MDedge Endocrinology

The country’s top medical organizations condemned the overturning of Roe v. Wade, saying the removal of federal protections for women to access abortion services marks a “dark day.”

“It is unfathomable. It is unfair. It is wrong,” said the President of the American College of Obstetricians and Gynecologists (ACOG) Iffath Abbasi Hoskins, MD.

“Today is a very dark day in health care. It is a dark day, indeed, for the tens of millions of patients who have suddenly and unfairly lost access to safe legal and evidence-based abortion care,” Dr. Hoskins said at a press conference June 24 sponsored by ACOG. 

“It is dark for the thousands of clinicians who now, instead of focusing on providing health care to their patients, have to live with the threats of legal, civil, and even professional penalties,” Dr. Hoskins added.

ACOG has 62,000 members and is the leading group of doctors that provides obstetric and gynecologic care.
 

Dilemma for some doctors?

“I’d like to take a moment to talk about the future of the medical profession,” said ACOG Chief Executive Officer Maureen G. Phipps, MD, MPH. “[The] decision is, as Dr. Hoskins clearly said, a tragic one for our patients in states across the country, but the harm does not end there.”

Dr. Phipps described overturning Roe v. Wade as “the boldest act of legislative interference that we have seen in this country. It will allow state legislators to tell physicians what care they can and cannot provide to their patients.”

“It will leave physicians looking over our shoulders, wondering if a patient is in enough of a crisis to permit an exception to a law,” Dr. Phipps added. “This is an affront to all that drew my colleagues and me into medicine.”

Although the impact on doctor training remains to be seen, she said 44% of ob.gyn. residents are trained in states now empowered to ban abortions.

The effect of the Supreme Court decision on miscarriage management is another unknown.

“It’s going to be very difficult for us, the clinicians, to manage miscarriage,” Dr. Hoskins said. “Many miscarriages could be what we call ‘incomplete’ in the beginning,” where there is still a heartbeat and the patient is cramping and/or bleeding.

In that instance, Dr. Hoskins said, clinicians may be thinking that they have to wait.

“They may be needing to get additional opinions, whether it’s a legal opinion ... or another medical opinion.”

“It’s going to have a devastating effect on every aspect of a woman’s health care, including if she is spontaneously miscarrying,” Dr. Hoskins predicted.

Physician protect thyself?

To what extent doctors can shield themselves from potential prosecution “is a hard question to answer,” Molly Meegan, JD, ACOG’s chief legal officer and general counsel, said.

Ms. Meegan recommended members speak to the risk managers at their individual institutions for guidance.

“It is a real patchwork [of laws] out there, she said. “And that patchwork itself is a danger to people as they seek essential reproductive health care.”

Also, she added, “If a doctor can’t tell what the law is at the time they’re trying to provide the care, it has a terribly chilling effect on medical care.”

Another potential threat to doctors in states that still allow abortion services is action from a neighboring state.

“We are going to be advocating very strongly that states do not have extra-territorial jurisdiction to reach beyond the edges of their state.”

The worry is if a doctor in New Mexico, where abortion is legal, performs an abortion for a person from Texas, where it will soon be illegal, is then prosecuted by Texas, for example.
 

Medication abortion

Asked about any potential effects on medication abortions, ACOG’s Jen Villavicencio, MD, said it remains to be seen.

“Certainly many of the laws that we have seen, including trigger ban laws, encompass medication abortion,” she said. Several states have these so-called trigger laws, which put into effect laws passed to ban abortion in case Roe was overturned.

This means, she said, that any abortion option, whether it’s procedural or medication, could be and will be banned in some of these states.

Ms. Meegan added that ACOG will continue to support access to medication abortion and that it should be decided by the U.S. Food and Drug Administration and not individual states.
 

Maternal mortality may rise

“Maternal mortality in and of itself is a very difficult topic,” Dr. Hoskins said, but [the] decision amplifies the implications. “I think of the patients who will have to manage severe complications and mental health challenges while they are carrying a pregnancy that they are forced to carry.”

“I also think of the patients who need to end their pregnancies in order to save their own lives,” Dr. Hoskins added.

Dr. Hoskins said the United States already has a high maternal mortality rate. This new law, she added, could force women into higher-risk situations if they experience high blood pressure, preeclampsia, or bleeding after the birth of the baby.
 

Growing inequality possible?

“The grievous inequities that exist in this country will grow and expand unchecked without safe access to legal abortion,” Dr. Phipps said.

She noted that women, based on location, will continue “to have protected access to safe evidence-based abortion. Others will have the means and resources and opportunities to secure the care.”

But the same may not be true for women in underserved or disadvantaged communities, Dr. Phipps added.
 

American Medical Association

ACOG was not the only group to react. “The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half century of precedent protecting patients’ right to critical reproductive health care,” President Jack Resneck Jr., MD, said in a statement.

The decision represents “an egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services.”

American Academy of Family Physicians

“The American Academy of Family Physicians is disappointed and disheartened by the Supreme Court’s decision to strike down longstanding protections afforded by Roe v. Wade and Planned Parenthood v. Casey,” President Sterling N. Ransone Jr., MD, said in a statement.

The organization has 127,600 physician and medical student members.

“This decision negatively impacts our practices and our patients by undermining the patient-physician relationship and potentially criminalizing evidence-based medical care,” added Dr. Ransone.
 

American College of Physicians

“A patient’s decision about whether to continue a pregnancy should be a private decision made in consultation with a physician or other health care professional, without interference from the government,” President Ryan D. Mire, MD, said in a statement. “We strongly oppose medically unnecessary government restrictions on any health care services,” added Dr. Mire on behalf of the group’s 161,000 members.

American Academy of Pediatrics

“This decision carries grave consequences for our adolescent patients, who already face many more barriers than adults in accessing comprehensive reproductive health care services and abortion care,” President Moira Szilagyi, MD, PhD, said in a statement. 

“In the wake of this ruling, the American Academy of Pediatrics will continue to support our chapters as states consider policies affecting access to abortion care, and pediatricians will continue to support our patients,” Dr. Szilagyi added.
 

American Public Health Association

The court’s decision “is a catastrophic judicial failure that will reverberate differently in each state and portends to jeopardize the health and lives of all Americans,” Executive Director Georges C. Benjamin, MD, said in a statement.

American Urogynecologic Society

“The American Urogynecologic Society opposes any ruling that restricts a person’s access to health care and criminalizes the practice of medicine,” the group said in a statement. “This ruling ultimately poses a serious threat to the patient-provider relationship and subsequent decisionmaking necessary to ensure optimal outcomes for patients. As practitioners, we should be free to provide what is in the best interest of our patients.”

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

The country’s top medical organizations condemned the overturning of Roe v. Wade, saying the removal of federal protections for women to access abortion services marks a “dark day.”

“It is unfathomable. It is unfair. It is wrong,” said the President of the American College of Obstetricians and Gynecologists (ACOG) Iffath Abbasi Hoskins, MD.

