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Doc’s lawsuit tests new crackdown on noncompete clauses
In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.
David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However,
Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.
“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”
Lutheran Health’s media relations department did not respond to requests for comment.
Noncompete clauses ‘extremely common’
Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.
However, the tide has been turning against them.
About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.
For more about state-by-state restrictions on noncompete clauses, check this chart.
In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.
Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions.
In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023.
Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.
Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”
The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
Impact on patients
The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.
State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.
However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.
The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”
For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
A version of this article first appeared on Medscape.com.
In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.
David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However,
Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.
“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”
Lutheran Health’s media relations department did not respond to requests for comment.
Noncompete clauses ‘extremely common’
Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.
However, the tide has been turning against them.
About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.
For more about state-by-state restrictions on noncompete clauses, check this chart.
In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.
Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions.
In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023.
Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.
Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”
The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
Impact on patients
The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.
State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.
However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.
The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”
For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
A version of this article first appeared on Medscape.com.
In a test of one of the nation’s most restrictive laws limiting noncompete clauses in medicine, an Indiana pediatric critical-care physician is suing to stop his former hospital employer from controlling his future employment prospects.
David Lankford, DO, acknowledges that he signed a contract with the Lutheran Health Network that included a noncompete clause. However,
Indiana’s law is notable among states because if a physician terminates his/her job for cause, the noncompete may be considered unenforceable.
“When you have physicians who are unable to work in their community, it creates a barrier for access to care for patients,” Dr. Lankford said in an interview. “I’m fighting to decrease barriers and continue to have patients be able to see their doctors in their own hometown or their own county.”
Lutheran Health’s media relations department did not respond to requests for comment.
Noncompete clauses ‘extremely common’
Non-compete clauses – which typically restrict when and where employees can take future jobs – are common in physician contracts, Anu Murthy, JD, who reviews employee contracts for a firm called Contract Diagnostics, said in an interview.
However, the tide has been turning against them.
About a dozen states and the District of Columbia have enacted legislation to limit the use of noncompetes in employment contracts, and about half of states have pending legislation that could dilute noncompete clauses, Ms. Murthy said. In June, the state of New York sent a noncompete ban bill to the governor’s desk.
For more about state-by-state restrictions on noncompete clauses, check this chart.
In his lawsuit, Dr. Lankford said he was hired in 2017 to work at Lutheran Hospital in Fort Wayne.
Dr. Lankford signed an employee renewal contract in 2020 that included a noncompete clause; his attorneys declined to provide details about the clause because of confidentiality restrictions.
In 2022, the lawsuit says, Lutheran Hospital told Dr. Lankford that he’d need to take on more work due to layoffs of pediatric hospitalists. His patient load subsequently grew by 4-5 times, and he quit as of Jan. 7, 2023.
Dr. Lankford wrote that he found a new job at Parkview Regional Medical Center in Fort Wayne, but his former employer threatened to take action under the noncompete clause, and Parkview withdrew its offer.
Among other things, the new Indiana law says that the clauses are not enforceable “if physician terminates the physician’s employment for cause.”
The lawsuit asks for a judge to prevent Lutheran Health Network from enforcing the clause.
Impact on patients
The new Indiana law also bans noncompete clauses for primary care physicians. Kathleen A. DeLaney, JD, one of Dr. Lankford’s attorneys, said in an interview that this provision came about because rural legislators didn’t want to add to the challenges of attracting primary care doctors to move to their communities.
State legislators have become less friendly to noncompete clauses in medicine because they’re wary of the negative effects on patients, Evan Starr, PhD, said in an interview. The clauses prevent doctors from taking new jobs where they could continue to treat their previous patients, said Dr. Starr, associate professor in the department of management and organization at the University of Maryland.
However, he said, hospitals are fighting to preserve the clauses, arguing that they provide a base of patients to physicians in return for their agreement not to go work for a competitor.
The legal landscape may change even more. The Federal Trade Commission has proposed banning the clauses nationally, and a decision is expected in 2024. However, it’s an election year, which may delay a decision, attorney Ms. Murthy said, “and there is also language in the proposed rule that could exempt nonprofit hospitals, which further complicates the issues.”
For now, Ms. Murthy said, “we are still seeing noncompetes and other restrictive covenants in almost every contract we review in all 50 states and across all specialties. We explicitly explain to every client that they should only sign the agreement with the expectation that their specific noncompete will be enforced as written. Large employer groups, including hospital systems, will likely fight any kind of restriction or dilution of noncompetes, and these types of legal challenges could be tied up in court for many years.”
A version of this article first appeared on Medscape.com.
Creating a fair time-off policy
It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?
First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.
Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.
. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.
Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)
Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.
Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.
The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.
When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.
What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.
When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.
What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?
First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.
Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.
. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.
Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)
Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.
Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.
The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.
When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.
What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.
When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.
What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
It’s interesting how questions often arrive in clusters. This week, my inbox is packed with queries about paid sick leave and paid time off (PTO); what is the difference, which is preferable, what is required, and how does one implement a fair and legal time-off policy for a medical office?
First, the difference: Paid sick leave is the time off allotted to each employee for illness or injury, whereas PTO is an all-encompassing bundle that includes vacation and any other miscellaneous time benefits in addition to sick leave.
Which is preferable? That depends on whom you ask, and sometimes, on the legal situation in your state. Employees generally like the PTO concept, because most never use all of their sick leave. The ability to take the difference as extra vacation time makes them happy and makes your office more attractive to excellent prospects. They also appreciate making their own decisions about taking time off.
. Reasons for absences are now irrelevant, so feigned illnesses are a thing of the past. If an employee requests a day off with adequate notice, and there is adequate coverage of that employee’s duties, you don’t need to know (or care) about the reason for the request.
Critics of PTO say employees are absent more often, since employees who never used their full allotment of sick leave will typically use all of their PTO; but that, in a sense, is the idea. Time off is necessary and important for good office morale, and should be taken by all employees, as well as by all employers. (Remember Eastern’s First Law: Your last words will NOT be, “I wish I had spent more time in the office.”)
Moreover, you should be suspicious of any employee who refuses to take vacations. They may be embezzlers who fear that their illicit modus operandi will be discovered during their absence.
Another common criticism of PTO is the possibility that employees will not stay home when they are truly sick because some employees may view all PTO as vacation time, and don’t want to “waste” any of it on illness. You should make it very clear that sick employees should stay home – and will be sent home if they come to work sick. You have an obligation to protect your other employees – and of course your patients, particularly those who are elderly or immunocompromised – from a staff member with a potentially communicable illness.
The legal requirements of time off are variable. There are currently no federal laws requiring employers to offer paid time off, but each state has its own PTO and sick leave requirements, so you will need to check your state’s specific guidelines before creating or updating a time off policy.
When drafting your policy, make sure everyone knows they will have to request PTO in advance, except for emergencies. Start with defining “in advance” (72 hours? A week?), and then “emergency”; and put these definitions in writing. Illnesses are emergencies, of course, but what about waking up with a bad hangover? A sick child qualifies if your employee is the only available caregiver, but what if the employee’s car has broken down? Some circumstances will have to be decided on a case-by-case basis; but you will have fewer hassles if you anticipate and settle more situations in advance.
What about allowing employees to take salary in exchange for unused PTO, or to roll it over into the next year? We don’t permit either in my office, but some states (for instance, California, Montana, and Nebraska) prohibit use-it-or-lose-it policies.
When an employee leaves or is terminated, do you have to pay accrued PTO? No federal law requires it, but some states do.
What about employees who use up their allotted PTO and request unpaid time off? In my office, we require employees to submit a written request, explaining why they need it, and why it’s a special situation and won’t be a regular occurrence. Even if you (almost) always approve such requests, forcing your employees to jump through a hoop or two makes it less likely that anyone will abuse the privilege. Moreover, this allows you to make judgments on a case-by-case basis, while still being able to honestly say you offer it as a blanket policy to all your employees.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Remote teams offer chance to improve difficult-to-treat PsA
DUBLIN – according to presenters at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
In the same session at the meeting, GRAPPA also announced a new initiative to define difficult-to-treat PsA.
Deepak Jadon, MBBCh, PhD, a rheumatologist with Cambridge (England) University Hospitals NHS Foundation Trust, described his experience of running a clinic for patients with difficult-to-treat PsA in eastern England, covering a catchment area of approximately 6 million people between six and seven hospitals. He discussed how the MDT in his region operates to discuss the management of such patients, whose treatment options may also have indications for comorbidities such as inflammatory bowel disease or uveitis, or have complicating factors such as metabolic syndrome.
“You have to have an interested and engaged colleague to form that collaboration,” Dr. Jadon said. “If you are working in isolation, without your colleagues in the same building, that becomes harder. We have been running remote multispecialty meetings without the patient being present, and I have had the good fortune of having medical students brought into our practice. We discussed approximately 220 patients, initially in our psoriasis-spondyloarthritis MDT and subsequently in our inflammatory bowel disease–spondyloarthritis MDT.”
There are also MDTs with hepatologist colleagues carried out on an ad hoc basis to discuss patients with nonalcoholic fatty liver disease, as well as patients with hepatitis or a transplanted liver, who have psoriatic disease.
This difficult-to-treat cohort is discussed in MDT meetings conducted on Zoom. At MDT meetings, carried out with frequencies ranging from monthly to bimonthly, Dr. Jadon said there would be two dermatologists, two rheumatologists, one to four dermatology and rheumatology trainees and fellows, one to four specialist nurses, one to three research nurses, and one biologics pharmacist. They record the meetings and discuss anywhere from 4 to 18 patients, reviewing items in their electronic medical record, calling or writing patients and/or their primary care clinician as needed. They take about an hour to meet, with a half hour of prep time and another 1.5 hours to undertake necessary actions.
“Generally, the question is, how can we change treatment to best cover the domains of disease?” Dr. Jadon said. “Progressively, more patients are being put onto biologics as a result of these conversations, and I do feel that it has helped our patients and us to consolidate their management plan. Naturally, as all clinicians do, we doubt ourselves and wonder if we are missing something. Is there an aspect of the disease [being missed]? Is there a treatment that I haven’t been using? [The meetings have] been reassuring in that regard. I also learn from my colleagues who have earlier access to treatments, especially in dermatology.”
In a small number of patients, some combinations of advanced therapies, such as combining a Janus kinase inhibitor with a biologic, have been used as a result of these collaborations, “and to discuss this in an MDT has been reassuring, including from a medico-legal perspective,” Dr. Jadon said. “One of the main things we found to be useful is having a brief referral pro forma. Usually, by the time patients reach this forum, they have used a lot of treatments, and it can be difficult to remember that on the spot. It is also important to focus on what the actual question is. Naturally, in these discussions, where you talk about the complexities and various facets of disease, you can get a bit lost and sometimes you actually don’t address the original question.”
He also said it has been very beneficial to use screen sharing in the remote MDTs so that different disciplines can review images together, such as with radiology colleagues. “There are varying skill sets among our colleagues, especially in radiology, and it has been quite nice to review their peripheral imaging, their axial imaging, laboratory markers, and skin lesions together.”
New GRAPPA project to provide clarity
A new GRAPPA project has been devised to help physicians identify and define difficult-to-treat and difficult-to-manage PsA in order to help physicians to categorize and treat these patients.
“We have a growing treatment armamentarium ... but we still do not reach all the patients that we would like to,” said Fabian Proft, MD, of Charité University Medicine, Berlin. “We set our targets, but we see in the real world that we are only reaching them in 40% or 50% of our patients. So, we need to do better, and in order to do better, we need to understand better.”
“We should not only make a definition of difficult-to-treat PsA, which is nonresponse to treatment with objective signs of inflammation, but also we need to address and acknowledge difficult-to-manage [patients],” Dr. Proft said. “We should not stop as soon as we come up with a definition. This will be a working definition and will need to be validated.”
The speakers reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
DUBLIN – according to presenters at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
In the same session at the meeting, GRAPPA also announced a new initiative to define difficult-to-treat PsA.
Deepak Jadon, MBBCh, PhD, a rheumatologist with Cambridge (England) University Hospitals NHS Foundation Trust, described his experience of running a clinic for patients with difficult-to-treat PsA in eastern England, covering a catchment area of approximately 6 million people between six and seven hospitals. He discussed how the MDT in his region operates to discuss the management of such patients, whose treatment options may also have indications for comorbidities such as inflammatory bowel disease or uveitis, or have complicating factors such as metabolic syndrome.
“You have to have an interested and engaged colleague to form that collaboration,” Dr. Jadon said. “If you are working in isolation, without your colleagues in the same building, that becomes harder. We have been running remote multispecialty meetings without the patient being present, and I have had the good fortune of having medical students brought into our practice. We discussed approximately 220 patients, initially in our psoriasis-spondyloarthritis MDT and subsequently in our inflammatory bowel disease–spondyloarthritis MDT.”
There are also MDTs with hepatologist colleagues carried out on an ad hoc basis to discuss patients with nonalcoholic fatty liver disease, as well as patients with hepatitis or a transplanted liver, who have psoriatic disease.
This difficult-to-treat cohort is discussed in MDT meetings conducted on Zoom. At MDT meetings, carried out with frequencies ranging from monthly to bimonthly, Dr. Jadon said there would be two dermatologists, two rheumatologists, one to four dermatology and rheumatology trainees and fellows, one to four specialist nurses, one to three research nurses, and one biologics pharmacist. They record the meetings and discuss anywhere from 4 to 18 patients, reviewing items in their electronic medical record, calling or writing patients and/or their primary care clinician as needed. They take about an hour to meet, with a half hour of prep time and another 1.5 hours to undertake necessary actions.
