is the trajectory, the education of those providers seeing these patients is critical,” he said.
Offering Standards, Dispelling Myths
Guidelines can also help “shorten the learning curve,” said Dr. Mason, who said that he’s had to piece together evidence over the last few decades. Once published, the standards can be used in residency, for board exams, and continuing medical education, he said.
Not only do they offer a “kind of a shortcut to what we all know and agree on,” they also specify where the edges of knowledge are, he said.
Guidelines can also dissuade clinicians from practices that have no evidence to support them, such as “medication holidays,” said Dr. Mason. That has been employed to give children, especially, a break from side effects, but studies have shown that it actually increases side effects, he said.
Dr. Goodman and Dr. Sibley expect the guidelines to help with the challenge of diagnosis. Approximately 38% of adults with ADHD have a mood disorder and 48% have anxiety, said Dr. Goodman. Many others have coexisting posttraumatic stress disorder, substance use disorders, or medical illnesses that compound cognitive problems.
If an individual has several psychiatric conditions, “the question is how do you diagnostically prioritize which you treat first, second, and third, with the goal of treating one without making the others worse,” said Dr. Goodman.
“ADHD takes more detective work than other disorders,” said Dr. Sibley, adding that without an objective diagnostic and with overlaps with other comorbid disorders, “there are very complex issues that all of us wrestle with.”
While the guidelines will not provide algorithms, they will provide information that “will help guide them in the tougher diagnostic context,” she said.
Dr. Mason agreed. “It’s a complicated disorder to diagnose and treat. It’s hard for somebody to jump into it. [The guidelines] are going to give us — here’s what you really have to know, here’s what you have to do,” he said.
And it won’t just be clinicians who look to the guidelines. Calls to National Resource Center on ADHD — which CHADD runs for the federal government — from adults wanting to know more about their own condition “have increased exponentially” in the last few years, said Dr. Kulikosky. “We know adults are seeking out information, they are seeking out diagnosis and treatment,” she said.
Dr. Goodman and Dr. Sibley reported no relevant financial relationships. Dr. Mason reported that he consults for Otsuka and is a speaker for Iron Shore.
A version of this article first appeared on Medscape.com.
The first US clinical guidelines to diagnose and treat attention-deficit/hyperactivity disorder (ADHD) in adults are expected to be released this fall, providing patients, clinicians, insurers, and policymakers with a long overdue and much-needed standardized framework.
The initiative comes under the auspices of the American Professional Society of ADHD and Related Disorders (APSARD). David Goodman, MD, a member of the APSARD guidelines executive committee and assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine in Baltimore, Maryland, noted that the US lags behind several other nations, including Canada, the United Kingdom, Australia, and New Zealand who already have guidelines in place.
Dr. Goodman would not go into any detail as to why the country has been so slow off the mark but told this news organization that in part it has been due to a lack of specific funding. In addition, he said, “adult psychiatry abdicated responsibility for ADHD in adults.”
The American Psychiatric Association (APA) would not comment, although a spokesperson said two of its members are working with APSARD on the guidelines.
Estimates show that there are 10-11 million American adults (4.4%) with ADHD, making it the second most common psychiatric disorder in adults.
Surveys show that mental health professionals, including psychiatrists, report a lack of familiarity with ADHD in adults, said Margaret Sibley, PhD, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine in Seattle and chair of the APSARD guidelines diagnostic and screening committee.
Many don’t consider an ADHD diagnosis in adults “because they were always trained to conceptualize it as something that’s relevant only in childhood,” Dr. Sibley told this new organization. However, research shows that people with ADHD do not outgrow the disorder.
“ADHD itself is still present and has unique problems associated with it in adults,” Dr. Sibley said.
Filling the Leadership Gap
Laurie Kulikosky, CEO of the advocacy group CHADD, said that the organization views the development of guidelines “as a huge step forward in the ability for more people to understand ADHD, particularly on the adult side.”
Oren Mason, MD, a primary care physician who specializes in ADHD at his Grand Rapids, Michigan-based practice, said “there hasn’t been a single specialty that has taken lead responsibility in adult ADHD,” which has contributed to the lag in guideline development.