“Today is a very dark day in health care. It is a dark day, indeed, for the tens of millions of patients who have suddenly and unfairly lost access to safe legal and evidence-based abortion care,” Dr. Hoskins said at a press conference June 24 sponsored by ACOG. 

“It is dark for the thousands of clinicians who now, instead of focusing on providing health care to their patients, have to live with the threats of legal, civil, and even professional penalties,” Dr. Hoskins added.

ACOG has 62,000 members and is the leading group of doctors that provides obstetric and gynecologic care.
 

Dilemma for some doctors?

“I’d like to take a moment to talk about the future of the medical profession,” said ACOG Chief Executive Officer Maureen G. Phipps, MD, MPH. “[The] decision is, as Dr. Hoskins clearly said, a tragic one for our patients in states across the country, but the harm does not end there.”

Dr. Phipps described overturning Roe v. Wade as “the boldest act of legislative interference that we have seen in this country. It will allow state legislators to tell physicians what care they can and cannot provide to their patients.”

“It will leave physicians looking over our shoulders, wondering if a patient is in enough of a crisis to permit an exception to a law,” Dr. Phipps added. “This is an affront to all that drew my colleagues and me into medicine.”

Although the impact on doctor training remains to be seen, she said 44% of ob.gyn. residents are trained in states now empowered to ban abortions.

The effect of the Supreme Court decision on miscarriage management is another unknown.

“It’s going to be very difficult for us, the clinicians, to manage miscarriage,” Dr. Hoskins said. “Many miscarriages could be what we call ‘incomplete’ in the beginning,” where there is still a heartbeat and the patient is cramping and/or bleeding.

In that instance, Dr. Hoskins said, clinicians may be thinking that they have to wait.

“They may be needing to get additional opinions, whether it’s a legal opinion ... or another medical opinion.”

“It’s going to have a devastating effect on every aspect of a woman’s health care, including if she is spontaneously miscarrying,” Dr. Hoskins predicted.

Physician protect thyself?

To what extent doctors can shield themselves from potential prosecution “is a hard question to answer,” Molly Meegan, JD, ACOG’s chief legal officer and general counsel, said.

Ms. Meegan recommended members speak to the risk managers at their individual institutions for guidance.

“It is a real patchwork [of laws] out there, she said. “And that patchwork itself is a danger to people as they seek essential reproductive health care.”

Also, she added, “If a doctor can’t tell what the law is at the time they’re trying to provide the care, it has a terribly chilling effect on medical care.”

Another potential threat to doctors in states that still allow abortion services is action from a neighboring state.

“We are going to be advocating very strongly that states do not have extra-territorial jurisdiction to reach beyond the edges of their state.”

The worry is if a doctor in New Mexico, where abortion is legal, performs an abortion for a person from Texas, where it will soon be illegal, is then prosecuted by Texas, for example.
 

Medication abortion

Asked about any potential effects on medication abortions, ACOG’s Jen Villavicencio, MD, said it remains to be seen.

“Certainly many of the laws that we have seen, including trigger ban laws, encompass medication abortion,” she said. Several states have these so-called trigger laws, which put into effect laws passed to ban abortion in case Roe was overturned.

This means, she said, that any abortion option, whether it’s procedural or medication, could be and will be banned in some of these states.

Ms. Meegan added that ACOG will continue to support access to medication abortion and that it should be decided by the U.S. Food and Drug Administration and not individual states.
 

Maternal mortality may rise

“Maternal mortality in and of itself is a very difficult topic,” Dr. Hoskins said, but [the] decision amplifies the implications. “I think of the patients who will have to manage severe complications and mental health challenges while they are carrying a pregnancy that they are forced to carry.”

“I also think of the patients who need to end their pregnancies in order to save their own lives,” Dr. Hoskins added.

Dr. Hoskins said the United States already has a high maternal mortality rate. This new law, she added, could force women into higher-risk situations if they experience high blood pressure, preeclampsia, or bleeding after the birth of the baby.
 

Growing inequality possible?

“The grievous inequities that exist in this country will grow and expand unchecked without safe access to legal abortion,” Dr. Phipps said.

She noted that women, based on location, will continue “to have protected access to safe evidence-based abortion. Others will have the means and resources and opportunities to secure the care.”

But the same may not be true for women in underserved or disadvantaged communities, Dr. Phipps added.
 

American Medical Association

ACOG was not the only group to react. “The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half century of precedent protecting patients’ right to critical reproductive health care,” President Jack Resneck Jr., MD, said in a statement.

The decision represents “an egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services.”

American Academy of Family Physicians

“The American Academy of Family Physicians is disappointed and disheartened by the Supreme Court’s decision to strike down longstanding protections afforded by Roe v. Wade and Planned Parenthood v. Casey,” President Sterling N. Ransone Jr., MD, said in a statement.

The organization has 127,600 physician and medical student members.

“This decision negatively impacts our practices and our patients by undermining the patient-physician relationship and potentially criminalizing evidence-based medical care,” added Dr. Ransone.
 

American College of Physicians

“A patient’s decision about whether to continue a pregnancy should be a private decision made in consultation with a physician or other health care professional, without interference from the government,” President Ryan D. Mire, MD, said in a statement. “We strongly oppose medically unnecessary government restrictions on any health care services,” added Dr. Mire on behalf of the group’s 161,000 members.

American Academy of Pediatrics

“This decision carries grave consequences for our adolescent patients, who already face many more barriers than adults in accessing comprehensive reproductive health care services and abortion care,” President Moira Szilagyi, MD, PhD, said in a statement. 

“In the wake of this ruling, the American Academy of Pediatrics will continue to support our chapters as states consider policies affecting access to abortion care, and pediatricians will continue to support our patients,” Dr. Szilagyi added.
 

American Public Health Association

The court’s decision “is a catastrophic judicial failure that will reverberate differently in each state and portends to jeopardize the health and lives of all Americans,” Executive Director Georges C. Benjamin, MD, said in a statement.

American Urogynecologic Society

“The American Urogynecologic Society opposes any ruling that restricts a person’s access to health care and criminalizes the practice of medicine,” the group said in a statement. “This ruling ultimately poses a serious threat to the patient-provider relationship and subsequent decisionmaking necessary to ensure optimal outcomes for patients. As practitioners, we should be free to provide what is in the best interest of our patients.”

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

The country’s top medical organizations condemned the overturning of Roe v. Wade, saying the removal of federal protections for women to access abortion services marks a “dark day.”

“It is unfathomable. It is unfair. It is wrong,” said the President of the American College of Obstetricians and Gynecologists (ACOG) Iffath Abbasi Hoskins, MD.

“Today is a very dark day in health care. It is a dark day, indeed, for the tens of millions of patients who have suddenly and unfairly lost access to safe legal and evidence-based abortion care,” Dr. Hoskins said at a press conference June 24 sponsored by ACOG. 