“Generally, the question is, how can we change treatment to best cover the domains of disease?” Dr. Jadon said. “Progressively, more patients are being put onto biologics as a result of these conversations, and I do feel that it has helped our patients and us to consolidate their management plan. Naturally, as all clinicians do, we doubt ourselves and wonder if we are missing something. Is there an aspect of the disease [being missed]? Is there a treatment that I haven’t been using? [The meetings have] been reassuring in that regard. I also learn from my colleagues who have earlier access to treatments, especially in dermatology.”
In a small number of patients, some combinations of advanced therapies, such as combining a Janus kinase inhibitor with a biologic, have been used as a result of these collaborations, “and to discuss this in an MDT has been reassuring, including from a medico-legal perspective,” Dr. Jadon said. “One of the main things we found to be useful is having a brief referral pro forma. Usually, by the time patients reach this forum, they have used a lot of treatments, and it can be difficult to remember that on the spot. It is also important to focus on what the actual question is. Naturally, in these discussions, where you talk about the complexities and various facets of disease, you can get a bit lost and sometimes you actually don’t address the original question.”
He also said it has been very beneficial to use screen sharing in the remote MDTs so that different disciplines can review images together, such as with radiology colleagues. “There are varying skill sets among our colleagues, especially in radiology, and it has been quite nice to review their peripheral imaging, their axial imaging, laboratory markers, and skin lesions together.”
New GRAPPA project to provide clarity
A new GRAPPA project has been devised to help physicians identify and define difficult-to-treat and difficult-to-manage PsA in order to help physicians to categorize and treat these patients.
“We have a growing treatment armamentarium ... but we still do not reach all the patients that we would like to,” said Fabian Proft, MD, of Charité University Medicine, Berlin. “We set our targets, but we see in the real world that we are only reaching them in 40% or 50% of our patients. So, we need to do better, and in order to do better, we need to understand better.”
“We should not only make a definition of difficult-to-treat PsA, which is nonresponse to treatment with objective signs of inflammation, but also we need to address and acknowledge difficult-to-manage [patients],” Dr. Proft said. “We should not stop as soon as we come up with a definition. This will be a working definition and will need to be validated.”
The speakers reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
DUBLIN – according to presenters at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
In the same session at the meeting, GRAPPA also announced a new initiative to define difficult-to-treat PsA.
Deepak Jadon, MBBCh, PhD, a rheumatologist with Cambridge (England) University Hospitals NHS Foundation Trust, described his experience of running a clinic for patients with difficult-to-treat PsA in eastern England, covering a catchment area of approximately 6 million people between six and seven hospitals. He discussed how the MDT in his region operates to discuss the management of such patients, whose treatment options may also have indications for comorbidities such as inflammatory bowel disease or uveitis, or have complicating factors such as metabolic syndrome.
“You have to have an interested and engaged colleague to form that collaboration,” Dr. Jadon said. “If you are working in isolation, without your colleagues in the same building, that becomes harder. We have been running remote multispecialty meetings without the patient being present, and I have had the good fortune of having medical students brought into our practice. We discussed approximately 220 patients, initially in our psoriasis-spondyloarthritis MDT and subsequently in our inflammatory bowel disease–spondyloarthritis MDT.”
There are also MDTs with hepatologist colleagues carried out on an ad hoc basis to discuss patients with nonalcoholic fatty liver disease, as well as patients with hepatitis or a transplanted liver, who have psoriatic disease.
This difficult-to-treat cohort is discussed in MDT meetings conducted on Zoom. At MDT meetings, carried out with frequencies ranging from monthly to bimonthly, Dr. Jadon said there would be two dermatologists, two rheumatologists, one to four dermatology and rheumatology trainees and fellows, one to four specialist nurses, one to three research nurses, and one biologics pharmacist. They record the meetings and discuss anywhere from 4 to 18 patients, reviewing items in their electronic medical record, calling or writing patients and/or their primary care clinician as needed. They take about an hour to meet, with a half hour of prep time and another 1.5 hours to undertake necessary actions.
“Generally, the question is, how can we change treatment to best cover the domains of disease?” Dr. Jadon said. “Progressively, more patients are being put onto biologics as a result of these conversations, and I do feel that it has helped our patients and us to consolidate their management plan. Naturally, as all clinicians do, we doubt ourselves and wonder if we are missing something. Is there an aspect of the disease [being missed]? Is there a treatment that I haven’t been using? [The meetings have] been reassuring in that regard. I also learn from my colleagues who have earlier access to treatments, especially in dermatology.”
In a small number of patients, some combinations of advanced therapies, such as combining a Janus kinase inhibitor with a biologic, have been used as a result of these collaborations, “and to discuss this in an MDT has been reassuring, including from a medico-legal perspective,” Dr. Jadon said. “One of the main things we found to be useful is having a brief referral pro forma. Usually, by the time patients reach this forum, they have used a lot of treatments, and it can be difficult to remember that on the spot. It is also important to focus on what the actual question is. Naturally, in these discussions, where you talk about the complexities and various facets of disease, you can get a bit lost and sometimes you actually don’t address the original question.”
He also said it has been very beneficial to use screen sharing in the remote MDTs so that different disciplines can review images together, such as with radiology colleagues. “There are varying skill sets among our colleagues, especially in radiology, and it has been quite nice to review their peripheral imaging, their axial imaging, laboratory markers, and skin lesions together.”
New GRAPPA project to provide clarity
A new GRAPPA project has been devised to help physicians identify and define difficult-to-treat and difficult-to-manage PsA in order to help physicians to categorize and treat these patients.
“We have a growing treatment armamentarium ... but we still do not reach all the patients that we would like to,” said Fabian Proft, MD, of Charité University Medicine, Berlin. “We set our targets, but we see in the real world that we are only reaching them in 40% or 50% of our patients. So, we need to do better, and in order to do better, we need to understand better.”
“We should not only make a definition of difficult-to-treat PsA, which is nonresponse to treatment with objective signs of inflammation, but also we need to address and acknowledge difficult-to-manage [patients],” Dr. Proft said. “We should not stop as soon as we come up with a definition. This will be a working definition and will need to be validated.”
The speakers reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
AT GRAPPA 2023
Keep depression, anxiety screening top of mind in patients with psoriatic disease
DUBLIN – , warranting routine screening and having community contacts for mental health professional referrals, Elizabeth Wallace, MD, said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Dr. Wallace, of Cherry Hills Dermatology, Englewood, Colo., discussed the complex interactions between mental illness and psoriatic disease and the potential pitfalls of this comorbidity for these patients.
The topic of mental health is “consistently at the top of our patients’ minds, and certainly our minds too,” said session comoderator and GRAPPA president-elect Joseph F. Merola, MD, MMSc.
“In the U.S., around 17% of people with psoriasis have depression vs. 9% in those without psoriasis,” Dr. Wallace explained. “Psoriasis patients are twice as likely to have depression, compared to those without psoriasis, and psoriasis patients are 33% more likely to attempt suicide and 20% more likely to complete suicide, compared to those without psoriasis.” More severe psoriasis and younger age of onset are also associated with a greater likelihood of suicidality, she added.
Mediators of depression
“The inflammatory mechanisms driving PsD can drive depression and anxiety, and vice-versa,” she said. “There are often also genetic links, for example genetic variations in serotonin receptors, and psychological issues in psoriatic disease are predictably worsened by feelings of stigmatization, embarrassment, and social isolation.”
There are also efforts underway in clinics to “normalize” screening for anxiety and depression among this patient cohort, Dr. Wallace said. “We know that our psoriasis patients face social stigma from the visibility of their disease, and that stress can lead to flares of their condition,” she told the attendees. “We also know that patients who experience stigma also have an increased risk of depressive symptoms. We all know now that psoriasis has well-established pathways with upregulated proinflammatory cytokines.
“Increased cytokines stimulate indoleamine 2,3-dioxygenase, which converts tryptophan to kynurenine. Kynurenine is metabolized to quinolinic acid, which is neurotoxic.” She explained that because serotonin derives from tryptophan, decreases in tryptophan lead to reduced serotonin, and therefore increased risk of depression.
Interleukin-6 is known to be upregulated in depression and downregulated with the use of antidepressant medications, Dr. Wallace said. Mouse models in research have shown that deletion of the IL-6 gene produces antidepressant effects, and studies in humans have shown that IL-6, more than any other serum cytokine, is found at higher levels in humans with depression and psoriatic disease.
IL-17 is also implicated in psoriatic disease and mental health problems, Dr. Wallace said. “With stress, you get upregulation of the Tc17 cells, which produce IL-17,” she explained. “IL-17, along with other inflammatory markers, can actually make the blood-brain barrier more permeable, and when you get more permeability to the blood-brain barrier, you get these cytokines that can cross from the periphery and into the brain.
“With this crossing into the brain, you get further activation of more Th17 [cells] and that, on neurons, leads to increased potassium production, which is directly neurotoxic, so you get neuron destruction.”
Talking about depression
“So, what can we share with our patients?” Dr. Wallace asked. “We can discuss with them that psoriatic patients in general are more likely to be depressed or to have higher rates of suicide. The literature consistently shows that patients whose psoriasis is successfully treated experience reduced depression, and we can provide an understandable review of systemic medications, with warnings on depression and/or suicidality.”
Dr. Wallace advised to screen for depression with the Patient Health Questionnaire-2 (PHQ-2), a validated, two-item tool that asks, “Over the past 2 weeks, how often have you been bothered by having little interest or pleasure in doing things?” and “Over the past 2 weeks, how often have you been bothered by feeling down, depressed, or hopeless?”
She presented a case study illustrative of the type of presentation she sees in her clinic. It involved a 32-year-old man with plaque psoriasis and a high degree of body surface affected. “It’s now July in Colorado, it’s getting warm, people want to wear their shorts and T-shirts, but he said he could no longer hide his psoriasis,” said Dr. Wallace. “Further, it’s in areas that he cannot hide, such as his scalp, his beard, and he also has nail disease. Often, these patients don’t want to shake hands with their bosses or their colleagues and that’s very embarrassing for them.”
Dr. Wallace explained that this patient had seen advertisements for biologic drugs and requested to commence a treatment course. “During the exam, and now that you are developing some rapport with him, you discover that he is feeling down, is embarrassed at work, and has started to avoid social situations.” This is illustrative of a patient who should be screened for mental health conditions, specifically using PHQ-2, she said.
“You can be the person at the front line to screen these patients for mental health conditions, and, specifically for depression, with PHQ-2,” she said. PHQ-2 scores range from 0 to 6, and a score of 3 or higher is considered a positive screen.
“This is where your relationship with another health provider who is most qualified to care for these patients and validate them for their mental health condition can be absolutely critical,” Dr. Wallace said.
Successful PsD treatment lessens the risk for mental health comorbidities, and this is also seen in psoriatic arthritis, Dr. Wallace pointed out. Patient education is critical regarding their increased risk for depression and potential suicidal ideation, she added.
“It’s our job as clinicians to provide patients with an understandable, easy-to-digest review of systemic medications and warnings on depression and suicidality so that they can be aware of these factors.”
Perspective from Dr. Merola
In an interview, Dr. Merola, a double board-certified dermatologist and rheumatologist at Brigham and Women’s Hospital, Boston, discussed the interactions between mental and physical illness.
“One of the things we are learning is that it’s very much a multifactorial issue, in that skin and joints contribute, in some obvious ways, to anxiety and depression, like the fact that somebody doesn’t feel good about their appearance, or they can’t complete daily activities,” he said. “Those are the more obvious ones. But there is data and evidence that there is a biology behind that as well – inflammatory cytokines that drive skin disease probably also have a direct impact on the CNS and probably also drive anxiety and depression.
“We know that disordered sleep contributes to anxiety – think about how we feel if we get a horrible night’s sleep ... it’s hard to pick apart: ‘Am I depressed, am I anxious because I am having too much coffee? Because I am fatigued?’ So, we get into these circles, but the point is, we have to break these cycles, and we have to do it in multiple places. Yes, we have to fix the skin and the joints, but we also have to have interventions and think about how to screen for anxiety and depression. We also have to think about identifying disordered sleep, and how we intervene there as well.”
These challenges require a collaborative approach among physicians. “We can help patients to build their team that gets them help for their skin, for their joints, for their anxiety or depression, their disordered sleep, for their nutritional disorders, their obesity, and so on. So, we are trying to pick apart and unpack those complexities,” he said.
In regard to the potential impacts of this holistic strategy on physician workloads, Dr. Merola acknowledged it is important to consider physician wellness. “There’s no question that we want to be doing the best we can for our colleagues, but we don’t want to overload our colleagues by saying, ‘By the way, not only should we be treating their skin and joints,’ which of course we should be doing, but ‘could you also manage their diabetes, their obesity, their disordered sleep, their anxiety, their depression, difficulties with insurance, getting access to treatments, etc.’
“This is where effective collaboration between physicians becomes important,” he stressed. “We can’t manage every single piece, but we can make sure our patients are informed, are aware, and assist them to get the help that they need.”
In the United States, there “is a real issue” with access to mental health care and greater awareness needs to be created around this issue, he added.
Dr. Wallace and Dr. Merola report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DUBLIN – , warranting routine screening and having community contacts for mental health professional referrals, Elizabeth Wallace, MD, said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Dr. Wallace, of Cherry Hills Dermatology, Englewood, Colo., discussed the complex interactions between mental illness and psoriatic disease and the potential pitfalls of this comorbidity for these patients.
The topic of mental health is “consistently at the top of our patients’ minds, and certainly our minds too,” said session comoderator and GRAPPA president-elect Joseph F. Merola, MD, MMSc.
“In the U.S., around 17% of people with psoriasis have depression vs. 9% in those without psoriasis,” Dr. Wallace explained. “Psoriasis patients are twice as likely to have depression, compared to those without psoriasis, and psoriasis patients are 33% more likely to attempt suicide and 20% more likely to complete suicide, compared to those without psoriasis.” More severe psoriasis and younger age of onset are also associated with a greater likelihood of suicidality, she added.