In addition, Dr. Mason said, “trying to come up with adult guidelines even 5 or 10 years ago wouldn’t have yielded nearly as robust a set of guidelines because it’s taken awhile to have the evidence base to be able to make a few pronouncements really confidently.”
Not only has the evidence base grown but so has telehealth, especially during the height of the COVID-19 pandemic. That led to concerns that ADHD was not rigorously evaluated and that stimulants were prescribed too easily, said Dr. Goodman.
Several telehealth providers came under federal scrutiny, with the DEA accusing Cerebral’s pharmacy of dispensing stimulants for nonmedical reasons. The agency said that some 72,000 prescriptions for controlled substances, mostly stimulants, were written between 2020 and 2022.
APSARD felt it was time to act, said Dr. Goodman.
“We could not allow entrepreneurs who felt there was a business opportunity here to, under the auspices of advocating for mental health, increase the distribution of potentially addictive medications in the community,” he said
Ensuring Psychiatrist Buy-In
Development of the APSARD guidelines is led by Thomas Spencer, MD, a retired associate professor of psychiatry at Harvard Medical School, and Frances Rudnick Levin, MD, the Kennedy-Leavy Professor of Psychiatry at Columbia University, both of whom have decades of experience and clinical work in adults with ADHD.
Dr. Goodman is joined on the executive committee by Lenard Adler, MD (NYU Grossman School of Medicine), and Stephen Faraone, PhD (SUNY Upstate Medical University), along with 30 others who have expertise in psychiatry, psychology, primary care, and other health professions.
To participate in the development of the guidelines, experts had to agree to disengage from any potential conflicts and devote themselves — unpaid — to the process, said Dr. Goodman. The goal is to head off any charges of conflicts or biases, he said.
Three subcommittees — diagnosis and assessment, medical treatment, and nonmedical treatment — will review the literature, grade the evidence base, and use the Delphi consensus method to write the draft guidelines.
The draft will go out to the public and to medical specialties for comment, which will be considered for inclusion in the final publication, said Dr. Goodman.
The guidelines panel has been working closely with the APA and following the APA guideline development process in an effort to get buy-in from psychiatrists, he said.
Critical Educational Tool
“Doctors are often surprised to hear that there are no guidelines for adult ADHD in the US,” said Ann Childress, MD, APSARD president, when the group announced its effort in 2023. “Whether diagnosis and treatment are provided in office or online, the standard of care should be the same throughout the country,” she said.
Guidelines will “reduce mythology and error or at least when we run into mythology and error we can say no, there’s a giant consensus with hundreds of experts that disagree with that and so if you want to counter that you better bring some heavy machinery, you can’t just throw out an opinion and leave it unsupported,” said Dr. Mason.
Dr. Sibley said that, although there are no good data, anecdotally it appears many clinicians rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM) when treating adults with ADHD.
The DSM “tells people what they should do but it doesn’t exactly tell them what’s the best way to do it,” she said, adding that often physicians follow what they learned from whoever they were trained by.
“Some people have been trained by people who are well versed in best practices and so they might be doing things that we would say have a research support to them, and other people might be doing things based on people who developed their own opinions about the best way to diagnose ADHD based on lived experience which may or may not be best practices,” Dr. Sibley said.
Her subcommittee aims to offer guidance on screening “that will be helpful in primary care, in terms of what are the most efficient ways to do it” and to help with accuracy, she said. Currently, there are likely some clinicians who are making too liberal a diagnosis and others who are making too conservative a diagnosis, she said.
With so many clinicians — especially in primary care — having a lack of experience, the guidelines could increase “the ability for more different kinds of providers to help,” said Dr. Kulikosky.
Guidelines should also provide a template for ongoing education, especially for clinicians who have never received any training in ADHD.
Dr. Goodman said it is increasingly likely that primary care physicians will be writing more prescriptions for ADHD medications than psychiatrists. “If that is the trajectory, the education of those providers seeing these patients is critical,” he said.
Offering Standards, Dispelling Myths
Guidelines can also help “shorten the learning curve,” said Dr. Mason, who said that he’s had to piece together evidence over the last few decades. Once published, the standards can be used in residency, for board exams, and continuing medical education, he said.
