Gaps in ulcerative colitis care expectations, perceptions

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Thu, 06/30/2022 - 11:40

Gaps in priorities and perceptions about managing disease exist between physicians and patients with ulcerative colitis (UC), according to survey findings recently published in Therapeutic Advances in Gastroenterology.

The results – which come from the Ulcerative Colitis Narrative Survey from Japan – point to the ongoing need to foster a good relationship between physicians and patients, even as treatment methods for UC become more sophisticated, wrote the researchers led by Kenji Watanabe, MD, PhD, professor of internal medicine at Keio (Japan) University.

“While adjustments of the treatment regimens according to the results of objective monitoring in the treat-to-target strategy have led to improvements in UC management, the importance of patient-physician communication should not be neglected, as shared decision-making is a major driver of treatment satisfaction,” they wrote.

The UC Narrative is a multinational initiative sponsored by Pfizer meant to identify barriers to care and find solutions to those barriers. A total of 210 patients and 151 physicians completed the survey.

Overall, 65% of patients said they wished they had more time at appointments with their physicians, and 52% said their physician rarely had time to address all their questions and concerns. The majority of physicians (79%) also said they wish they had more time at appointments.

About half of patients (54%) ranked avoiding toileting accidents as a top priority more than any other concern, but physicians perceived this as less of a concern, with just 28% saying it was a top priority. For physicians, healing of mucosa was the second-highest ranked concern, with 59% saying it was a top priority, compared with just 29% for patients, and they also overestimated the importance of avoiding hospitalization among patients (56% vs. 38%).

Most patients (72%) said they felt comfortable raising concerns with their physician. But of those, 66% said they wished they had talked more about their fears of medical treatments, 53% said they worried that they would be seen as difficult if they asked too many questions, and 51% said their physician rarely had time to address all of their concerns.

Still, 85% of patients said they were satisfied overall with the communication they have with their physician, while physicians underestimated patient satisfaction, thinking that just 71% of their patients are satisfied with the communication.

The survey also found that physicians were more likely to discuss treatment-related topics than quality of life topics. And 52% of patients said they felt their doctor could do better in explaining the hereditary nature of UC, and just over half (52%) said their physician could do better in helping them access information and support from patient advocacy organizations.

The survey also found problems with patients’ knowledge of ulcerative colitis. About 26% said they thought that if their symptoms were under control then their disease was not active, and 23% said they didn’t know it was important to keep their disease under control to reduce long-term complications.

The majority of patients (82%) said their UC was mentally exhausting, and 64% said they felt they would be more successful if they didn’t have UC.

“This survey highlights the importance of regularly monitoring patients’ mental health,” the researchers wrote.

Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute at the Cleveland Clinic, said the findings illustrate the need for, and point to the challenges of establishing, quality communication between patients and physicians, which he said is “vitally important.”

“I find that physicians who listen, ask questions, and pause to hear the answers with honest dialogue on quality of life, have a physician-patient relationship that allows [them] to probe important topics of quality of life, depression, anxiety, stress,” he said. “As the Japanese study found, physicians may focus on the objective outcomes of UC treatment” – for example, mucosal healing – “but not always ask about the ‘whole person’ issues of UC,” such as quality of life.

According to Dr. Regueiro, Cleveland Clinic has developed an “IBD (inflammatory bowel disease) home” that includes doctors, dietitians, psychologists, nurses, and others that allows them to consider and manage many factors associated with the illness, not just the clinical picture.

“The team allows for the ‘How does UC impact you?’ discussions on a regular basis, and we have found that this whole-person approach is greatly appreciated by patients,” he said.

He suggested that physicians ask open-ended questions, such as: “What are two to three things that are bothering you or that you want out of the visit?”

“Even though one physician may not be able to address all of the problems,” he said, “the physician can start the narrative.”

The survey was sponsored by Pfizer. Dr. Watanabe reported receiving research funding or consulting fees from several companies including Pfizer, as well as Asahi Kasei Medical, Mitsubishi Tanabe, AbbVie Japan, Janssen, Takeda, and others. Dr. Regueiro reported advisory board work or consulting for AbbVie, Janssen, Takeda, Pfizer, Celgene, and other companies.

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Gaps in priorities and perceptions about managing disease exist between physicians and patients with ulcerative colitis (UC), according to survey findings recently published in Therapeutic Advances in Gastroenterology.

The results – which come from the Ulcerative Colitis Narrative Survey from Japan – point to the ongoing need to foster a good relationship between physicians and patients, even as treatment methods for UC become more sophisticated, wrote the researchers led by Kenji Watanabe, MD, PhD, professor of internal medicine at Keio (Japan) University.

“While adjustments of the treatment regimens according to the results of objective monitoring in the treat-to-target strategy have led to improvements in UC management, the importance of patient-physician communication should not be neglected, as shared decision-making is a major driver of treatment satisfaction,” they wrote.

The UC Narrative is a multinational initiative sponsored by Pfizer meant to identify barriers to care and find solutions to those barriers. A total of 210 patients and 151 physicians completed the survey.

Overall, 65% of patients said they wished they had more time at appointments with their physicians, and 52% said their physician rarely had time to address all their questions and concerns. The majority of physicians (79%) also said they wish they had more time at appointments.

About half of patients (54%) ranked avoiding toileting accidents as a top priority more than any other concern, but physicians perceived this as less of a concern, with just 28% saying it was a top priority. For physicians, healing of mucosa was the second-highest ranked concern, with 59% saying it was a top priority, compared with just 29% for patients, and they also overestimated the importance of avoiding hospitalization among patients (56% vs. 38%).

Most patients (72%) said they felt comfortable raising concerns with their physician. But of those, 66% said they wished they had talked more about their fears of medical treatments, 53% said they worried that they would be seen as difficult if they asked too many questions, and 51% said their physician rarely had time to address all of their concerns.

Still, 85% of patients said they were satisfied overall with the communication they have with their physician, while physicians underestimated patient satisfaction, thinking that just 71% of their patients are satisfied with the communication.

The survey also found that physicians were more likely to discuss treatment-related topics than quality of life topics. And 52% of patients said they felt their doctor could do better in explaining the hereditary nature of UC, and just over half (52%) said their physician could do better in helping them access information and support from patient advocacy organizations.

The survey also found problems with patients’ knowledge of ulcerative colitis. About 26% said they thought that if their symptoms were under control then their disease was not active, and 23% said they didn’t know it was important to keep their disease under control to reduce long-term complications.

The majority of patients (82%) said their UC was mentally exhausting, and 64% said they felt they would be more successful if they didn’t have UC.

“This survey highlights the importance of regularly monitoring patients’ mental health,” the researchers wrote.

Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute at the Cleveland Clinic, said the findings illustrate the need for, and point to the challenges of establishing, quality communication between patients and physicians, which he said is “vitally important.”

“I find that physicians who listen, ask questions, and pause to hear the answers with honest dialogue on quality of life, have a physician-patient relationship that allows [them] to probe important topics of quality of life, depression, anxiety, stress,” he said. “As the Japanese study found, physicians may focus on the objective outcomes of UC treatment” – for example, mucosal healing – “but not always ask about the ‘whole person’ issues of UC,” such as quality of life.

According to Dr. Regueiro, Cleveland Clinic has developed an “IBD (inflammatory bowel disease) home” that includes doctors, dietitians, psychologists, nurses, and others that allows them to consider and manage many factors associated with the illness, not just the clinical picture.

“The team allows for the ‘How does UC impact you?’ discussions on a regular basis, and we have found that this whole-person approach is greatly appreciated by patients,” he said.

He suggested that physicians ask open-ended questions, such as: “What are two to three things that are bothering you or that you want out of the visit?”

“Even though one physician may not be able to address all of the problems,” he said, “the physician can start the narrative.”

The survey was sponsored by Pfizer. Dr. Watanabe reported receiving research funding or consulting fees from several companies including Pfizer, as well as Asahi Kasei Medical, Mitsubishi Tanabe, AbbVie Japan, Janssen, Takeda, and others. Dr. Regueiro reported advisory board work or consulting for AbbVie, Janssen, Takeda, Pfizer, Celgene, and other companies.

Gaps in priorities and perceptions about managing disease exist between physicians and patients with ulcerative colitis (UC), according to survey findings recently published in Therapeutic Advances in Gastroenterology.

The results – which come from the Ulcerative Colitis Narrative Survey from Japan – point to the ongoing need to foster a good relationship between physicians and patients, even as treatment methods for UC become more sophisticated, wrote the researchers led by Kenji Watanabe, MD, PhD, professor of internal medicine at Keio (Japan) University.

“While adjustments of the treatment regimens according to the results of objective monitoring in the treat-to-target strategy have led to improvements in UC management, the importance of patient-physician communication should not be neglected, as shared decision-making is a major driver of treatment satisfaction,” they wrote.

The UC Narrative is a multinational initiative sponsored by Pfizer meant to identify barriers to care and find solutions to those barriers. A total of 210 patients and 151 physicians completed the survey.

Overall, 65% of patients said they wished they had more time at appointments with their physicians, and 52% said their physician rarely had time to address all their questions and concerns. The majority of physicians (79%) also said they wish they had more time at appointments.

About half of patients (54%) ranked avoiding toileting accidents as a top priority more than any other concern, but physicians perceived this as less of a concern, with just 28% saying it was a top priority. For physicians, healing of mucosa was the second-highest ranked concern, with 59% saying it was a top priority, compared with just 29% for patients, and they also overestimated the importance of avoiding hospitalization among patients (56% vs. 38%).

Most patients (72%) said they felt comfortable raising concerns with their physician. But of those, 66% said they wished they had talked more about their fears of medical treatments, 53% said they worried that they would be seen as difficult if they asked too many questions, and 51% said their physician rarely had time to address all of their concerns.

Still, 85% of patients said they were satisfied overall with the communication they have with their physician, while physicians underestimated patient satisfaction, thinking that just 71% of their patients are satisfied with the communication.

The survey also found that physicians were more likely to discuss treatment-related topics than quality of life topics. And 52% of patients said they felt their doctor could do better in explaining the hereditary nature of UC, and just over half (52%) said their physician could do better in helping them access information and support from patient advocacy organizations.

The survey also found problems with patients’ knowledge of ulcerative colitis. About 26% said they thought that if their symptoms were under control then their disease was not active, and 23% said they didn’t know it was important to keep their disease under control to reduce long-term complications.

The majority of patients (82%) said their UC was mentally exhausting, and 64% said they felt they would be more successful if they didn’t have UC.

“This survey highlights the importance of regularly monitoring patients’ mental health,” the researchers wrote.

Miguel Regueiro, MD, chair of the Digestive Disease & Surgery Institute at the Cleveland Clinic, said the findings illustrate the need for, and point to the challenges of establishing, quality communication between patients and physicians, which he said is “vitally important.”

“I find that physicians who listen, ask questions, and pause to hear the answers with honest dialogue on quality of life, have a physician-patient relationship that allows [them] to probe important topics of quality of life, depression, anxiety, stress,” he said. “As the Japanese study found, physicians may focus on the objective outcomes of UC treatment” – for example, mucosal healing – “but not always ask about the ‘whole person’ issues of UC,” such as quality of life.

According to Dr. Regueiro, Cleveland Clinic has developed an “IBD (inflammatory bowel disease) home” that includes doctors, dietitians, psychologists, nurses, and others that allows them to consider and manage many factors associated with the illness, not just the clinical picture.

“The team allows for the ‘How does UC impact you?’ discussions on a regular basis, and we have found that this whole-person approach is greatly appreciated by patients,” he said.

He suggested that physicians ask open-ended questions, such as: “What are two to three things that are bothering you or that you want out of the visit?”

“Even though one physician may not be able to address all of the problems,” he said, “the physician can start the narrative.”

The survey was sponsored by Pfizer. Dr. Watanabe reported receiving research funding or consulting fees from several companies including Pfizer, as well as Asahi Kasei Medical, Mitsubishi Tanabe, AbbVie Japan, Janssen, Takeda, and others. Dr. Regueiro reported advisory board work or consulting for AbbVie, Janssen, Takeda, Pfizer, Celgene, and other companies.

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How can doctors protect their practices against monkeypox?

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Fri, 06/24/2022 - 15:00

Globally, as of June 22, the number of patients with monkeypox has risen to 3,308, according to the U.S. Centers for Disease Control and Prevention. In Germany, 521 people have been infected to date. “There does not seem to be a monkeypox pandemic,” wrote Germany’s Federal Minister of Health Karl Lauterbach, MD. At the moment, the probability that doctors will see a patient infected with the monkeypox virus is quite small. Nevertheless, health care professionals should be prepared. The Robert Koch Institute (RKI), a German federal government agency, has compiled suggestions for inpatient and outpatient sectors.

Characteristics of the virus

All hygiene measures are oriented around the currently known characteristics of the monkeypox virus. According to the RKI, skin or mucosal contact with infectious material from the skin lesions of an infected person plays a key role in human-to-human transmission.

The virus remains biologically active for a certain amount of time, even in dried flakes of skin or dried secretion. Therefore, in general, “careful and thorough cleaning and disinfection of the patient environment or surfaces is necessary,” wrote the RKI. Droplet infections or contaminated surfaces are less often of importance.
 

Basic hygiene measures

“Fundamentally, all basic hygiene measures should of course be followed when dealing with the infected,” said the RKI. Doctors and other health care professionals should use hand sanitizer with proven, at least viricidal, efficacy.

Manufacturers provide such details on the packaging. Both the RKI and the Association for Applied Hygiene (VAH) have published compilations.
 

Measures in medical practices

In the outpatient sector, there is the (currently still quite low) danger that patients with monkeypox will infect other patients or practice employees. To prevent this, the RKI advised organizational measures.

If employees suspect that patients have monkeypox when they first arrive at the practice, or when they first speak to them over the phone, they must be separated. Waiting and treatment rooms with surfaces that can be wipe disinfected are well suited for this. Even if only suspected, all employees should wear disposable gloves and mouth-and-nose protection, which has become standard during COVID.
 

Measures in the clinical sector

In terms of accommodation, the RKI recommends isolation rooms with a washroom and, if possible, an antechamber that doctors and nurses can use to put on and take off their personal protective equipment (PPE). PPE includes disposable gloves, mouth-and-nose protection (for direct treatment, at least an FFP2 mask), and protective eyeglasses.

Special attention should be paid to the disinfection of surfaces. In addition to the selection of suitable preparations, the RKI advised that the high stability of the virus, especially in skin particles, be taken into account. When cleaning, particular care should be taken not to disturb any particles, according to the recommendations. In addition, the manufacturer’s application time must be strictly observed.

In the inpatient sector, such measures are important for all surfaces close to patients, such as bedside tables, wet zones, or door handles.

Medical devices such as stethoscopes or electrodes should be disinfected immediately after use. If possible, thermal treatment is preferred, such as for surgical apparatus, as long as they are not disposable products. The RKI has compiled separate recommendations for medical devices.

For laundry such as towels or bed linen, there is the danger that infectious particles will be stirred up. They should be collected and transported for treatment in sealable bags. Details on the selection of preparations can be found in the RKI or VAH list.

Contaminated waste is classified under waste code ASN 18 01 03 (“Guidelines for disposal of waste from healthcare institutions”) and may only be destroyed thermally in suitable facilities.

This article was translated from the Medscape German edition. A version of this article first appeared on Medscape.com.

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Globally, as of June 22, the number of patients with monkeypox has risen to 3,308, according to the U.S. Centers for Disease Control and Prevention. In Germany, 521 people have been infected to date. “There does not seem to be a monkeypox pandemic,” wrote Germany’s Federal Minister of Health Karl Lauterbach, MD. At the moment, the probability that doctors will see a patient infected with the monkeypox virus is quite small. Nevertheless, health care professionals should be prepared. The Robert Koch Institute (RKI), a German federal government agency, has compiled suggestions for inpatient and outpatient sectors.

Characteristics of the virus

All hygiene measures are oriented around the currently known characteristics of the monkeypox virus. According to the RKI, skin or mucosal contact with infectious material from the skin lesions of an infected person plays a key role in human-to-human transmission.

The virus remains biologically active for a certain amount of time, even in dried flakes of skin or dried secretion. Therefore, in general, “careful and thorough cleaning and disinfection of the patient environment or surfaces is necessary,” wrote the RKI. Droplet infections or contaminated surfaces are less often of importance.
 

Basic hygiene measures

“Fundamentally, all basic hygiene measures should of course be followed when dealing with the infected,” said the RKI. Doctors and other health care professionals should use hand sanitizer with proven, at least viricidal, efficacy.

Manufacturers provide such details on the packaging. Both the RKI and the Association for Applied Hygiene (VAH) have published compilations.
 

Measures in medical practices

In the outpatient sector, there is the (currently still quite low) danger that patients with monkeypox will infect other patients or practice employees. To prevent this, the RKI advised organizational measures.

If employees suspect that patients have monkeypox when they first arrive at the practice, or when they first speak to them over the phone, they must be separated. Waiting and treatment rooms with surfaces that can be wipe disinfected are well suited for this. Even if only suspected, all employees should wear disposable gloves and mouth-and-nose protection, which has become standard during COVID.
 

Measures in the clinical sector

In terms of accommodation, the RKI recommends isolation rooms with a washroom and, if possible, an antechamber that doctors and nurses can use to put on and take off their personal protective equipment (PPE). PPE includes disposable gloves, mouth-and-nose protection (for direct treatment, at least an FFP2 mask), and protective eyeglasses.

Special attention should be paid to the disinfection of surfaces. In addition to the selection of suitable preparations, the RKI advised that the high stability of the virus, especially in skin particles, be taken into account. When cleaning, particular care should be taken not to disturb any particles, according to the recommendations. In addition, the manufacturer’s application time must be strictly observed.

In the inpatient sector, such measures are important for all surfaces close to patients, such as bedside tables, wet zones, or door handles.

Medical devices such as stethoscopes or electrodes should be disinfected immediately after use. If possible, thermal treatment is preferred, such as for surgical apparatus, as long as they are not disposable products. The RKI has compiled separate recommendations for medical devices.

For laundry such as towels or bed linen, there is the danger that infectious particles will be stirred up. They should be collected and transported for treatment in sealable bags. Details on the selection of preparations can be found in the RKI or VAH list.

Contaminated waste is classified under waste code ASN 18 01 03 (“Guidelines for disposal of waste from healthcare institutions”) and may only be destroyed thermally in suitable facilities.

This article was translated from the Medscape German edition. A version of this article first appeared on Medscape.com.

Globally, as of June 22, the number of patients with monkeypox has risen to 3,308, according to the U.S. Centers for Disease Control and Prevention. In Germany, 521 people have been infected to date. “There does not seem to be a monkeypox pandemic,” wrote Germany’s Federal Minister of Health Karl Lauterbach, MD. At the moment, the probability that doctors will see a patient infected with the monkeypox virus is quite small. Nevertheless, health care professionals should be prepared. The Robert Koch Institute (RKI), a German federal government agency, has compiled suggestions for inpatient and outpatient sectors.

Characteristics of the virus

All hygiene measures are oriented around the currently known characteristics of the monkeypox virus. According to the RKI, skin or mucosal contact with infectious material from the skin lesions of an infected person plays a key role in human-to-human transmission.

The virus remains biologically active for a certain amount of time, even in dried flakes of skin or dried secretion. Therefore, in general, “careful and thorough cleaning and disinfection of the patient environment or surfaces is necessary,” wrote the RKI. Droplet infections or contaminated surfaces are less often of importance.
 

Basic hygiene measures

“Fundamentally, all basic hygiene measures should of course be followed when dealing with the infected,” said the RKI. Doctors and other health care professionals should use hand sanitizer with proven, at least viricidal, efficacy.