“It is dark for the thousands of clinicians who now, instead of focusing on providing health care to their patients, have to live with the threats of legal, civil, and even professional penalties,” Dr. Hoskins added.

ACOG has 62,000 members and is the leading group of doctors that provides obstetric and gynecologic care.
 

Dilemma for some doctors?

“I’d like to take a moment to talk about the future of the medical profession,” said ACOG Chief Executive Officer Maureen G. Phipps, MD, MPH. “[The] decision is, as Dr. Hoskins clearly said, a tragic one for our patients in states across the country, but the harm does not end there.”

Dr. Phipps described overturning Roe v. Wade as “the boldest act of legislative interference that we have seen in this country. It will allow state legislators to tell physicians what care they can and cannot provide to their patients.”

“It will leave physicians looking over our shoulders, wondering if a patient is in enough of a crisis to permit an exception to a law,” Dr. Phipps added. “This is an affront to all that drew my colleagues and me into medicine.”

Although the impact on doctor training remains to be seen, she said 44% of ob.gyn. residents are trained in states now empowered to ban abortions.

The effect of the Supreme Court decision on miscarriage management is another unknown.

“It’s going to be very difficult for us, the clinicians, to manage miscarriage,” Dr. Hoskins said. “Many miscarriages could be what we call ‘incomplete’ in the beginning,” where there is still a heartbeat and the patient is cramping and/or bleeding.

In that instance, Dr. Hoskins said, clinicians may be thinking that they have to wait.

“They may be needing to get additional opinions, whether it’s a legal opinion ... or another medical opinion.”

“It’s going to have a devastating effect on every aspect of a woman’s health care, including if she is spontaneously miscarrying,” Dr. Hoskins predicted.

Physician protect thyself?

To what extent doctors can shield themselves from potential prosecution “is a hard question to answer,” Molly Meegan, JD, ACOG’s chief legal officer and general counsel, said.

Ms. Meegan recommended members speak to the risk managers at their individual institutions for guidance.

“It is a real patchwork [of laws] out there, she said. “And that patchwork itself is a danger to people as they seek essential reproductive health care.”

Also, she added, “If a doctor can’t tell what the law is at the time they’re trying to provide the care, it has a terribly chilling effect on medical care.”

Another potential threat to doctors in states that still allow abortion services is action from a neighboring state.

“We are going to be advocating very strongly that states do not have extra-territorial jurisdiction to reach beyond the edges of their state.”

The worry is if a doctor in New Mexico, where abortion is legal, performs an abortion for a person from Texas, where it will soon be illegal, is then prosecuted by Texas, for example.
 

Medication abortion

Asked about any potential effects on medication abortions, ACOG’s Jen Villavicencio, MD, said it remains to be seen.

“Certainly many of the laws that we have seen, including trigger ban laws, encompass medication abortion,” she said. Several states have these so-called trigger laws, which put into effect laws passed to ban abortion in case Roe was overturned.

This means, she said, that any abortion option, whether it’s procedural or medication, could be and will be banned in some of these states.

Ms. Meegan added that ACOG will continue to support access to medication abortion and that it should be decided by the U.S. Food and Drug Administration and not individual states.
 

Maternal mortality may rise

“Maternal mortality in and of itself is a very difficult topic,” Dr. Hoskins said, but [the] decision amplifies the implications. “I think of the patients who will have to manage severe complications and mental health challenges while they are carrying a pregnancy that they are forced to carry.”

“I also think of the patients who need to end their pregnancies in order to save their own lives,” Dr. Hoskins added.

Dr. Hoskins said the United States already has a high maternal mortality rate. This new law, she added, could force women into higher-risk situations if they experience high blood pressure, preeclampsia, or bleeding after the birth of the baby.
 

Growing inequality possible?

“The grievous inequities that exist in this country will grow and expand unchecked without safe access to legal abortion,” Dr. Phipps said.

She noted that women, based on location, will continue “to have protected access to safe evidence-based abortion. Others will have the means and resources and opportunities to secure the care.”

But the same may not be true for women in underserved or disadvantaged communities, Dr. Phipps added.
 

American Medical Association

ACOG was not the only group to react. “The American Medical Association is deeply disturbed by the U.S. Supreme Court’s decision to overturn nearly a half century of precedent protecting patients’ right to critical reproductive health care,” President Jack Resneck Jr., MD, said in a statement.

The decision represents “an egregious allowance of government intrusion into the medical examination room, a direct attack on the practice of medicine and the patient-physician relationship, and a brazen violation of patients’ rights to evidence-based reproductive health services.”

American Academy of Family Physicians

“The American Academy of Family Physicians is disappointed and disheartened by the Supreme Court’s decision to strike down longstanding protections afforded by Roe v. Wade and Planned Parenthood v. Casey,” President Sterling N. Ransone Jr., MD, said in a statement.

The organization has 127,600 physician and medical student members.

“This decision negatively impacts our practices and our patients by undermining the patient-physician relationship and potentially criminalizing evidence-based medical care,” added Dr. Ransone.
 

American College of Physicians

“A patient’s decision about whether to continue a pregnancy should be a private decision made in consultation with a physician or other health care professional, without interference from the government,” President Ryan D. Mire, MD, said in a statement. “We strongly oppose medically unnecessary government restrictions on any health care services,” added Dr. Mire on behalf of the group’s 161,000 members.

American Academy of Pediatrics

“This decision carries grave consequences for our adolescent patients, who already face many more barriers than adults in accessing comprehensive reproductive health care services and abortion care,” President Moira Szilagyi, MD, PhD, said in a statement. 

“In the wake of this ruling, the American Academy of Pediatrics will continue to support our chapters as states consider policies affecting access to abortion care, and pediatricians will continue to support our patients,” Dr. Szilagyi added.
 

American Public Health Association

The court’s decision “is a catastrophic judicial failure that will reverberate differently in each state and portends to jeopardize the health and lives of all Americans,” Executive Director Georges C. Benjamin, MD, said in a statement.

American Urogynecologic Society

“The American Urogynecologic Society opposes any ruling that restricts a person’s access to health care and criminalizes the practice of medicine,” the group said in a statement. “This ruling ultimately poses a serious threat to the patient-provider relationship and subsequent decisionmaking necessary to ensure optimal outcomes for patients. As practitioners, we should be free to provide what is in the best interest of our patients.”

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

Infertility, pregnancy loss, and stillbirth increased women’s later risk of both nonfatal and fatal stroke, based on data from more than 600,000 women.

“To date, multiple studies have generated an expanding body of evidence on the association between pregnancy complications (e.g., gestational diabetes and preeclampsia) and the long-term risk of stroke, but studies on associations with infertility, miscarriage, or stillbirth have produced mixed evidence,” Chen Liang, a PhD candidate at the University of Queensland, Brisbane, Australia, and colleagues wrote.