Not only do they offer a “kind of a shortcut to what we all know and agree on,” they also specify where the edges of knowledge are, he said.
Guidelines can also dissuade clinicians from practices that have no evidence to support them, such as “medication holidays,” said Dr. Mason. That has been employed to give children, especially, a break from side effects, but studies have shown that it actually increases side effects, he said.
Dr. Goodman and Dr. Sibley expect the guidelines to help with the challenge of diagnosis. Approximately 38% of adults with ADHD have a mood disorder and 48% have anxiety, said Dr. Goodman. Many others have coexisting posttraumatic stress disorder, substance use disorders, or medical illnesses that compound cognitive problems.
If an individual has several psychiatric conditions, “the question is how do you diagnostically prioritize which you treat first, second, and third, with the goal of treating one without making the others worse,” said Dr. Goodman.
“ADHD takes more detective work than other disorders,” said Dr. Sibley, adding that without an objective diagnostic and with overlaps with other comorbid disorders, “there are very complex issues that all of us wrestle with.”
While the guidelines will not provide algorithms, they will provide information that “will help guide them in the tougher diagnostic context,” she said.
Dr. Mason agreed. “It’s a complicated disorder to diagnose and treat. It’s hard for somebody to jump into it. [The guidelines] are going to give us — here’s what you really have to know, here’s what you have to do,” he said.
And it won’t just be clinicians who look to the guidelines. Calls to National Resource Center on ADHD — which CHADD runs for the federal government — from adults wanting to know more about their own condition “have increased exponentially” in the last few years, said Dr. Kulikosky. “We know adults are seeking out information, they are seeking out diagnosis and treatment,” she said.
Dr. Goodman and Dr. Sibley reported no relevant financial relationships. Dr. Mason reported that he consults for Otsuka and is a speaker for Iron Shore.
A version of this article first appeared on Medscape.com.
The first US clinical guidelines to diagnose and treat attention-deficit/hyperactivity disorder (ADHD) in adults are expected to be released this fall, providing patients, clinicians, insurers, and policymakers with a long overdue and much-needed standardized framework.
The initiative comes under the auspices of the American Professional Society of ADHD and Related Disorders (APSARD). David Goodman, MD, a member of the APSARD guidelines executive committee and assistant professor in the Department of Psychiatry and Behavioral Sciences at Johns Hopkins School of Medicine in Baltimore, Maryland, noted that the US lags behind several other nations, including Canada, the United Kingdom, Australia, and New Zealand who already have guidelines in place.
Dr. Goodman would not go into any detail as to why the country has been so slow off the mark but told this news organization that in part it has been due to a lack of specific funding. In addition, he said, “adult psychiatry abdicated responsibility for ADHD in adults.”
The American Psychiatric Association (APA) would not comment, although a spokesperson said two of its members are working with APSARD on the guidelines.
Estimates show that there are 10-11 million American adults (4.4%) with ADHD, making it the second most common psychiatric disorder in adults.
Surveys show that mental health professionals, including psychiatrists, report a lack of familiarity with ADHD in adults, said Margaret Sibley, PhD, professor of psychiatry and behavioral sciences at the University of Washington School of Medicine in Seattle and chair of the APSARD guidelines diagnostic and screening committee.
Many don’t consider an ADHD diagnosis in adults “because they were always trained to conceptualize it as something that’s relevant only in childhood,” Dr. Sibley told this new organization. However, research shows that people with ADHD do not outgrow the disorder.
“ADHD itself is still present and has unique problems associated with it in adults,” Dr. Sibley said.
Filling the Leadership Gap
Laurie Kulikosky, CEO of the advocacy group CHADD, said that the organization views the development of guidelines “as a huge step forward in the ability for more people to understand ADHD, particularly on the adult side.”
Oren Mason, MD, a primary care physician who specializes in ADHD at his Grand Rapids, Michigan-based practice, said “there hasn’t been a single specialty that has taken lead responsibility in adult ADHD,” which has contributed to the lag in guideline development.
In addition, Dr. Mason said, “trying to come up with adult guidelines even 5 or 10 years ago wouldn’t have yielded nearly as robust a set of guidelines because it’s taken awhile to have the evidence base to be able to make a few pronouncements really confidently.”