Manufacturers provide such details on the packaging. Both the RKI and the Association for Applied Hygiene (VAH) have published compilations.
 

Measures in medical practices

In the outpatient sector, there is the (currently still quite low) danger that patients with monkeypox will infect other patients or practice employees. To prevent this, the RKI advised organizational measures.

If employees suspect that patients have monkeypox when they first arrive at the practice, or when they first speak to them over the phone, they must be separated. Waiting and treatment rooms with surfaces that can be wipe disinfected are well suited for this. Even if only suspected, all employees should wear disposable gloves and mouth-and-nose protection, which has become standard during COVID.
 

Measures in the clinical sector

In terms of accommodation, the RKI recommends isolation rooms with a washroom and, if possible, an antechamber that doctors and nurses can use to put on and take off their personal protective equipment (PPE). PPE includes disposable gloves, mouth-and-nose protection (for direct treatment, at least an FFP2 mask), and protective eyeglasses.

Special attention should be paid to the disinfection of surfaces. In addition to the selection of suitable preparations, the RKI advised that the high stability of the virus, especially in skin particles, be taken into account. When cleaning, particular care should be taken not to disturb any particles, according to the recommendations. In addition, the manufacturer’s application time must be strictly observed.

In the inpatient sector, such measures are important for all surfaces close to patients, such as bedside tables, wet zones, or door handles.

Medical devices such as stethoscopes or electrodes should be disinfected immediately after use. If possible, thermal treatment is preferred, such as for surgical apparatus, as long as they are not disposable products. The RKI has compiled separate recommendations for medical devices.

For laundry such as towels or bed linen, there is the danger that infectious particles will be stirred up. They should be collected and transported for treatment in sealable bags. Details on the selection of preparations can be found in the RKI or VAH list.

Contaminated waste is classified under waste code ASN 18 01 03 (“Guidelines for disposal of waste from healthcare institutions”) and may only be destroyed thermally in suitable facilities.

This article was translated from the Medscape German edition. A version of this article first appeared on Medscape.com.

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New light on why some psych patients don’t respond to therapy

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Fri, 06/24/2022 - 14:54

Although most psychiatrists have encountered patients who don’t improve with treatment, novel research sheds some light on one possible explanation for this phenomenon.

Investigators found that among patients who were “stuck” many believed that they didn’t deserve to get better and were significantly less likely to adhere to, or complete, a treatment program.

“To the best of my knowledge, this subject hasn’t been written about or explored before because we operate under the assumption that someone coming for ambulatory treatment, of course, wants to get better and thinks that they deserve to get better,” lead author Mark Zimmerman, MD, professor of psychiatry and human behavior at Brown University, Providence, R.I., said in an interview.

“This issue is not something complicated that a clinician would need to explore by administering some scale or clinical rating instrument. All you have to do is ask patients if they think they deserve to get better, particularly patients who seem to be ‘stuck,’ and explore what’s underlying that belief,” added Zimmerman, who is also the director of the Outpatient Division at the partial hospital program, Rhode Island Hospital, Providence.

The findings were published online in the Journal of Clinical Psychiatry.
 

Obstacle to therapy

Results from a study examining the prevalence of this belief in more than 400 patients admitted to a partial hospital program showed that 17% of the participants either did not believe they deserved to get better or weren’t sure if they deserved to get better.

When compared with their peers, patients who felt they were undeserving were significantly less likely to complete the treatment program and missed significantly more days of treatment while in the program.

Of the patients who did complete the program, those who believed they were undeserving were in treatment for significantly longer periods of time than those who believed they deserved to get better.

The average length of stay for patients in the partial hospital program is usually about 2 weeks, the investigators note. However, a minority of patients end up in treatment for more than a month and during this prolonged period, some do not seem to improve in their symptoms or functioning despite “intensive psychotherapy and ongoing pharmacotherapy.”

The researchers wanted to understand the reasons for some patients’ lack of progress and examined whether those who did not believe they were worthy of getting better actually took longer to respond to treatment.

In the current research, Dr. Zimmerman wanted to focus on these patients and assess whether they did take longer to improve and what diagnoses might be associated with feeling undeserving.

Of the 405 patients in the study, the majority (83%) reported they believed they deserved to get better, 12.8% said they were unsure, and 4.2% reported they did not believe they deserved to get better.

The researchers combined those who were unsure and those who did not believe they deserved to get better and compared them with patients who believed they did deserve to get better.

Although there were no differences between these patients in gender, race, or marital status, those who did not believe they deserved to get better were significantly younger than their counterparts who believed they deserved to get better (mean age, 32.2 years vs. 37.7 years, respectively; P < .01).

They also were diagnosed with a greater number of disorders at the time of the evaluation (mean, 3.6 vs. 2.9; P < .01).
 

 

 

Mirrors clinical experience

Participants who did not indicate they deserved to get better were significantly more often diagnosed with several conditions, compared with their counterparts who indicated they did deserve to get better:

  • Major depressive disorder (MDD): 75.4% vs. 53.3%, respectively; P < .01.
  • Panic disorder: 36.2% vs. 23.2%; P < .05.
  • Agoraphobia: 27.5% vs. 11.6%; P < .01.
  • Obsessive-compulsive disorder (OCD): 14.5% vs. 4.5%; P < .01.
  • Posttraumatic stress disorder: 44.9% vs. 25.9%; P < .01.
  • Borderline personality disorder: 29.0% vs. 17.9%; P < .05.

There were also significant differences between those who did not vs, did believe they deserved to get better in program completion (52.3% vs. 68.8%, respectively; P < .01), missed days (mean, 1.7 vs. 1.3; P < .05), and length of treatment (mean days, 14.1 vs. 11.8; P < .05).

Dr. Zimmerman called these preliminary findings “consistent” with his clinical experience.

He noted he was “surprised” that OCD had the highest odds ratio (OR, 3.5) of being associated with a sense of undeservingness. “But when I thought about it, I realized that it makes sense because people with OCD have insight and are often embarrassed by their symptoms,” he added.

Dr. Zimmerman was not surprised that MDD was associated with this sense of undeservingness. A second study currently under review is focusing specifically on MDD.

“One of the things we found, not surprisingly, was that some of the cognitive symptoms of depression, such as guilt and sense of worthlessness, are associated with it,” he said.
 

‘Snapshot in time’

Commenting for this news organization, Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness called this a “novel, important, and creative study.”

The “hypothesized role of shame squares with my experience. And the association with OCD, depression, and trauma are also consistent with what I have seen,” said Dr. Duckworth, who is also an assistant clinical professor at Harvard Medical School, Boston. He was not involved with the current research.

“The role of hopelessness, often seen as a core feature of depression and to some extent OCD and trauma, is an opportunity to see if treatments like cognitive-behavioral therapy [CBT] can make a difference. How to engage people in CBT, which works directly at changing one’s automatic negative thoughts, is important,” Dr. Duckworth said.

Describing the study as a “snapshot in time,” he noted it would be interesting to follow patients longitudinally.

“I think a whole subset would look back and say, ‘I remember feeling [undeserving] but now that I’ve gotten medication or CBT or therapy, I’m happy I got better,’” said Dr. Duckworth.

No source of study funding was listed. Dr. Zimmerman, his coauthor, and Dr. Duckworth report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Although most psychiatrists have encountered patients who don’t improve with treatment, novel research sheds some light on one possible explanation for this phenomenon.

Investigators found that among patients who were “stuck” many believed that they didn’t deserve to get better and were significantly less likely to adhere to, or complete, a treatment program.

“To the best of my knowledge, this subject hasn’t been written about or explored before because we operate under the assumption that someone coming for ambulatory treatment, of course, wants to get better and thinks that they deserve to get better,” lead author Mark Zimmerman, MD, professor of psychiatry and human behavior at Brown University, Providence, R.I., said in an interview.

“This issue is not something complicated that a clinician would need to explore by administering some scale or clinical rating instrument. All you have to do is ask patients if they think they deserve to get better, particularly patients who seem to be ‘stuck,’ and explore what’s underlying that belief,” added Zimmerman, who is also the director of the Outpatient Division at the partial hospital program, Rhode Island Hospital, Providence.

The findings were published online in the Journal of Clinical Psychiatry.
 

Obstacle to therapy

Results from a study examining the prevalence of this belief in more than 400 patients admitted to a partial hospital program showed that 17% of the participants either did not believe they deserved to get better or weren’t sure if they deserved to get better.

When compared with their peers, patients who felt they were undeserving were significantly less likely to complete the treatment program and missed significantly more days of treatment while in the program.

Of the patients who did complete the program, those who believed they were undeserving were in treatment for significantly longer periods of time than those who believed they deserved to get better.

The average length of stay for patients in the partial hospital program is usually about 2 weeks, the investigators note. However, a minority of patients end up in treatment for more than a month and during this prolonged period, some do not seem to improve in their symptoms or functioning despite “intensive psychotherapy and ongoing pharmacotherapy.”

The researchers wanted to understand the reasons for some patients’ lack of progress and examined whether those who did not believe they were worthy of getting better actually took longer to respond to treatment.

In the current research, Dr. Zimmerman wanted to focus on these patients and assess whether they did take longer to improve and what diagnoses might be associated with feeling undeserving.

Of the 405 patients in the study, the majority (83%) reported they believed they deserved to get better, 12.8% said they were unsure, and 4.2% reported they did not believe they deserved to get better.

The researchers combined those who were unsure and those who did not believe they deserved to get better and compared them with patients who believed they did deserve to get better.

Although there were no differences between these patients in gender, race, or marital status, those who did not believe they deserved to get better were significantly younger than their counterparts who believed they deserved to get better (mean age, 32.2 years vs. 37.7 years, respectively; P < .01).

They also were diagnosed with a greater number of disorders at the time of the evaluation (mean, 3.6 vs. 2.9; P < .01).
 

 

 

Mirrors clinical experience

Participants who did not indicate they deserved to get better were significantly more often diagnosed with several conditions, compared with their counterparts who indicated they did deserve to get better:

  • Major depressive disorder (MDD): 75.4% vs. 53.3%, respectively; P < .01.
  • Panic disorder: 36.2% vs. 23.2%; P < .05.
  • Agoraphobia: 27.5% vs. 11.6%; P < .01.
  • Obsessive-compulsive disorder (OCD): 14.5% vs. 4.5%; P < .01.
  • Posttraumatic stress disorder: 44.9% vs. 25.9%; P < .01.
  • Borderline personality disorder: 29.0% vs. 17.9%; P < .05.

There were also significant differences between those who did not vs, did believe they deserved to get better in program completion (52.3% vs. 68.8%, respectively; P < .01), missed days (mean, 1.7 vs. 1.3; P < .05), and length of treatment (mean days, 14.1 vs. 11.8; P < .05).

Dr. Zimmerman called these preliminary findings “consistent” with his clinical experience.

He noted he was “surprised” that OCD had the highest odds ratio (OR, 3.5) of being associated with a sense of undeservingness. “But when I thought about it, I realized that it makes sense because people with OCD have insight and are often embarrassed by their symptoms,” he added.

Dr. Zimmerman was not surprised that MDD was associated with this sense of undeservingness. A second study currently under review is focusing specifically on MDD.

“One of the things we found, not surprisingly, was that some of the cognitive symptoms of depression, such as guilt and sense of worthlessness, are associated with it,” he said.
 

‘Snapshot in time’

Commenting for this news organization, Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness called this a “novel, important, and creative study.”

The “hypothesized role of shame squares with my experience. And the association with OCD, depression, and trauma are also consistent with what I have seen,” said Dr. Duckworth, who is also an assistant clinical professor at Harvard Medical School, Boston. He was not involved with the current research.

“The role of hopelessness, often seen as a core feature of depression and to some extent OCD and trauma, is an opportunity to see if treatments like cognitive-behavioral therapy [CBT] can make a difference. How to engage people in CBT, which works directly at changing one’s automatic negative thoughts, is important,” Dr. Duckworth said.

Describing the study as a “snapshot in time,” he noted it would be interesting to follow patients longitudinally.

“I think a whole subset would look back and say, ‘I remember feeling [undeserving] but now that I’ve gotten medication or CBT or therapy, I’m happy I got better,’” said Dr. Duckworth.

No source of study funding was listed. Dr. Zimmerman, his coauthor, and Dr. Duckworth report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Although most psychiatrists have encountered patients who don’t improve with treatment, novel research sheds some light on one possible explanation for this phenomenon.

Investigators found that among patients who were “stuck” many believed that they didn’t deserve to get better and were significantly less likely to adhere to, or complete, a treatment program.

“To the best of my knowledge, this subject hasn’t been written about or explored before because we operate under the assumption that someone coming for ambulatory treatment, of course, wants to get better and thinks that they deserve to get better,” lead author Mark Zimmerman, MD, professor of psychiatry and human behavior at Brown University, Providence, R.I., said in an interview.

“This issue is not something complicated that a clinician would need to explore by administering some scale or clinical rating instrument. All you have to do is ask patients if they think they deserve to get better, particularly patients who seem to be ‘stuck,’ and explore what’s underlying that belief,” added Zimmerman, who is also the director of the Outpatient Division at the partial hospital program, Rhode Island Hospital, Providence.

The findings were published online in the Journal of Clinical Psychiatry.
 

Obstacle to therapy

Results from a study examining the prevalence of this belief in more than 400 patients admitted to a partial hospital program showed that 17% of the participants either did not believe they deserved to get better or weren’t sure if they deserved to get better.

When compared with their peers, patients who felt they were undeserving were significantly less likely to complete the treatment program and missed significantly more days of treatment while in the program.

Of the patients who did complete the program, those who believed they were undeserving were in treatment for significantly longer periods of time than those who believed they deserved to get better.

The average length of stay for patients in the partial hospital program is usually about 2 weeks, the investigators note. However, a minority of patients end up in treatment for more than a month and during this prolonged period, some do not seem to improve in their symptoms or functioning despite “intensive psychotherapy and ongoing pharmacotherapy.”

The researchers wanted to understand the reasons for some patients’ lack of progress and examined whether those who did not believe they were worthy of getting better actually took longer to respond to treatment.

In the current research, Dr. Zimmerman wanted to focus on these patients and assess whether they did take longer to improve and what diagnoses might be associated with feeling undeserving.

Of the 405 patients in the study, the majority (83%) reported they believed they deserved to get better, 12.8% said they were unsure, and 4.2% reported they did not believe they deserved to get better.

The researchers combined those who were unsure and those who did not believe they deserved to get better and compared them with patients who believed they did deserve to get better.

Although there were no differences between these patients in gender, race, or marital status, those who did not believe they deserved to get better were significantly younger than their counterparts who believed they deserved to get better (mean age, 32.2 years vs. 37.7 years, respectively; P < .01).

They also were diagnosed with a greater number of disorders at the time of the evaluation (mean, 3.6 vs. 2.9; P < .01).
 

 

 

Mirrors clinical experience

Participants who did not indicate they deserved to get better were significantly more often diagnosed with several conditions, compared with their counterparts who indicated they did deserve to get better:

  • Major depressive disorder (MDD): 75.4% vs. 53.3%, respectively; P < .01.
  • Panic disorder: 36.2% vs. 23.2%; P < .05.
  • Agoraphobia: 27.5% vs. 11.6%; P < .01.
  • Obsessive-compulsive disorder (OCD): 14.5% vs. 4.5%; P < .01.
  • Posttraumatic stress disorder: 44.9% vs. 25.9%; P < .01.
  • Borderline personality disorder: 29.0% vs. 17.9%; P < .05.

There were also significant differences between those who did not vs, did believe they deserved to get better in program completion (52.3% vs. 68.8%, respectively; P < .01), missed days (mean, 1.7 vs. 1.3; P < .05), and length of treatment (mean days, 14.1 vs. 11.8; P < .05).

Dr. Zimmerman called these preliminary findings “consistent” with his clinical experience.

He noted he was “surprised” that OCD had the highest odds ratio (OR, 3.5) of being associated with a sense of undeservingness. “But when I thought about it, I realized that it makes sense because people with OCD have insight and are often embarrassed by their symptoms,” he added.

Dr. Zimmerman was not surprised that MDD was associated with this sense of undeservingness. A second study currently under review is focusing specifically on MDD.

“One of the things we found, not surprisingly, was that some of the cognitive symptoms of depression, such as guilt and sense of worthlessness, are associated with it,” he said.
 

‘Snapshot in time’

Commenting for this news organization, Ken Duckworth, MD, chief medical officer of the National Alliance on Mental Illness called this a “novel, important, and creative study.”

The “hypothesized role of shame squares with my experience. And the association with OCD, depression, and trauma are also consistent with what I have seen,” said Dr. Duckworth, who is also an assistant clinical professor at Harvard Medical School, Boston. He was not involved with the current research.

“The role of hopelessness, often seen as a core feature of depression and to some extent OCD and trauma, is an opportunity to see if treatments like cognitive-behavioral therapy [CBT] can make a difference. How to engage people in CBT, which works directly at changing one’s automatic negative thoughts, is important,” Dr. Duckworth said.

Describing the study as a “snapshot in time,” he noted it would be interesting to follow patients longitudinally.

“I think a whole subset would look back and say, ‘I remember feeling [undeserving] but now that I’ve gotten medication or CBT or therapy, I’m happy I got better,’” said Dr. Duckworth.

No source of study funding was listed. Dr. Zimmerman, his coauthor, and Dr. Duckworth report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Roe reversal may go well beyond abortion

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Roe reversal may go well beyond abortion

Kami, a mother of one daughter in central Texas, lost three pregnancies in 2008. The third one nearly killed her.

The embryo became implanted in one of the fallopian tubes connecting her ovaries to her uterus. Because fallopian tubes can’t stretch to accommodate a fetus, patients must undergo surgery to remove the embryo before the tube ruptures. Failure to do so can result in internal bleeding and death.

But when Kami – who did not want to use her last name to avoid harassment – underwent an ultrasound to start the process of extracting the embryo, her doctor miscalculated how far along in the pregnancy she was and told her to come back in a few weeks.

She eventually did return, but only after passing out in the bathtub and waking up in a pool of her own blood. The tube had ruptured, and to remove it, emergency surgery was necessary.

Stories such as Kami’s could become more common in the aftermath of the U.S. Supreme Court’s decision to overturn Roe v. Wade, the 1973 case that created a right to an abortion.

Experts fear that antiabortion laws that take effect in the United States following the court’s decision will lead to a medical and legal limbo for thousands of people like Kami – people with uncommon reproductive conditions whose treatments involve the termination of pregnancies or the destruction of embryos.
 

Vague exceptions prompt concerns

According to the Guttmacher Institute, a nonprofit group for reproductive health, 13 states currently have trigger laws on the books that make abortion illegal in the absence of Roe. Nine other states have laws that would outlaw or severely restrict abortion without a federal right to the procedure.

Each of these laws carves out exceptions that allow the termination of a pregnancy to prevent the death of the pregnant individual. But the language of the provisions is not always precise in describing what those exceptions mean in practice, according to Elizabeth Nash, the principal policy associate for state issues at the Guttmacher Institute.

“These exceptions are designed to be extraordinarily narrow. These aren’t really designed to be usable exceptions,” Ms. Nash said. “There’s so much misinformation about abortion that there are probably legislators out there who think that it’s never needed to save a life.”
 

Tubal pregnancies

One of the best examples of a pregnancy termination that’s necessary to avoid death is in the case of an ectopic pregnancy such as Kami experienced. Without treatment to end the pregnancy, the embryo will eventually grow so large that the tube ruptures, causing massive bleeding that can kill the mother.

Most state laws regarding abortion exclude treatment of ectopic pregnancy, according to Ms. Nash. But, “if the state does not exclude ectopic pregnancy from all the regulations, then people might not be able to get the care that they need when they need it.”