Mediators of depression
“The inflammatory mechanisms driving PsD can drive depression and anxiety, and vice-versa,” she said. “There are often also genetic links, for example genetic variations in serotonin receptors, and psychological issues in psoriatic disease are predictably worsened by feelings of stigmatization, embarrassment, and social isolation.”
There are also efforts underway in clinics to “normalize” screening for anxiety and depression among this patient cohort, Dr. Wallace said. “We know that our psoriasis patients face social stigma from the visibility of their disease, and that stress can lead to flares of their condition,” she told the attendees. “We also know that patients who experience stigma also have an increased risk of depressive symptoms. We all know now that psoriasis has well-established pathways with upregulated proinflammatory cytokines.
“Increased cytokines stimulate indoleamine 2,3-dioxygenase, which converts tryptophan to kynurenine. Kynurenine is metabolized to quinolinic acid, which is neurotoxic.” She explained that because serotonin derives from tryptophan, decreases in tryptophan lead to reduced serotonin, and therefore increased risk of depression.
Interleukin-6 is known to be upregulated in depression and downregulated with the use of antidepressant medications, Dr. Wallace said. Mouse models in research have shown that deletion of the IL-6 gene produces antidepressant effects, and studies in humans have shown that IL-6, more than any other serum cytokine, is found at higher levels in humans with depression and psoriatic disease.
IL-17 is also implicated in psoriatic disease and mental health problems, Dr. Wallace said. “With stress, you get upregulation of the Tc17 cells, which produce IL-17,” she explained. “IL-17, along with other inflammatory markers, can actually make the blood-brain barrier more permeable, and when you get more permeability to the blood-brain barrier, you get these cytokines that can cross from the periphery and into the brain.
“With this crossing into the brain, you get further activation of more Th17 [cells] and that, on neurons, leads to increased potassium production, which is directly neurotoxic, so you get neuron destruction.”
Talking about depression
“So, what can we share with our patients?” Dr. Wallace asked. “We can discuss with them that psoriatic patients in general are more likely to be depressed or to have higher rates of suicide. The literature consistently shows that patients whose psoriasis is successfully treated experience reduced depression, and we can provide an understandable review of systemic medications, with warnings on depression and/or suicidality.”
Dr. Wallace advised to screen for depression with the Patient Health Questionnaire-2 (PHQ-2), a validated, two-item tool that asks, “Over the past 2 weeks, how often have you been bothered by having little interest or pleasure in doing things?” and “Over the past 2 weeks, how often have you been bothered by feeling down, depressed, or hopeless?”
She presented a case study illustrative of the type of presentation she sees in her clinic. It involved a 32-year-old man with plaque psoriasis and a high degree of body surface affected. “It’s now July in Colorado, it’s getting warm, people want to wear their shorts and T-shirts, but he said he could no longer hide his psoriasis,” said Dr. Wallace. “Further, it’s in areas that he cannot hide, such as his scalp, his beard, and he also has nail disease. Often, these patients don’t want to shake hands with their bosses or their colleagues and that’s very embarrassing for them.”
Dr. Wallace explained that this patient had seen advertisements for biologic drugs and requested to commence a treatment course. “During the exam, and now that you are developing some rapport with him, you discover that he is feeling down, is embarrassed at work, and has started to avoid social situations.” This is illustrative of a patient who should be screened for mental health conditions, specifically using PHQ-2, she said.
“You can be the person at the front line to screen these patients for mental health conditions, and, specifically for depression, with PHQ-2,” she said. PHQ-2 scores range from 0 to 6, and a score of 3 or higher is considered a positive screen.
“This is where your relationship with another health provider who is most qualified to care for these patients and validate them for their mental health condition can be absolutely critical,” Dr. Wallace said.
Successful PsD treatment lessens the risk for mental health comorbidities, and this is also seen in psoriatic arthritis, Dr. Wallace pointed out. Patient education is critical regarding their increased risk for depression and potential suicidal ideation, she added.
“It’s our job as clinicians to provide patients with an understandable, easy-to-digest review of systemic medications and warnings on depression and suicidality so that they can be aware of these factors.”
Perspective from Dr. Merola
In an interview, Dr. Merola, a double board-certified dermatologist and rheumatologist at Brigham and Women’s Hospital, Boston, discussed the interactions between mental and physical illness.
“One of the things we are learning is that it’s very much a multifactorial issue, in that skin and joints contribute, in some obvious ways, to anxiety and depression, like the fact that somebody doesn’t feel good about their appearance, or they can’t complete daily activities,” he said. “Those are the more obvious ones. But there is data and evidence that there is a biology behind that as well – inflammatory cytokines that drive skin disease probably also have a direct impact on the CNS and probably also drive anxiety and depression.
“We know that disordered sleep contributes to anxiety – think about how we feel if we get a horrible night’s sleep ... it’s hard to pick apart: ‘Am I depressed, am I anxious because I am having too much coffee? Because I am fatigued?’ So, we get into these circles, but the point is, we have to break these cycles, and we have to do it in multiple places. Yes, we have to fix the skin and the joints, but we also have to have interventions and think about how to screen for anxiety and depression. We also have to think about identifying disordered sleep, and how we intervene there as well.”
These challenges require a collaborative approach among physicians. “We can help patients to build their team that gets them help for their skin, for their joints, for their anxiety or depression, their disordered sleep, for their nutritional disorders, their obesity, and so on. So, we are trying to pick apart and unpack those complexities,” he said.
In regard to the potential impacts of this holistic strategy on physician workloads, Dr. Merola acknowledged it is important to consider physician wellness. “There’s no question that we want to be doing the best we can for our colleagues, but we don’t want to overload our colleagues by saying, ‘By the way, not only should we be treating their skin and joints,’ which of course we should be doing, but ‘could you also manage their diabetes, their obesity, their disordered sleep, their anxiety, their depression, difficulties with insurance, getting access to treatments, etc.’
“This is where effective collaboration between physicians becomes important,” he stressed. “We can’t manage every single piece, but we can make sure our patients are informed, are aware, and assist them to get the help that they need.”
In the United States, there “is a real issue” with access to mental health care and greater awareness needs to be created around this issue, he added.
Dr. Wallace and Dr. Merola report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
DUBLIN – , warranting routine screening and having community contacts for mental health professional referrals, Elizabeth Wallace, MD, said at the annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis.
Dr. Wallace, of Cherry Hills Dermatology, Englewood, Colo., discussed the complex interactions between mental illness and psoriatic disease and the potential pitfalls of this comorbidity for these patients.
The topic of mental health is “consistently at the top of our patients’ minds, and certainly our minds too,” said session comoderator and GRAPPA president-elect Joseph F. Merola, MD, MMSc.
“In the U.S., around 17% of people with psoriasis have depression vs. 9% in those without psoriasis,” Dr. Wallace explained. “Psoriasis patients are twice as likely to have depression, compared to those without psoriasis, and psoriasis patients are 33% more likely to attempt suicide and 20% more likely to complete suicide, compared to those without psoriasis.” More severe psoriasis and younger age of onset are also associated with a greater likelihood of suicidality, she added.
Mediators of depression
“The inflammatory mechanisms driving PsD can drive depression and anxiety, and vice-versa,” she said. “There are often also genetic links, for example genetic variations in serotonin receptors, and psychological issues in psoriatic disease are predictably worsened by feelings of stigmatization, embarrassment, and social isolation.”
There are also efforts underway in clinics to “normalize” screening for anxiety and depression among this patient cohort, Dr. Wallace said. “We know that our psoriasis patients face social stigma from the visibility of their disease, and that stress can lead to flares of their condition,” she told the attendees. “We also know that patients who experience stigma also have an increased risk of depressive symptoms. We all know now that psoriasis has well-established pathways with upregulated proinflammatory cytokines.
“Increased cytokines stimulate indoleamine 2,3-dioxygenase, which converts tryptophan to kynurenine. Kynurenine is metabolized to quinolinic acid, which is neurotoxic.” She explained that because serotonin derives from tryptophan, decreases in tryptophan lead to reduced serotonin, and therefore increased risk of depression.
Interleukin-6 is known to be upregulated in depression and downregulated with the use of antidepressant medications, Dr. Wallace said. Mouse models in research have shown that deletion of the IL-6 gene produces antidepressant effects, and studies in humans have shown that IL-6, more than any other serum cytokine, is found at higher levels in humans with depression and psoriatic disease.
IL-17 is also implicated in psoriatic disease and mental health problems, Dr. Wallace said. “With stress, you get upregulation of the Tc17 cells, which produce IL-17,” she explained. “IL-17, along with other inflammatory markers, can actually make the blood-brain barrier more permeable, and when you get more permeability to the blood-brain barrier, you get these cytokines that can cross from the periphery and into the brain.
“With this crossing into the brain, you get further activation of more Th17 [cells] and that, on neurons, leads to increased potassium production, which is directly neurotoxic, so you get neuron destruction.”
Talking about depression
“So, what can we share with our patients?” Dr. Wallace asked. “We can discuss with them that psoriatic patients in general are more likely to be depressed or to have higher rates of suicide. The literature consistently shows that patients whose psoriasis is successfully treated experience reduced depression, and we can provide an understandable review of systemic medications, with warnings on depression and/or suicidality.”
Dr. Wallace advised to screen for depression with the Patient Health Questionnaire-2 (PHQ-2), a validated, two-item tool that asks, “Over the past 2 weeks, how often have you been bothered by having little interest or pleasure in doing things?” and “Over the past 2 weeks, how often have you been bothered by feeling down, depressed, or hopeless?”
She presented a case study illustrative of the type of presentation she sees in her clinic. It involved a 32-year-old man with plaque psoriasis and a high degree of body surface affected. “It’s now July in Colorado, it’s getting warm, people want to wear their shorts and T-shirts, but he said he could no longer hide his psoriasis,” said Dr. Wallace. “Further, it’s in areas that he cannot hide, such as his scalp, his beard, and he also has nail disease. Often, these patients don’t want to shake hands with their bosses or their colleagues and that’s very embarrassing for them.”
Dr. Wallace explained that this patient had seen advertisements for biologic drugs and requested to commence a treatment course. “During the exam, and now that you are developing some rapport with him, you discover that he is feeling down, is embarrassed at work, and has started to avoid social situations.” This is illustrative of a patient who should be screened for mental health conditions, specifically using PHQ-2, she said.
“You can be the person at the front line to screen these patients for mental health conditions, and, specifically for depression, with PHQ-2,” she said. PHQ-2 scores range from 0 to 6, and a score of 3 or higher is considered a positive screen.
“This is where your relationship with another health provider who is most qualified to care for these patients and validate them for their mental health condition can be absolutely critical,” Dr. Wallace said.
Successful PsD treatment lessens the risk for mental health comorbidities, and this is also seen in psoriatic arthritis, Dr. Wallace pointed out. Patient education is critical regarding their increased risk for depression and potential suicidal ideation, she added.
“It’s our job as clinicians to provide patients with an understandable, easy-to-digest review of systemic medications and warnings on depression and suicidality so that they can be aware of these factors.”
Perspective from Dr. Merola
In an interview, Dr. Merola, a double board-certified dermatologist and rheumatologist at Brigham and Women’s Hospital, Boston, discussed the interactions between mental and physical illness.
“One of the things we are learning is that it’s very much a multifactorial issue, in that skin and joints contribute, in some obvious ways, to anxiety and depression, like the fact that somebody doesn’t feel good about their appearance, or they can’t complete daily activities,” he said. “Those are the more obvious ones. But there is data and evidence that there is a biology behind that as well – inflammatory cytokines that drive skin disease probably also have a direct impact on the CNS and probably also drive anxiety and depression.
“We know that disordered sleep contributes to anxiety – think about how we feel if we get a horrible night’s sleep ... it’s hard to pick apart: ‘Am I depressed, am I anxious because I am having too much coffee? Because I am fatigued?’ So, we get into these circles, but the point is, we have to break these cycles, and we have to do it in multiple places. Yes, we have to fix the skin and the joints, but we also have to have interventions and think about how to screen for anxiety and depression. We also have to think about identifying disordered sleep, and how we intervene there as well.”
These challenges require a collaborative approach among physicians. “We can help patients to build their team that gets them help for their skin, for their joints, for their anxiety or depression, their disordered sleep, for their nutritional disorders, their obesity, and so on. So, we are trying to pick apart and unpack those complexities,” he said.
In regard to the potential impacts of this holistic strategy on physician workloads, Dr. Merola acknowledged it is important to consider physician wellness. “There’s no question that we want to be doing the best we can for our colleagues, but we don’t want to overload our colleagues by saying, ‘By the way, not only should we be treating their skin and joints,’ which of course we should be doing, but ‘could you also manage their diabetes, their obesity, their disordered sleep, their anxiety, their depression, difficulties with insurance, getting access to treatments, etc.’
“This is where effective collaboration between physicians becomes important,” he stressed. “We can’t manage every single piece, but we can make sure our patients are informed, are aware, and assist them to get the help that they need.”
In the United States, there “is a real issue” with access to mental health care and greater awareness needs to be created around this issue, he added.
Dr. Wallace and Dr. Merola report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT GRAPPA 2023
For love or money: How do doctors choose their specialty?
Medical student loans top hundreds of thousands of dollars, so it’s understandable that physicians may want to select a specialty that pays well.
Moreover, most advised young doctors to follow their hearts rather than their wallets.
“There is no question that many young kids immediately think about money when deciding to pursue medicine, but the thought of a big paycheck will never sustain someone long enough to get them here,” says Sergio Alvarez, MD, a board-certified plastic surgeon based in Miami, Fla., and the CEO and medical director of Mia Aesthetics, which has several national locations.