In a study published in the BMJ, the researchers reviewed data from eight observational cohort studies across seven countries (Australia, China, Japan, the Netherlands, Sweden, the United Kingdom, and the United States). The participants were part of the InterLACE (International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events) consortium established in 2021. Most observational studies included in the analysis began between 1990 and 2000.

The study population included 618,851 women aged 32-73 years at baseline for whom data on infertility, miscarriage, or stillbirth, were available. The primary outcome was the association of infertility, recurrent miscarriage, and stillbirth with risk of first fatal or nonfatal stroke, and the results were further stratified by subtype. Stroke was identified through self-reports, linked hospital data, national patient registers, or death registry data. Baseline was defined as the first incidence of infertility, miscarriage, or stillbirth. The exception was the National Survey of Health and Development, a British birth cohort started in 1946, that collected data retrospectively.

The median follow-up period was 13 years for nonfatal stroke and 9.4 years for fatal stroke.

Overall, 17.2%, 16.6%, and 4.6% of the women experienced infertility, miscarriage, and stillbirth, respectively.

Women with a history of infertility had a significantly higher nonfatal stroke risk, compared with those without infertility (hazard ratio, 1.14). Further analysis by stroke subtypes showed an increased association between miscarriage and ischemic stroke (HR, 1.15).

Those with a history of miscarriage also had an increased risk of nonfatal stroke, compared with those without miscarriages (HR, 1.11). In the miscarriage group, the risk of stroke increased with the number of miscarriages, with adjusted HRs of 1.07, 1.12, and 1.35 for women with one, two, and three or more miscarriages, respectively. When stratified by stroke subtype, women with three or more miscarriages were more likely than women with no miscarriages to experience ischemic and hemorrhagic nonfatal strokes.

Associations were similar between miscarriage history and fatal stroke risk. Women with one, two, and three or more miscarriages had increased risk of fatal stroke, compared with those with no miscarriages (aHR, 1.08, 1.26, and 1.82, respectively, and women with three or more miscarriages had a higher risk of ischemic and hemorrhagic stroke (aHR, 1.83 and 1.84, respectively).

Women with a history of stillbirth had an approximately 31% increased risk of nonfatal stroke, compared with those with no history of stillbirth, with aHRs similar for single and recurrent stillbirths (1.32 and 1.29, respectively). Ischemic nonfatal stroke risk was higher in women with any stillbirth, compared with those without stillbirth (aHR, 1.77). Fatal stroke risk also was higher in women with any stillbirth, compared with those without, and this risk increased with the number of stillbirths (HR, 0.97 and HR, 1.26 for those with one stillbirth and two or more, respectively).

“The increased risk of stroke associated with infertility or recurrent stillbirths was mainly driven by a single subtype of stroke (nonfatal ischemic stroke or fatal hemorrhagic stroke, respectively), whereas the risk of stroke associated with recurrent miscarriages was driven by both subtypes,” the researchers wrote.

The researchers cited endothelial dysfunction as a potential underlying mechanism for increased stroke risk associated with pregnancy complications. “Endothelial dysfunction might lead to pregnancy loss through placentation-related defects, persist after a complicated pregnancy, and contribute to the development of stroke through reduced vasodilation, proinflammatory status, and prothrombic properties,” and that history of recurrent pregnancy loss might be a female-specific risk factor for stroke.

To mitigate this risk, they advised early monitoring of women with a history of recurrent miscarriages and stillbirths for stroke risk factors such as high blood pressure, blood sugar levels, and lipid levels.

The study findings were limited by several factors including the use of questionnaires to collect information on infertility, miscarriage, and stillbirth, and the potential variation in definitions of infertility, miscarriage, and stillbirth across the included studies, and a lack of data on the effect of different causes or treatments based on reproductive histories, the researchers noted. Other limitations include incomplete data on stroke subtypes and inability to adjust for all covariates such as thyroid disorders and endometriosis. However, the results were strengthened by the large study size and geographically and racially diverse population, extend the current knowledge on associations between infertility, miscarriage, and stillbirth with stroke, and highlight the need for more research on underlying mechanisms.
 

Data support gender-specific stroke risk stratification

“Studies that seek to understand gender differences and disparities in adverse outcomes, such as stroke risk, are extremely important given that women historically were excluded from research studies,” Catherine M. Albright, MD, of the University of Washington, Seattle, said in an interview. “By doing these studies, we are able to better risk stratify people in order to better predict and modify risks,” added Dr. Albright, who was not involved in the current study.

“It is well known than adverse pregnancy outcomes such as hypertension in pregnancy, fetal growth restriction, and preterm birth, lead to increased risk of cardiovascular disease and stroke later in life, so the general findings of an association between other adverse reproductive and pregnancy outcomes leads to increased stroke risk are not surprising,” she said.

“The take-home message is that outcomes for pregnancy really do provide a window to future health,” said Dr. Albright. “For clinicians, especially non-ob.gyns., knowing a complete pregnancy history for any new patient is important and can help risk-stratify patients, especially as we continue to gain knowledge like what is shown in this study.”

However, “this study did not evaluate why individual patients may have had infertility, recurrent pregnancy loss, or stillbirth, so research to look further into this association to determine if there is an underlying medical condition that could be treated and therefore possibly reduce both pregnancy complications and future stroke risks would be important,” Dr. Albright noted.

The study was supported by the Australian National Health and Medical Research Council Centres of Research Excellence; one corresponding author was supported by an Australian National Health and Medical Research Council Investigator grant. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Infertility, pregnancy loss, and stillbirth increased women’s later risk of both nonfatal and fatal stroke, based on data from more than 600,000 women.

“To date, multiple studies have generated an expanding body of evidence on the association between pregnancy complications (e.g., gestational diabetes and preeclampsia) and the long-term risk of stroke, but studies on associations with infertility, miscarriage, or stillbirth have produced mixed evidence,” Chen Liang, a PhD candidate at the University of Queensland, Brisbane, Australia, and colleagues wrote.

In a study published in the BMJ, the researchers reviewed data from eight observational cohort studies across seven countries (Australia, China, Japan, the Netherlands, Sweden, the United Kingdom, and the United States). The participants were part of the InterLACE (International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events) consortium established in 2021. Most observational studies included in the analysis began between 1990 and 2000.

The study population included 618,851 women aged 32-73 years at baseline for whom data on infertility, miscarriage, or stillbirth, were available. The primary outcome was the association of infertility, recurrent miscarriage, and stillbirth with risk of first fatal or nonfatal stroke, and the results were further stratified by subtype. Stroke was identified through self-reports, linked hospital data, national patient registers, or death registry data. Baseline was defined as the first incidence of infertility, miscarriage, or stillbirth. The exception was the National Survey of Health and Development, a British birth cohort started in 1946, that collected data retrospectively.

The median follow-up period was 13 years for nonfatal stroke and 9.4 years for fatal stroke.