The current abortion law in Texas, for example, prohibits ending a pregnancy after 6 weeks, or after cardiac activity becomes present. Cardiac activity can be present in cases of ectopic pregnancies, which account for between 1% and 2% of all pregnancies and are the leading cause of maternal deaths in the first trimester. And treatment definitely ends the life of the embryo or fetus in the fallopian tube, said Lisa Harris, MD, PhD, an ob.gyn. and medical ethicist at the University of Michigan, Ann Arbor.

Dr. Harris said she has never doubted that an ectopic pregnancy cannot possibly result in a live birth. But she recalled an encounter with another clinician on a surgical team for an ectopic pregnancy who said: “So you’re going to take it out of the tube and put it in the uterus, right?”

“It was a startling moment,” Dr. Harris recalled. She regarded the procedure as a “lifesaving, obvious surgery,” but her colleague, whose suggestion was a medical impossibility since the window of implantation is very brief after fertilization, viewed it “as an abortion, as killing an embryo or fetus.”

Dr. Harris said she isn’t concerned that physicians would stop treating ectopic pregnancies in a post-Roe world. Rather, she worries about two other possibilities: an overzealous prosecutor might not believe it was an ectopic pregnancy and press charges; or laws will cause physicians to second guess their clinical decisions for patients.

“What it means, in the middle of the night, when someone comes in with a 10-week ectopic pregnancy with a heartbeat, is the doctor may hesitate,” Dr. Harris said. Despite knowing the appropriate treatment, the doctor may want to speak with a lawyer or ethicist first to ensure they are covered legally. “And as that process unfolds, which could take hours or days, the person might have a complication.” s

Not treating an ectopic pregnancy would be malpractice, but “some doctors may not provide the standard of care that they would have ordinarily provided because they don’t want to risk breaking the law,” she said.

Even more ambiguous are cornual ectopic pregnancies, in which the implantation occurs at the junction of a fallopian tube and the uterus. These pregnancies, which make up 2%-4% of all tubal pregnancies, are immediately adjacent to the uterus. If an abortion is defined as the termination of an embryo or fetus in the womb, how such a legal definition would apply to these pregnancies is unclear.

An ob.gyn. wouldn’t regard ending an ectopic pregnancy as an abortion, but “this is not about logic or clinical meaning,” Dr. Harris said. “This is people outside of medicine making determinations that all pregnancies must continue, and when you think of a ban that way, you could see why a doctor would be frightened to end a pregnancy, whether it might be viable in the future or not.”

That’s true even if the pregnancy is located fully in the uterus. Dr. Harris described a pregnant patient she saw who had traveled from Texas to Michigan with a fetus that had a lethal defect.

The fetus had “an anomaly where the lungs couldn’t develop, where there were no kidneys. There was no chance this baby could be born and live. Her doctors were very clear that there will never be a baby that [she could] take home at the end of this pregnancy, yet they would not end her pregnancy because that would be an abortion,” Dr. Harris said.

Texas law “doesn’t make any allowances for whether a pregnancy will ever actually result in a baby or not,” Dr. Harris said. “The law, in effect, just says all pregnancies must continue.”
 

 

 

Selective reduction

How abortion laws in different states might affect selective reduction, which is used in some pregnancies to reduce the total number of fetuses a person is carrying, is even more ambiguous. The goal of selective reduction is to decrease health risks to the pregnant individual and increase the likelihood of survival for the remaining fetuses. Current Texas law prohibits these procedures.

Someone pregnant with quintuplets, for example, might seek selection reduction to reduce the pregnancy outcome to triplets or twins. A related procedure, selective termination, is used to terminate the life of a fetus with abnormalities while the pregnancy of the fetus’ in utero siblings continues.

The advent of assisted reproduction methods, such as in vitro fertilization (IVF), greatly increased the incidence of higher-order multiples, those with three or more fetuses. The first IVF baby was born in 1978. By 1998, the rate of higher-order multiple births was 1.9 per 1,000 births, five times the figure in 1980. The rate has since decreased by nearly half, to 1 per 1,000 births, but with 3.75 million live births a year, that’s still a lot of pregnancies with higher-order multiples.

The American College of Obstetricians and Gynecologists does not provide explicit guidance on when selective reduction is warranted, but its committee opinion on multifetal pregnancy reduction provides an ethical framework for providers to use when counseling people with pregnancies of three or more fetuses. How would various state laws that outlaw abortion affect these decisions? No one knows.

“Selective reduction ends the life of a fetus or embryo, but it doesn’t end the pregnancy,” Dr. Harris said. “So, if the pregnancy continues but it kills an embryo or fetus, is that an abortion?”
 

‘The question of the hour’

Dr. Harris and other doctors are haunted by potential medical cases in which continuing a pregnancy may result in the death of the person carrying the fetus but in which such death may not be so imminent that the law would allow immediate termination of the pregnancy.

Michael Northrup, MD, an intensive care pediatrician in Winston-Salem, N.C., recalled a particularly harrowing case that illustrates the peril in deciding when someone’s life is “enough” in danger to qualify as an exception to abortion bans.

The 14-year-old girl had severe lupus and kidney failure that required treatment with methotrexate and immediate dialysis to replace her electrolytes. A standard pretreatment pregnancy test revealed that she had been carrying a child for at least 10 weeks. Her pregnancy presented two problems. Methotrexate is so severely toxic that it’s sometimes used to end pregnancies. Even at low doses, fetuses that survive usually have severe deformities. In addition, dialysis requires administration of a blood thinner. If the teen miscarried while taking a blood thinner during dialysis, she risked bleeding to death.

Treatment could be delayed until week 24 of pregnancy, at which time delivery could be attempted, but the patient likely wouldn’t have any kidney function left by then. In addition, at 24 weeks, it was unlikely that the baby would survive anyway.

Dr. Northrup said that, had she chosen that route, “I’m not sure she would have made it. This was a religious family, people who very much were believers. They had their head of church come in, who fairly quickly determined that the best thing for her health was to terminate this pregnancy immediately and get the treatment she needed for her body.”

Would such a situation qualify for an emergency termination? The girl wasn’t going to die within 24 or 48 hours, but it may not have been possible to pinpoint the time of death within a day or 2.

“The family was sad, but they made that choice, and I wonder, would we have to justify that with these new laws?” Dr. Northrup said. “You definitely worry, being in the hot seat, ‘Does this count enough? Is she close enough to death?’ ”

The same question comes up when someone’s water breaks early in the second trimester. Since a live-birth delivery would be highly unlikely, given the age of the fetus, the standard of care is to offer to terminate the pregnancy to avoid a serious infection, Dr. Harris said. But if the infection hasn’t yet developed – even if it’s likely to develop soon – doctors in a state that outlaws abortion would not be able to offer termination. But as providers wait for an infection to develop, the person’s risk of dying from infection rapidly increases.

“How likely does someone need to be to die for it to count to get a life-preserving abortion?” Dr. Harris asked. “That, I think, is the question of the hour.”

Different institutions may decide to determine their own risk thresholds. One hospital, for example, may decide that any health threat that is associated with a 10% risk of death qualifies for a lifesaving abortion. But for many people, a 1 in 10 chance of dying is quite high.

“Who gets to decide what’s meaningful?” Dr. Harris asked, especially if the patient is already a parent of living children and doesn’t want to take any risk at all of orphaning them for a pregnancy with severe complications.

“The point is that this is way more complicated than anybody really knows, way more complicated than any legislator or justice could possibly know, and it creates all kinds of complicated ambiguities, some of which could result in harm to women,” she said. “I’ve been a doctor almost 30 years, and every week, sometimes every day, I’m humbled by how complicated pregnancy is and how complicated people’s bodies and life situations are.”

That’s what makes it so dangerous for policymakers to “insert themselves into medical practice,” Ms. Nash said. She worries about the legal ramifications of overturning Roe, such as prosecution of people who illegally undergo an abortion or of physicians who perform a procedure that a judge deems to be in violation of abortion law.

“There are already local prosecutors who have misused the law to go after people who have managed their own abortions,” Ms. Nash said. “Criminal abortion law, fetal homicide, child neglect, practicing medicine without a license – these are things people have actually been arrested and convicted under.”

Some laws may target the person seeking an abortion, whereas others may target clinicians providing abortions, or even people who simply help someone obtain an abortion, as the Texas law does. In Dr. Harris’s own state of Michigan, a group of Republican lawmakers recently introduced a bill that would imprison abortion providers for up to 10 years and anyone creating or distributing abortion medication for up to 20 years.

Michigan Gov. Gretchen Whitmer, a Democrat who called the proposed legislation “disturbing” and “infuriating,” would almost certainly veto the bill, but it’s just one of dozens already filed or that are expected to be filed across the United States.

The antiabortion organization National Right to Life has published a “post-Roe model abortion law” for states to adopt. The model includes an exemption for abortions that, “based on reasonable medical judgment, [were] necessary to prevent the death of the pregnant woman” – but, again, it does not clarify what that means in practice.
 

 

 

Lectures from strangers

Four years after nearly dying, Kami gave birth to a healthy girl following an uncomplicated pregnancy. But her journey to having more children presented more challenges.

Two years after the birth of her child, she had another ectopic pregnancy. Her doctor sent her prescriptions for medication that would end this pregnancy, but a pharmacist refused to fill the prescription.

“Do you know these are very serious medications?” the pharmacist asked her. She did – she had taken them once before for another ectopic pregnancy. She was with her daughter, feeling devastated about losing yet another desired pregnancy. She simply wanted to get the medication and go home.

“‘So you’re trying to have a cheap abortion,’ he said, and 30 heads turned and looked at me. The whole pharmacy heard,” Kami said.

She told the pharmacist that she’d miscarried. She said he responded with: “So you have a dead baby in your body.”

Even after her doctor called to insist on filling the order, the man refused to fill it.

Kami left without the prescription, and her doctor performed a surgical dilation and curettage to remove the embryo from her fallopian tube for no fee.

Kami later tried again to have more children. She experienced another ruptured tube that she said nearly killed her.

“There was such a sense of pain knowing that I couldn’t have any more kids, but also the relief of knowing that I don’t have to go through this again,” Kami said. Now, however, with the Supreme Court having overturned Roe v. Wade, she has a new worry: “That my daughter will not have the same rights and access to health care that I did.”

A version of this article first appeared on Medscape.com.

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Kami, a mother of one daughter in central Texas, lost three pregnancies in 2008. The third one nearly killed her.

The embryo became implanted in one of the fallopian tubes connecting her ovaries to her uterus. Because fallopian tubes can’t stretch to accommodate a fetus, patients must undergo surgery to remove the embryo before the tube ruptures. Failure to do so can result in internal bleeding and death.

But when Kami – who did not want to use her last name to avoid harassment – underwent an ultrasound to start the process of extracting the embryo, her doctor miscalculated how far along in the pregnancy she was and told her to come back in a few weeks.

She eventually did return, but only after passing out in the bathtub and waking up in a pool of her own blood. The tube had ruptured, and to remove it, emergency surgery was necessary.

Stories such as Kami’s could become more common in the aftermath of the U.S. Supreme Court’s decision to overturn Roe v. Wade, the 1973 case that created a right to an abortion.

Experts fear that antiabortion laws that take effect in the United States following the court’s decision will lead to a medical and legal limbo for thousands of people like Kami – people with uncommon reproductive conditions whose treatments involve the termination of pregnancies or the destruction of embryos.
 

Vague exceptions prompt concerns

According to the Guttmacher Institute, a nonprofit group for reproductive health, 13 states currently have trigger laws on the books that make abortion illegal in the absence of Roe. Nine other states have laws that would outlaw or severely restrict abortion without a federal right to the procedure.

Each of these laws carves out exceptions that allow the termination of a pregnancy to prevent the death of the pregnant individual. But the language of the provisions is not always precise in describing what those exceptions mean in practice, according to Elizabeth Nash, the principal policy associate for state issues at the Guttmacher Institute.

“These exceptions are designed to be extraordinarily narrow. These aren’t really designed to be usable exceptions,” Ms. Nash said. “There’s so much misinformation about abortion that there are probably legislators out there who think that it’s never needed to save a life.”
 

Tubal pregnancies

One of the best examples of a pregnancy termination that’s necessary to avoid death is in the case of an ectopic pregnancy such as Kami experienced. Without treatment to end the pregnancy, the embryo will eventually grow so large that the tube ruptures, causing massive bleeding that can kill the mother.

Most state laws regarding abortion exclude treatment of ectopic pregnancy, according to Ms. Nash. But, “if the state does not exclude ectopic pregnancy from all the regulations, then people might not be able to get the care that they need when they need it.”

The current abortion law in Texas, for example, prohibits ending a pregnancy after 6 weeks, or after cardiac activity becomes present. Cardiac activity can be present in cases of ectopic pregnancies, which account for between 1% and 2% of all pregnancies and are the leading cause of maternal deaths in the first trimester. And treatment definitely ends the life of the embryo or fetus in the fallopian tube, said Lisa Harris, MD, PhD, an ob.gyn. and medical ethicist at the University of Michigan, Ann Arbor.

Dr. Harris said she has never doubted that an ectopic pregnancy cannot possibly result in a live birth. But she recalled an encounter with another clinician on a surgical team for an ectopic pregnancy who said: “So you’re going to take it out of the tube and put it in the uterus, right?”

“It was a startling moment,” Dr. Harris recalled. She regarded the procedure as a “lifesaving, obvious surgery,” but her colleague, whose suggestion was a medical impossibility since the window of implantation is very brief after fertilization, viewed it “as an abortion, as killing an embryo or fetus.”

Dr. Harris said she isn’t concerned that physicians would stop treating ectopic pregnancies in a post-Roe world. Rather, she worries about two other possibilities: an overzealous prosecutor might not believe it was an ectopic pregnancy and press charges; or laws will cause physicians to second guess their clinical decisions for patients.

“What it means, in the middle of the night, when someone comes in with a 10-week ectopic pregnancy with a heartbeat, is the doctor may hesitate,” Dr. Harris said. Despite knowing the appropriate treatment, the doctor may want to speak with a lawyer or ethicist first to ensure they are covered legally. “And as that process unfolds, which could take hours or days, the person might have a complication.” s

Not treating an ectopic pregnancy would be malpractice, but “some doctors may not provide the standard of care that they would have ordinarily provided because they don’t want to risk breaking the law,” she said.

Even more ambiguous are cornual ectopic pregnancies, in which the implantation occurs at the junction of a fallopian tube and the uterus. These pregnancies, which make up 2%-4% of all tubal pregnancies, are immediately adjacent to the uterus. If an abortion is defined as the termination of an embryo or fetus in the womb, how such a legal definition would apply to these pregnancies is unclear.

An ob.gyn. wouldn’t regard ending an ectopic pregnancy as an abortion, but “this is not about logic or clinical meaning,” Dr. Harris said. “This is people outside of medicine making determinations that all pregnancies must continue, and when you think of a ban that way, you could see why a doctor would be frightened to end a pregnancy, whether it might be viable in the future or not.”

That’s true even if the pregnancy is located fully in the uterus. Dr. Harris described a pregnant patient she saw who had traveled from Texas to Michigan with a fetus that had a lethal defect.

The fetus had “an anomaly where the lungs couldn’t develop, where there were no kidneys. There was no chance this baby could be born and live. Her doctors were very clear that there will never be a baby that [she could] take home at the end of this pregnancy, yet they would not end her pregnancy because that would be an abortion,” Dr. Harris said.

Texas law “doesn’t make any allowances for whether a pregnancy will ever actually result in a baby or not,” Dr. Harris said. “The law, in effect, just says all pregnancies must continue.”
 

 

 

Selective reduction

How abortion laws in different states might affect selective reduction, which is used in some pregnancies to reduce the total number of fetuses a person is carrying, is even more ambiguous. The goal of selective reduction is to decrease health risks to the pregnant individual and increase the likelihood of survival for the remaining fetuses. Current Texas law prohibits these procedures.

Someone pregnant with quintuplets, for example, might seek selection reduction to reduce the pregnancy outcome to triplets or twins. A related procedure, selective termination, is used to terminate the life of a fetus with abnormalities while the pregnancy of the fetus’ in utero siblings continues.

The advent of assisted reproduction methods, such as in vitro fertilization (IVF), greatly increased the incidence of higher-order multiples, those with three or more fetuses. The first IVF baby was born in 1978. By 1998, the rate of higher-order multiple births was 1.9 per 1,000 births, five times the figure in 1980. The rate has since decreased by nearly half, to 1 per 1,000 births, but with 3.75 million live births a year, that’s still a lot of pregnancies with higher-order multiples.

The American College of Obstetricians and Gynecologists does not provide explicit guidance on when selective reduction is warranted, but its committee opinion on multifetal pregnancy reduction provides an ethical framework for providers to use when counseling people with pregnancies of three or more fetuses. How would various state laws that outlaw abortion affect these decisions? No one knows.

“Selective reduction ends the life of a fetus or embryo, but it doesn’t end the pregnancy,” Dr. Harris said. “So, if the pregnancy continues but it kills an embryo or fetus, is that an abortion?”
 

‘The question of the hour’

Dr. Harris and other doctors are haunted by potential medical cases in which continuing a pregnancy may result in the death of the person carrying the fetus but in which such death may not be so imminent that the law would allow immediate termination of the pregnancy.

Michael Northrup, MD, an intensive care pediatrician in Winston-Salem, N.C., recalled a particularly harrowing case that illustrates the peril in deciding when someone’s life is “enough” in danger to qualify as an exception to abortion bans.

The 14-year-old girl had severe lupus and kidney failure that required treatment with methotrexate and immediate dialysis to replace her electrolytes. A standard pretreatment pregnancy test revealed that she had been carrying a child for at least 10 weeks. Her pregnancy presented two problems. Methotrexate is so severely toxic that it’s sometimes used to end pregnancies. Even at low doses, fetuses that survive usually have severe deformities. In addition, dialysis requires administration of a blood thinner. If the teen miscarried while taking a blood thinner during dialysis, she risked bleeding to death.

Treatment could be delayed until week 24 of pregnancy, at which time delivery could be attempted, but the patient likely wouldn’t have any kidney function left by then. In addition, at 24 weeks, it was unlikely that the baby would survive anyway.

Dr. Northrup said that, had she chosen that route, “I’m not sure she would have made it. This was a religious family, people who very much were believers. They had their head of church come in, who fairly quickly determined that the best thing for her health was to terminate this pregnancy immediately and get the treatment she needed for her body.”

Would such a situation qualify for an emergency termination? The girl wasn’t going to die within 24 or 48 hours, but it may not have been possible to pinpoint the time of death within a day or 2.

“The family was sad, but they made that choice, and I wonder, would we have to justify that with these new laws?” Dr. Northrup said. “You definitely worry, being in the hot seat, ‘Does this count enough? Is she close enough to death?’ ”

The same question comes up when someone’s water breaks early in the second trimester. Since a live-birth delivery would be highly unlikely, given the age of the fetus, the standard of care is to offer to terminate the pregnancy to avoid a serious infection, Dr. Harris said. But if the infection hasn’t yet developed – even if it’s likely to develop soon – doctors in a state that outlaws abortion would not be able to offer termination. But as providers wait for an infection to develop, the person’s risk of dying from infection rapidly increases.

“How likely does someone need to be to die for it to count to get a life-preserving abortion?” Dr. Harris asked. “That, I think, is the question of the hour.”

Different institutions may decide to determine their own risk thresholds. One hospital, for example, may decide that any health threat that is associated with a 10% risk of death qualifies for a lifesaving abortion. But for many people, a 1 in 10 chance of dying is quite high.

“Who gets to decide what’s meaningful?” Dr. Harris asked, especially if the patient is already a parent of living children and doesn’t want to take any risk at all of orphaning them for a pregnancy with severe complications.