“Getting into medicine is a long game, and there are many hurdles along the way that only the dedicated overcome,” says Dr. Alvarez.
Unfortunately, he says it may be late in that long game before some realize that the pay rate for certain specialties isn’t commensurate with the immense workload and responsibility they require.
“The short of it is that to become a happy doctor, medicine really needs to be a calling: a passion! There are far easier things to do to make money.”
Here is what physicians said about choosing between love or money.
The lowest-paying subspecialty in a low-paying specialty
Sophia Yen, MD, MPH, cofounder and CEO of Pandia Health, a women-founded, doctor-led birth control delivery service in Sunnyvale, Calif., and clinical associate professor at Stanford (Calif.) University, says you should pursue a specialty because you love the work.
“I chose the lowest-paying subspecialty (adolescent medicine) of a low-paying specialty (pediatrics), but I’d do it all again because I love the patient population – I love what I do.”
Dr. Yen says she chose adolescent medicine because she loves doing “outpatient gynecology” without going through the surgical training of a full ob.gyn. “I love the target population of young adults because you can talk to the patient versus in pediatrics, where you often talk to the parent. With young adults you can catch things – for example, teach a young person about consent, alcohol, marijuana’s effects on the growing brain, prevent unplanned pregnancies and sexually transmitted infections, instill healthy eating, and more.
“Do I wish that I got paid as much as a surgeon?” Dr. Yen says yes. “I hope that someday society will realize the time spent preventing future disease is worth it and pay us accordingly.”
Unfortunately, she says, since the health care system makes more money if you get pregnant, need a cardiac bypass, or need gastric surgery, those who deliver babies or do surgery get paid more than someone who prevents the need for those services.
Money doesn’t buy happiness
Stella Bard, MD, a rheumatologist in McKinney, Tex., says she eats, lives, and breathes rheumatology. “I never regret the decision of choosing this specialty for a single second,” says Dr. Bard. “I feel like it’s a rewarding experience with every single patient encounter.” Dr. Bard notes that money is no guarantee of happiness and that she feels blessed to wake up every morning doing what she loves.
Career or calling?
For Dr. Alvarez, inspiration came when watching his father help change people’s lives. “I saw how impactful a doctor is during a person’s most desperate moments, and that was enough to make medicine my life’s passion at the age of 10.”
He says once you’re in medical school, choosing a specialty is far easier than you think. “Each specialty requires a certain personality or specific characteristics, and some will call to you while others simply won’t.”
“For me, plastics was about finesse, art, and life-changing surgeries that affected people from kids to adults and involved every aspect of the human body. Changing someone’s outward appearance has a profoundly positive impact on their confidence and self-esteem, making plastic surgery a genuinely transformative experience.”
Patricia Celan, MD, a postgraduate psychiatry resident in Canada, also chose psychiatry for the love of the field. “I enjoy helping vulnerable people and exploring what makes a person tick, the source of their difficulties, and how to help people counteract and overcome the difficult cards they’ve been dealt in life.”
She says it’s incredibly rewarding to watch someone turn their life around from severe mental illness, especially those who have been victimized and traumatized, and learn to trust people again.
“I could have made more money in a higher-paying specialty, yes, but I’m not sure I would have felt as fulfilled as psychiatry can make me feel.”
Dr. Celan says everyone has their calling, and some lucky people find their deepest passion in higher-paying specialties. “My calling is psychiatry, and I am at peace with this no matter the money.”
For the love of surgery
“In my experience, most people don’t choose their specialty based on money,” says Nicole Aaronson, MD, MBA, an otolaryngologist and board-certified in the subspecialty of pediatric otolaryngology, an attending surgeon at Nemours Children’s Health of Delaware and clinical associate professor of otolaryngology and pediatrics at Sidney Kimmel Medical College, Philadelphia.
“The first decision point in medical school is usually figuring out if you are a surgery person or a medicine person. I knew very early that I wanted to be a surgeon and wanted to spend time in the OR fixing problems with my hands.”
Part of what attracted Dr. Aaronson to otolaryngology was the variety of conditions managed within the specialty, from head and neck cancer to voice problems to sleep disorders to sinus disease. “I chose my subspecialty because I enjoy working with children and making an impact that will help them live their best possible lives.”
She says a relatively simple surgery like placing ear tubes may help a child’s hearing and allow them to be more successful in school, opening up a new world of opportunities for the child’s future.
“While I don’t think most people choose their specialty based on prospective compensation, I do think all physicians want to be compensated fairly for their time, effort, and level of training,” says Dr. Aaronson.
Choosing a specialty for the money can lead to burnout and dissatisfaction
“For me, the decision to pursue gastroenterology went beyond financial considerations,” says Saurabh Sethi, MD, MPH, a gastroenterologist specializing in hepatology and interventional endoscopy. “While financial stability is undoubtedly important, no doctor enters this field solely for the love of money. The primary driving force for most medical professionals, myself included, is the passion to help people and make a positive difference in their lives.”
Dr. Sethi says the gratification that comes from providing quality care and witnessing patients’ improved well-being is priceless. Moreover, he believes that selecting a specialty based solely on financial gain is likely to lead to burnout and greater dissatisfaction over time.
“By following my love for gut health and prioritizing patient care, I have found a sense of fulfillment and purpose in my career. It has been a rewarding journey, and I’m grateful for the opportunity to contribute to the well-being of my patients through my expertise in gastroenterology.”
Key takeaways: Love or money?
Multiple factors influence doctors’ specialty choices, including genuine love for the work and the future of the specialty. Others include job prospects, hands-on experience they receive, mentors, childhood dreams, parental expectations, complexity of cases, the lifestyle of each specialty, including office hours worked, on-call requirements, and autonomy.
Physicians also mentioned other factors they considered when choosing their specialty:
- Personal interest.
- Intellectual stimulation.
- Work-life balance.
- Patient populations.
- Future opportunities.
- Desire to make a difference.
- Passion.
- Financial stability.
- Being personally fulfilled.
Overwhelmingly, doctors say to pick a specialty you can envision yourself loving 40 years from now and you won’t go wrong.
A version of this article first appeared on Medscape.com.
Medical student loans top hundreds of thousands of dollars, so it’s understandable that physicians may want to select a specialty that pays well.
Moreover, most advised young doctors to follow their hearts rather than their wallets.
“There is no question that many young kids immediately think about money when deciding to pursue medicine, but the thought of a big paycheck will never sustain someone long enough to get them here,” says Sergio Alvarez, MD, a board-certified plastic surgeon based in Miami, Fla., and the CEO and medical director of Mia Aesthetics, which has several national locations.
“Getting into medicine is a long game, and there are many hurdles along the way that only the dedicated overcome,” says Dr. Alvarez.
Unfortunately, he says it may be late in that long game before some realize that the pay rate for certain specialties isn’t commensurate with the immense workload and responsibility they require.
“The short of it is that to become a happy doctor, medicine really needs to be a calling: a passion! There are far easier things to do to make money.”
Here is what physicians said about choosing between love or money.
The lowest-paying subspecialty in a low-paying specialty
Sophia Yen, MD, MPH, cofounder and CEO of Pandia Health, a women-founded, doctor-led birth control delivery service in Sunnyvale, Calif., and clinical associate professor at Stanford (Calif.) University, says you should pursue a specialty because you love the work.
“I chose the lowest-paying subspecialty (adolescent medicine) of a low-paying specialty (pediatrics), but I’d do it all again because I love the patient population – I love what I do.”
Dr. Yen says she chose adolescent medicine because she loves doing “outpatient gynecology” without going through the surgical training of a full ob.gyn. “I love the target population of young adults because you can talk to the patient versus in pediatrics, where you often talk to the parent. With young adults you can catch things – for example, teach a young person about consent, alcohol, marijuana’s effects on the growing brain, prevent unplanned pregnancies and sexually transmitted infections, instill healthy eating, and more.
“Do I wish that I got paid as much as a surgeon?” Dr. Yen says yes. “I hope that someday society will realize the time spent preventing future disease is worth it and pay us accordingly.”
Unfortunately, she says, since the health care system makes more money if you get pregnant, need a cardiac bypass, or need gastric surgery, those who deliver babies or do surgery get paid more than someone who prevents the need for those services.
Money doesn’t buy happiness
Stella Bard, MD, a rheumatologist in McKinney, Tex., says she eats, lives, and breathes rheumatology. “I never regret the decision of choosing this specialty for a single second,” says Dr. Bard. “I feel like it’s a rewarding experience with every single patient encounter.” Dr. Bard notes that money is no guarantee of happiness and that she feels blessed to wake up every morning doing what she loves.
Career or calling?
For Dr. Alvarez, inspiration came when watching his father help change people’s lives. “I saw how impactful a doctor is during a person’s most desperate moments, and that was enough to make medicine my life’s passion at the age of 10.”
He says once you’re in medical school, choosing a specialty is far easier than you think. “Each specialty requires a certain personality or specific characteristics, and some will call to you while others simply won’t.”
“For me, plastics was about finesse, art, and life-changing surgeries that affected people from kids to adults and involved every aspect of the human body. Changing someone’s outward appearance has a profoundly positive impact on their confidence and self-esteem, making plastic surgery a genuinely transformative experience.”
Patricia Celan, MD, a postgraduate psychiatry resident in Canada, also chose psychiatry for the love of the field. “I enjoy helping vulnerable people and exploring what makes a person tick, the source of their difficulties, and how to help people counteract and overcome the difficult cards they’ve been dealt in life.”
She says it’s incredibly rewarding to watch someone turn their life around from severe mental illness, especially those who have been victimized and traumatized, and learn to trust people again.
“I could have made more money in a higher-paying specialty, yes, but I’m not sure I would have felt as fulfilled as psychiatry can make me feel.”
Dr. Celan says everyone has their calling, and some lucky people find their deepest passion in higher-paying specialties. “My calling is psychiatry, and I am at peace with this no matter the money.”
For the love of surgery
“In my experience, most people don’t choose their specialty based on money,” says Nicole Aaronson, MD, MBA, an otolaryngologist and board-certified in the subspecialty of pediatric otolaryngology, an attending surgeon at Nemours Children’s Health of Delaware and clinical associate professor of otolaryngology and pediatrics at Sidney Kimmel Medical College, Philadelphia.
“The first decision point in medical school is usually figuring out if you are a surgery person or a medicine person. I knew very early that I wanted to be a surgeon and wanted to spend time in the OR fixing problems with my hands.”
Part of what attracted Dr. Aaronson to otolaryngology was the variety of conditions managed within the specialty, from head and neck cancer to voice problems to sleep disorders to sinus disease. “I chose my subspecialty because I enjoy working with children and making an impact that will help them live their best possible lives.”
She says a relatively simple surgery like placing ear tubes may help a child’s hearing and allow them to be more successful in school, opening up a new world of opportunities for the child’s future.
“While I don’t think most people choose their specialty based on prospective compensation, I do think all physicians want to be compensated fairly for their time, effort, and level of training,” says Dr. Aaronson.
Choosing a specialty for the money can lead to burnout and dissatisfaction
“For me, the decision to pursue gastroenterology went beyond financial considerations,” says Saurabh Sethi, MD, MPH, a gastroenterologist specializing in hepatology and interventional endoscopy. “While financial stability is undoubtedly important, no doctor enters this field solely for the love of money. The primary driving force for most medical professionals, myself included, is the passion to help people and make a positive difference in their lives.”
Dr. Sethi says the gratification that comes from providing quality care and witnessing patients’ improved well-being is priceless. Moreover, he believes that selecting a specialty based solely on financial gain is likely to lead to burnout and greater dissatisfaction over time.
“By following my love for gut health and prioritizing patient care, I have found a sense of fulfillment and purpose in my career. It has been a rewarding journey, and I’m grateful for the opportunity to contribute to the well-being of my patients through my expertise in gastroenterology.”
Key takeaways: Love or money?
Multiple factors influence doctors’ specialty choices, including genuine love for the work and the future of the specialty. Others include job prospects, hands-on experience they receive, mentors, childhood dreams, parental expectations, complexity of cases, the lifestyle of each specialty, including office hours worked, on-call requirements, and autonomy.
Physicians also mentioned other factors they considered when choosing their specialty:
- Personal interest.
- Intellectual stimulation.
- Work-life balance.
- Patient populations.
- Future opportunities.
- Desire to make a difference.
- Passion.
- Financial stability.
- Being personally fulfilled.
Overwhelmingly, doctors say to pick a specialty you can envision yourself loving 40 years from now and you won’t go wrong.
A version of this article first appeared on Medscape.com.
Medical student loans top hundreds of thousands of dollars, so it’s understandable that physicians may want to select a specialty that pays well.
Moreover, most advised young doctors to follow their hearts rather than their wallets.
“There is no question that many young kids immediately think about money when deciding to pursue medicine, but the thought of a big paycheck will never sustain someone long enough to get them here,” says Sergio Alvarez, MD, a board-certified plastic surgeon based in Miami, Fla., and the CEO and medical director of Mia Aesthetics, which has several national locations.
“Getting into medicine is a long game, and there are many hurdles along the way that only the dedicated overcome,” says Dr. Alvarez.
Unfortunately, he says it may be late in that long game before some realize that the pay rate for certain specialties isn’t commensurate with the immense workload and responsibility they require.
“The short of it is that to become a happy doctor, medicine really needs to be a calling: a passion! There are far easier things to do to make money.”
Here is what physicians said about choosing between love or money.
The lowest-paying subspecialty in a low-paying specialty
Sophia Yen, MD, MPH, cofounder and CEO of Pandia Health, a women-founded, doctor-led birth control delivery service in Sunnyvale, Calif., and clinical associate professor at Stanford (Calif.) University, says you should pursue a specialty because you love the work.