Overall, 17.2%, 16.6%, and 4.6% of the women experienced infertility, miscarriage, and stillbirth, respectively.

Women with a history of infertility had a significantly higher nonfatal stroke risk, compared with those without infertility (hazard ratio, 1.14). Further analysis by stroke subtypes showed an increased association between miscarriage and ischemic stroke (HR, 1.15).

Those with a history of miscarriage also had an increased risk of nonfatal stroke, compared with those without miscarriages (HR, 1.11). In the miscarriage group, the risk of stroke increased with the number of miscarriages, with adjusted HRs of 1.07, 1.12, and 1.35 for women with one, two, and three or more miscarriages, respectively. When stratified by stroke subtype, women with three or more miscarriages were more likely than women with no miscarriages to experience ischemic and hemorrhagic nonfatal strokes.

Associations were similar between miscarriage history and fatal stroke risk. Women with one, two, and three or more miscarriages had increased risk of fatal stroke, compared with those with no miscarriages (aHR, 1.08, 1.26, and 1.82, respectively, and women with three or more miscarriages had a higher risk of ischemic and hemorrhagic stroke (aHR, 1.83 and 1.84, respectively).

Women with a history of stillbirth had an approximately 31% increased risk of nonfatal stroke, compared with those with no history of stillbirth, with aHRs similar for single and recurrent stillbirths (1.32 and 1.29, respectively). Ischemic nonfatal stroke risk was higher in women with any stillbirth, compared with those without stillbirth (aHR, 1.77). Fatal stroke risk also was higher in women with any stillbirth, compared with those without, and this risk increased with the number of stillbirths (HR, 0.97 and HR, 1.26 for those with one stillbirth and two or more, respectively).

“The increased risk of stroke associated with infertility or recurrent stillbirths was mainly driven by a single subtype of stroke (nonfatal ischemic stroke or fatal hemorrhagic stroke, respectively), whereas the risk of stroke associated with recurrent miscarriages was driven by both subtypes,” the researchers wrote.

The researchers cited endothelial dysfunction as a potential underlying mechanism for increased stroke risk associated with pregnancy complications. “Endothelial dysfunction might lead to pregnancy loss through placentation-related defects, persist after a complicated pregnancy, and contribute to the development of stroke through reduced vasodilation, proinflammatory status, and prothrombic properties,” and that history of recurrent pregnancy loss might be a female-specific risk factor for stroke.

To mitigate this risk, they advised early monitoring of women with a history of recurrent miscarriages and stillbirths for stroke risk factors such as high blood pressure, blood sugar levels, and lipid levels.

The study findings were limited by several factors including the use of questionnaires to collect information on infertility, miscarriage, and stillbirth, and the potential variation in definitions of infertility, miscarriage, and stillbirth across the included studies, and a lack of data on the effect of different causes or treatments based on reproductive histories, the researchers noted. Other limitations include incomplete data on stroke subtypes and inability to adjust for all covariates such as thyroid disorders and endometriosis. However, the results were strengthened by the large study size and geographically and racially diverse population, extend the current knowledge on associations between infertility, miscarriage, and stillbirth with stroke, and highlight the need for more research on underlying mechanisms.
 

Data support gender-specific stroke risk stratification

“Studies that seek to understand gender differences and disparities in adverse outcomes, such as stroke risk, are extremely important given that women historically were excluded from research studies,” Catherine M. Albright, MD, of the University of Washington, Seattle, said in an interview. “By doing these studies, we are able to better risk stratify people in order to better predict and modify risks,” added Dr. Albright, who was not involved in the current study.

“It is well known than adverse pregnancy outcomes such as hypertension in pregnancy, fetal growth restriction, and preterm birth, lead to increased risk of cardiovascular disease and stroke later in life, so the general findings of an association between other adverse reproductive and pregnancy outcomes leads to increased stroke risk are not surprising,” she said.

“The take-home message is that outcomes for pregnancy really do provide a window to future health,” said Dr. Albright. “For clinicians, especially non-ob.gyns., knowing a complete pregnancy history for any new patient is important and can help risk-stratify patients, especially as we continue to gain knowledge like what is shown in this study.”

However, “this study did not evaluate why individual patients may have had infertility, recurrent pregnancy loss, or stillbirth, so research to look further into this association to determine if there is an underlying medical condition that could be treated and therefore possibly reduce both pregnancy complications and future stroke risks would be important,” Dr. Albright noted.

The study was supported by the Australian National Health and Medical Research Council Centres of Research Excellence; one corresponding author was supported by an Australian National Health and Medical Research Council Investigator grant. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Infertility, pregnancy loss, and stillbirth increased women’s later risk of both nonfatal and fatal stroke, based on data from more than 600,000 women.

“To date, multiple studies have generated an expanding body of evidence on the association between pregnancy complications (e.g., gestational diabetes and preeclampsia) and the long-term risk of stroke, but studies on associations with infertility, miscarriage, or stillbirth have produced mixed evidence,” Chen Liang, a PhD candidate at the University of Queensland, Brisbane, Australia, and colleagues wrote.

In a study published in the BMJ, the researchers reviewed data from eight observational cohort studies across seven countries (Australia, China, Japan, the Netherlands, Sweden, the United Kingdom, and the United States). The participants were part of the InterLACE (International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events) consortium established in 2021. Most observational studies included in the analysis began between 1990 and 2000.

The study population included 618,851 women aged 32-73 years at baseline for whom data on infertility, miscarriage, or stillbirth, were available. The primary outcome was the association of infertility, recurrent miscarriage, and stillbirth with risk of first fatal or nonfatal stroke, and the results were further stratified by subtype. Stroke was identified through self-reports, linked hospital data, national patient registers, or death registry data. Baseline was defined as the first incidence of infertility, miscarriage, or stillbirth. The exception was the National Survey of Health and Development, a British birth cohort started in 1946, that collected data retrospectively.

The median follow-up period was 13 years for nonfatal stroke and 9.4 years for fatal stroke.

Overall, 17.2%, 16.6%, and 4.6% of the women experienced infertility, miscarriage, and stillbirth, respectively.

Women with a history of infertility had a significantly higher nonfatal stroke risk, compared with those without infertility (hazard ratio, 1.14). Further analysis by stroke subtypes showed an increased association between miscarriage and ischemic stroke (HR, 1.15).

Those with a history of miscarriage also had an increased risk of nonfatal stroke, compared with those without miscarriages (HR, 1.11). In the miscarriage group, the risk of stroke increased with the number of miscarriages, with adjusted HRs of 1.07, 1.12, and 1.35 for women with one, two, and three or more miscarriages, respectively. When stratified by stroke subtype, women with three or more miscarriages were more likely than women with no miscarriages to experience ischemic and hemorrhagic nonfatal strokes.