“The point is that this is way more complicated than anybody really knows, way more complicated than any legislator or justice could possibly know, and it creates all kinds of complicated ambiguities, some of which could result in harm to women,” she said. “I’ve been a doctor almost 30 years, and every week, sometimes every day, I’m humbled by how complicated pregnancy is and how complicated people’s bodies and life situations are.”

That’s what makes it so dangerous for policymakers to “insert themselves into medical practice,” Ms. Nash said. She worries about the legal ramifications of overturning Roe, such as prosecution of people who illegally undergo an abortion or of physicians who perform a procedure that a judge deems to be in violation of abortion law.

“There are already local prosecutors who have misused the law to go after people who have managed their own abortions,” Ms. Nash said. “Criminal abortion law, fetal homicide, child neglect, practicing medicine without a license – these are things people have actually been arrested and convicted under.”

Some laws may target the person seeking an abortion, whereas others may target clinicians providing abortions, or even people who simply help someone obtain an abortion, as the Texas law does. In Dr. Harris’s own state of Michigan, a group of Republican lawmakers recently introduced a bill that would imprison abortion providers for up to 10 years and anyone creating or distributing abortion medication for up to 20 years.

Michigan Gov. Gretchen Whitmer, a Democrat who called the proposed legislation “disturbing” and “infuriating,” would almost certainly veto the bill, but it’s just one of dozens already filed or that are expected to be filed across the United States.

The antiabortion organization National Right to Life has published a “post-Roe model abortion law” for states to adopt. The model includes an exemption for abortions that, “based on reasonable medical judgment, [were] necessary to prevent the death of the pregnant woman” – but, again, it does not clarify what that means in practice.
 

 

 

Lectures from strangers

Four years after nearly dying, Kami gave birth to a healthy girl following an uncomplicated pregnancy. But her journey to having more children presented more challenges.

Two years after the birth of her child, she had another ectopic pregnancy. Her doctor sent her prescriptions for medication that would end this pregnancy, but a pharmacist refused to fill the prescription.

“Do you know these are very serious medications?” the pharmacist asked her. She did – she had taken them once before for another ectopic pregnancy. She was with her daughter, feeling devastated about losing yet another desired pregnancy. She simply wanted to get the medication and go home.

“‘So you’re trying to have a cheap abortion,’ he said, and 30 heads turned and looked at me. The whole pharmacy heard,” Kami said.

She told the pharmacist that she’d miscarried. She said he responded with: “So you have a dead baby in your body.”

Even after her doctor called to insist on filling the order, the man refused to fill it.

Kami left without the prescription, and her doctor performed a surgical dilation and curettage to remove the embryo from her fallopian tube for no fee.

Kami later tried again to have more children. She experienced another ruptured tube that she said nearly killed her.

“There was such a sense of pain knowing that I couldn’t have any more kids, but also the relief of knowing that I don’t have to go through this again,” Kami said. Now, however, with the Supreme Court having overturned Roe v. Wade, she has a new worry: “That my daughter will not have the same rights and access to health care that I did.”

A version of this article first appeared on Medscape.com.

Kami, a mother of one daughter in central Texas, lost three pregnancies in 2008. The third one nearly killed her.

The embryo became implanted in one of the fallopian tubes connecting her ovaries to her uterus. Because fallopian tubes can’t stretch to accommodate a fetus, patients must undergo surgery to remove the embryo before the tube ruptures. Failure to do so can result in internal bleeding and death.

But when Kami – who did not want to use her last name to avoid harassment – underwent an ultrasound to start the process of extracting the embryo, her doctor miscalculated how far along in the pregnancy she was and told her to come back in a few weeks.

She eventually did return, but only after passing out in the bathtub and waking up in a pool of her own blood. The tube had ruptured, and to remove it, emergency surgery was necessary.

Stories such as Kami’s could become more common in the aftermath of the U.S. Supreme Court’s decision to overturn Roe v. Wade, the 1973 case that created a right to an abortion.

Experts fear that antiabortion laws that take effect in the United States following the court’s decision will lead to a medical and legal limbo for thousands of people like Kami – people with uncommon reproductive conditions whose treatments involve the termination of pregnancies or the destruction of embryos.
 

Vague exceptions prompt concerns

According to the Guttmacher Institute, a nonprofit group for reproductive health, 13 states currently have trigger laws on the books that make abortion illegal in the absence of Roe. Nine other states have laws that would outlaw or severely restrict abortion without a federal right to the procedure.

Each of these laws carves out exceptions that allow the termination of a pregnancy to prevent the death of the pregnant individual. But the language of the provisions is not always precise in describing what those exceptions mean in practice, according to Elizabeth Nash, the principal policy associate for state issues at the Guttmacher Institute.

“These exceptions are designed to be extraordinarily narrow. These aren’t really designed to be usable exceptions,” Ms. Nash said. “There’s so much misinformation about abortion that there are probably legislators out there who think that it’s never needed to save a life.”
 

Tubal pregnancies

One of the best examples of a pregnancy termination that’s necessary to avoid death is in the case of an ectopic pregnancy such as Kami experienced. Without treatment to end the pregnancy, the embryo will eventually grow so large that the tube ruptures, causing massive bleeding that can kill the mother.

Most state laws regarding abortion exclude treatment of ectopic pregnancy, according to Ms. Nash. But, “if the state does not exclude ectopic pregnancy from all the regulations, then people might not be able to get the care that they need when they need it.”

The current abortion law in Texas, for example, prohibits ending a pregnancy after 6 weeks, or after cardiac activity becomes present. Cardiac activity can be present in cases of ectopic pregnancies, which account for between 1% and 2% of all pregnancies and are the leading cause of maternal deaths in the first trimester. And treatment definitely ends the life of the embryo or fetus in the fallopian tube, said Lisa Harris, MD, PhD, an ob.gyn. and medical ethicist at the University of Michigan, Ann Arbor.

Dr. Harris said she has never doubted that an ectopic pregnancy cannot possibly result in a live birth. But she recalled an encounter with another clinician on a surgical team for an ectopic pregnancy who said: “So you’re going to take it out of the tube and put it in the uterus, right?”

“It was a startling moment,” Dr. Harris recalled. She regarded the procedure as a “lifesaving, obvious surgery,” but her colleague, whose suggestion was a medical impossibility since the window of implantation is very brief after fertilization, viewed it “as an abortion, as killing an embryo or fetus.”

Dr. Harris said she isn’t concerned that physicians would stop treating ectopic pregnancies in a post-Roe world. Rather, she worries about two other possibilities: an overzealous prosecutor might not believe it was an ectopic pregnancy and press charges; or laws will cause physicians to second guess their clinical decisions for patients.

“What it means, in the middle of the night, when someone comes in with a 10-week ectopic pregnancy with a heartbeat, is the doctor may hesitate,” Dr. Harris said. Despite knowing the appropriate treatment, the doctor may want to speak with a lawyer or ethicist first to ensure they are covered legally. “And as that process unfolds, which could take hours or days, the person might have a complication.” s

Not treating an ectopic pregnancy would be malpractice, but “some doctors may not provide the standard of care that they would have ordinarily provided because they don’t want to risk breaking the law,” she said.

Even more ambiguous are cornual ectopic pregnancies, in which the implantation occurs at the junction of a fallopian tube and the uterus. These pregnancies, which make up 2%-4% of all tubal pregnancies, are immediately adjacent to the uterus. If an abortion is defined as the termination of an embryo or fetus in the womb, how such a legal definition would apply to these pregnancies is unclear.

An ob.gyn. wouldn’t regard ending an ectopic pregnancy as an abortion, but “this is not about logic or clinical meaning,” Dr. Harris said. “This is people outside of medicine making determinations that all pregnancies must continue, and when you think of a ban that way, you could see why a doctor would be frightened to end a pregnancy, whether it might be viable in the future or not.”

That’s true even if the pregnancy is located fully in the uterus. Dr. Harris described a pregnant patient she saw who had traveled from Texas to Michigan with a fetus that had a lethal defect.

The fetus had “an anomaly where the lungs couldn’t develop, where there were no kidneys. There was no chance this baby could be born and live. Her doctors were very clear that there will never be a baby that [she could] take home at the end of this pregnancy, yet they would not end her pregnancy because that would be an abortion,” Dr. Harris said.

Texas law “doesn’t make any allowances for whether a pregnancy will ever actually result in a baby or not,” Dr. Harris said. “The law, in effect, just says all pregnancies must continue.”
 

 

 

Selective reduction

How abortion laws in different states might affect selective reduction, which is used in some pregnancies to reduce the total number of fetuses a person is carrying, is even more ambiguous. The goal of selective reduction is to decrease health risks to the pregnant individual and increase the likelihood of survival for the remaining fetuses. Current Texas law prohibits these procedures.

Someone pregnant with quintuplets, for example, might seek selection reduction to reduce the pregnancy outcome to triplets or twins. A related procedure, selective termination, is used to terminate the life of a fetus with abnormalities while the pregnancy of the fetus’ in utero siblings continues.

The advent of assisted reproduction methods, such as in vitro fertilization (IVF), greatly increased the incidence of higher-order multiples, those with three or more fetuses. The first IVF baby was born in 1978. By 1998, the rate of higher-order multiple births was 1.9 per 1,000 births, five times the figure in 1980. The rate has since decreased by nearly half, to 1 per 1,000 births, but with 3.75 million live births a year, that’s still a lot of pregnancies with higher-order multiples.

The American College of Obstetricians and Gynecologists does not provide explicit guidance on when selective reduction is warranted, but its committee opinion on multifetal pregnancy reduction provides an ethical framework for providers to use when counseling people with pregnancies of three or more fetuses. How would various state laws that outlaw abortion affect these decisions? No one knows.

“Selective reduction ends the life of a fetus or embryo, but it doesn’t end the pregnancy,” Dr. Harris said. “So, if the pregnancy continues but it kills an embryo or fetus, is that an abortion?”
 

‘The question of the hour’

Dr. Harris and other doctors are haunted by potential medical cases in which continuing a pregnancy may result in the death of the person carrying the fetus but in which such death may not be so imminent that the law would allow immediate termination of the pregnancy.

Michael Northrup, MD, an intensive care pediatrician in Winston-Salem, N.C., recalled a particularly harrowing case that illustrates the peril in deciding when someone’s life is “enough” in danger to qualify as an exception to abortion bans.

The 14-year-old girl had severe lupus and kidney failure that required treatment with methotrexate and immediate dialysis to replace her electrolytes. A standard pretreatment pregnancy test revealed that she had been carrying a child for at least 10 weeks. Her pregnancy presented two problems. Methotrexate is so severely toxic that it’s sometimes used to end pregnancies. Even at low doses, fetuses that survive usually have severe deformities. In addition, dialysis requires administration of a blood thinner. If the teen miscarried while taking a blood thinner during dialysis, she risked bleeding to death.

Treatment could be delayed until week 24 of pregnancy, at which time delivery could be attempted, but the patient likely wouldn’t have any kidney function left by then. In addition, at 24 weeks, it was unlikely that the baby would survive anyway.

Dr. Northrup said that, had she chosen that route, “I’m not sure she would have made it. This was a religious family, people who very much were believers. They had their head of church come in, who fairly quickly determined that the best thing for her health was to terminate this pregnancy immediately and get the treatment she needed for her body.”

Would such a situation qualify for an emergency termination? The girl wasn’t going to die within 24 or 48 hours, but it may not have been possible to pinpoint the time of death within a day or 2.

“The family was sad, but they made that choice, and I wonder, would we have to justify that with these new laws?” Dr. Northrup said. “You definitely worry, being in the hot seat, ‘Does this count enough? Is she close enough to death?’ ”

The same question comes up when someone’s water breaks early in the second trimester. Since a live-birth delivery would be highly unlikely, given the age of the fetus, the standard of care is to offer to terminate the pregnancy to avoid a serious infection, Dr. Harris said. But if the infection hasn’t yet developed – even if it’s likely to develop soon – doctors in a state that outlaws abortion would not be able to offer termination. But as providers wait for an infection to develop, the person’s risk of dying from infection rapidly increases.

“How likely does someone need to be to die for it to count to get a life-preserving abortion?” Dr. Harris asked. “That, I think, is the question of the hour.”

Different institutions may decide to determine their own risk thresholds. One hospital, for example, may decide that any health threat that is associated with a 10% risk of death qualifies for a lifesaving abortion. But for many people, a 1 in 10 chance of dying is quite high.

“Who gets to decide what’s meaningful?” Dr. Harris asked, especially if the patient is already a parent of living children and doesn’t want to take any risk at all of orphaning them for a pregnancy with severe complications.

“The point is that this is way more complicated than anybody really knows, way more complicated than any legislator or justice could possibly know, and it creates all kinds of complicated ambiguities, some of which could result in harm to women,” she said. “I’ve been a doctor almost 30 years, and every week, sometimes every day, I’m humbled by how complicated pregnancy is and how complicated people’s bodies and life situations are.”

That’s what makes it so dangerous for policymakers to “insert themselves into medical practice,” Ms. Nash said. She worries about the legal ramifications of overturning Roe, such as prosecution of people who illegally undergo an abortion or of physicians who perform a procedure that a judge deems to be in violation of abortion law.

“There are already local prosecutors who have misused the law to go after people who have managed their own abortions,” Ms. Nash said. “Criminal abortion law, fetal homicide, child neglect, practicing medicine without a license – these are things people have actually been arrested and convicted under.”

Some laws may target the person seeking an abortion, whereas others may target clinicians providing abortions, or even people who simply help someone obtain an abortion, as the Texas law does. In Dr. Harris’s own state of Michigan, a group of Republican lawmakers recently introduced a bill that would imprison abortion providers for up to 10 years and anyone creating or distributing abortion medication for up to 20 years.

Michigan Gov. Gretchen Whitmer, a Democrat who called the proposed legislation “disturbing” and “infuriating,” would almost certainly veto the bill, but it’s just one of dozens already filed or that are expected to be filed across the United States.

The antiabortion organization National Right to Life has published a “post-Roe model abortion law” for states to adopt. The model includes an exemption for abortions that, “based on reasonable medical judgment, [were] necessary to prevent the death of the pregnant woman” – but, again, it does not clarify what that means in practice.
 

 

 

Lectures from strangers

Four years after nearly dying, Kami gave birth to a healthy girl following an uncomplicated pregnancy. But her journey to having more children presented more challenges.

Two years after the birth of her child, she had another ectopic pregnancy. Her doctor sent her prescriptions for medication that would end this pregnancy, but a pharmacist refused to fill the prescription.

“Do you know these are very serious medications?” the pharmacist asked her. She did – she had taken them once before for another ectopic pregnancy. She was with her daughter, feeling devastated about losing yet another desired pregnancy. She simply wanted to get the medication and go home.

“‘So you’re trying to have a cheap abortion,’ he said, and 30 heads turned and looked at me. The whole pharmacy heard,” Kami said.

She told the pharmacist that she’d miscarried. She said he responded with: “So you have a dead baby in your body.”

Even after her doctor called to insist on filling the order, the man refused to fill it.

Kami left without the prescription, and her doctor performed a surgical dilation and curettage to remove the embryo from her fallopian tube for no fee.

Kami later tried again to have more children. She experienced another ruptured tube that she said nearly killed her.

“There was such a sense of pain knowing that I couldn’t have any more kids, but also the relief of knowing that I don’t have to go through this again,” Kami said. Now, however, with the Supreme Court having overturned Roe v. Wade, she has a new worry: “That my daughter will not have the same rights and access to health care that I did.”

A version of this article first appeared on Medscape.com.

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Why it’s so hard to prevent physician suicide

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Mon, 06/27/2022 - 11:29

Kip Wenger, DO, an emergency physician and systems medical director of Team Health, Knoxville, Tenn., was asked to see a patient in the emergency department. He was shocked when he realized who the patient was – a 33-year-old female physician friend and colleague.

She was bleeding from multiple self-inflicted injuries and ultimately died. “I was devastated and couldn’t wrap my head around what had just happened,” Dr. Wenger told this news organization.

It’s important for physicians to be aware of warning signs in their colleagues, such as showing up late, being irritable and short-tempered with staff, missing shifts, making mistakes, or receiving an increasing number of patient complaints, Dr. Wenger says.

Dr. Wenger had had dinner with her several weeks earlier and saw some subtle changes. He had known her as a “positive, upbeat person,” but her demeanor was different during dinner.

“There were no typical telltale signs – she was talking about her plans for the future, including buying a new bicycle – but she wasn’t herself and seemed to become tearful when I hugged her at the end of the evening,” he said. He later heard from another colleague that she had shared feeling “hopeless.”
 

The scope of the problem

According to the American Society for Suicide Prevention, roughly 300-400 physicians die by suicide annually. Although one study suggests a lower number, official reports likely underestimate suicides, study author Katherine Gold, MD, MSW, associate professor of family medicine, obstetrics, and gynecology, Michigan Medicine, University of Michigan, Ann Arbor, said in an interview.

Peter Yellowlees, MD, MBBS, professor of psychiatry, University of California, Davis, concurs, suggesting that some single-car accidents involving physicians might be suicides. Perry Lin, MD, assistant clinical professor, Heritage College of Osteopathic Medicine, Ohio University, Athens, and national co-chair of the Physician Suicide Awareness Committee of the American Association of Suicidology, says that some death certificates state that the deceased died of “accidental causes” because the physician who completes the certificate, possibly a colleague, is reluctant to list the actual cause of death to protect his colleague’s memory or the family’s feelings.

In general, and among physicians, White men older than 65 “represent the largest percentage of people who die from suicide nationwide,” says Dr. Lin.

But younger people are also susceptible, Dr. Lin adds. One of the most vulnerable periods for potential suicide is during the first few months of residency. This dovetails with the findings of Medscape’s 2022 report Suicide: A Tragedy of the Profession. In that report, a difference was found between frequency of suicidal thoughts in younger physicians, compared with older physicians (14% in those < 35 years vs. 8% for those ≥ 45 years).
 

Hurdles to preventing physician suicide

“The best thing that can happen in our profession is upstream intervention – if people seek help before they get to the point of suicidality, recognizing they’re under stress and duress and that they might be going down a bad pathway,” says Dr. Lin. But research suggests that many physicians don’t do so.

Gary Price, MD, attending surgeon and clinical assistant professor of surgery, Yale–New Haven Hospital, Connecticut, and president of the Physicians Foundation, says his organization has identified barriers that prevent physicians from seeking help.

The major concern is that, in many states, licensing applications still ask whether the physician has been in treatment for a mental health condition. Physicians feel they may put their licensure at risk if they admit to receiving help for mental issues. These concerns were expressed by respondents in Medscape’s above mentioned 2022 report, many of whom didn’t seek treatment for depression, burnout, or suicidal thoughts lest it affect their professional standing when renewing their license or seeking credentialing.

Although organizations and societies are advocating against these questions, a recent study found that almost 70% of U.S. states and territories continue to ask physicians about their mental health, and 28% ask for diagnoses (beyond current impairments) – a violation of the Americans With Disabilities Act.

“Mental health illness is different from mental health impairment,” Ryan Mire, MD, a Nashville, Tenn.–based internist, said in an interview. “As physicians, we’re comfortable with licensing boards asking whether the physician has any condition that might impair their care for patients, but not about a history of mental illness.”

The second barrier, says Dr. Price, is that hospital credentialing committees sometimes ask similar questions, as do commercial and malpractice insurers.

Another roadblock is that in some states, undergoing treatment for a mental health problem could be subject to discovery by a plaintiff’s attorney in a malpractice case, even if the physician’s mental health history had no effect on patient care. But that’s uncommon, says Daniel Shapiro, PhD, author of “Delivering Doctor Amelia,” a book about his treatment of a suicidal physician who underwent a malpractice lawsuit. “I’ve never seen that happen.”