“I chose the lowest-paying subspecialty (adolescent medicine) of a low-paying specialty (pediatrics), but I’d do it all again because I love the patient population – I love what I do.”
Dr. Yen says she chose adolescent medicine because she loves doing “outpatient gynecology” without going through the surgical training of a full ob.gyn. “I love the target population of young adults because you can talk to the patient versus in pediatrics, where you often talk to the parent. With young adults you can catch things – for example, teach a young person about consent, alcohol, marijuana’s effects on the growing brain, prevent unplanned pregnancies and sexually transmitted infections, instill healthy eating, and more.
“Do I wish that I got paid as much as a surgeon?” Dr. Yen says yes. “I hope that someday society will realize the time spent preventing future disease is worth it and pay us accordingly.”
Unfortunately, she says, since the health care system makes more money if you get pregnant, need a cardiac bypass, or need gastric surgery, those who deliver babies or do surgery get paid more than someone who prevents the need for those services.
Money doesn’t buy happiness
Stella Bard, MD, a rheumatologist in McKinney, Tex., says she eats, lives, and breathes rheumatology. “I never regret the decision of choosing this specialty for a single second,” says Dr. Bard. “I feel like it’s a rewarding experience with every single patient encounter.” Dr. Bard notes that money is no guarantee of happiness and that she feels blessed to wake up every morning doing what she loves.
Career or calling?
For Dr. Alvarez, inspiration came when watching his father help change people’s lives. “I saw how impactful a doctor is during a person’s most desperate moments, and that was enough to make medicine my life’s passion at the age of 10.”
He says once you’re in medical school, choosing a specialty is far easier than you think. “Each specialty requires a certain personality or specific characteristics, and some will call to you while others simply won’t.”
“For me, plastics was about finesse, art, and life-changing surgeries that affected people from kids to adults and involved every aspect of the human body. Changing someone’s outward appearance has a profoundly positive impact on their confidence and self-esteem, making plastic surgery a genuinely transformative experience.”
Patricia Celan, MD, a postgraduate psychiatry resident in Canada, also chose psychiatry for the love of the field. “I enjoy helping vulnerable people and exploring what makes a person tick, the source of their difficulties, and how to help people counteract and overcome the difficult cards they’ve been dealt in life.”
She says it’s incredibly rewarding to watch someone turn their life around from severe mental illness, especially those who have been victimized and traumatized, and learn to trust people again.
“I could have made more money in a higher-paying specialty, yes, but I’m not sure I would have felt as fulfilled as psychiatry can make me feel.”
Dr. Celan says everyone has their calling, and some lucky people find their deepest passion in higher-paying specialties. “My calling is psychiatry, and I am at peace with this no matter the money.”
For the love of surgery
“In my experience, most people don’t choose their specialty based on money,” says Nicole Aaronson, MD, MBA, an otolaryngologist and board-certified in the subspecialty of pediatric otolaryngology, an attending surgeon at Nemours Children’s Health of Delaware and clinical associate professor of otolaryngology and pediatrics at Sidney Kimmel Medical College, Philadelphia.
“The first decision point in medical school is usually figuring out if you are a surgery person or a medicine person. I knew very early that I wanted to be a surgeon and wanted to spend time in the OR fixing problems with my hands.”
Part of what attracted Dr. Aaronson to otolaryngology was the variety of conditions managed within the specialty, from head and neck cancer to voice problems to sleep disorders to sinus disease. “I chose my subspecialty because I enjoy working with children and making an impact that will help them live their best possible lives.”
She says a relatively simple surgery like placing ear tubes may help a child’s hearing and allow them to be more successful in school, opening up a new world of opportunities for the child’s future.
“While I don’t think most people choose their specialty based on prospective compensation, I do think all physicians want to be compensated fairly for their time, effort, and level of training,” says Dr. Aaronson.
Choosing a specialty for the money can lead to burnout and dissatisfaction
“For me, the decision to pursue gastroenterology went beyond financial considerations,” says Saurabh Sethi, MD, MPH, a gastroenterologist specializing in hepatology and interventional endoscopy. “While financial stability is undoubtedly important, no doctor enters this field solely for the love of money. The primary driving force for most medical professionals, myself included, is the passion to help people and make a positive difference in their lives.”
Dr. Sethi says the gratification that comes from providing quality care and witnessing patients’ improved well-being is priceless. Moreover, he believes that selecting a specialty based solely on financial gain is likely to lead to burnout and greater dissatisfaction over time.
“By following my love for gut health and prioritizing patient care, I have found a sense of fulfillment and purpose in my career. It has been a rewarding journey, and I’m grateful for the opportunity to contribute to the well-being of my patients through my expertise in gastroenterology.”
Key takeaways: Love or money?
Multiple factors influence doctors’ specialty choices, including genuine love for the work and the future of the specialty. Others include job prospects, hands-on experience they receive, mentors, childhood dreams, parental expectations, complexity of cases, the lifestyle of each specialty, including office hours worked, on-call requirements, and autonomy.
Physicians also mentioned other factors they considered when choosing their specialty:
- Personal interest.
- Intellectual stimulation.
- Work-life balance.
- Patient populations.
- Future opportunities.
- Desire to make a difference.
- Passion.
- Financial stability.
- Being personally fulfilled.
Overwhelmingly, doctors say to pick a specialty you can envision yourself loving 40 years from now and you won’t go wrong.
A version of this article first appeared on Medscape.com.
Few patients with BMI of 30-35 get bariatric surgery
Although multiple international medical societies over recent years have recommended lowering the threshold for bariatric surgery to a body mass index (BMI) of 30-35 (class 1 obesity) in certain patients, very few patients in this weight category have had such surgery, according to a new study.
On the basis of data from a large U.S. national registry, during 2015 through 2021,
Most surgeries (96.5%) were in patients with a BMI greater than 35. This reflects advice from a 1991 consensus statement by the National Institutes of Health stating that bariatric surgery can be offered to patients with BMI greater than or equal to 40, or greater than or equal to 35 with comorbidities.
However, medical societies have recommended lower cutoffs in position statements in 2016, 2018, and 2022.
Paul Wisniowski, MD, a surgical resident at Keck School of Medicine of University of Southern California, Los Angeles, presented the study findings in an e-poster at the annual meeting of the American Society for Metabolic & Bariatric Surgery.
“Professional guidelines and increasing data support bariatric surgery for patients beginning at BMI 30, which is a tipping point for disease progression. Now it needs to happen in the real world,” outgoing ASMBS president Teresa LaMasters, MD, who was not involved with this research, said in an ASMBS press release.
“We encourage greater consideration of this important treatment option earlier in the disease process,” stressed Dr. LaMasters, a bariatric surgeon and Medical Director, Unity Point Clinic Weight Loss Specialists, West Des Moines, IA.
‘Not unexpected,’ ‘need to expand eligibility’
“We expected that there had been little widespread adoption of the new BMI criteria/cutoffs,” senior study author Matthew J. Martin, MD, said in an interview.
“We know that bariatric surgery is already underutilized, as only about 1%-2% of eligible patients who would benefit end up getting surgery,” added Dr. Martin, Chief, Emergency General Surgery, and Director, Acute Care Surgery Research, USC Medical Center and Keck School of Medicine.
He suggests that the main reason that more patients with lower BMIs are not being offered surgery is related to insurance coverage and reimbursement.
“Even though the professional society guidelines have changed, based on the scientific evidence, most insurers are still using the very outdated (1990s) NIH consensus criteria of BMI greater than 35 with comorbidities, or BMI greater than 40.”
Another potential reason is “the lack of awareness of the changing guidelines and recommendation among primary care physicians who refer patients for a bariatric surgery evaluation.”
“I think it is too early in the experience with the new, more effective antiobesity medications to say which group will benefit the most or will prefer them over surgery,” he said.
“There is still only a small minority of patients who end up getting the [newer antiobesity] medications or surgery.”
“The takeaway,” Dr. Martin summarized, “is that bariatric surgery remains the only intervention with a high success rate for patients with class 1 or higher obesity in terms of weight loss, comorbidity improvement or resolution, and sustained health benefits.”
“We need to expand the availability of bariatric surgery for all eligible patients, particularly the class 1 obesity population who are currently the most underserved,” he said.
“This will take continued lobbying and working with the insurance companies to update their guidelines/criteria, education of patients, and education of primary care physicians so that patients can be appropriately referred for a surgical evaluation.”
Surgery vs. pharmacotherapy
Invited to comment on this study, Neil Skolnik, MD, who was not involved with this research, noted that data from patients with a lower BMI “has continued to accumulate, showing much greater safety than earlier studies and giving further support of efficacy.”
However, “[new] recommendations take time to take hold,” noted Dr. Skolnik, a family physician and professor in the department of family medicine, Thomas Jefferson University, Philadelphia.
“And from March of 2020 through 2021, surgery referrals were likely influenced by the COVID pandemic,” he added in an email.
Dr. Skolnik authored a commentary sharing his reservations about ASMBS recommendations issued in 2022 for lower BMI thresholds for this surgery.
“Medications are a safe, effective option for patients with a BMI from 30 to 35,” he said, “and [they] achieve approximately a 15%-20% average weight loss, which is enough to markedly improved both metabolic parameters and biomechanical issues such as knee pain, hip pain, and back pain.”
However, “bariatric surgery remains an excellent option for patients who do not respond sufficiently to pharmacotherapy,” he acknowledged.
National registry study, 2015-2021
Dr. Wisniowski and colleagues analyzed data from around 900 U.S. centers that are currently part of the Metabolic Bariatric Surgery Accreditation Quality Improvement Program.
They found that from 2015 to 2021, 38,669 patients (3.5%) with type 1 obesity and 1,1067,094 patients (96.5%) with a higher BMI had metabolic and bariatric surgery.
Compared with patients with BMI greater than 35, those with class 1 obesity had shorter operating times and hospital stays, but they lost less weight on short-term evaluation, after multivariable adjustment.
There were no significant differences between the two patient groups in rates of postoperative complications (< 5%) or mortality (< 0.1%).
Sleeve gastrectomy was the most common procedure and increased from 70% to 76% of all procedures during the study period.
Single-center study
In a second e-poster presented at the meeting, Tina T. Thomas, MD, New Jersey Bariatric Center, analyzed data from 23 patients with BMI less than 35 or less than 30 with comorbidities who had sleeve gastrectomy or Roux-en-Y gastric bypass at their center during 2017 to 2021 and who had 6 months of follow-up data.
At study entry, the patients had a mean BMI of 33.5. At 6 months after the surgery, they had a mean BMI of 25.6, and on average, they had lost 55% of their excess weight.
Nearly 60% of the patients had lost at least 50% of their excess weight, and 9 of 16 patients (56%) with comorbidities had improved or resolved comorbidities. None of the patients died or had surgery-related complications.
“Our study shows significant weight loss and health benefits, as well as the safety and efficacy of the gastric bypass and gastric sleeve procedures, for this patient population,” Ajay Goyal, MD, senior author, and bariatric surgeon at New Jersey Bariatric Center, said in an ASMBS press release.
“Often by the time a patient qualifies for bariatric surgery, their weight-related medical conditions such as [type 2] diabetes and hypertension are severe. By expanding access to bariatric surgery to patients with a lower BMI with obesity-related illnesses, patients can halt the progression, and in some cases resolve, significant and uncontrolled weight-related chronic diseases through weight loss.”
Societies call for lower BMI thresholds
Providers, hospitals, and insurers currently use BMI thresholds greater than or equal to 40, or greater than or equal to 35 with an obesity-related comorbidity, to define patients eligible for metabolic and bariatric surgery, based on criteria established in a 1991 consensus statement by NIH.
As more data accumulated, in 2016, a position statement from 45 societies recommended that bariatric surgery should be “considered for patients with [type 2 diabetes] and BMI 30.0-34.9 kg/m2 if hyperglycemia is inadequately controlled” despite optimal medical treatment.
Similarly, in 2018, the ASMBS issued a position statement saying that “for patients with BMI 30-35 kg/m2 and obesity-related comorbidities who do not achieve substantial, durable weight loss and comorbidity improvement with reasonable nonsurgical methods, bariatric surgery should be offered” to suitable individuals.
Then in October 2022, the ASMBS and International Federation for the Surgery of Obesity and Metabolic Disorders issued a joint statement that recommended lowering the thresholds for bariatric surgery to a BMI greater than or equal to 35 or greater than or equal to 30 with weight-related comorbidities.
A version of this article appeared on Medscape.com.
Although multiple international medical societies over recent years have recommended lowering the threshold for bariatric surgery to a body mass index (BMI) of 30-35 (class 1 obesity) in certain patients, very few patients in this weight category have had such surgery, according to a new study.
On the basis of data from a large U.S. national registry, during 2015 through 2021,
Most surgeries (96.5%) were in patients with a BMI greater than 35. This reflects advice from a 1991 consensus statement by the National Institutes of Health stating that bariatric surgery can be offered to patients with BMI greater than or equal to 40, or greater than or equal to 35 with comorbidities.
However, medical societies have recommended lower cutoffs in position statements in 2016, 2018, and 2022.
Paul Wisniowski, MD, a surgical resident at Keck School of Medicine of University of Southern California, Los Angeles, presented the study findings in an e-poster at the annual meeting of the American Society for Metabolic & Bariatric Surgery.
“Professional guidelines and increasing data support bariatric surgery for patients beginning at BMI 30, which is a tipping point for disease progression. Now it needs to happen in the real world,” outgoing ASMBS president Teresa LaMasters, MD, who was not involved with this research, said in an ASMBS press release.
“We encourage greater consideration of this important treatment option earlier in the disease process,” stressed Dr. LaMasters, a bariatric surgeon and Medical Director, Unity Point Clinic Weight Loss Specialists, West Des Moines, IA.