Not only has the evidence base grown but so has telehealth, especially during the height of the COVID-19 pandemic. That led to concerns that ADHD was not rigorously evaluated and that stimulants were prescribed too easily, said Dr. Goodman.
Several telehealth providers came under federal scrutiny, with the DEA accusing Cerebral’s pharmacy of dispensing stimulants for nonmedical reasons. The agency said that some 72,000 prescriptions for controlled substances, mostly stimulants, were written between 2020 and 2022.
APSARD felt it was time to act, said Dr. Goodman.
“We could not allow entrepreneurs who felt there was a business opportunity here to, under the auspices of advocating for mental health, increase the distribution of potentially addictive medications in the community,” he said
Ensuring Psychiatrist Buy-In
Development of the APSARD guidelines is led by Thomas Spencer, MD, a retired associate professor of psychiatry at Harvard Medical School, and Frances Rudnick Levin, MD, the Kennedy-Leavy Professor of Psychiatry at Columbia University, both of whom have decades of experience and clinical work in adults with ADHD.
Dr. Goodman is joined on the executive committee by Lenard Adler, MD (NYU Grossman School of Medicine), and Stephen Faraone, PhD (SUNY Upstate Medical University), along with 30 others who have expertise in psychiatry, psychology, primary care, and other health professions.
To participate in the development of the guidelines, experts had to agree to disengage from any potential conflicts and devote themselves — unpaid — to the process, said Dr. Goodman. The goal is to head off any charges of conflicts or biases, he said.
Three subcommittees — diagnosis and assessment, medical treatment, and nonmedical treatment — will review the literature, grade the evidence base, and use the Delphi consensus method to write the draft guidelines.
The draft will go out to the public and to medical specialties for comment, which will be considered for inclusion in the final publication, said Dr. Goodman.
The guidelines panel has been working closely with the APA and following the APA guideline development process in an effort to get buy-in from psychiatrists, he said.
Critical Educational Tool
“Doctors are often surprised to hear that there are no guidelines for adult ADHD in the US,” said Ann Childress, MD, APSARD president, when the group announced its effort in 2023. “Whether diagnosis and treatment are provided in office or online, the standard of care should be the same throughout the country,” she said.
Guidelines will “reduce mythology and error or at least when we run into mythology and error we can say no, there’s a giant consensus with hundreds of experts that disagree with that and so if you want to counter that you better bring some heavy machinery, you can’t just throw out an opinion and leave it unsupported,” said Dr. Mason.
Dr. Sibley said that, although there are no good data, anecdotally it appears many clinicians rely on the Diagnostic and Statistical Manual of Mental Disorders (DSM) when treating adults with ADHD.
The DSM “tells people what they should do but it doesn’t exactly tell them what’s the best way to do it,” she said, adding that often physicians follow what they learned from whoever they were trained by.
“Some people have been trained by people who are well versed in best practices and so they might be doing things that we would say have a research support to them, and other people might be doing things based on people who developed their own opinions about the best way to diagnose ADHD based on lived experience which may or may not be best practices,” Dr. Sibley said.
Her subcommittee aims to offer guidance on screening “that will be helpful in primary care, in terms of what are the most efficient ways to do it” and to help with accuracy, she said. Currently, there are likely some clinicians who are making too liberal a diagnosis and others who are making too conservative a diagnosis, she said.
With so many clinicians — especially in primary care — having a lack of experience, the guidelines could increase “the ability for more different kinds of providers to help,” said Dr. Kulikosky.
Guidelines should also provide a template for ongoing education, especially for clinicians who have never received any training in ADHD.
Dr. Goodman said it is increasingly likely that primary care physicians will be writing more prescriptions for ADHD medications than psychiatrists. “If that is the trajectory, the education of those providers seeing these patients is critical,” he said.
Offering Standards, Dispelling Myths
Guidelines can also help “shorten the learning curve,” said Dr. Mason, who said that he’s had to piece together evidence over the last few decades. Once published, the standards can be used in residency, for board exams, and continuing medical education, he said.
Not only do they offer a “kind of a shortcut to what we all know and agree on,” they also specify where the edges of knowledge are, he said.