A final barrier is that many employers require employees to receive treatment within their own institution or health system. “Physicians may be reluctant to get help where they work, with colleagues and friends knowing about their illness or being involved with their care,” says Dr. Price.

In 2022, the American College of Physicians (ACP) issued a toolkit to help members encourage licensing and credentialing boards to remove questions about mental health on applications and include language that supports receiving treatment, Dr. Mire says.
 

Layers of vulnerability

There are few data regarding relative risk among particular races or ethnicities, “but we know racism is a social stressor,” says Dr. Mire. “Obviously, people from historically disadvantaged populations tend to have societal stressors like discrimination and racism that add an extra layer of burden.”

Intersectionality – having multiple intersecting risk factors – may confer even higher risk. “For example, if you’re a female physician from a historically marginalized race and a resident dealing with the ‘hidden curriculum’ of trying to be resilient, you have multiple layers of vulnerability.”

There are also limited data regarding which specialties or work environments are associated with highest risk. “Obviously, challenges exist in every segment of medicine and at different ages, stages, and work environments, and they intersect with each individual physician’s personal risk factors,” says Dr. Mire, president of the ACP and assistant clinical professor of clinical medical education, University of Tennessee Health Science Center, Memphis.

Pamela Wible, MD, is an Oregon-based retired physician who herself went through a suicidal period about 11 years into her career that motivated her to embrace a new vision of clinical practice and change her practice model. After a series of physician suicides in her area, she began to speak and write openly about physician suicide, and since her retirement from clinical practice, she makes herself available on a full-time basis to distressed physicians. “When I address a conference of a particular medical specialty or a group in a particular geographical region, I focus on the specific vulnerabilities in that specialty or region,” she says.
 

 

 

What increases the chances of suicide?

“Many factors, both within and outside the professional setting, affect someone’s decision to die by suicide – after all, physicians have the same stressors as other people, like family, finances, and their own health,” Dr. Mire says. When it comes to non–work-related factors, marital stressors and comorbid psychiatric illness particularly raise the risk, says Dr. Lin.

But certain drivers are specific to the practice of medicine, with burnout and depression first in line.

Dr. Shapiro, who is vice dean for faculty and administrative affairs, Penn State University, Hershey, and the Garner James Cline Professor of Medical Humanism, conducts burnout evaluations throughout the country. “Simple depression screeners prior to the pandemic showed about a 10% major depression rate in physicians,” he told this news organization. “Now, we’re seeing a 30%-33% depression rate, even in those who weren’t frontline providers during the pandemic.”

Dr. Price agrees, noting that burnout in physicians has gone from 40% to 60% since the pandemic. But burnout doesn’t always lead to suicide. It’s when burnout progresses to depression, becomes more severe, and is untreated that the suicidal risk arises, he emphasizes.

Additionally, being a doctor isn’t “just a profession” but a “calling and identity,” says Dr. Gold. Job-related problems (for example, a malpractice suit, complaints to the medical board, loss of autonomy, changing work demands) can raise suicidal risk.

And job-related problems can inform the location of suicide, says Dr. Wible, who is the author of “Physicians Suicide Letters – Answered.”

“A work-related catalyst makes it more likely that the person will attempt or complete suicide in the work setting. Physicians have stepped off hospital rooftops, shot or stabbed themselves in hospital parking lots, or [hanged] themselves in hospital chapels. Perhaps it’s because they’re choosing to die in the place where they’ve been most wounded.”
 

You are not at fault

“If you’re feeling suicidal, you might feel utterly alone, but if there’s one message I can give you, it’s that you’re not alone, and there are many things you can do to mitigate your pain and despair,” Dr. Wible says. “And you’re not defective. It’s the health care system that’s defective. You have nothing to be ashamed of.”

Some institutions have a “buddy system” that pairs clinicians to provide mutual peer support. A partner who notices concerning signs can refer the other partner for help. Physicians can also be paired with a “buddy,” even without a formal institutional structure.

A “buddy” is a step in the right direction, but Dr. Shapiro cautions it might be necessary to consult a trained professional for serious depression or suicidality. Several states provide connection to local resources. Employee assistance programs (EAPs) might be helpful, although many physicians don’t trust their institution’s EAP. Or physicians can ask colleagues to recommend a “doctor’s doctor” who specializes in treating physicians, suggests Dr. Yellowlees, author of “Physician Suicide: Cases and Commentaries.”

In Medscape’s 2022 report, almost all respondents who reported having suicidal colleagues said they offered help, including emotional support, practical assistance, referrals, speaking to family members, or even personally taking the colleague to the ED or to a therapist.

To enhance physicians’ ability to help each other, Dr. Lin recommends “gatekeeper training,” which has been shown to reduce suicide. “This strategy utilizes a peer-to-peer model, but, rather than a single ‘peer buddy,’ everyone is a ‘gatekeeper’ trained in approaches, such as QPR – Question, Persuade, Refer. ‘Gatekeepers’ are taught how to recognize warning signs of suicide, question the potentially suicidal individual, persuade him/her to get help, and provide referrals.”
 

Other ways to prevent suicide

Dr. Lin advises physicians to “create a personalized safety plan and write down signs and clues that they may be going down the wrong path and what they can do – like breathing exercises, relaxation – and identifying people to talk to, places to go, or phone numbers to call, if those initial measures aren’t enough.” The plan is private and allows the physician to determine at what point help is needed and who should be consulted. “Sometimes, when a person is in acute stress, even looking up a phone number can seem insurmountable. But having it on paper lowers the barrier, making it more achievable.”

Resources should be posted in places where physicians gather so that those who don’t already have a safety plan have easy access to that information, he suggests.

In addition, consideration may be given to reaching out for support if a colleague has died by suicide, experts suggest. Whether offered by one’s institution, a peer arrangement, spiritual counseling, or psychotherapy, one may need help dealing with the trauma, guilt, and grief that often accompany this type of loss.

A version of this article first appeared on Medscape.com.

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Kip Wenger, DO, an emergency physician and systems medical director of Team Health, Knoxville, Tenn., was asked to see a patient in the emergency department. He was shocked when he realized who the patient was – a 33-year-old female physician friend and colleague.

She was bleeding from multiple self-inflicted injuries and ultimately died. “I was devastated and couldn’t wrap my head around what had just happened,” Dr. Wenger told this news organization.

It’s important for physicians to be aware of warning signs in their colleagues, such as showing up late, being irritable and short-tempered with staff, missing shifts, making mistakes, or receiving an increasing number of patient complaints, Dr. Wenger says.

Dr. Wenger had had dinner with her several weeks earlier and saw some subtle changes. He had known her as a “positive, upbeat person,” but her demeanor was different during dinner.

“There were no typical telltale signs – she was talking about her plans for the future, including buying a new bicycle – but she wasn’t herself and seemed to become tearful when I hugged her at the end of the evening,” he said. He later heard from another colleague that she had shared feeling “hopeless.”
 

The scope of the problem

According to the American Society for Suicide Prevention, roughly 300-400 physicians die by suicide annually. Although one study suggests a lower number, official reports likely underestimate suicides, study author Katherine Gold, MD, MSW, associate professor of family medicine, obstetrics, and gynecology, Michigan Medicine, University of Michigan, Ann Arbor, said in an interview.

Peter Yellowlees, MD, MBBS, professor of psychiatry, University of California, Davis, concurs, suggesting that some single-car accidents involving physicians might be suicides. Perry Lin, MD, assistant clinical professor, Heritage College of Osteopathic Medicine, Ohio University, Athens, and national co-chair of the Physician Suicide Awareness Committee of the American Association of Suicidology, says that some death certificates state that the deceased died of “accidental causes” because the physician who completes the certificate, possibly a colleague, is reluctant to list the actual cause of death to protect his colleague’s memory or the family’s feelings.

In general, and among physicians, White men older than 65 “represent the largest percentage of people who die from suicide nationwide,” says Dr. Lin.

But younger people are also susceptible, Dr. Lin adds. One of the most vulnerable periods for potential suicide is during the first few months of residency. This dovetails with the findings of Medscape’s 2022 report Suicide: A Tragedy of the Profession. In that report, a difference was found between frequency of suicidal thoughts in younger physicians, compared with older physicians (14% in those < 35 years vs. 8% for those ≥ 45 years).
 

Hurdles to preventing physician suicide

“The best thing that can happen in our profession is upstream intervention – if people seek help before they get to the point of suicidality, recognizing they’re under stress and duress and that they might be going down a bad pathway,” says Dr. Lin. But research suggests that many physicians don’t do so.

Gary Price, MD, attending surgeon and clinical assistant professor of surgery, Yale–New Haven Hospital, Connecticut, and president of the Physicians Foundation, says his organization has identified barriers that prevent physicians from seeking help.

The major concern is that, in many states, licensing applications still ask whether the physician has been in treatment for a mental health condition. Physicians feel they may put their licensure at risk if they admit to receiving help for mental issues. These concerns were expressed by respondents in Medscape’s above mentioned 2022 report, many of whom didn’t seek treatment for depression, burnout, or suicidal thoughts lest it affect their professional standing when renewing their license or seeking credentialing.

Although organizations and societies are advocating against these questions, a recent study found that almost 70% of U.S. states and territories continue to ask physicians about their mental health, and 28% ask for diagnoses (beyond current impairments) – a violation of the Americans With Disabilities Act.

“Mental health illness is different from mental health impairment,” Ryan Mire, MD, a Nashville, Tenn.–based internist, said in an interview. “As physicians, we’re comfortable with licensing boards asking whether the physician has any condition that might impair their care for patients, but not about a history of mental illness.”

The second barrier, says Dr. Price, is that hospital credentialing committees sometimes ask similar questions, as do commercial and malpractice insurers.

Another roadblock is that in some states, undergoing treatment for a mental health problem could be subject to discovery by a plaintiff’s attorney in a malpractice case, even if the physician’s mental health history had no effect on patient care. But that’s uncommon, says Daniel Shapiro, PhD, author of “Delivering Doctor Amelia,” a book about his treatment of a suicidal physician who underwent a malpractice lawsuit. “I’ve never seen that happen.”

A final barrier is that many employers require employees to receive treatment within their own institution or health system. “Physicians may be reluctant to get help where they work, with colleagues and friends knowing about their illness or being involved with their care,” says Dr. Price.

In 2022, the American College of Physicians (ACP) issued a toolkit to help members encourage licensing and credentialing boards to remove questions about mental health on applications and include language that supports receiving treatment, Dr. Mire says.
 

Layers of vulnerability

There are few data regarding relative risk among particular races or ethnicities, “but we know racism is a social stressor,” says Dr. Mire. “Obviously, people from historically disadvantaged populations tend to have societal stressors like discrimination and racism that add an extra layer of burden.”

Intersectionality – having multiple intersecting risk factors – may confer even higher risk. “For example, if you’re a female physician from a historically marginalized race and a resident dealing with the ‘hidden curriculum’ of trying to be resilient, you have multiple layers of vulnerability.”

There are also limited data regarding which specialties or work environments are associated with highest risk. “Obviously, challenges exist in every segment of medicine and at different ages, stages, and work environments, and they intersect with each individual physician’s personal risk factors,” says Dr. Mire, president of the ACP and assistant clinical professor of clinical medical education, University of Tennessee Health Science Center, Memphis.

Pamela Wible, MD, is an Oregon-based retired physician who herself went through a suicidal period about 11 years into her career that motivated her to embrace a new vision of clinical practice and change her practice model. After a series of physician suicides in her area, she began to speak and write openly about physician suicide, and since her retirement from clinical practice, she makes herself available on a full-time basis to distressed physicians. “When I address a conference of a particular medical specialty or a group in a particular geographical region, I focus on the specific vulnerabilities in that specialty or region,” she says.
 

 

 

What increases the chances of suicide?

“Many factors, both within and outside the professional setting, affect someone’s decision to die by suicide – after all, physicians have the same stressors as other people, like family, finances, and their own health,” Dr. Mire says. When it comes to non–work-related factors, marital stressors and comorbid psychiatric illness particularly raise the risk, says Dr. Lin.

But certain drivers are specific to the practice of medicine, with burnout and depression first in line.

Dr. Shapiro, who is vice dean for faculty and administrative affairs, Penn State University, Hershey, and the Garner James Cline Professor of Medical Humanism, conducts burnout evaluations throughout the country. “Simple depression screeners prior to the pandemic showed about a 10% major depression rate in physicians,” he told this news organization. “Now, we’re seeing a 30%-33% depression rate, even in those who weren’t frontline providers during the pandemic.”

Dr. Price agrees, noting that burnout in physicians has gone from 40% to 60% since the pandemic. But burnout doesn’t always lead to suicide. It’s when burnout progresses to depression, becomes more severe, and is untreated that the suicidal risk arises, he emphasizes.

Additionally, being a doctor isn’t “just a profession” but a “calling and identity,” says Dr. Gold. Job-related problems (for example, a malpractice suit, complaints to the medical board, loss of autonomy, changing work demands) can raise suicidal risk.

And job-related problems can inform the location of suicide, says Dr. Wible, who is the author of “Physicians Suicide Letters – Answered.”

“A work-related catalyst makes it more likely that the person will attempt or complete suicide in the work setting. Physicians have stepped off hospital rooftops, shot or stabbed themselves in hospital parking lots, or [hanged] themselves in hospital chapels. Perhaps it’s because they’re choosing to die in the place where they’ve been most wounded.”
 

You are not at fault

“If you’re feeling suicidal, you might feel utterly alone, but if there’s one message I can give you, it’s that you’re not alone, and there are many things you can do to mitigate your pain and despair,” Dr. Wible says. “And you’re not defective. It’s the health care system that’s defective. You have nothing to be ashamed of.”

Some institutions have a “buddy system” that pairs clinicians to provide mutual peer support. A partner who notices concerning signs can refer the other partner for help. Physicians can also be paired with a “buddy,” even without a formal institutional structure.

A “buddy” is a step in the right direction, but Dr. Shapiro cautions it might be necessary to consult a trained professional for serious depression or suicidality. Several states provide connection to local resources. Employee assistance programs (EAPs) might be helpful, although many physicians don’t trust their institution’s EAP. Or physicians can ask colleagues to recommend a “doctor’s doctor” who specializes in treating physicians, suggests Dr. Yellowlees, author of “Physician Suicide: Cases and Commentaries.”

In Medscape’s 2022 report, almost all respondents who reported having suicidal colleagues said they offered help, including emotional support, practical assistance, referrals, speaking to family members, or even personally taking the colleague to the ED or to a therapist.

To enhance physicians’ ability to help each other, Dr. Lin recommends “gatekeeper training,” which has been shown to reduce suicide. “This strategy utilizes a peer-to-peer model, but, rather than a single ‘peer buddy,’ everyone is a ‘gatekeeper’ trained in approaches, such as QPR – Question, Persuade, Refer. ‘Gatekeepers’ are taught how to recognize warning signs of suicide, question the potentially suicidal individual, persuade him/her to get help, and provide referrals.”
 

Other ways to prevent suicide

Dr. Lin advises physicians to “create a personalized safety plan and write down signs and clues that they may be going down the wrong path and what they can do – like breathing exercises, relaxation – and identifying people to talk to, places to go, or phone numbers to call, if those initial measures aren’t enough.” The plan is private and allows the physician to determine at what point help is needed and who should be consulted. “Sometimes, when a person is in acute stress, even looking up a phone number can seem insurmountable. But having it on paper lowers the barrier, making it more achievable.”

Resources should be posted in places where physicians gather so that those who don’t already have a safety plan have easy access to that information, he suggests.

In addition, consideration may be given to reaching out for support if a colleague has died by suicide, experts suggest. Whether offered by one’s institution, a peer arrangement, spiritual counseling, or psychotherapy, one may need help dealing with the trauma, guilt, and grief that often accompany this type of loss.

A version of this article first appeared on Medscape.com.

Kip Wenger, DO, an emergency physician and systems medical director of Team Health, Knoxville, Tenn., was asked to see a patient in the emergency department. He was shocked when he realized who the patient was – a 33-year-old female physician friend and colleague.

She was bleeding from multiple self-inflicted injuries and ultimately died. “I was devastated and couldn’t wrap my head around what had just happened,” Dr. Wenger told this news organization.

It’s important for physicians to be aware of warning signs in their colleagues, such as showing up late, being irritable and short-tempered with staff, missing shifts, making mistakes, or receiving an increasing number of patient complaints, Dr. Wenger says.

Dr. Wenger had had dinner with her several weeks earlier and saw some subtle changes. He had known her as a “positive, upbeat person,” but her demeanor was different during dinner.

“There were no typical telltale signs – she was talking about her plans for the future, including buying a new bicycle – but she wasn’t herself and seemed to become tearful when I hugged her at the end of the evening,” he said. He later heard from another colleague that she had shared feeling “hopeless.”
 

The scope of the problem

According to the American Society for Suicide Prevention, roughly 300-400 physicians die by suicide annually. Although one study suggests a lower number, official reports likely underestimate suicides, study author Katherine Gold, MD, MSW, associate professor of family medicine, obstetrics, and gynecology, Michigan Medicine, University of Michigan, Ann Arbor, said in an interview.

Peter Yellowlees, MD, MBBS, professor of psychiatry, University of California, Davis, concurs, suggesting that some single-car accidents involving physicians might be suicides. Perry Lin, MD, assistant clinical professor, Heritage College of Osteopathic Medicine, Ohio University, Athens, and national co-chair of the Physician Suicide Awareness Committee of the American Association of Suicidology, says that some death certificates state that the deceased died of “accidental causes” because the physician who completes the certificate, possibly a colleague, is reluctant to list the actual cause of death to protect his colleague’s memory or the family’s feelings.

In general, and among physicians, White men older than 65 “represent the largest percentage of people who die from suicide nationwide,” says Dr. Lin.

But younger people are also susceptible, Dr. Lin adds. One of the most vulnerable periods for potential suicide is during the first few months of residency. This dovetails with the findings of Medscape’s 2022 report Suicide: A Tragedy of the Profession. In that report, a difference was found between frequency of suicidal thoughts in younger physicians, compared with older physicians (14% in those < 35 years vs. 8% for those ≥ 45 years).
 

Hurdles to preventing physician suicide

“The best thing that can happen in our profession is upstream intervention – if people seek help before they get to the point of suicidality, recognizing they’re under stress and duress and that they might be going down a bad pathway,” says Dr. Lin. But research suggests that many physicians don’t do so.

Gary Price, MD, attending surgeon and clinical assistant professor of surgery, Yale–New Haven Hospital, Connecticut, and president of the Physicians Foundation, says his organization has identified barriers that prevent physicians from seeking help.

The major concern is that, in many states, licensing applications still ask whether the physician has been in treatment for a mental health condition. Physicians feel they may put their licensure at risk if they admit to receiving help for mental issues. These concerns were expressed by respondents in Medscape’s above mentioned 2022 report, many of whom didn’t seek treatment for depression, burnout, or suicidal thoughts lest it affect their professional standing when renewing their license or seeking credentialing.

Although organizations and societies are advocating against these questions, a recent study found that almost 70% of U.S. states and territories continue to ask physicians about their mental health, and 28% ask for diagnoses (beyond current impairments) – a violation of the Americans With Disabilities Act.

“Mental health illness is different from mental health impairment,” Ryan Mire, MD, a Nashville, Tenn.–based internist, said in an interview. “As physicians, we’re comfortable with licensing boards asking whether the physician has any condition that might impair their care for patients, but not about a history of mental illness.”

The second barrier, says Dr. Price, is that hospital credentialing committees sometimes ask similar questions, as do commercial and malpractice insurers.