Associations were similar between miscarriage history and fatal stroke risk. Women with one, two, and three or more miscarriages had increased risk of fatal stroke, compared with those with no miscarriages (aHR, 1.08, 1.26, and 1.82, respectively, and women with three or more miscarriages had a higher risk of ischemic and hemorrhagic stroke (aHR, 1.83 and 1.84, respectively).

Women with a history of stillbirth had an approximately 31% increased risk of nonfatal stroke, compared with those with no history of stillbirth, with aHRs similar for single and recurrent stillbirths (1.32 and 1.29, respectively). Ischemic nonfatal stroke risk was higher in women with any stillbirth, compared with those without stillbirth (aHR, 1.77). Fatal stroke risk also was higher in women with any stillbirth, compared with those without, and this risk increased with the number of stillbirths (HR, 0.97 and HR, 1.26 for those with one stillbirth and two or more, respectively).

“The increased risk of stroke associated with infertility or recurrent stillbirths was mainly driven by a single subtype of stroke (nonfatal ischemic stroke or fatal hemorrhagic stroke, respectively), whereas the risk of stroke associated with recurrent miscarriages was driven by both subtypes,” the researchers wrote.

The researchers cited endothelial dysfunction as a potential underlying mechanism for increased stroke risk associated with pregnancy complications. “Endothelial dysfunction might lead to pregnancy loss through placentation-related defects, persist after a complicated pregnancy, and contribute to the development of stroke through reduced vasodilation, proinflammatory status, and prothrombic properties,” and that history of recurrent pregnancy loss might be a female-specific risk factor for stroke.

To mitigate this risk, they advised early monitoring of women with a history of recurrent miscarriages and stillbirths for stroke risk factors such as high blood pressure, blood sugar levels, and lipid levels.

The study findings were limited by several factors including the use of questionnaires to collect information on infertility, miscarriage, and stillbirth, and the potential variation in definitions of infertility, miscarriage, and stillbirth across the included studies, and a lack of data on the effect of different causes or treatments based on reproductive histories, the researchers noted. Other limitations include incomplete data on stroke subtypes and inability to adjust for all covariates such as thyroid disorders and endometriosis. However, the results were strengthened by the large study size and geographically and racially diverse population, extend the current knowledge on associations between infertility, miscarriage, and stillbirth with stroke, and highlight the need for more research on underlying mechanisms.
 

Data support gender-specific stroke risk stratification

“Studies that seek to understand gender differences and disparities in adverse outcomes, such as stroke risk, are extremely important given that women historically were excluded from research studies,” Catherine M. Albright, MD, of the University of Washington, Seattle, said in an interview. “By doing these studies, we are able to better risk stratify people in order to better predict and modify risks,” added Dr. Albright, who was not involved in the current study.

“It is well known than adverse pregnancy outcomes such as hypertension in pregnancy, fetal growth restriction, and preterm birth, lead to increased risk of cardiovascular disease and stroke later in life, so the general findings of an association between other adverse reproductive and pregnancy outcomes leads to increased stroke risk are not surprising,” she said.

“The take-home message is that outcomes for pregnancy really do provide a window to future health,” said Dr. Albright. “For clinicians, especially non-ob.gyns., knowing a complete pregnancy history for any new patient is important and can help risk-stratify patients, especially as we continue to gain knowledge like what is shown in this study.”

However, “this study did not evaluate why individual patients may have had infertility, recurrent pregnancy loss, or stillbirth, so research to look further into this association to determine if there is an underlying medical condition that could be treated and therefore possibly reduce both pregnancy complications and future stroke risks would be important,” Dr. Albright noted.

The study was supported by the Australian National Health and Medical Research Council Centres of Research Excellence; one corresponding author was supported by an Australian National Health and Medical Research Council Investigator grant. The researchers had no financial conflicts to disclose. Dr. Albright had no financial conflicts to disclose.

Infants who were introduced to a low-protein diet – high in fruit, vegetables, and roots – ate more fruits and vegetables at 12 and 18 months of age, compared with those who ate a conventional diet, in a new study.

The “Nordic diet” has shown health benefits in children and adults, but has not been studied in infants, said Ulrica Johansson, MD, of Umeå (Sweden) University, in a presentation on the study at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition.

A healthy and sustainable diet early in life could have a significant impact on future health, Dr. Johansson said in an interview.

Dr. Johansson and colleagues aimed to investigate the effect of a Nordic diet in infants aged 4-18 months in the OTIS trial. All infants were breastfed or formula-fed at baseline.
 

Study methods and results

A total of 250 infants aged 4-6 months were randomized to consuming a Nordic diet or a conventional diet. Those in the Nordic group received exposures to Nordic foods and flavors, including Nordic fruit, berries, vegetables, and roots. Those in the conventional group received baby food products that followed the current Swedish dietary recommendations for infants. The researchers collected data on dietary intake, biomarkers, and growth from baseline up to 18 months of age.

Notably, acceptance of all the flavors in the Nordic diet was high, including those with sour or bitter taste, such as cranberry and white radish, Dr. Johansson said in her presentation. Food refusals were few, and did not differ among the Nordic food offerings.

At both 12- and 18-month follow-ups, infants in the Nordic group consumed 42%-45% more fruits and vegetables compared with those in the conventional group (P < .001). Plasma folate levels also were significantly higher in the Nordic group compared with in the conventional group, at both 12 months and 18 months (P < .001 and P < .003, respectively).

The daily mean protein intake ranged from 17% to 29% lower in the Nordic group compared with in the conventional group, at both 12 months and 18 months. The intake of protein in terms of g/kg of body weight was significantly lower in the Nordic group, at both time points. Lower protein intake was confirmed by blood urea nitrogen measurements.

The protein intake in the Nordic group still fell within the safe level recommended for healthy growth in young children by the World Health Organization, noted Dr. Johansson, and no significant differences were observed in growth between the groups. Total energy intake, iron status, and duration of breastfeeding also remained similar between the groups throughout the study period.

Parents received support from research nurses via social media and monthly clinic visits, which she believes contributed to the success of the intervention, she said.
 

Nordic diet offers feasible encouragement of healthy eating

The key message for clinicians, and for parents of young children, is that “the protein-reduced, Nordic diet is both feasible and safe for infants’ growth, nutritional requirements, and development during the complementary feeding period,” Dr. Johansson said in an interview. “Thus, it may serve as a healthy and environmentally sustainable diet alternative for infants and their parents in the future.”

“Nordic foods are feasible to use when exposing infants to a variety of flavors so that healthy food preferences can be established early in life; Nordic berries and some root vegetables are preferable when introducing bitter and sour tastes during the sensitive period,” she added.

“Multicomponent interventions with long-term follow-up are required to advance the field of child nutrition research,” Dr. Johansson emphasized. Home-based interventions are lacking, and “more studies are needed to bridge the gap in research between the transfer period from baby food to family food at 1-2 years of age.”