Guidelines can also dissuade clinicians from practices that have no evidence to support them, such as “medication holidays,” said Dr. Mason. That has been employed to give children, especially, a break from side effects, but studies have shown that it actually increases side effects, he said.
Dr. Goodman and Dr. Sibley expect the guidelines to help with the challenge of diagnosis. Approximately 38% of adults with ADHD have a mood disorder and 48% have anxiety, said Dr. Goodman. Many others have coexisting posttraumatic stress disorder, substance use disorders, or medical illnesses that compound cognitive problems.
If an individual has several psychiatric conditions, “the question is how do you diagnostically prioritize which you treat first, second, and third, with the goal of treating one without making the others worse,” said Dr. Goodman.
“ADHD takes more detective work than other disorders,” said Dr. Sibley, adding that without an objective diagnostic and with overlaps with other comorbid disorders, “there are very complex issues that all of us wrestle with.”
While the guidelines will not provide algorithms, they will provide information that “will help guide them in the tougher diagnostic context,” she said.
Dr. Mason agreed. “It’s a complicated disorder to diagnose and treat. It’s hard for somebody to jump into it. [The guidelines] are going to give us — here’s what you really have to know, here’s what you have to do,” he said.
And it won’t just be clinicians who look to the guidelines. Calls to National Resource Center on ADHD — which CHADD runs for the federal government — from adults wanting to know more about their own condition “have increased exponentially” in the last few years, said Dr. Kulikosky. “We know adults are seeking out information, they are seeking out diagnosis and treatment,” she said.
Dr. Goodman and Dr. Sibley reported no relevant financial relationships. Dr. Mason reported that he consults for Otsuka and is a speaker for Iron Shore.
A version of this article first appeared on Medscape.com.
Androgenetic Alopecia: Study Finds Efficacy of Topical and Oral Minoxidil Similar
Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.
Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.
The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.
“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.
Both Dr. Lipner and Dr. Friedman said the study was well-designed.
The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.
They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.
The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.
At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.
Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.
Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).
Hypertrichosis, Headache
Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.
Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.
“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.
Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.
“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.
However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.
Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”
The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.
Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.
Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.
The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.
“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.
Both Dr. Lipner and Dr. Friedman said the study was well-designed.
The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.
They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.
The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.
At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.
Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.
Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).
Hypertrichosis, Headache
Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.
Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.
“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.
Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.
“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.
However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.
Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”
The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.
Oral minoxidil, 5 mg once a day, “did not demonstrate superiority” over topical minoxidil, 5%, applied twice a day, after 24 weeks, reported Mariana Alvares Penha, MD, of the department of dermatology at São Paulo State University, in Botucatu, Brazil, and coauthors. Their randomized, controlled, double-blind study was published online in JAMA Dermatology.
Topical minoxidil is approved by the US Food and Drug Administration (FDA) for androgenetic alopecia (AGA), but there has been increasing interest worldwide in the use of low-dose oral minoxidil, a vasodilator approved as an antihypertensive, as an alternative treatment.
The trial “is important information that’s never been elucidated before,” Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said in an interview. The data, he added, can be used to reassure patients who do not want to take the oral form of the drug that a topical is just as effective.
“This study does let us counsel patients better and really give them the evidence,” said Shari Lipner, MD, PhD, associate professor of clinical dermatology at Weill Cornell Medicine, New York, who was also asked to comment on the results.
Both Dr. Lipner and Dr. Friedman said the study was well-designed.
The investigators enrolled 90 men aged 18-55; 68 completed the trial. Most had mild to moderate AGA. Men were excluded if they had received treatment for alopecia in the previous 6 months, a history of hair transplant, cardiopathy, nephropathy, dermatoses involving the scalp, any clinical conditions causing hair loss, or hypersensitivity to minoxidil.
They were randomized to receive either 5 mg of oral minoxidil a day, plus a placebo solution to apply to the scalp, or topical minoxidil solution (5%) applied twice a day plus placebo capsules. They were told to take a capsule at bedtime and to apply 1 mL of the solution to dry hair in the morning and at night.
The final analysis included 35 men in the topical group and 33 in the oral group (mean age, 36.6 years). Seven people in the topical group and 11 in the oral group were not able to attend the final appointment at 24 weeks. Three additional patients in the topical group dropped out for insomnia, hair shedding, and scalp eczema, while one dropped out of the oral group because of headache.