Another roadblock is that in some states, undergoing treatment for a mental health problem could be subject to discovery by a plaintiff’s attorney in a malpractice case, even if the physician’s mental health history had no effect on patient care. But that’s uncommon, says Daniel Shapiro, PhD, author of “Delivering Doctor Amelia,” a book about his treatment of a suicidal physician who underwent a malpractice lawsuit. “I’ve never seen that happen.”

A final barrier is that many employers require employees to receive treatment within their own institution or health system. “Physicians may be reluctant to get help where they work, with colleagues and friends knowing about their illness or being involved with their care,” says Dr. Price.

In 2022, the American College of Physicians (ACP) issued a toolkit to help members encourage licensing and credentialing boards to remove questions about mental health on applications and include language that supports receiving treatment, Dr. Mire says.
 

Layers of vulnerability

There are few data regarding relative risk among particular races or ethnicities, “but we know racism is a social stressor,” says Dr. Mire. “Obviously, people from historically disadvantaged populations tend to have societal stressors like discrimination and racism that add an extra layer of burden.”

Intersectionality – having multiple intersecting risk factors – may confer even higher risk. “For example, if you’re a female physician from a historically marginalized race and a resident dealing with the ‘hidden curriculum’ of trying to be resilient, you have multiple layers of vulnerability.”

There are also limited data regarding which specialties or work environments are associated with highest risk. “Obviously, challenges exist in every segment of medicine and at different ages, stages, and work environments, and they intersect with each individual physician’s personal risk factors,” says Dr. Mire, president of the ACP and assistant clinical professor of clinical medical education, University of Tennessee Health Science Center, Memphis.

Pamela Wible, MD, is an Oregon-based retired physician who herself went through a suicidal period about 11 years into her career that motivated her to embrace a new vision of clinical practice and change her practice model. After a series of physician suicides in her area, she began to speak and write openly about physician suicide, and since her retirement from clinical practice, she makes herself available on a full-time basis to distressed physicians. “When I address a conference of a particular medical specialty or a group in a particular geographical region, I focus on the specific vulnerabilities in that specialty or region,” she says.
 

 

 

What increases the chances of suicide?

“Many factors, both within and outside the professional setting, affect someone’s decision to die by suicide – after all, physicians have the same stressors as other people, like family, finances, and their own health,” Dr. Mire says. When it comes to non–work-related factors, marital stressors and comorbid psychiatric illness particularly raise the risk, says Dr. Lin.

But certain drivers are specific to the practice of medicine, with burnout and depression first in line.

Dr. Shapiro, who is vice dean for faculty and administrative affairs, Penn State University, Hershey, and the Garner James Cline Professor of Medical Humanism, conducts burnout evaluations throughout the country. “Simple depression screeners prior to the pandemic showed about a 10% major depression rate in physicians,” he told this news organization. “Now, we’re seeing a 30%-33% depression rate, even in those who weren’t frontline providers during the pandemic.”

Dr. Price agrees, noting that burnout in physicians has gone from 40% to 60% since the pandemic. But burnout doesn’t always lead to suicide. It’s when burnout progresses to depression, becomes more severe, and is untreated that the suicidal risk arises, he emphasizes.

Additionally, being a doctor isn’t “just a profession” but a “calling and identity,” says Dr. Gold. Job-related problems (for example, a malpractice suit, complaints to the medical board, loss of autonomy, changing work demands) can raise suicidal risk.

And job-related problems can inform the location of suicide, says Dr. Wible, who is the author of “Physicians Suicide Letters – Answered.”

“A work-related catalyst makes it more likely that the person will attempt or complete suicide in the work setting. Physicians have stepped off hospital rooftops, shot or stabbed themselves in hospital parking lots, or [hanged] themselves in hospital chapels. Perhaps it’s because they’re choosing to die in the place where they’ve been most wounded.”
 

You are not at fault

“If you’re feeling suicidal, you might feel utterly alone, but if there’s one message I can give you, it’s that you’re not alone, and there are many things you can do to mitigate your pain and despair,” Dr. Wible says. “And you’re not defective. It’s the health care system that’s defective. You have nothing to be ashamed of.”

Some institutions have a “buddy system” that pairs clinicians to provide mutual peer support. A partner who notices concerning signs can refer the other partner for help. Physicians can also be paired with a “buddy,” even without a formal institutional structure.

A “buddy” is a step in the right direction, but Dr. Shapiro cautions it might be necessary to consult a trained professional for serious depression or suicidality. Several states provide connection to local resources. Employee assistance programs (EAPs) might be helpful, although many physicians don’t trust their institution’s EAP. Or physicians can ask colleagues to recommend a “doctor’s doctor” who specializes in treating physicians, suggests Dr. Yellowlees, author of “Physician Suicide: Cases and Commentaries.”

In Medscape’s 2022 report, almost all respondents who reported having suicidal colleagues said they offered help, including emotional support, practical assistance, referrals, speaking to family members, or even personally taking the colleague to the ED or to a therapist.

To enhance physicians’ ability to help each other, Dr. Lin recommends “gatekeeper training,” which has been shown to reduce suicide. “This strategy utilizes a peer-to-peer model, but, rather than a single ‘peer buddy,’ everyone is a ‘gatekeeper’ trained in approaches, such as QPR – Question, Persuade, Refer. ‘Gatekeepers’ are taught how to recognize warning signs of suicide, question the potentially suicidal individual, persuade him/her to get help, and provide referrals.”
 

Other ways to prevent suicide

Dr. Lin advises physicians to “create a personalized safety plan and write down signs and clues that they may be going down the wrong path and what they can do – like breathing exercises, relaxation – and identifying people to talk to, places to go, or phone numbers to call, if those initial measures aren’t enough.” The plan is private and allows the physician to determine at what point help is needed and who should be consulted. “Sometimes, when a person is in acute stress, even looking up a phone number can seem insurmountable. But having it on paper lowers the barrier, making it more achievable.”

Resources should be posted in places where physicians gather so that those who don’t already have a safety plan have easy access to that information, he suggests.

In addition, consideration may be given to reaching out for support if a colleague has died by suicide, experts suggest. Whether offered by one’s institution, a peer arrangement, spiritual counseling, or psychotherapy, one may need help dealing with the trauma, guilt, and grief that often accompany this type of loss.

A version of this article first appeared on Medscape.com.

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Antibiotics during pregnancy may increase child’s risk for asthma and other atopic diseases

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Children born to mothers who take antibiotics during pregnancy may be at an increased risk of developing pediatric asthma and other diseases involved in the atopic march, a systematic review and meta-analysis reports.

“Antibiotic use during pregnancy is significantly associated with the development of asthma in children. Additionally prenatal antibiotic exposure is also associated with disorders present in the atopic march including atopic sensitization, dermatitis/eczema, food allergy, allergic rhinitis, and wheeze,” lead study author Alissa Cait, PhD, of Malaghan Institute of Medical Research in Wellington, New Zealand, and colleagues write in Allergy.

“Antibiotics account for 80% of prescribed medications during pregnancy, and it is estimated that 20%-25% of pregnant women receive at least one course of an antibiotic during this time period,” they add.

The researchers evaluated prenatal antibiotic exposure and the risk for childhood wheeze or asthma, as well as for diseases associated with the atopic march, by searching standard medical databases for controlled trials in English, German, French, Dutch, or Arabic involving the use of any antibiotic at any time during pregnancy and for atopic disease incidence in children with asthma or wheeze as primary outcome. They excluded reviews, preclinical data, and descriptive studies.

From the 6,060 citations the search returned, 11 prospective and 16 retrospective studies met the authors’ selection criteria. For each study, they evaluated risk of bias using the Newcastle-Ottawa Quality Assessment Scale, and they rated certainty of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol.

The studies, published between 2002 and 2020, were conducted in Europe, North America, Asia, and South America. Exposure to antibiotics during the prenatal period was assessed through unsupervised questionnaires, interviews by medical professionals, or extraction from official medical databases.

The results showed that:

  • Antibiotic use during pregnancy was linked with increased relative risk of developing wheeze (relative risk, 1.51; 95% confidence interval, 1.17-1.94) or asthma (RR, 1.28; 95% CI, 1.22-1.34) during childhood.
  • Antibiotic use during pregnancy also increased a child’s risk for eczema or dermatitis (RR, 1.28; 95% CI, 1.06-1.53) and allergic rhinitis (RR, 1.13; 95% CI, 1.02-1.25).
  • Food allergy increased in one study (RR, 1.81; 95% CI, 1.11-2.95).

Quality of studies

“These results have importance for antibiotic stewardship throughout the prenatal period,” the authors write. However, due to issues including high heterogeneity, publication bias, and lack of population numbers in some studies, the overall quality of the evidence presented in the studies was low. Other limitations include mainly White and European study populations, underpowered studies, and study protocol inconsistencies.

“Though there is evidence that antibiotic treatment during pregnancy is a driver of the atopic march, due to a large heterogeneity between studies more research is needed to draw firm conclusions on this matter,” the authors add. “Future studies should employ and report more direct and objective measurement methods rather than self-reported questionnaires.”

Dustin D. Flannery, DO, MSCE, a neonatologist and clinical researcher in perinatal infectious diseases and neonatal antimicrobial resistance and stewardship at Children’s Hospital of Philadelphia, said in an email that the study was well done.

He noted, though, that “although the study reports an association, it cannot prove causation. The relationship between prenatal antibiotics and childhood allergic disorders is likely multifactorial and quite complex.”

He joins the authors in recommending further related research. “Due to the variation in how exposures and outcomes were defined across the studies, more rigorous research will be needed in this area.”

Despite the study’s limitations, “given that some studies have found associations between prenatal antibiotic exposure and childhood atopic and allergic disorders, including asthma, while other studies have not, this systematic review and meta-analysis asks an important question,” Dr. Flannery, who was not involved in the study, said in an interview.

“Investigators found a strong association between prenatal antibiotic exposure and risk of childhood asthma and other disorders,” he said. “This finding supports efforts to safely reduce antibiotic use during pregnancy.”

The study was supported by the Deutsche Forschungsgemeinschaft and by the Konrad Adenauer Foundation. The authors and Dr. Flannery have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Children born to mothers who take antibiotics during pregnancy may be at an increased risk of developing pediatric asthma and other diseases involved in the atopic march, a systematic review and meta-analysis reports.

“Antibiotic use during pregnancy is significantly associated with the development of asthma in children. Additionally prenatal antibiotic exposure is also associated with disorders present in the atopic march including atopic sensitization, dermatitis/eczema, food allergy, allergic rhinitis, and wheeze,” lead study author Alissa Cait, PhD, of Malaghan Institute of Medical Research in Wellington, New Zealand, and colleagues write in Allergy.

“Antibiotics account for 80% of prescribed medications during pregnancy, and it is estimated that 20%-25% of pregnant women receive at least one course of an antibiotic during this time period,” they add.

The researchers evaluated prenatal antibiotic exposure and the risk for childhood wheeze or asthma, as well as for diseases associated with the atopic march, by searching standard medical databases for controlled trials in English, German, French, Dutch, or Arabic involving the use of any antibiotic at any time during pregnancy and for atopic disease incidence in children with asthma or wheeze as primary outcome. They excluded reviews, preclinical data, and descriptive studies.

From the 6,060 citations the search returned, 11 prospective and 16 retrospective studies met the authors’ selection criteria. For each study, they evaluated risk of bias using the Newcastle-Ottawa Quality Assessment Scale, and they rated certainty of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol.

The studies, published between 2002 and 2020, were conducted in Europe, North America, Asia, and South America. Exposure to antibiotics during the prenatal period was assessed through unsupervised questionnaires, interviews by medical professionals, or extraction from official medical databases.

The results showed that:

  • Antibiotic use during pregnancy was linked with increased relative risk of developing wheeze (relative risk, 1.51; 95% confidence interval, 1.17-1.94) or asthma (RR, 1.28; 95% CI, 1.22-1.34) during childhood.
  • Antibiotic use during pregnancy also increased a child’s risk for eczema or dermatitis (RR, 1.28; 95% CI, 1.06-1.53) and allergic rhinitis (RR, 1.13; 95% CI, 1.02-1.25).
  • Food allergy increased in one study (RR, 1.81; 95% CI, 1.11-2.95).

Quality of studies

“These results have importance for antibiotic stewardship throughout the prenatal period,” the authors write. However, due to issues including high heterogeneity, publication bias, and lack of population numbers in some studies, the overall quality of the evidence presented in the studies was low. Other limitations include mainly White and European study populations, underpowered studies, and study protocol inconsistencies.

“Though there is evidence that antibiotic treatment during pregnancy is a driver of the atopic march, due to a large heterogeneity between studies more research is needed to draw firm conclusions on this matter,” the authors add. “Future studies should employ and report more direct and objective measurement methods rather than self-reported questionnaires.”

Dustin D. Flannery, DO, MSCE, a neonatologist and clinical researcher in perinatal infectious diseases and neonatal antimicrobial resistance and stewardship at Children’s Hospital of Philadelphia, said in an email that the study was well done.

He noted, though, that “although the study reports an association, it cannot prove causation. The relationship between prenatal antibiotics and childhood allergic disorders is likely multifactorial and quite complex.”

He joins the authors in recommending further related research. “Due to the variation in how exposures and outcomes were defined across the studies, more rigorous research will be needed in this area.”

Despite the study’s limitations, “given that some studies have found associations between prenatal antibiotic exposure and childhood atopic and allergic disorders, including asthma, while other studies have not, this systematic review and meta-analysis asks an important question,” Dr. Flannery, who was not involved in the study, said in an interview.

“Investigators found a strong association between prenatal antibiotic exposure and risk of childhood asthma and other disorders,” he said. “This finding supports efforts to safely reduce antibiotic use during pregnancy.”

The study was supported by the Deutsche Forschungsgemeinschaft and by the Konrad Adenauer Foundation. The authors and Dr. Flannery have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Children born to mothers who take antibiotics during pregnancy may be at an increased risk of developing pediatric asthma and other diseases involved in the atopic march, a systematic review and meta-analysis reports.

“Antibiotic use during pregnancy is significantly associated with the development of asthma in children. Additionally prenatal antibiotic exposure is also associated with disorders present in the atopic march including atopic sensitization, dermatitis/eczema, food allergy, allergic rhinitis, and wheeze,” lead study author Alissa Cait, PhD, of Malaghan Institute of Medical Research in Wellington, New Zealand, and colleagues write in Allergy.

“Antibiotics account for 80% of prescribed medications during pregnancy, and it is estimated that 20%-25% of pregnant women receive at least one course of an antibiotic during this time period,” they add.

The researchers evaluated prenatal antibiotic exposure and the risk for childhood wheeze or asthma, as well as for diseases associated with the atopic march, by searching standard medical databases for controlled trials in English, German, French, Dutch, or Arabic involving the use of any antibiotic at any time during pregnancy and for atopic disease incidence in children with asthma or wheeze as primary outcome. They excluded reviews, preclinical data, and descriptive studies.

From the 6,060 citations the search returned, 11 prospective and 16 retrospective studies met the authors’ selection criteria. For each study, they evaluated risk of bias using the Newcastle-Ottawa Quality Assessment Scale, and they rated certainty of the evidence using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) protocol.

The studies, published between 2002 and 2020, were conducted in Europe, North America, Asia, and South America. Exposure to antibiotics during the prenatal period was assessed through unsupervised questionnaires, interviews by medical professionals, or extraction from official medical databases.

The results showed that:

  • Antibiotic use during pregnancy was linked with increased relative risk of developing wheeze (relative risk, 1.51; 95% confidence interval, 1.17-1.94) or asthma (RR, 1.28; 95% CI, 1.22-1.34) during childhood.
  • Antibiotic use during pregnancy also increased a child’s risk for eczema or dermatitis (RR, 1.28; 95% CI, 1.06-1.53) and allergic rhinitis (RR, 1.13; 95% CI, 1.02-1.25).
  • Food allergy increased in one study (RR, 1.81; 95% CI, 1.11-2.95).

Quality of studies

“These results have importance for antibiotic stewardship throughout the prenatal period,” the authors write. However, due to issues including high heterogeneity, publication bias, and lack of population numbers in some studies, the overall quality of the evidence presented in the studies was low. Other limitations include mainly White and European study populations, underpowered studies, and study protocol inconsistencies.

“Though there is evidence that antibiotic treatment during pregnancy is a driver of the atopic march, due to a large heterogeneity between studies more research is needed to draw firm conclusions on this matter,” the authors add. “Future studies should employ and report more direct and objective measurement methods rather than self-reported questionnaires.”

Dustin D. Flannery, DO, MSCE, a neonatologist and clinical researcher in perinatal infectious diseases and neonatal antimicrobial resistance and stewardship at Children’s Hospital of Philadelphia, said in an email that the study was well done.

He noted, though, that “although the study reports an association, it cannot prove causation. The relationship between prenatal antibiotics and childhood allergic disorders is likely multifactorial and quite complex.”

He joins the authors in recommending further related research. “Due to the variation in how exposures and outcomes were defined across the studies, more rigorous research will be needed in this area.”

Despite the study’s limitations, “given that some studies have found associations between prenatal antibiotic exposure and childhood atopic and allergic disorders, including asthma, while other studies have not, this systematic review and meta-analysis asks an important question,” Dr. Flannery, who was not involved in the study, said in an interview.

“Investigators found a strong association between prenatal antibiotic exposure and risk of childhood asthma and other disorders,” he said. “This finding supports efforts to safely reduce antibiotic use during pregnancy.”

The study was supported by the Deutsche Forschungsgemeinschaft and by the Konrad Adenauer Foundation. The authors and Dr. Flannery have disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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$150K: Average industry payment to top 1% of oncologists

Article Type
Changed
Thu, 12/15/2022 - 14:30

A small number of U.S. medical oncologists make more than $100,000 a year in general payments from drug companies, a new study shows.

These high-payment physicians represent just 1% of all U.S. medical oncologists, yet they account for 37% of industry payments. These oncologists often hold important leadership positions, draft treatment guidelines, and sit on journal editorial boards.

The findings highlight a risk for “perceived and real conflict of interest,” corresponding author Christopher Booth, MD, of Queen’s University Cancer Research Center, Kingston, Ont., said in an interview. “Because of the leadership positions they hold, the potential impact of this small group of physicians on oncology practice and policy may be substantial.”

The study was published online in JCO Oncology Practice.
 

‘We have a problem’

It’s no secret that many oncologists have financial relationships with pharmaceutical companies. They receive payments for research initiatives, but they also receive more general, personal payments in the form of honoraria, consultant fees, gifts, and reimbursement for travel and meals.

Prior studies have shown that these payments are typically modest, but a small subset of medical oncologists receive more than $100,000 annually. Dr. Booth and colleagues wanted to know more about the characteristics of these “high-payment” oncologists.

Using the national Open Payments database, the researchers identified a total of 139 medical oncologists who practice in the United States and who received $100,000 or more in general payments linked to cancer medications in 2018.

In U.S. dollars, the median payment was $154,613, and the total was $24.2 million.

The majority (95%) of high-payment oncologists were active in clinical work, 56% worked in an academic setting, 31% worked at National Cancer Institute–designated cancer centers, and 23% worked at National Comprehensive Cancer Network (NCCN) centers.

Many were based in California (17%), Texas (12%), Florida (10%), and New York (8%).

Most currently hold or have held hospital leadership positions (60%) or faculty appointments (72%) and 21% have held leadership positions in specialty associations in the past 5 years. Nearly one-quarter (24%) have served on journal editorial boards, and 10% have authored clinical practice guidelines in the past 5 years.

More specifically, three physicians authored NCCN guidelines, and two authored American Society of Clinical Oncology guidelines during 2016-2021; one guideline was published in 2018 when payments were made.

“Oncology specialty associations, guideline panels, and journal editorial boards should reconsider if it is appropriate for physicians with such large payments to hold these high-profile positions,” Dr. Booth said.