‘Not unexpected,’ ‘need to expand eligibility’
“We expected that there had been little widespread adoption of the new BMI criteria/cutoffs,” senior study author Matthew J. Martin, MD, said in an interview.
“We know that bariatric surgery is already underutilized, as only about 1%-2% of eligible patients who would benefit end up getting surgery,” added Dr. Martin, Chief, Emergency General Surgery, and Director, Acute Care Surgery Research, USC Medical Center and Keck School of Medicine.
He suggests that the main reason that more patients with lower BMIs are not being offered surgery is related to insurance coverage and reimbursement.
“Even though the professional society guidelines have changed, based on the scientific evidence, most insurers are still using the very outdated (1990s) NIH consensus criteria of BMI greater than 35 with comorbidities, or BMI greater than 40.”
Another potential reason is “the lack of awareness of the changing guidelines and recommendation among primary care physicians who refer patients for a bariatric surgery evaluation.”
“I think it is too early in the experience with the new, more effective antiobesity medications to say which group will benefit the most or will prefer them over surgery,” he said.
“There is still only a small minority of patients who end up getting the [newer antiobesity] medications or surgery.”
“The takeaway,” Dr. Martin summarized, “is that bariatric surgery remains the only intervention with a high success rate for patients with class 1 or higher obesity in terms of weight loss, comorbidity improvement or resolution, and sustained health benefits.”
“We need to expand the availability of bariatric surgery for all eligible patients, particularly the class 1 obesity population who are currently the most underserved,” he said.
“This will take continued lobbying and working with the insurance companies to update their guidelines/criteria, education of patients, and education of primary care physicians so that patients can be appropriately referred for a surgical evaluation.”
Surgery vs. pharmacotherapy
Invited to comment on this study, Neil Skolnik, MD, who was not involved with this research, noted that data from patients with a lower BMI “has continued to accumulate, showing much greater safety than earlier studies and giving further support of efficacy.”
However, “[new] recommendations take time to take hold,” noted Dr. Skolnik, a family physician and professor in the department of family medicine, Thomas Jefferson University, Philadelphia.
“And from March of 2020 through 2021, surgery referrals were likely influenced by the COVID pandemic,” he added in an email.
Dr. Skolnik authored a commentary sharing his reservations about ASMBS recommendations issued in 2022 for lower BMI thresholds for this surgery.
“Medications are a safe, effective option for patients with a BMI from 30 to 35,” he said, “and [they] achieve approximately a 15%-20% average weight loss, which is enough to markedly improved both metabolic parameters and biomechanical issues such as knee pain, hip pain, and back pain.”
However, “bariatric surgery remains an excellent option for patients who do not respond sufficiently to pharmacotherapy,” he acknowledged.
National registry study, 2015-2021
Dr. Wisniowski and colleagues analyzed data from around 900 U.S. centers that are currently part of the Metabolic Bariatric Surgery Accreditation Quality Improvement Program.
They found that from 2015 to 2021, 38,669 patients (3.5%) with type 1 obesity and 1,1067,094 patients (96.5%) with a higher BMI had metabolic and bariatric surgery.
Compared with patients with BMI greater than 35, those with class 1 obesity had shorter operating times and hospital stays, but they lost less weight on short-term evaluation, after multivariable adjustment.
There were no significant differences between the two patient groups in rates of postoperative complications (< 5%) or mortality (< 0.1%).
Sleeve gastrectomy was the most common procedure and increased from 70% to 76% of all procedures during the study period.
Single-center study
In a second e-poster presented at the meeting, Tina T. Thomas, MD, New Jersey Bariatric Center, analyzed data from 23 patients with BMI less than 35 or less than 30 with comorbidities who had sleeve gastrectomy or Roux-en-Y gastric bypass at their center during 2017 to 2021 and who had 6 months of follow-up data.
At study entry, the patients had a mean BMI of 33.5. At 6 months after the surgery, they had a mean BMI of 25.6, and on average, they had lost 55% of their excess weight.
Nearly 60% of the patients had lost at least 50% of their excess weight, and 9 of 16 patients (56%) with comorbidities had improved or resolved comorbidities. None of the patients died or had surgery-related complications.
“Our study shows significant weight loss and health benefits, as well as the safety and efficacy of the gastric bypass and gastric sleeve procedures, for this patient population,” Ajay Goyal, MD, senior author, and bariatric surgeon at New Jersey Bariatric Center, said in an ASMBS press release.
“Often by the time a patient qualifies for bariatric surgery, their weight-related medical conditions such as [type 2] diabetes and hypertension are severe. By expanding access to bariatric surgery to patients with a lower BMI with obesity-related illnesses, patients can halt the progression, and in some cases resolve, significant and uncontrolled weight-related chronic diseases through weight loss.”
Societies call for lower BMI thresholds
Providers, hospitals, and insurers currently use BMI thresholds greater than or equal to 40, or greater than or equal to 35 with an obesity-related comorbidity, to define patients eligible for metabolic and bariatric surgery, based on criteria established in a 1991 consensus statement by NIH.
As more data accumulated, in 2016, a position statement from 45 societies recommended that bariatric surgery should be “considered for patients with [type 2 diabetes] and BMI 30.0-34.9 kg/m2 if hyperglycemia is inadequately controlled” despite optimal medical treatment.
Similarly, in 2018, the ASMBS issued a position statement saying that “for patients with BMI 30-35 kg/m2 and obesity-related comorbidities who do not achieve substantial, durable weight loss and comorbidity improvement with reasonable nonsurgical methods, bariatric surgery should be offered” to suitable individuals.
Then in October 2022, the ASMBS and International Federation for the Surgery of Obesity and Metabolic Disorders issued a joint statement that recommended lowering the thresholds for bariatric surgery to a BMI greater than or equal to 35 or greater than or equal to 30 with weight-related comorbidities.
A version of this article appeared on Medscape.com.
Although multiple international medical societies over recent years have recommended lowering the threshold for bariatric surgery to a body mass index (BMI) of 30-35 (class 1 obesity) in certain patients, very few patients in this weight category have had such surgery, according to a new study.
On the basis of data from a large U.S. national registry, during 2015 through 2021,
Most surgeries (96.5%) were in patients with a BMI greater than 35. This reflects advice from a 1991 consensus statement by the National Institutes of Health stating that bariatric surgery can be offered to patients with BMI greater than or equal to 40, or greater than or equal to 35 with comorbidities.
However, medical societies have recommended lower cutoffs in position statements in 2016, 2018, and 2022.
Paul Wisniowski, MD, a surgical resident at Keck School of Medicine of University of Southern California, Los Angeles, presented the study findings in an e-poster at the annual meeting of the American Society for Metabolic & Bariatric Surgery.
“Professional guidelines and increasing data support bariatric surgery for patients beginning at BMI 30, which is a tipping point for disease progression. Now it needs to happen in the real world,” outgoing ASMBS president Teresa LaMasters, MD, who was not involved with this research, said in an ASMBS press release.
“We encourage greater consideration of this important treatment option earlier in the disease process,” stressed Dr. LaMasters, a bariatric surgeon and Medical Director, Unity Point Clinic Weight Loss Specialists, West Des Moines, IA.
‘Not unexpected,’ ‘need to expand eligibility’
“We expected that there had been little widespread adoption of the new BMI criteria/cutoffs,” senior study author Matthew J. Martin, MD, said in an interview.
“We know that bariatric surgery is already underutilized, as only about 1%-2% of eligible patients who would benefit end up getting surgery,” added Dr. Martin, Chief, Emergency General Surgery, and Director, Acute Care Surgery Research, USC Medical Center and Keck School of Medicine.
He suggests that the main reason that more patients with lower BMIs are not being offered surgery is related to insurance coverage and reimbursement.
“Even though the professional society guidelines have changed, based on the scientific evidence, most insurers are still using the very outdated (1990s) NIH consensus criteria of BMI greater than 35 with comorbidities, or BMI greater than 40.”
Another potential reason is “the lack of awareness of the changing guidelines and recommendation among primary care physicians who refer patients for a bariatric surgery evaluation.”
“I think it is too early in the experience with the new, more effective antiobesity medications to say which group will benefit the most or will prefer them over surgery,” he said.
“There is still only a small minority of patients who end up getting the [newer antiobesity] medications or surgery.”
“The takeaway,” Dr. Martin summarized, “is that bariatric surgery remains the only intervention with a high success rate for patients with class 1 or higher obesity in terms of weight loss, comorbidity improvement or resolution, and sustained health benefits.”
“We need to expand the availability of bariatric surgery for all eligible patients, particularly the class 1 obesity population who are currently the most underserved,” he said.
“This will take continued lobbying and working with the insurance companies to update their guidelines/criteria, education of patients, and education of primary care physicians so that patients can be appropriately referred for a surgical evaluation.”
Surgery vs. pharmacotherapy
Invited to comment on this study, Neil Skolnik, MD, who was not involved with this research, noted that data from patients with a lower BMI “has continued to accumulate, showing much greater safety than earlier studies and giving further support of efficacy.”
However, “[new] recommendations take time to take hold,” noted Dr. Skolnik, a family physician and professor in the department of family medicine, Thomas Jefferson University, Philadelphia.
“And from March of 2020 through 2021, surgery referrals were likely influenced by the COVID pandemic,” he added in an email.
Dr. Skolnik authored a commentary sharing his reservations about ASMBS recommendations issued in 2022 for lower BMI thresholds for this surgery.
“Medications are a safe, effective option for patients with a BMI from 30 to 35,” he said, “and [they] achieve approximately a 15%-20% average weight loss, which is enough to markedly improved both metabolic parameters and biomechanical issues such as knee pain, hip pain, and back pain.”
However, “bariatric surgery remains an excellent option for patients who do not respond sufficiently to pharmacotherapy,” he acknowledged.
National registry study, 2015-2021
Dr. Wisniowski and colleagues analyzed data from around 900 U.S. centers that are currently part of the Metabolic Bariatric Surgery Accreditation Quality Improvement Program.
They found that from 2015 to 2021, 38,669 patients (3.5%) with type 1 obesity and 1,1067,094 patients (96.5%) with a higher BMI had metabolic and bariatric surgery.
Compared with patients with BMI greater than 35, those with class 1 obesity had shorter operating times and hospital stays, but they lost less weight on short-term evaluation, after multivariable adjustment.
There were no significant differences between the two patient groups in rates of postoperative complications (< 5%) or mortality (< 0.1%).
Sleeve gastrectomy was the most common procedure and increased from 70% to 76% of all procedures during the study period.
Single-center study
In a second e-poster presented at the meeting, Tina T. Thomas, MD, New Jersey Bariatric Center, analyzed data from 23 patients with BMI less than 35 or less than 30 with comorbidities who had sleeve gastrectomy or Roux-en-Y gastric bypass at their center during 2017 to 2021 and who had 6 months of follow-up data.
At study entry, the patients had a mean BMI of 33.5. At 6 months after the surgery, they had a mean BMI of 25.6, and on average, they had lost 55% of their excess weight.
Nearly 60% of the patients had lost at least 50% of their excess weight, and 9 of 16 patients (56%) with comorbidities had improved or resolved comorbidities. None of the patients died or had surgery-related complications.
“Our study shows significant weight loss and health benefits, as well as the safety and efficacy of the gastric bypass and gastric sleeve procedures, for this patient population,” Ajay Goyal, MD, senior author, and bariatric surgeon at New Jersey Bariatric Center, said in an ASMBS press release.
“Often by the time a patient qualifies for bariatric surgery, their weight-related medical conditions such as [type 2] diabetes and hypertension are severe. By expanding access to bariatric surgery to patients with a lower BMI with obesity-related illnesses, patients can halt the progression, and in some cases resolve, significant and uncontrolled weight-related chronic diseases through weight loss.”
Societies call for lower BMI thresholds
Providers, hospitals, and insurers currently use BMI thresholds greater than or equal to 40, or greater than or equal to 35 with an obesity-related comorbidity, to define patients eligible for metabolic and bariatric surgery, based on criteria established in a 1991 consensus statement by NIH.
As more data accumulated, in 2016, a position statement from 45 societies recommended that bariatric surgery should be “considered for patients with [type 2 diabetes] and BMI 30.0-34.9 kg/m2 if hyperglycemia is inadequately controlled” despite optimal medical treatment.
Similarly, in 2018, the ASMBS issued a position statement saying that “for patients with BMI 30-35 kg/m2 and obesity-related comorbidities who do not achieve substantial, durable weight loss and comorbidity improvement with reasonable nonsurgical methods, bariatric surgery should be offered” to suitable individuals.
Then in October 2022, the ASMBS and International Federation for the Surgery of Obesity and Metabolic Disorders issued a joint statement that recommended lowering the thresholds for bariatric surgery to a BMI greater than or equal to 35 or greater than or equal to 30 with weight-related comorbidities.
A version of this article appeared on Medscape.com.
Fibromyalgia linked to higher mortality risk
People who experience chronic pain and tiredness from fibromyalgia have an increased risk for all-cause mortality, a new analysis of evidence says.
The condition can lead people to be vulnerable to accidents, infections, and even suicide, according to the report published in RMD Open.
The researchers suggest that care providers monitor physical and mental health to lower the dangers.
People with fibromyalgia often have other health issues, including rheumatic, gut, neurological, and mental health disorders, according to The BMJ. More and more people are being diagnosed with fibromyalgia. The cause of the illness remains unclear.
The researchers looked at eight studies published between 1999 and 2020 and pooled results from six of them. The studies involved a total of 188,000 adults.
The analysis of the data revealed that fibromyalgia was linked to a 27% greater risk of death from all causes.