Large, randomized controlled studies of Nordic diet during infancy and later childhood are needed as well, said Dr. Johansson. “The long-term effects of the Nordic diet during this highly dynamic period of childhood need continued follow-up to school age to give indications of any lasting health effects,” and the researchers plan to follow the current study population at 7 years of age.

Findings reinforce need for better nutrition

Previous research documents concern for childhood obesity associated with higher intake of protein, fats and overall calories in infancy, said Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview. “The inclusion of high-calorie, high-fat foods contributes to obesity in all children, so focusing on intake of fruits and vegetables is extremely important early in life,” she said.

A key barrier to the widespread use of a Nordic-type diet is that and vegetables tend to be more expensive than other foods and may not be readily available to all families, especially lower income families, Dr. Haut added.

However, for primary care clinicians, the current study reinforces the need to encourage the intake of fruits and vegetables at all ages, beginning in infancy, she said.

Looking ahead, “there is still limited information in the literature about the ideal recommended daily protein, except for increased amounts needed for preterm infants, early infancy, and during periods of healing,” Dr. Haut emphasized. “Some controls for this study were not included in the abstract, such as monitoring what foods were given to the infants in the conventional group. Parent and caregiver interpretation of recommendations can be highly variable,” she noted. Also, “The activity levels of late infancy and toddlers can vary in terms of energy usage, especially when crawling, walking, running and other exercise-related activities begin. These factors were not readily available in the abstract/study,” she said.  

The OTIS trial was sponsored by Semper. Dr. Johansson had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News.

Infants who were introduced to a low-protein diet – high in fruit, vegetables, and roots – ate more fruits and vegetables at 12 and 18 months of age, compared with those who ate a conventional diet, in a new study.

The “Nordic diet” has shown health benefits in children and adults, but has not been studied in infants, said Ulrica Johansson, MD, of Umeå (Sweden) University, in a presentation on the study at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition.

A healthy and sustainable diet early in life could have a significant impact on future health, Dr. Johansson said in an interview.

Dr. Johansson and colleagues aimed to investigate the effect of a Nordic diet in infants aged 4-18 months in the OTIS trial. All infants were breastfed or formula-fed at baseline.
 

Study methods and results

A total of 250 infants aged 4-6 months were randomized to consuming a Nordic diet or a conventional diet. Those in the Nordic group received exposures to Nordic foods and flavors, including Nordic fruit, berries, vegetables, and roots. Those in the conventional group received baby food products that followed the current Swedish dietary recommendations for infants. The researchers collected data on dietary intake, biomarkers, and growth from baseline up to 18 months of age.

Notably, acceptance of all the flavors in the Nordic diet was high, including those with sour or bitter taste, such as cranberry and white radish, Dr. Johansson said in her presentation. Food refusals were few, and did not differ among the Nordic food offerings.

At both 12- and 18-month follow-ups, infants in the Nordic group consumed 42%-45% more fruits and vegetables compared with those in the conventional group (P < .001). Plasma folate levels also were significantly higher in the Nordic group compared with in the conventional group, at both 12 months and 18 months (P < .001 and P < .003, respectively).

The daily mean protein intake ranged from 17% to 29% lower in the Nordic group compared with in the conventional group, at both 12 months and 18 months. The intake of protein in terms of g/kg of body weight was significantly lower in the Nordic group, at both time points. Lower protein intake was confirmed by blood urea nitrogen measurements.

The protein intake in the Nordic group still fell within the safe level recommended for healthy growth in young children by the World Health Organization, noted Dr. Johansson, and no significant differences were observed in growth between the groups. Total energy intake, iron status, and duration of breastfeeding also remained similar between the groups throughout the study period.

Parents received support from research nurses via social media and monthly clinic visits, which she believes contributed to the success of the intervention, she said.
 

Nordic diet offers feasible encouragement of healthy eating

The key message for clinicians, and for parents of young children, is that “the protein-reduced, Nordic diet is both feasible and safe for infants’ growth, nutritional requirements, and development during the complementary feeding period,” Dr. Johansson said in an interview. “Thus, it may serve as a healthy and environmentally sustainable diet alternative for infants and their parents in the future.”

“Nordic foods are feasible to use when exposing infants to a variety of flavors so that healthy food preferences can be established early in life; Nordic berries and some root vegetables are preferable when introducing bitter and sour tastes during the sensitive period,” she added.

“Multicomponent interventions with long-term follow-up are required to advance the field of child nutrition research,” Dr. Johansson emphasized. Home-based interventions are lacking, and “more studies are needed to bridge the gap in research between the transfer period from baby food to family food at 1-2 years of age.”

Large, randomized controlled studies of Nordic diet during infancy and later childhood are needed as well, said Dr. Johansson. “The long-term effects of the Nordic diet during this highly dynamic period of childhood need continued follow-up to school age to give indications of any lasting health effects,” and the researchers plan to follow the current study population at 7 years of age.

Findings reinforce need for better nutrition

Previous research documents concern for childhood obesity associated with higher intake of protein, fats and overall calories in infancy, said Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview. “The inclusion of high-calorie, high-fat foods contributes to obesity in all children, so focusing on intake of fruits and vegetables is extremely important early in life,” she said.

A key barrier to the widespread use of a Nordic-type diet is that and vegetables tend to be more expensive than other foods and may not be readily available to all families, especially lower income families, Dr. Haut added.

However, for primary care clinicians, the current study reinforces the need to encourage the intake of fruits and vegetables at all ages, beginning in infancy, she said.

Looking ahead, “there is still limited information in the literature about the ideal recommended daily protein, except for increased amounts needed for preterm infants, early infancy, and during periods of healing,” Dr. Haut emphasized. “Some controls for this study were not included in the abstract, such as monitoring what foods were given to the infants in the conventional group. Parent and caregiver interpretation of recommendations can be highly variable,” she noted. Also, “The activity levels of late infancy and toddlers can vary in terms of energy usage, especially when crawling, walking, running and other exercise-related activities begin. These factors were not readily available in the abstract/study,” she said.  

The OTIS trial was sponsored by Semper. Dr. Johansson had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News.

Infants who were introduced to a low-protein diet – high in fruit, vegetables, and roots – ate more fruits and vegetables at 12 and 18 months of age, compared with those who ate a conventional diet, in a new study.

The “Nordic diet” has shown health benefits in children and adults, but has not been studied in infants, said Ulrica Johansson, MD, of Umeå (Sweden) University, in a presentation on the study at the annual meeting of the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition.

A healthy and sustainable diet early in life could have a significant impact on future health, Dr. Johansson said in an interview.

Dr. Johansson and colleagues aimed to investigate the effect of a Nordic diet in infants aged 4-18 months in the OTIS trial. All infants were breastfed or formula-fed at baseline.
 

Study methods and results

A total of 250 infants aged 4-6 months were randomized to consuming a Nordic diet or a conventional diet. Those in the Nordic group received exposures to Nordic foods and flavors, including Nordic fruit, berries, vegetables, and roots. Those in the conventional group received baby food products that followed the current Swedish dietary recommendations for infants. The researchers collected data on dietary intake, biomarkers, and growth from baseline up to 18 months of age.