Following publication of the study, some oncologists took to Twitter with reactions, including Manni Mohyuddin, MD (@ManniMD1), from the Huntsman Cancer Institute, University of Utah, Salt Lake City, who wrote: “I recognize that some conflict of interest ‘may’ be unavoidable in order to run trials. But when greater than TWICE the average American household annual salary is taken in payments from industry by those in leadership/editorial roles, we have a problem.”

Weighing in on the results, ASCO CEO Clifford A. Hudis, MD, told this news organization that the “limitations of the study make it difficult to draw conclusions about the scope or potential impact of these payments on care.”

For example, he explained, some payments attributed to individuals may have been made directly to the physicians’ institutions or employers for sponsored research expenses.

Dr. Hudis also noted that the payments examined in the study were made in 2018, whereas the potentially relevant leadership positions could have been attained at a different time.

Furthermore, in 2020, an editorial appeared in Cancer, showing that errors in Open Payments are “fairly common,” Dr. Hudis said. It’s also unclear whether the reported financial relationships were appropriately disclosed and were managed at the time under relevant conflict of interest policies, he said.

“The question left unanswered by this study is whether or not these relationships influence patient care,” said Dr. Hudis. He noted that decisions about care should come from physicians and patients who are informed of the best available, unbiased, peer-reviewed, scientific evidence.

“The potential impact of financial conflicts of interest on this effort is an issue of concern, even if this study does not directly address it,” Dr. Hudis said.

The study had no specific funding. Dr. Booth has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article. Dr. Hudis has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A small number of U.S. medical oncologists make more than $100,000 a year in general payments from drug companies, a new study shows.

These high-payment physicians represent just 1% of all U.S. medical oncologists, yet they account for 37% of industry payments. These oncologists often hold important leadership positions, draft treatment guidelines, and sit on journal editorial boards.

The findings highlight a risk for “perceived and real conflict of interest,” corresponding author Christopher Booth, MD, of Queen’s University Cancer Research Center, Kingston, Ont., said in an interview. “Because of the leadership positions they hold, the potential impact of this small group of physicians on oncology practice and policy may be substantial.”

The study was published online in JCO Oncology Practice.
 

‘We have a problem’

It’s no secret that many oncologists have financial relationships with pharmaceutical companies. They receive payments for research initiatives, but they also receive more general, personal payments in the form of honoraria, consultant fees, gifts, and reimbursement for travel and meals.

Prior studies have shown that these payments are typically modest, but a small subset of medical oncologists receive more than $100,000 annually. Dr. Booth and colleagues wanted to know more about the characteristics of these “high-payment” oncologists.

Using the national Open Payments database, the researchers identified a total of 139 medical oncologists who practice in the United States and who received $100,000 or more in general payments linked to cancer medications in 2018.

In U.S. dollars, the median payment was $154,613, and the total was $24.2 million.

The majority (95%) of high-payment oncologists were active in clinical work, 56% worked in an academic setting, 31% worked at National Cancer Institute–designated cancer centers, and 23% worked at National Comprehensive Cancer Network (NCCN) centers.

Many were based in California (17%), Texas (12%), Florida (10%), and New York (8%).

Most currently hold or have held hospital leadership positions (60%) or faculty appointments (72%) and 21% have held leadership positions in specialty associations in the past 5 years. Nearly one-quarter (24%) have served on journal editorial boards, and 10% have authored clinical practice guidelines in the past 5 years.

More specifically, three physicians authored NCCN guidelines, and two authored American Society of Clinical Oncology guidelines during 2016-2021; one guideline was published in 2018 when payments were made.

“Oncology specialty associations, guideline panels, and journal editorial boards should reconsider if it is appropriate for physicians with such large payments to hold these high-profile positions,” Dr. Booth said.

Following publication of the study, some oncologists took to Twitter with reactions, including Manni Mohyuddin, MD (@ManniMD1), from the Huntsman Cancer Institute, University of Utah, Salt Lake City, who wrote: “I recognize that some conflict of interest ‘may’ be unavoidable in order to run trials. But when greater than TWICE the average American household annual salary is taken in payments from industry by those in leadership/editorial roles, we have a problem.”

Weighing in on the results, ASCO CEO Clifford A. Hudis, MD, told this news organization that the “limitations of the study make it difficult to draw conclusions about the scope or potential impact of these payments on care.”

For example, he explained, some payments attributed to individuals may have been made directly to the physicians’ institutions or employers for sponsored research expenses.

Dr. Hudis also noted that the payments examined in the study were made in 2018, whereas the potentially relevant leadership positions could have been attained at a different time.

Furthermore, in 2020, an editorial appeared in Cancer, showing that errors in Open Payments are “fairly common,” Dr. Hudis said. It’s also unclear whether the reported financial relationships were appropriately disclosed and were managed at the time under relevant conflict of interest policies, he said.

“The question left unanswered by this study is whether or not these relationships influence patient care,” said Dr. Hudis. He noted that decisions about care should come from physicians and patients who are informed of the best available, unbiased, peer-reviewed, scientific evidence.

“The potential impact of financial conflicts of interest on this effort is an issue of concern, even if this study does not directly address it,” Dr. Hudis said.

The study had no specific funding. Dr. Booth has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article. Dr. Hudis has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A small number of U.S. medical oncologists make more than $100,000 a year in general payments from drug companies, a new study shows.

These high-payment physicians represent just 1% of all U.S. medical oncologists, yet they account for 37% of industry payments. These oncologists often hold important leadership positions, draft treatment guidelines, and sit on journal editorial boards.

The findings highlight a risk for “perceived and real conflict of interest,” corresponding author Christopher Booth, MD, of Queen’s University Cancer Research Center, Kingston, Ont., said in an interview. “Because of the leadership positions they hold, the potential impact of this small group of physicians on oncology practice and policy may be substantial.”

The study was published online in JCO Oncology Practice.
 

‘We have a problem’

It’s no secret that many oncologists have financial relationships with pharmaceutical companies. They receive payments for research initiatives, but they also receive more general, personal payments in the form of honoraria, consultant fees, gifts, and reimbursement for travel and meals.

Prior studies have shown that these payments are typically modest, but a small subset of medical oncologists receive more than $100,000 annually. Dr. Booth and colleagues wanted to know more about the characteristics of these “high-payment” oncologists.

Using the national Open Payments database, the researchers identified a total of 139 medical oncologists who practice in the United States and who received $100,000 or more in general payments linked to cancer medications in 2018.

In U.S. dollars, the median payment was $154,613, and the total was $24.2 million.

The majority (95%) of high-payment oncologists were active in clinical work, 56% worked in an academic setting, 31% worked at National Cancer Institute–designated cancer centers, and 23% worked at National Comprehensive Cancer Network (NCCN) centers.

Many were based in California (17%), Texas (12%), Florida (10%), and New York (8%).

Most currently hold or have held hospital leadership positions (60%) or faculty appointments (72%) and 21% have held leadership positions in specialty associations in the past 5 years. Nearly one-quarter (24%) have served on journal editorial boards, and 10% have authored clinical practice guidelines in the past 5 years.

More specifically, three physicians authored NCCN guidelines, and two authored American Society of Clinical Oncology guidelines during 2016-2021; one guideline was published in 2018 when payments were made.

“Oncology specialty associations, guideline panels, and journal editorial boards should reconsider if it is appropriate for physicians with such large payments to hold these high-profile positions,” Dr. Booth said.

Following publication of the study, some oncologists took to Twitter with reactions, including Manni Mohyuddin, MD (@ManniMD1), from the Huntsman Cancer Institute, University of Utah, Salt Lake City, who wrote: “I recognize that some conflict of interest ‘may’ be unavoidable in order to run trials. But when greater than TWICE the average American household annual salary is taken in payments from industry by those in leadership/editorial roles, we have a problem.”

Weighing in on the results, ASCO CEO Clifford A. Hudis, MD, told this news organization that the “limitations of the study make it difficult to draw conclusions about the scope or potential impact of these payments on care.”

For example, he explained, some payments attributed to individuals may have been made directly to the physicians’ institutions or employers for sponsored research expenses.

Dr. Hudis also noted that the payments examined in the study were made in 2018, whereas the potentially relevant leadership positions could have been attained at a different time.

Furthermore, in 2020, an editorial appeared in Cancer, showing that errors in Open Payments are “fairly common,” Dr. Hudis said. It’s also unclear whether the reported financial relationships were appropriately disclosed and were managed at the time under relevant conflict of interest policies, he said.

“The question left unanswered by this study is whether or not these relationships influence patient care,” said Dr. Hudis. He noted that decisions about care should come from physicians and patients who are informed of the best available, unbiased, peer-reviewed, scientific evidence.

“The potential impact of financial conflicts of interest on this effort is an issue of concern, even if this study does not directly address it,” Dr. Hudis said.

The study had no specific funding. Dr. Booth has disclosed no relevant financial relationships. A complete list of author disclosures is available with the original article. Dr. Hudis has disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Childhood melatonin poisonings skyrocket in the past 10 years

Article Type
Changed
Wed, 06/29/2022 - 12:44

The number of children in the United States who unintentionally ingested melatonin supplements over the past 10 years has skyrocketed to the point where, as of 2021, melatonin ingestions by children accounted for almost 5% of all poisonings reported to poison control centers in the United States, data from the National Poison Data System (NPDS) indicate.

This compared with only 0.6% of melatonin ingestions reported to poison control centers in 2012, the authors added.

“Basically the number of pediatric melatonin ingestions increased 530% from 8,337 in 2012 to 52,563 in 2021 so it’s a 6.3-fold increase from the beginning of the study until the end,” Michael Toce, MD, one of the study authors and attending, pediatric emergency medicine/medical toxicology, Boston Children’s Hospital, said in an interview.

“And I think the biggest driver of this increase is simply that sales of melatonin have increased astronomically so there is just more melatonin at home and studies have shown there is a correlation between the amount of an individual medication in the home and the risk of pediatric exposure – so simply put: The more of a single substance in a home, the greater the chance that a child is going to get into it,” he underscored.

The study was published in the Morbidity and Mortality Weekly Report .

Melatonin ingestions

All cases of single substance melatonin ingestions involving children and adolescents between Jan. 1, 2012, and Dec. 31, 2021, were included in the analysis. During the 10-year study interval, 260,435 pediatric melatonin ingestions were reported to the NPDS. Over 94% of the reported ingestions were unintentional and 99% occurred in the home.

Over 88% of them were managed on-site; most involved young male children aged 5 years and under, and almost 83% of children who ingested melatonin supplements remained asymptomatic. On the other hand, 27,795 patients sought care at a health care facility and close to 15% of them were hospitalized. Among all melatonin ingestions, 1.6% resulted in more serious outcomes; more serious outcomes being defined as a moderate or major effects or death. Five children required mechanical ventilation in order to treat their symptoms and 2 patients died.

The largest number of patients who were hospitalized were adolescents who took melatonin intentionally but the largest increase in the rate of exposure was in young, unintentional patients, as Dr. Toce observed. Interestingly, the largest yearly increase in pediatric melatonin ingestions – almost 38% – coincided with the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” the authors speculate. Moreover, sleep disturbances were common during the pandemic, leading to a greater likelihood that parents were buying melatonin and thus exposing children to more melatonin at home.

Taken appropriately and at normal does, melatonin in itself is quite safe, as Dr. Toce stressed. However, “for any substance, the dose makes the poison, so taken in any significant quantity, anything is going to be dangerous.” Moreover, it’s important to appreciate that melatonin, at least in the United States, is regulated as a dietary supplement, not as a pharmaceutical.

“Thus, it doesn’t get the same rigorous testing that something like acetaminophen does by the FDA and that means two things,” Dr. Toce noted. First, if the product says that each gummy contains 3 mg of melatonin, no independent body is verifying whether or not that statement is true so there could be 3 mg of melatonin in each gummy or there could be 10 mg,.

Secondly, because there is no impartial oversight for dietary supplements, there may in fact be no melatonin at all in the product or something else may be added to it that might be harmful. “Just because something is sold over-the-counter does not necessarily mean that it’s safe,” Dr. Toce stressed. To keep children safe from pharmaceuticals and supplements, he recommended several generic poison prevention tips. This advice could be passed on to patients who are parents.

  • Keep all pharmaceuticals and supplements preferably locked away so there is less risk of children and adolescents taking products either unintentionally or intentionally
  • If parents have no place to lock their products up, put them out of reach, high-up so children cannot easily access them
  • Keep the product in the original child-resistant packaging as opposed to taking the pills out of the packaging and putting it in a plastic bag bag. “Certainly we’ve seen that when medications are moved into a non–child-resistant container, ingestions go up,” Dr. Toce warned
  • Don’t refer to any medicine or supplement a child might take as “candy.” “A lot of children have difficulty taking medications so some families will say: ‘It’s time for your candy,’ ” Dr. Toce explained. Then, if a child does discover the “candy” on a table where they have access to it, they will not recognize it as medication and they’re likely to pop it into their mouth, thinking it is candy.

Lastly, and most importantly, parents who are considering trying a melatonin supplement to help a child sleep better should first establish a stable sleep routine for their child. “They also need to limit caffeinated beverages before bed as well as screen time,” Dr. Toce added.

And they should talk with their primary care provider as to whether or not initiation of a melatonin supplement is appropriate for their child – “and not just jump right into giving them melatonin without first discussing whether it is appropriate to do so,” Dr. Toce stressed.

Remarkable rise

In a comment on his own experience with melatonin poisoning over recent years, toxicology expert Kevin Osterhoudt, MD, of the University of Pennsylvania, Philadelphia and the Children’s Hospital of Philadelphia, noted that it has been their experience that there has been a remarkable rise in poison center reports of children ingesting melatonin in the recent past. For example, the Poison Control Center at CHOP received nearly 4,000 calls involving melatonin ingestion by children 5 years old or younger in the 5 years between 2017 and 2021 with increasing numbers every year.

“The [current study] supports that our regional observation that this has been a national trend,” Dr. Osterhoudt said. Dr. Osterhoudt agreed with Dr. Toce that good sleep is healthy, and it is very important to develop good sleep habits and a regular bedtime routine in order to do so. “In some situations, melatonin may be useful as a short-term sleep aid and that’s a good discussion to have with your child’s health care provider.”

If parents do decide to give their child a melatonin supplement, they need to keep in mind that melatonin may alter how the body handles other drugs such as those used to treat epilepsy or blood clotting. They also need to know experts are still uncertain about how melatonin affects the body over the long term and whether it is safe for mothers to take during pregnancy.

Dr. Osterhoudt offered his own recommendations for safe melatonin use in the home:

  • Discuss planned melatonin use with your health care provider.
  • Buy only high-quality supplements by looking for the “USP Verified” mark.
  • Insist that manufacturers sell products in child-resistant bottles.
  • Periodically inspect the medications in your home and dispose of medications that are no longer being used.
  • Program the phone number of your regional poison control center into your phone; poison center experts are available 24/7 to answer questions and concerns about ingestions of melatonin (in the United States the number is 1-800-222-1222).

The study authors and neither Dr. Toce nor Dr. Osterhoudt had any relevant conflicts of interest to declare.

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The number of children in the United States who unintentionally ingested melatonin supplements over the past 10 years has skyrocketed to the point where, as of 2021, melatonin ingestions by children accounted for almost 5% of all poisonings reported to poison control centers in the United States, data from the National Poison Data System (NPDS) indicate.

This compared with only 0.6% of melatonin ingestions reported to poison control centers in 2012, the authors added.

“Basically the number of pediatric melatonin ingestions increased 530% from 8,337 in 2012 to 52,563 in 2021 so it’s a 6.3-fold increase from the beginning of the study until the end,” Michael Toce, MD, one of the study authors and attending, pediatric emergency medicine/medical toxicology, Boston Children’s Hospital, said in an interview.

“And I think the biggest driver of this increase is simply that sales of melatonin have increased astronomically so there is just more melatonin at home and studies have shown there is a correlation between the amount of an individual medication in the home and the risk of pediatric exposure – so simply put: The more of a single substance in a home, the greater the chance that a child is going to get into it,” he underscored.

The study was published in the Morbidity and Mortality Weekly Report .

Melatonin ingestions

All cases of single substance melatonin ingestions involving children and adolescents between Jan. 1, 2012, and Dec. 31, 2021, were included in the analysis. During the 10-year study interval, 260,435 pediatric melatonin ingestions were reported to the NPDS. Over 94% of the reported ingestions were unintentional and 99% occurred in the home.

Over 88% of them were managed on-site; most involved young male children aged 5 years and under, and almost 83% of children who ingested melatonin supplements remained asymptomatic. On the other hand, 27,795 patients sought care at a health care facility and close to 15% of them were hospitalized. Among all melatonin ingestions, 1.6% resulted in more serious outcomes; more serious outcomes being defined as a moderate or major effects or death. Five children required mechanical ventilation in order to treat their symptoms and 2 patients died.

The largest number of patients who were hospitalized were adolescents who took melatonin intentionally but the largest increase in the rate of exposure was in young, unintentional patients, as Dr. Toce observed. Interestingly, the largest yearly increase in pediatric melatonin ingestions – almost 38% – coincided with the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” the authors speculate. Moreover, sleep disturbances were common during the pandemic, leading to a greater likelihood that parents were buying melatonin and thus exposing children to more melatonin at home.

Taken appropriately and at normal does, melatonin in itself is quite safe, as Dr. Toce stressed. However, “for any substance, the dose makes the poison, so taken in any significant quantity, anything is going to be dangerous.” Moreover, it’s important to appreciate that melatonin, at least in the United States, is regulated as a dietary supplement, not as a pharmaceutical.

“Thus, it doesn’t get the same rigorous testing that something like acetaminophen does by the FDA and that means two things,” Dr. Toce noted. First, if the product says that each gummy contains 3 mg of melatonin, no independent body is verifying whether or not that statement is true so there could be 3 mg of melatonin in each gummy or there could be 10 mg,.

Secondly, because there is no impartial oversight for dietary supplements, there may in fact be no melatonin at all in the product or something else may be added to it that might be harmful. “Just because something is sold over-the-counter does not necessarily mean that it’s safe,” Dr. Toce stressed. To keep children safe from pharmaceuticals and supplements, he recommended several generic poison prevention tips. This advice could be passed on to patients who are parents.

  • Keep all pharmaceuticals and supplements preferably locked away so there is less risk of children and adolescents taking products either unintentionally or intentionally
  • If parents have no place to lock their products up, put them out of reach, high-up so children cannot easily access them
  • Keep the product in the original child-resistant packaging as opposed to taking the pills out of the packaging and putting it in a plastic bag bag. “Certainly we’ve seen that when medications are moved into a non–child-resistant container, ingestions go up,” Dr. Toce warned
  • Don’t refer to any medicine or supplement a child might take as “candy.” “A lot of children have difficulty taking medications so some families will say: ‘It’s time for your candy,’ ” Dr. Toce explained. Then, if a child does discover the “candy” on a table where they have access to it, they will not recognize it as medication and they’re likely to pop it into their mouth, thinking it is candy.

Lastly, and most importantly, parents who are considering trying a melatonin supplement to help a child sleep better should first establish a stable sleep routine for their child. “They also need to limit caffeinated beverages before bed as well as screen time,” Dr. Toce added.

And they should talk with their primary care provider as to whether or not initiation of a melatonin supplement is appropriate for their child – “and not just jump right into giving them melatonin without first discussing whether it is appropriate to do so,” Dr. Toce stressed.

Remarkable rise

In a comment on his own experience with melatonin poisoning over recent years, toxicology expert Kevin Osterhoudt, MD, of the University of Pennsylvania, Philadelphia and the Children’s Hospital of Philadelphia, noted that it has been their experience that there has been a remarkable rise in poison center reports of children ingesting melatonin in the recent past. For example, the Poison Control Center at CHOP received nearly 4,000 calls involving melatonin ingestion by children 5 years old or younger in the 5 years between 2017 and 2021 with increasing numbers every year.