At 24 weeks, the percentage increase in terminal hair density in the oral minoxidil group was 27% higher (P = .005) in the vertex and 13% higher (P = .15) in the frontal scalp, compared with the topical-treated group.
Total hair density increased by 2% in the oral group compared with topical treatment in the vertex and decreased by 0.2% in the frontal area compared with topical treatment. None of these differences were statistically significant.
Three dermatologists blinded to the treatments, who analyzed photographs, determined that 60% of the men in the oral group and 48% in the topical group had clinical improvement in the frontal area, which was not statistically significant. More orally-treated patients had improvement in the vertex area: 70% compared with 46% of those on topical treatment (P = .04).
Hypertrichosis, Headache
Of the original 90 patients in the trial, more men taking oral minoxidil had hypertrichosis: 49% compared with 25% in the topical formulation group. Headache was also more common among those on oral minoxidil: six cases (14%) vs. one case (2%) among those on topical minoxidil. There was no difference in mean arterial blood pressure or resting heart rate between the two groups. Transient hair loss was more common with topical treatment, but it was not significant.
Dr. Friedman said that the study results would not change how he practices, but that it would give him data to use to inform patients who do not want to take oral minoxidil. He generally prescribes the oral form, unless patients do not want to take it or there is a medical contraindication, which he said is rare.
“I personally think oral is superior to topical,” mainly “because the patient’s actually using it,” said Dr. Friedman. “They’re more likely to take a pill a day versus apply something topically twice a day,” he added.
Both Dr. Lipner and Dr. Friedman said that they doubted that individuals could — or would want to — follow the twice-daily topical regimen used in the trial.
“In real life, not in the clinical trial scenario, it may be very hard for patients to comply with putting on the topical minoxidil twice a day or even once a day,” Dr. Lipner said.
However, she continues to prescribe more topical minoxidil than oral, because she believes “there’s less potential for side effects.” For patients who can adhere to the topical regimen, the study shows that they will get results, said Dr. Lipner.
Dr. Friedman, however, said that for patients who are looking at a lifetime of medication, “an oral will always win out on a topical to the scalp from an adherence perspective.”
The study was supported by the Brazilian Dermatology Society Support Fund. Dr. Penha reported receiving grants from the fund; no other disclosures were reported. Dr. Friedman and Dr. Lipner reported no conflicts related to minoxidil.
FROM JAMA DERMATOLOGY
Physicians Received $12 Billion from Drug, Device Makers in Less Than 10 Years
A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.
Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.
Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.
Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.
Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.
The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.
The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.
The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.
“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.
“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.
Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”
The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.
“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
Top Earners Range From $195,000 to $4.8 Million
Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.
Overall, the median payment was $48 per physician.
But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.
“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.
Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
Payments Mostly for High-Dollar Products
The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.
The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.
Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.
The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
Industry Influence May Lead to Higher Cost, Poor Quality Care
Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.
“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.
One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”
Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.
For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.
Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.
In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.
The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”
Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
A version of this article appeared on Medscape.com.
A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.
Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.
Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.
Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.
Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.
The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.
The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.
The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.
“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.
“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.
Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”
The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.
“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
Top Earners Range From $195,000 to $4.8 Million
Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.
Overall, the median payment was $48 per physician.
But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.
“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.
Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
Payments Mostly for High-Dollar Products
The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.
The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.
Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.
The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
Industry Influence May Lead to Higher Cost, Poor Quality Care
Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.
“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.
One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”
Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.
For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.
Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.
In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.
The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”
Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
A version of this article appeared on Medscape.com.
A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.
Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.
Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.
Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.
Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.
The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.
The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.
The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.
“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.
“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.
Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”
The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.
“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.
“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
Top Earners Range From $195,000 to $4.8 Million
Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.
Overall, the median payment was $48 per physician.
But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.
“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.
Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
Payments Mostly for High-Dollar Products
The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.
The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.
Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.
The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
Industry Influence May Lead to Higher Cost, Poor Quality Care
Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.
“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.
One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”
Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.
For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.
Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.
In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.
The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”
Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.
A version of this article appeared on Medscape.com.
FROM JAMA