Those with fibromyalgia were at a 44% greater risk of infections, including pneumonia. Their suicide risk was more than three times higher.
The greater risk of all-cause death could result from fatigue, poor sleep, and concentration problems, The BMJ said.
The patients had a 12% lower risk of dying from cancer, the analysis found. This could be because they tend to make more visits to health care professionals, the authors suggest.
“Fibromyalgia is often called an ‘imaginary condition,’ with ongoing debates on the legitimacy and clinical usefulness of this diagnosis. Our review provides further proof that fibromyalgia patients should be taken seriously, with particular focus on screening for suicidal ideation, prevention of accidents, and prevention and treatment of infections,” the researchers say.
A version of this article appeared on WebMD.com.
People who experience chronic pain and tiredness from fibromyalgia have an increased risk for all-cause mortality, a new analysis of evidence says.
The condition can lead people to be vulnerable to accidents, infections, and even suicide, according to the report published in RMD Open.
The researchers suggest that care providers monitor physical and mental health to lower the dangers.
People with fibromyalgia often have other health issues, including rheumatic, gut, neurological, and mental health disorders, according to The BMJ. More and more people are being diagnosed with fibromyalgia. The cause of the illness remains unclear.
The researchers looked at eight studies published between 1999 and 2020 and pooled results from six of them. The studies involved a total of 188,000 adults.
The analysis of the data revealed that fibromyalgia was linked to a 27% greater risk of death from all causes.
Those with fibromyalgia were at a 44% greater risk of infections, including pneumonia. Their suicide risk was more than three times higher.
The greater risk of all-cause death could result from fatigue, poor sleep, and concentration problems, The BMJ said.
The patients had a 12% lower risk of dying from cancer, the analysis found. This could be because they tend to make more visits to health care professionals, the authors suggest.
“Fibromyalgia is often called an ‘imaginary condition,’ with ongoing debates on the legitimacy and clinical usefulness of this diagnosis. Our review provides further proof that fibromyalgia patients should be taken seriously, with particular focus on screening for suicidal ideation, prevention of accidents, and prevention and treatment of infections,” the researchers say.
A version of this article appeared on WebMD.com.
People who experience chronic pain and tiredness from fibromyalgia have an increased risk for all-cause mortality, a new analysis of evidence says.
The condition can lead people to be vulnerable to accidents, infections, and even suicide, according to the report published in RMD Open.
The researchers suggest that care providers monitor physical and mental health to lower the dangers.
People with fibromyalgia often have other health issues, including rheumatic, gut, neurological, and mental health disorders, according to The BMJ. More and more people are being diagnosed with fibromyalgia. The cause of the illness remains unclear.
The researchers looked at eight studies published between 1999 and 2020 and pooled results from six of them. The studies involved a total of 188,000 adults.
The analysis of the data revealed that fibromyalgia was linked to a 27% greater risk of death from all causes.
Those with fibromyalgia were at a 44% greater risk of infections, including pneumonia. Their suicide risk was more than three times higher.
The greater risk of all-cause death could result from fatigue, poor sleep, and concentration problems, The BMJ said.
The patients had a 12% lower risk of dying from cancer, the analysis found. This could be because they tend to make more visits to health care professionals, the authors suggest.
“Fibromyalgia is often called an ‘imaginary condition,’ with ongoing debates on the legitimacy and clinical usefulness of this diagnosis. Our review provides further proof that fibromyalgia patients should be taken seriously, with particular focus on screening for suicidal ideation, prevention of accidents, and prevention and treatment of infections,” the researchers say.
A version of this article appeared on WebMD.com.
Antidrug antibody effects compared across RA biologics
TOPLINE:
In patients with rheumatoid arthritis, the presence of antidrug antibodies was associated with a diminished response to biologic disease-modifying antirheumatic drugs in a prospective cohort study.
METHODOLOGY:
- Researchers prospectively analyzed data from 230 patients (mean age, 54.3 years; 77.0% women) with RA diagnosis recruited from March 3, 2014, to June 21, 2016.
- All were initiating new treatment with an anti–tumor necrosis factor (TNF) monoclonal antibody (mAb; either infliximab or adalimumab), etanercept, tocilizumab, or rituximab, according to the choice of the treating physician.
- The primary outcome was the association of antidrug antibody positivity with European Alliance of Associations for Rheumatology (EULAR) response to treatment at month 12, assessed through univariate logistic regression.
TAKEAWAY:
- At month 12, antidrug antibody positivity was 38.2% in patients who were treated with anti-TNF mAbs, 6.1% with etanercept, 50.0% with rituximab, and 20.0% with tocilizumab.
- There was an inverse association between antidrug antibody positivity directed against all biologic drugs and EULAR response at month 12 (odds ratio, 0.19; 95% confidence interval, 0.09-0.38; P < .001).
- In the multivariable analysis, antidrug antibodies, body mass index, and rheumatoid factor were independently and inversely associated with response to treatment.
- There was a significantly higher drug concentration of anti-TNF mAbs in patients with antidrug antibody–negative vs. antidrug antibody–positive status (mean difference, –9.6 mg/L; 95% CI, –12.4 to –6.9; P < .001).
IN PRACTICE:
Findings of this study suggest that antidrug antibodies are associated with nonresponse to biologic drugs and can be monitored in the management of patients with RA, particularly nonresponders.
SOURCE:
Samuel Bitouin, MD, PhD, of the rheumatology department at Paris-Saclay University, and coauthors in the ABIRISK (Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk) consortium reported the study in JAMA Network Open. The work was funded by a grant from the European Union Innovative Medicines Initiative.
LIMITATIONS:
Though the study demonstrated an association when all biologic drugs were analyzed together, it was not powered to demonstrate an association for each drug class.
DISCLOSURES:
Many authors reported financial relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
In patients with rheumatoid arthritis, the presence of antidrug antibodies was associated with a diminished response to biologic disease-modifying antirheumatic drugs in a prospective cohort study.
METHODOLOGY:
- Researchers prospectively analyzed data from 230 patients (mean age, 54.3 years; 77.0% women) with RA diagnosis recruited from March 3, 2014, to June 21, 2016.
- All were initiating new treatment with an anti–tumor necrosis factor (TNF) monoclonal antibody (mAb; either infliximab or adalimumab), etanercept, tocilizumab, or rituximab, according to the choice of the treating physician.
- The primary outcome was the association of antidrug antibody positivity with European Alliance of Associations for Rheumatology (EULAR) response to treatment at month 12, assessed through univariate logistic regression.
TAKEAWAY:
- At month 12, antidrug antibody positivity was 38.2% in patients who were treated with anti-TNF mAbs, 6.1% with etanercept, 50.0% with rituximab, and 20.0% with tocilizumab.
- There was an inverse association between antidrug antibody positivity directed against all biologic drugs and EULAR response at month 12 (odds ratio, 0.19; 95% confidence interval, 0.09-0.38; P < .001).
- In the multivariable analysis, antidrug antibodies, body mass index, and rheumatoid factor were independently and inversely associated with response to treatment.
- There was a significantly higher drug concentration of anti-TNF mAbs in patients with antidrug antibody–negative vs. antidrug antibody–positive status (mean difference, –9.6 mg/L; 95% CI, –12.4 to –6.9; P < .001).
IN PRACTICE:
Findings of this study suggest that antidrug antibodies are associated with nonresponse to biologic drugs and can be monitored in the management of patients with RA, particularly nonresponders.
SOURCE:
Samuel Bitouin, MD, PhD, of the rheumatology department at Paris-Saclay University, and coauthors in the ABIRISK (Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk) consortium reported the study in JAMA Network Open. The work was funded by a grant from the European Union Innovative Medicines Initiative.
LIMITATIONS:
Though the study demonstrated an association when all biologic drugs were analyzed together, it was not powered to demonstrate an association for each drug class.
DISCLOSURES:
Many authors reported financial relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
TOPLINE:
In patients with rheumatoid arthritis, the presence of antidrug antibodies was associated with a diminished response to biologic disease-modifying antirheumatic drugs in a prospective cohort study.
METHODOLOGY:
- Researchers prospectively analyzed data from 230 patients (mean age, 54.3 years; 77.0% women) with RA diagnosis recruited from March 3, 2014, to June 21, 2016.
- All were initiating new treatment with an anti–tumor necrosis factor (TNF) monoclonal antibody (mAb; either infliximab or adalimumab), etanercept, tocilizumab, or rituximab, according to the choice of the treating physician.
- The primary outcome was the association of antidrug antibody positivity with European Alliance of Associations for Rheumatology (EULAR) response to treatment at month 12, assessed through univariate logistic regression.
TAKEAWAY:
- At month 12, antidrug antibody positivity was 38.2% in patients who were treated with anti-TNF mAbs, 6.1% with etanercept, 50.0% with rituximab, and 20.0% with tocilizumab.
- There was an inverse association between antidrug antibody positivity directed against all biologic drugs and EULAR response at month 12 (odds ratio, 0.19; 95% confidence interval, 0.09-0.38; P < .001).
- In the multivariable analysis, antidrug antibodies, body mass index, and rheumatoid factor were independently and inversely associated with response to treatment.
- There was a significantly higher drug concentration of anti-TNF mAbs in patients with antidrug antibody–negative vs. antidrug antibody–positive status (mean difference, –9.6 mg/L; 95% CI, –12.4 to –6.9; P < .001).
IN PRACTICE:
Findings of this study suggest that antidrug antibodies are associated with nonresponse to biologic drugs and can be monitored in the management of patients with RA, particularly nonresponders.
SOURCE:
Samuel Bitouin, MD, PhD, of the rheumatology department at Paris-Saclay University, and coauthors in the ABIRISK (Anti-Biopharmaceutical Immunization: Prediction and Analysis of Clinical Relevance to Minimize the Risk) consortium reported the study in JAMA Network Open. The work was funded by a grant from the European Union Innovative Medicines Initiative.
LIMITATIONS:
Though the study demonstrated an association when all biologic drugs were analyzed together, it was not powered to demonstrate an association for each drug class.
DISCLOSURES:
Many authors reported financial relationships with pharmaceutical companies.
A version of this article first appeared on Medscape.com.
FDA approves first over-the-counter birth control pill
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
The Food and Drug Administration’s approval today of the first birth control pill for women to be available without a prescription is being hailed by many as a long-needed development, but there remain questions to be resolved, including how much the drug will cost and how it will be used.
The drug, Opill, is expected to be available early next year, and its maker has yet to reveal a retail price. It is the same birth control pill that has been available by prescription for 50 years. But for the first time, women will be able to buy the contraception at a local pharmacy, other retail locations, or online without having to see a doctor first.
Likely to drive debate
Contraception in the United States is not without controversy. The FDA’s approval spurred reactions both for and against making hormonal birth control for women available without a prescription.
“It’s an exciting time, especially right now when reproductive rights are being curtailed in a lot of states. Giving people an additional option for contraception will change people’s lives,” said Beverly Gray, MD, division director of Women’s Community and Population Health at Duke University Medical Center in Durham, N.C.
“It’s a huge win for patients who need better access to contraception,” said Dr. Gray, who is also a spokesperson for the American College of Obstetricians and Gynecologists.
Women who want hormonal birth control but live in areas without convenient access to a doctor, women who cannot easily take time off of work to see a doctor and get a prescription filled, and women without insurance are examples of people who will benefit, she said.
The Catholic Medical Association, in contrast, expressed “deep concern and disappointment” after an FDA advisory committee’s unanimous vote on May 11 recommending the drug be available over the counter. In a statement after the vote, the group cited “extensive medical studies demonstrating the risks and adverse effects of hormonal contraceptives,” adding that “the social impact of [full approval] would be dramatic.”
But doctors largely disagreed.
“It is definitely a huge win for reproductive autonomy. I’m glad that the FDA is prioritizing patient safety and well-being over politics,” said Catherine Cansino, MD, MPH, an ob.gyn. and clinical professor in the University of California Davis department of obstetrics and gynecology. She said the FDA approved the over-the-counter version because the medication is safe.
While opponents like the Catholic Medical Association cite safety concerns and believe doctors should screen all women before prescribing hormonal contraception, Dr. Gray disagreed. “There’s a lot of evidence that patients can figure out if a progestin-only pill is right for them and safe for them. Medical professionals don’t have to be the gatekeepers for contraception,” she said.
Pricing unknown
Whether insurance companies will pay for Opill now that it will be available without a prescription remains unknown. For some medications, paying a copay through insurance can be less expensive than buying at a retail price.
“Although pricing issues will be relevant, the FDA’s decision will enhance women’s access to hormonal birth control,” said Andrew M. Kaunitz, MD, a professor and associate chairman in the department of obstetrics and gynecology at the University of Florida College of Medicine in Jacksonville.
The drugmaker, Perrigo, based in Ireland, has not yet announced how much the pill will cost. The price tag could affect how widely available this form of birth control is. The drug has been shown to be as much as 93% effective for pregnancy prevention. Perrigo says it plans to make the pill available at low or no cost to some women.
Caveats to consider
There are some women for whom hormonal contraceptives have always carried greater risks. For example, women who have breast cancer or a history of breast cancer should not use hormonal contraceptives, the FDA said in a news release announcing the approval. Women with other types of cancer should check with their doctors first, the agency noted.
Women who smoke, who take some medications to lower blood pressure, or who have migraines should also take caution, Dr. Cansino said. “People with migraines may not be suitable for over-the-counter oral contraceptives. But a simple screening through a provider can identify whether you are truly eligible or not.”
Irregular bleeding, headaches, dizziness, nausea, increased appetite, belly pain, cramps, or bloating are the most common side effects of Opill, the FDA said.