“The [current study] supports that our regional observation that this has been a national trend,” Dr. Osterhoudt said. Dr. Osterhoudt agreed with Dr. Toce that good sleep is healthy, and it is very important to develop good sleep habits and a regular bedtime routine in order to do so. “In some situations, melatonin may be useful as a short-term sleep aid and that’s a good discussion to have with your child’s health care provider.”

If parents do decide to give their child a melatonin supplement, they need to keep in mind that melatonin may alter how the body handles other drugs such as those used to treat epilepsy or blood clotting. They also need to know experts are still uncertain about how melatonin affects the body over the long term and whether it is safe for mothers to take during pregnancy.

Dr. Osterhoudt offered his own recommendations for safe melatonin use in the home:

  • Discuss planned melatonin use with your health care provider.
  • Buy only high-quality supplements by looking for the “USP Verified” mark.
  • Insist that manufacturers sell products in child-resistant bottles.
  • Periodically inspect the medications in your home and dispose of medications that are no longer being used.
  • Program the phone number of your regional poison control center into your phone; poison center experts are available 24/7 to answer questions and concerns about ingestions of melatonin (in the United States the number is 1-800-222-1222).

The study authors and neither Dr. Toce nor Dr. Osterhoudt had any relevant conflicts of interest to declare.

The number of children in the United States who unintentionally ingested melatonin supplements over the past 10 years has skyrocketed to the point where, as of 2021, melatonin ingestions by children accounted for almost 5% of all poisonings reported to poison control centers in the United States, data from the National Poison Data System (NPDS) indicate.

This compared with only 0.6% of melatonin ingestions reported to poison control centers in 2012, the authors added.

“Basically the number of pediatric melatonin ingestions increased 530% from 8,337 in 2012 to 52,563 in 2021 so it’s a 6.3-fold increase from the beginning of the study until the end,” Michael Toce, MD, one of the study authors and attending, pediatric emergency medicine/medical toxicology, Boston Children’s Hospital, said in an interview.

“And I think the biggest driver of this increase is simply that sales of melatonin have increased astronomically so there is just more melatonin at home and studies have shown there is a correlation between the amount of an individual medication in the home and the risk of pediatric exposure – so simply put: The more of a single substance in a home, the greater the chance that a child is going to get into it,” he underscored.

The study was published in the Morbidity and Mortality Weekly Report .

Melatonin ingestions

All cases of single substance melatonin ingestions involving children and adolescents between Jan. 1, 2012, and Dec. 31, 2021, were included in the analysis. During the 10-year study interval, 260,435 pediatric melatonin ingestions were reported to the NPDS. Over 94% of the reported ingestions were unintentional and 99% occurred in the home.

Over 88% of them were managed on-site; most involved young male children aged 5 years and under, and almost 83% of children who ingested melatonin supplements remained asymptomatic. On the other hand, 27,795 patients sought care at a health care facility and close to 15% of them were hospitalized. Among all melatonin ingestions, 1.6% resulted in more serious outcomes; more serious outcomes being defined as a moderate or major effects or death. Five children required mechanical ventilation in order to treat their symptoms and 2 patients died.

The largest number of patients who were hospitalized were adolescents who took melatonin intentionally but the largest increase in the rate of exposure was in young, unintentional patients, as Dr. Toce observed. Interestingly, the largest yearly increase in pediatric melatonin ingestions – almost 38% – coincided with the onset of the COVID-19 pandemic.

“This might be related to increased accessibility of melatonin during the pandemic, as children spent more time at home because of stay-at-home orders and school closures,” the authors speculate. Moreover, sleep disturbances were common during the pandemic, leading to a greater likelihood that parents were buying melatonin and thus exposing children to more melatonin at home.

Taken appropriately and at normal does, melatonin in itself is quite safe, as Dr. Toce stressed. However, “for any substance, the dose makes the poison, so taken in any significant quantity, anything is going to be dangerous.” Moreover, it’s important to appreciate that melatonin, at least in the United States, is regulated as a dietary supplement, not as a pharmaceutical.

“Thus, it doesn’t get the same rigorous testing that something like acetaminophen does by the FDA and that means two things,” Dr. Toce noted. First, if the product says that each gummy contains 3 mg of melatonin, no independent body is verifying whether or not that statement is true so there could be 3 mg of melatonin in each gummy or there could be 10 mg,.

Secondly, because there is no impartial oversight for dietary supplements, there may in fact be no melatonin at all in the product or something else may be added to it that might be harmful. “Just because something is sold over-the-counter does not necessarily mean that it’s safe,” Dr. Toce stressed. To keep children safe from pharmaceuticals and supplements, he recommended several generic poison prevention tips. This advice could be passed on to patients who are parents.

  • Keep all pharmaceuticals and supplements preferably locked away so there is less risk of children and adolescents taking products either unintentionally or intentionally
  • If parents have no place to lock their products up, put them out of reach, high-up so children cannot easily access them
  • Keep the product in the original child-resistant packaging as opposed to taking the pills out of the packaging and putting it in a plastic bag bag. “Certainly we’ve seen that when medications are moved into a non–child-resistant container, ingestions go up,” Dr. Toce warned
  • Don’t refer to any medicine or supplement a child might take as “candy.” “A lot of children have difficulty taking medications so some families will say: ‘It’s time for your candy,’ ” Dr. Toce explained. Then, if a child does discover the “candy” on a table where they have access to it, they will not recognize it as medication and they’re likely to pop it into their mouth, thinking it is candy.

Lastly, and most importantly, parents who are considering trying a melatonin supplement to help a child sleep better should first establish a stable sleep routine for their child. “They also need to limit caffeinated beverages before bed as well as screen time,” Dr. Toce added.

And they should talk with their primary care provider as to whether or not initiation of a melatonin supplement is appropriate for their child – “and not just jump right into giving them melatonin without first discussing whether it is appropriate to do so,” Dr. Toce stressed.

Remarkable rise

In a comment on his own experience with melatonin poisoning over recent years, toxicology expert Kevin Osterhoudt, MD, of the University of Pennsylvania, Philadelphia and the Children’s Hospital of Philadelphia, noted that it has been their experience that there has been a remarkable rise in poison center reports of children ingesting melatonin in the recent past. For example, the Poison Control Center at CHOP received nearly 4,000 calls involving melatonin ingestion by children 5 years old or younger in the 5 years between 2017 and 2021 with increasing numbers every year.

“The [current study] supports that our regional observation that this has been a national trend,” Dr. Osterhoudt said. Dr. Osterhoudt agreed with Dr. Toce that good sleep is healthy, and it is very important to develop good sleep habits and a regular bedtime routine in order to do so. “In some situations, melatonin may be useful as a short-term sleep aid and that’s a good discussion to have with your child’s health care provider.”

If parents do decide to give their child a melatonin supplement, they need to keep in mind that melatonin may alter how the body handles other drugs such as those used to treat epilepsy or blood clotting. They also need to know experts are still uncertain about how melatonin affects the body over the long term and whether it is safe for mothers to take during pregnancy.

Dr. Osterhoudt offered his own recommendations for safe melatonin use in the home:

  • Discuss planned melatonin use with your health care provider.
  • Buy only high-quality supplements by looking for the “USP Verified” mark.
  • Insist that manufacturers sell products in child-resistant bottles.
  • Periodically inspect the medications in your home and dispose of medications that are no longer being used.
  • Program the phone number of your regional poison control center into your phone; poison center experts are available 24/7 to answer questions and concerns about ingestions of melatonin (in the United States the number is 1-800-222-1222).

The study authors and neither Dr. Toce nor Dr. Osterhoudt had any relevant conflicts of interest to declare.

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Alcohol consumption habits can predict gout tophi

Article Type
Changed
Wed, 06/29/2022 - 12:57

The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.

The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.

Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.

copyright joloei/Thinkstock

Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.

“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.

This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.

Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.

Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
 

Results from US and clinically detected tophi

Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).

After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.

Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).

Dr. Angelo Gaffo

Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.

“I wouldn’t expect them to be specific to the Chinese population,” he said.

Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.

Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.

“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.

Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.



“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”

Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.

He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.

“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”

This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.

The authors of the study and Dr. Gaffo report no relevant financial relationships.

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The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.

The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.

Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.

copyright joloei/Thinkstock

Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.

“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.

This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.

Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.

Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
 

Results from US and clinically detected tophi

Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).

After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.

Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).

Dr. Angelo Gaffo

Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.

“I wouldn’t expect them to be specific to the Chinese population,” he said.

Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.

Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.

“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.

Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.



“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”

Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.

He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.

“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”

This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.

The authors of the study and Dr. Gaffo report no relevant financial relationships.

The more years a person drinks alcohol, the kind of alcohol consumed, and the amount consumed can help to predict gout tophi, researchers say in a newly published paper in Arthritis Care and Research.

The study, led by Lin Han, PhD, of the gout laboratory, Shandong provincial clinical research center for immune diseases and gout, Affiliated Hospital of Qingdao (China) University, helps clarify the already-established relationship between alcohol consumption and gout tophi.

Additionally, the effects of drinking alcohol on ultrasound (US)–detected tophi and subcutaneous tophi (subtophi) were evaluated separately for the first time in this work, the authors say.

copyright joloei/Thinkstock

Tophi may be underdiagnosed because they are hard to find with only a physical exam. US can help with early detection, especially with small clusters of crystals or those found deep in the tissues, and offers good diagnostic accuracy with high specificity.

“Unlike subtophi, which represent long-term subcutaneous MSU [monosodium urate] deposition over many years, US-detected tophi represent the early stage of tophi in both intra- and extra-articular settings,” the authors write.

This cross-sectional study in China included 554 patients with gout who had joint ultrasound and physical exams through the Affiliated Hospital of Qingdao University. Physicians gathered medical histories using the Biobank Information Management System.

Physicians also tracked alcohol consumption patterns through the biobank information, which included answers to a detailed drinking questionnaire.

Patients were classified as either nondrinkers (no history of drinking; n = 141), former drinkers (n = 60), or current regular drinkers (n = 353). Current regular drinkers were asked further questions about their drinking patterns, including how long they have been drinking, type of alcohol they drink, and how much and how often they drink. In China, the average drink is considered to contain 10 g of alcohol, according to the World Health Organization.
 

Results from US and clinically detected tophi

Compared with nondrinkers, excessive drinkers (more than 70 g/week); long-term drinkers (at least 10 years), and spirits drinkers had a greater proportion, size, and number of US-detected tophi and subtophi (all P < .05).

After adjusting for confounders, the researchers found that excessive drinking was significantly associated with having US-detected tophi (odds ratio, 1.79) and subtophi (OR, 2.00). Similar associations were found for consumption of alcohol for at least 10 years (OR, 1.96 for US-detected tophi; OR, 2.17 for sub-tophi) and drinking spirits (OR, 1.81 for US-detected tophi; OR, 2.10 for subtophi). All comparisons were P < .05.

Among patients who already have US-detected tophi or subtophi, moderate drinking (70 g/week or less) was linked with larger or multiple tophi (all P < .05).

Dr. Angelo Gaffo

Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham, said in an interview that the results are likely generalizable.

“I wouldn’t expect them to be specific to the Chinese population,” he said.

Most of the 554 patients were male (97.8%) and had no family history of gout (79.8%). The median duration of gout was 4 years, and the average age was 45.1 years.

Dr. Gaffo noted the population age was fairly young and the average duration of gout in these patients was fairly short. He also noted most had small tophi that were detected only by ultrasound and small numbers of tophi overall.

“I would like to see how these results will replicate in a population that has had gout for, say, 10 years on average,” he said.

Dr. Gaffo says he explores alcohol history with his patients with gout. If they are frequent drinkers, he encourages them to cut back.



“At the very least,” he said, “you have to restrict your intake to no more than 1-2 servings per week,” he said. “For some patients, even minimal amounts of alcohol intake can be associated with the development of flares.”

Still, research like this, he says, can help physicians point to evidence in their advice to patients about alcohol use.

He noted that the authors found the association between different types of alcohol and tophi was independent of serum urate level.

“That surprised me,” Dr. Gaffo said. “That’s a very unique finding.”

This work was supported by grants from the National Natural Science Foundation of China, the Natural Science Foundation of Shandong Province, Qingdao applied basic research project, National College Students’ Innovation and Entrepreneurship Training Program, and Shandong Provincial Science Foundation for Outstanding Youth Scholars.

The authors of the study and Dr. Gaffo report no relevant financial relationships.

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Evidence still lacking that vitamins prevent CVD, cancer: USPSTF

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Changed
Wed, 01/04/2023 - 17:16

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

 

 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

 

A version of this article first appeared on Medscape.com.

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There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

sodapix/thinkstockphotos.com

These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

 

 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

 

A version of this article first appeared on Medscape.com.

There is not enough evidence to recommend for or against taking most vitamin and mineral supplements to prevent heart disease, stroke, and cancer, a new report by the U.S. Preventive Services Task Force concludes.

However, there are two vitamins – vitamin E and beta-carotene – that the task force recommends against for the prevention of heart disease, stroke, and cancer. Evidence shows that there is no benefit to taking vitamin E and that beta-carotene can increase the risk for lung cancer in people already at risk, such as smokers and those with occupational exposure to asbestos.

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These are the main findings of the USPSTF’s final recommendation statement on vitamin, mineral, and multivitamin supplementation to prevent cardiovascular disease and cancer. The statement was published in JAMA.

“This is essentially the same recommendation that the task force made in 2014,” USPSTF member John Wong, MD, professor of medicine at Tufts University, Boston, said in an interview.

“We recognize that over half of people in the U.S. take a vitamin supplement of some sort every day and 30% take a vitamin/mineral combination. We wanted to review the evidence again to see if there was any benefit in terms of reducing the risk of cardiovascular disease or cancer or increasing the chances of living longer,” Dr. Wong explained.

“We looked hard for evidence, reviewing 84 studies in total. But we did not find sufficient evidence in favor of taking or not taking vitamins, with the two exceptions of beta-carotene and vitamin E, which we recommend against taking,” he noted.

Although there is evidence of some harm with beta-carotene, the main reason behind the recommendation against taking vitamin E is the consistent evidence of no benefit, Dr. Wong explained.

“While the evidence for some other vitamins is conflicting, there is more consistent evidence of no benefit for vitamin E,” he said.

The bulk of new evidence since the last review in 2014 was predominately for vitamin D supplementation, but despite the inclusion of 32 new randomized, controlled trials and two cohort studies, pooled estimates for all-cause mortality were similar to those in the previous review, with confidence intervals only slightly crossing 1, and point estimates that suggest at most a very small benefit, the task force noted.

“Apart from beta-carotene and vitamin E, after reviewing 84 studies – including 78 randomized controlled trials – in over a million patients, we can find no clear demonstration of benefit or harm of taking vitamins in terms of developing cardiovascular disease or cancer or the effect on all-cause mortality. So, we don’t know whether people should take vitamins or not, and we need more research,” Dr. Wong added.

On the use of a multivitamin supplement, Dr. Wong noted that the complete body of evidence did not find any benefit of taking a multivitamin on cardiovascular or cancer mortality. But there was a small reduction in cancer incidence.

However, he pointed out that the three studies that suggested a reduction in cancer incidence all had issues regarding generalizability.

“The recently published COSMOS trial had an average follow-up of only 3.6 years, which isn’t really long enough when thinking about the prevention of cancer, one of the other studies only used antioxidants, and the third study was conducted only in U.S. male physicians. So those limitations regarding generalizability limited our confidence in making recommendations about multivitamins,” Dr. Wong explained.

But he noted that the task force did not find any significant harms from taking multivitamins.

“There are possible harms from taking high doses of vitamin A and vitamin D, but generally the doses contained in a multivitamin tablet are lower than these. But if the goal for taking a multivitamin is to lower your risk of cancer or cardiovascular disease, we didn’t find sufficient evidence to be able to make a recommendation,” he said.

Asked what he would say to all the people currently taking multivitamins, Dr. Wong responded that he would advise them to have a conversation with a trusted health care professional about their particular circumstances.

“Our statement has quite a narrow focus. It is directed toward community-dwelling, nonpregnant adults. This recommendation does not apply to children, persons who are pregnant or may become pregnant, or persons who are chronically ill, are hospitalized, or have a known nutritional deficiency,” he commented.
 

 

 

‘Any benefit likely to be small’

In an editorial accompanying the publication of the USPSTF statement, Jenny Jia, MD; Natalie Cameron, MD; and Jeffrey Linder, MD – all from Northwestern University, Chicago – noted that the current evidence base includes 52 additional studies not available when the last USPSTF recommendation on this topic was published in 2014.

The editorialists pointed out that for multivitamins, proving the absence of a benefit is challenging, but at best, current evidence suggests that any potential benefits of a multivitamin to reduce mortality are likely to be small.

They gave an example of a healthy 65-year-old woman with a 9-year estimated mortality risk of about 8%, and note that taking a multivitamin for 5-10 years might reduce her estimated mortality risk to 7.5% (based on an odds ratio of 0.94).

“In addition to showing small potential benefit, this estimate is based on imperfect evidence, is imprecise, and is highly sensitive to how the data are interpreted and analyzed,” they said.

The editorialists recommended that lifestyle counseling to prevent chronic diseases should continue to focus on evidence-based approaches, including balanced diets that are high in fruits and vegetables and physical activity.

However, they added that healthy eating can be a challenge when the American industrialized food system does not prioritize health, and healthy foods tend to be more expensive, leading to access problems and food insecurity.

The editorialists suggested that, rather than focusing money, time, and attention on supplements, it would be better to emphasize lower-risk, higher-benefit activities, such as getting exercise, maintaining a healthy weight, and avoiding smoking, in addition to following a healthful diet.
 

Possible benefit for older adults?

Commenting on the USPSTF statement, JoAnn Manson, MD, chief, division of preventive medicine, Brigham and Women’s Hospital, Boston, who led the recent COSMOS study, said that vitamin and mineral supplements should not be perceived as a substitute for a healthful diet.

“The emphasis needs to be on getting nutritional needs from a healthy diet that is high in plant-based and whole foods that don’t strip the vitamins and minerals through excessive processing,” she said. “Although it’s easier to pop a pill each day than to focus on healthful dietary patterns, the mixture of phytochemicals, fiber, and all the other nutrients in actual foods just can’t be packaged into a pill. Also, vitamins and minerals tend to be better absorbed from food than from supplements and healthy foods can replace calories from less healthy foods, such as red meat and processed foods.”

However, Dr. Manson noted that the evidence is mounting that taking a tablet containing moderate doses of a wide range of vitamins and minerals is safe and may actually have benefits for some people.

She pointed out that the COSMOS and COSMOS-Mind studies showed benefits of multivitamins in slowing cognitive decline in older adults, but the findings need to be replicated.  

“The USPSTF did see a statistically significant 7% reduction in cancer with multivitamins in their meta-analysis of four randomized trials and a borderline 6% reduction in all-cause mortality,” she noted. “Plus, multivitamins have been shown to be quite safe in several large and long-term randomized trials. I agree the evidence is not sufficient to make a blanket recommendation for everyone to take multivitamins, but the evidence is mounting that this would be a prudent approach for many older adults,” Dr. Manson said.

“Many people view multivitamins as a form of insurance, as a way to hedge their bets,” she added. “Although this is a rational approach, especially for those who have concerns about the adequacy of their diet, it’s important that this mindset not lead to complacency about following healthy lifestyle practices, including healthy eating, regular physical activity, not smoking, making sure that blood pressure and cholesterol levels are well controlled, and many other practices that critically important for health but are more challenging than simply popping a pill each day.”

 

A version of this article first appeared on Medscape.com.

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