The Opill is a progestin-only birth control pill. Similar pills have been available in the United Kingdiom for about 2 years, often referred to as “mini pills” because they contain a single hormone. In contrast, prescription birth control pills in the United States and elsewhere contain more than one hormone, estrogen and progestin, to prevent pregnancy.
Prescription pill packs for combination contraception often feature a week of placebo pills without an active ingredient. While skipping a placebo pill might not make a difference in pregnancy prevention, Opill is different. Every pill in the packet will contain medication, Gray said. “So it’s important to take the pill the same time every day for it to be most effective.”
Even though this may mean one less visit to your doctor, Dr. Kaunitz hopes women will stay up to date on their other medical checkups. “One of our challenges as providers of care to women will be to encourage them to continue to receive important services, including cancer screening and vaccinations, even while they can initiate and continue hormonal contraception without contact with a provider.”
Just the beginning?
The American Medical Association hopes this approval signals more to come.
“While we applaud this move, the AMA continues to urge the FDA and HHS to consider a variety of oral contraceptive options for over-the-counter use,” the association, which has more than 250,000 doctor members, said in a statement. “It is important patients have options when choosing which type of birth control works best for them,”
The American College of Obstetricians and Gynecologists said the FDA’s decision will help many women. “We are glad that more patients will now be empowered to choose when and where they obtain a safe method of contraception without having to wait for a medical appointment or for a prescription to be filled,” Verda J. Hicks, MD, the group’s president, and Christopher M. Zahn, MD, interim chief executive officer, said in a statement.
“Allowing individuals to access birth control at their local pharmacy or drug store will eliminate some barriers,” they said.
A version of this article first appeared on WebMD.com.
This article was updated 7/13/23.
Evidence weighed for suicide/self-harm with obesity drugs
Following reports that the European Medicines Agency is looking into instances of suicide or self-harm after patients took the weight loss drugs semaglutide or liraglutide, the manufacturer, Novo Nordisk, issued a statement to this news organization in which it says it “remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”
U.S. experts say they haven’t personally seen this adverse effect in any patients except for one isolated case. An increase in suicidal ideation, particularly among younger people, has been reported following bariatric surgery for weight loss.
In the United States, the two drugs – both GLP-1 agonists – already come with a warning about the potential for these adverse effects on the branded versions approved for weight loss, Wegovy and Saxenda. (Years earlier, both drugs, marketed as Ozempic and Victoza, were also approved for treatment of type 2 diabetes.)
Of more than 1,200 reports of adverse reactions with semaglutide, 60 cases of suicidal ideation and 7 suicide attempts have been reported since 2018, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS) public database. For liraglutide, there were 71 cases of suicidal ideation, 28 suicide attempts, and 25 completed suicides out of more than 35,000 reports of adverse reactions.
The FAERS website cautions users that the data may be duplicated or incomplete, that rates of occurrence cannot be established using the data, that reports have not been verified, and that the existence of a report cannot establish causation.
The EMA is looking into about 150 reports of possible cases of self-injury and suicidal thoughts, according to a press release from the agency.
“It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors,” it says. The medicines are widely used in the European Union, according to the press release.
The review of Ozempic, Saxenda, and Wegovy, which started on July 3, 2023, has been extended to include other GLP-1 receptor agonists, which include dulaglutide, exenatide, and lixisenatide. This review is expected to conclude in November 2023.
In a statement, Novo Nordisk did not directly dispute a potential link between the drugs and suicidal ideation.
“In the U.S., FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation,” the statement indicates. “This event had been reported in clinical trials with other weight management products.”
It adds: “Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”
Important to know the denominator
“What’s important to know is the denominator,” said Holly Lofton, MD, a clinical associate professor of surgery and medicine and the director of the medical weight management program at NYU Langone, New York. “It needs a denominator with the total population on the medication so we can determine if that’s really a significant risk.”
Dr. Lofton described an isolated, anecdotal case of a patient who had no history of depression or mental health problems but developed suicidal thoughts after taking Saxenda for several months. In that case, the 25-year-old was experiencing problems in a personal relationship and with social media.
Two other weight loss specialists contacted by this news organization had not had patients who had experienced suicidal ideation with the drugs. “These are not very common in practice,” Dr. Lofton said in an interview.
The U.S. prescribing information for Saxenda, which contains liraglutide and has been approved as an adjunct to diet and exercise for chronic weight management, recommends monitoring for the emergence of depression and suicidal thoughts. In the clinical trials, 6 of the 3,384 patients who took the drug reported suicidal ideation; none of the 1,941 patients who received placebo did so, according to the FDA.
Similarly, the U.S. prescribing information for Wegovy, which contains semaglutide, recommends monitoring for the emergence of suicidal thoughts or depression, but this recommendation was based on clinical trials of other weight management products. The prescribing information for Ozempic, the brand name for semaglutide for type 2 diabetes, does not include this recommendation.
Is it the weight loss, rather than the meds? Seen with bariatric surgery too
Speculating what the link, if any, might be, Dr. Lofton suggested dopamine release could be playing a role. Small trials in humans as well as animal studies hint at a blunting of dopamine responses to usual triggers – including addictive substances and possibly food – that may also affect mood.
Young people (aged 18-34) who undergo bariatric surgery are at an increased risk of suicide during follow-up compared to their peers who don’t have surgery. And a study found an increase in events involving self-harm after bariatric surgery, especially among patients who already had a mental health disorder.
For a patient who derives comfort from food, not being able to eat in response to a stressful event may lead that patient to act out in more serious ways, according to Dr. Lofton. “That’s why, again, surgical follow-up is so important and their presurgical psychiatric evaluation is so important.”
A version of this article originally appeared on Medscape.com.
Following reports that the European Medicines Agency is looking into instances of suicide or self-harm after patients took the weight loss drugs semaglutide or liraglutide, the manufacturer, Novo Nordisk, issued a statement to this news organization in which it says it “remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”
U.S. experts say they haven’t personally seen this adverse effect in any patients except for one isolated case. An increase in suicidal ideation, particularly among younger people, has been reported following bariatric surgery for weight loss.
In the United States, the two drugs – both GLP-1 agonists – already come with a warning about the potential for these adverse effects on the branded versions approved for weight loss, Wegovy and Saxenda. (Years earlier, both drugs, marketed as Ozempic and Victoza, were also approved for treatment of type 2 diabetes.)
Of more than 1,200 reports of adverse reactions with semaglutide, 60 cases of suicidal ideation and 7 suicide attempts have been reported since 2018, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS) public database. For liraglutide, there were 71 cases of suicidal ideation, 28 suicide attempts, and 25 completed suicides out of more than 35,000 reports of adverse reactions.
The FAERS website cautions users that the data may be duplicated or incomplete, that rates of occurrence cannot be established using the data, that reports have not been verified, and that the existence of a report cannot establish causation.
The EMA is looking into about 150 reports of possible cases of self-injury and suicidal thoughts, according to a press release from the agency.
“It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors,” it says. The medicines are widely used in the European Union, according to the press release.
The review of Ozempic, Saxenda, and Wegovy, which started on July 3, 2023, has been extended to include other GLP-1 receptor agonists, which include dulaglutide, exenatide, and lixisenatide. This review is expected to conclude in November 2023.
In a statement, Novo Nordisk did not directly dispute a potential link between the drugs and suicidal ideation.
“In the U.S., FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation,” the statement indicates. “This event had been reported in clinical trials with other weight management products.”
It adds: “Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”
Important to know the denominator
“What’s important to know is the denominator,” said Holly Lofton, MD, a clinical associate professor of surgery and medicine and the director of the medical weight management program at NYU Langone, New York. “It needs a denominator with the total population on the medication so we can determine if that’s really a significant risk.”
Dr. Lofton described an isolated, anecdotal case of a patient who had no history of depression or mental health problems but developed suicidal thoughts after taking Saxenda for several months. In that case, the 25-year-old was experiencing problems in a personal relationship and with social media.
Two other weight loss specialists contacted by this news organization had not had patients who had experienced suicidal ideation with the drugs. “These are not very common in practice,” Dr. Lofton said in an interview.
The U.S. prescribing information for Saxenda, which contains liraglutide and has been approved as an adjunct to diet and exercise for chronic weight management, recommends monitoring for the emergence of depression and suicidal thoughts. In the clinical trials, 6 of the 3,384 patients who took the drug reported suicidal ideation; none of the 1,941 patients who received placebo did so, according to the FDA.
Similarly, the U.S. prescribing information for Wegovy, which contains semaglutide, recommends monitoring for the emergence of suicidal thoughts or depression, but this recommendation was based on clinical trials of other weight management products. The prescribing information for Ozempic, the brand name for semaglutide for type 2 diabetes, does not include this recommendation.
Is it the weight loss, rather than the meds? Seen with bariatric surgery too
Speculating what the link, if any, might be, Dr. Lofton suggested dopamine release could be playing a role. Small trials in humans as well as animal studies hint at a blunting of dopamine responses to usual triggers – including addictive substances and possibly food – that may also affect mood.
Young people (aged 18-34) who undergo bariatric surgery are at an increased risk of suicide during follow-up compared to their peers who don’t have surgery. And a study found an increase in events involving self-harm after bariatric surgery, especially among patients who already had a mental health disorder.
For a patient who derives comfort from food, not being able to eat in response to a stressful event may lead that patient to act out in more serious ways, according to Dr. Lofton. “That’s why, again, surgical follow-up is so important and their presurgical psychiatric evaluation is so important.”
A version of this article originally appeared on Medscape.com.
Following reports that the European Medicines Agency is looking into instances of suicide or self-harm after patients took the weight loss drugs semaglutide or liraglutide, the manufacturer, Novo Nordisk, issued a statement to this news organization in which it says it “remains confident in the benefit risk profile of the products and remains committed to ensuring patient safety.”
U.S. experts say they haven’t personally seen this adverse effect in any patients except for one isolated case. An increase in suicidal ideation, particularly among younger people, has been reported following bariatric surgery for weight loss.
In the United States, the two drugs – both GLP-1 agonists – already come with a warning about the potential for these adverse effects on the branded versions approved for weight loss, Wegovy and Saxenda. (Years earlier, both drugs, marketed as Ozempic and Victoza, were also approved for treatment of type 2 diabetes.)
Of more than 1,200 reports of adverse reactions with semaglutide, 60 cases of suicidal ideation and 7 suicide attempts have been reported since 2018, according to the Food and Drug Administration’s Adverse Event Reporting System (FAERS) public database. For liraglutide, there were 71 cases of suicidal ideation, 28 suicide attempts, and 25 completed suicides out of more than 35,000 reports of adverse reactions.
The FAERS website cautions users that the data may be duplicated or incomplete, that rates of occurrence cannot be established using the data, that reports have not been verified, and that the existence of a report cannot establish causation.
The EMA is looking into about 150 reports of possible cases of self-injury and suicidal thoughts, according to a press release from the agency.
“It is not yet clear whether the reported cases are linked to the medicines themselves or to the patients’ underlying conditions or other factors,” it says. The medicines are widely used in the European Union, according to the press release.
The review of Ozempic, Saxenda, and Wegovy, which started on July 3, 2023, has been extended to include other GLP-1 receptor agonists, which include dulaglutide, exenatide, and lixisenatide. This review is expected to conclude in November 2023.
In a statement, Novo Nordisk did not directly dispute a potential link between the drugs and suicidal ideation.
“In the U.S., FDA requires medications for chronic weight management that work on the central nervous system, including Wegovy and Saxenda, to carry a warning about suicidal behavior and ideation,” the statement indicates. “This event had been reported in clinical trials with other weight management products.”
It adds: “Novo Nordisk is continuously performing surveillance of the data from ongoing clinical trials and real-world use of its products and collaborates closely with the authorities to ensure patient safety and adequate information to healthcare professionals.”
Important to know the denominator
“What’s important to know is the denominator,” said Holly Lofton, MD, a clinical associate professor of surgery and medicine and the director of the medical weight management program at NYU Langone, New York. “It needs a denominator with the total population on the medication so we can determine if that’s really a significant risk.”
Dr. Lofton described an isolated, anecdotal case of a patient who had no history of depression or mental health problems but developed suicidal thoughts after taking Saxenda for several months. In that case, the 25-year-old was experiencing problems in a personal relationship and with social media.
Two other weight loss specialists contacted by this news organization had not had patients who had experienced suicidal ideation with the drugs. “These are not very common in practice,” Dr. Lofton said in an interview.
The U.S. prescribing information for Saxenda, which contains liraglutide and has been approved as an adjunct to diet and exercise for chronic weight management, recommends monitoring for the emergence of depression and suicidal thoughts. In the clinical trials, 6 of the 3,384 patients who took the drug reported suicidal ideation; none of the 1,941 patients who received placebo did so, according to the FDA.
Similarly, the U.S. prescribing information for Wegovy, which contains semaglutide, recommends monitoring for the emergence of suicidal thoughts or depression, but this recommendation was based on clinical trials of other weight management products. The prescribing information for Ozempic, the brand name for semaglutide for type 2 diabetes, does not include this recommendation.
Is it the weight loss, rather than the meds? Seen with bariatric surgery too
Speculating what the link, if any, might be, Dr. Lofton suggested dopamine release could be playing a role. Small trials in humans as well as animal studies hint at a blunting of dopamine responses to usual triggers – including addictive substances and possibly food – that may also affect mood.
Young people (aged 18-34) who undergo bariatric surgery are at an increased risk of suicide during follow-up compared to their peers who don’t have surgery. And a study found an increase in events involving self-harm after bariatric surgery, especially among patients who already had a mental health disorder.
For a patient who derives comfort from food, not being able to eat in response to a stressful event may lead that patient to act out in more serious ways, according to Dr. Lofton. “That’s why, again, surgical follow-up is so important and their presurgical psychiatric evaluation is so important.”
A version of this article originally appeared on Medscape.com.