Notably, acceptance of all the flavors in the Nordic diet was high, including those with sour or bitter taste, such as cranberry and white radish, Dr. Johansson said in her presentation. Food refusals were few, and did not differ among the Nordic food offerings.

At both 12- and 18-month follow-ups, infants in the Nordic group consumed 42%-45% more fruits and vegetables compared with those in the conventional group (P < .001). Plasma folate levels also were significantly higher in the Nordic group compared with in the conventional group, at both 12 months and 18 months (P < .001 and P < .003, respectively).

The daily mean protein intake ranged from 17% to 29% lower in the Nordic group compared with in the conventional group, at both 12 months and 18 months. The intake of protein in terms of g/kg of body weight was significantly lower in the Nordic group, at both time points. Lower protein intake was confirmed by blood urea nitrogen measurements.

The protein intake in the Nordic group still fell within the safe level recommended for healthy growth in young children by the World Health Organization, noted Dr. Johansson, and no significant differences were observed in growth between the groups. Total energy intake, iron status, and duration of breastfeeding also remained similar between the groups throughout the study period.

Parents received support from research nurses via social media and monthly clinic visits, which she believes contributed to the success of the intervention, she said.
 

Nordic diet offers feasible encouragement of healthy eating

The key message for clinicians, and for parents of young children, is that “the protein-reduced, Nordic diet is both feasible and safe for infants’ growth, nutritional requirements, and development during the complementary feeding period,” Dr. Johansson said in an interview. “Thus, it may serve as a healthy and environmentally sustainable diet alternative for infants and their parents in the future.”

“Nordic foods are feasible to use when exposing infants to a variety of flavors so that healthy food preferences can be established early in life; Nordic berries and some root vegetables are preferable when introducing bitter and sour tastes during the sensitive period,” she added.

“Multicomponent interventions with long-term follow-up are required to advance the field of child nutrition research,” Dr. Johansson emphasized. Home-based interventions are lacking, and “more studies are needed to bridge the gap in research between the transfer period from baby food to family food at 1-2 years of age.”

Large, randomized controlled studies of Nordic diet during infancy and later childhood are needed as well, said Dr. Johansson. “The long-term effects of the Nordic diet during this highly dynamic period of childhood need continued follow-up to school age to give indications of any lasting health effects,” and the researchers plan to follow the current study population at 7 years of age.

Findings reinforce need for better nutrition

Previous research documents concern for childhood obesity associated with higher intake of protein, fats and overall calories in infancy, said Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., in an interview. “The inclusion of high-calorie, high-fat foods contributes to obesity in all children, so focusing on intake of fruits and vegetables is extremely important early in life,” she said.

A key barrier to the widespread use of a Nordic-type diet is that and vegetables tend to be more expensive than other foods and may not be readily available to all families, especially lower income families, Dr. Haut added.

However, for primary care clinicians, the current study reinforces the need to encourage the intake of fruits and vegetables at all ages, beginning in infancy, she said.

Looking ahead, “there is still limited information in the literature about the ideal recommended daily protein, except for increased amounts needed for preterm infants, early infancy, and during periods of healing,” Dr. Haut emphasized. “Some controls for this study were not included in the abstract, such as monitoring what foods were given to the infants in the conventional group. Parent and caregiver interpretation of recommendations can be highly variable,” she noted. Also, “The activity levels of late infancy and toddlers can vary in terms of energy usage, especially when crawling, walking, running and other exercise-related activities begin. These factors were not readily available in the abstract/study,” she said.  

The OTIS trial was sponsored by Semper. Dr. Johansson had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose, but serves on the Editorial Advisory Board of Pediatric News.

It took Michael Golden, MD, 5 years to decide to switch to a concierge practice, in which patients pay a monthly or annual fee for more personalized care. Dr. Golden, an internist in Beverly, Mass., changed course in 2021, during the COVID-19 pandemic.

“I’m not sure why I hesitated for so long,” said Dr. Golden.

Once they take the plunge into concierge practice or direct primary care (DPC) – a related form of retainer-based practice – many doctors are delighted with the change. But taking the plunge is a big step that they sometimes put off for years.

“The main factors for waiting are fear, uncertainty, and doubt,” said Leigh “Jack” Forbush, DO, a family physician who runs a DPC practice in Hampden, Maine, and mentors doctors contemplating the switch.

According to Dr. Forbush, the critical questions doctors ask themselves are, “Will I be able to find enough paying patients?” and – in the case of DPC practices, which cancel insurance – “Can I live without the money I get from insurers?”

Terry Bauer, CEO of Specialdocs Consultants in Highland Park, Ill., which helps doctors move to a concierge practice, said many of his clients put off the decision for as long as 15 years.

“Clients became progressively worn out – or even burnt out – by the demands of fee-for-service medicine,” said Dr. Bauer. “For women, the tipping point can be when their kids ask, ‘Mom, do you like your job better than me?’ For men, it may be more about feeling tired and unsatisfied with their work.”

But once these doctors make the switch, it’s with all their heart. “A client recently told me that if he couldn’t open a concierge practice, he might have to quit medicine,” Dr. Bauer said. “And he’s only 51.”
 

Few doctors regret switching

A 2020 survey of DPC physicians for the Society of Actuaries found that 99% reported having better or much better overall personal and professional satisfaction.

Retainer-based physicians report feeling much more relaxed after they start a concierge practice. On many workdays, Dr. Golden takes a walk on a trail in the woods behind his office. “That’s something I couldn’t do before,” he said. “And I go to my kids’ soccer games. I’m able to be present in their lives now.”

Since retainer-based doctors have markedly fewer patients, they can form personal relationships with each one. When Dr. Golden switched, he “went from having a couple of thousand patients to a few hundred,” he said.

“I know each patient now,” said Dorothy Cohen Serna, MD, an internist in Cypress, Tex., who moved to concierge in 2017. “I don’t need to look at their chart to know who they are.”

Dr. Serna said patients’ close relationship with her helped them get through the worst months of the pandemic. “They were scared, depressed, and concerned, and they needed a lot of individual attention,” she said.

Because they see fewer patients, concierge doctors can lengthen appointment times to about 30 minutes – or longer, if necessary. They no longer have a problem answering patients’ “doorknob questions” – wholly new concerns brought up at the end of the visit.

“The appointment might be for a sprained ankle, and then the patient might mention they haven’t been sleeping well,” Dr. Golden said. “I have time to talk about that without worrying that my schedule is getting backed up.”
 

Why patients sign up

Retainer-based practices are still an exotic concept in many areas, but patients are beginning to understand the value, said Shalini Kaneriya, MD, an internist in Herndon, Va,, who switched her practice to concierge in 2018.

Several hundred patients followed her into her new practice because “people realized their care would be better if they had a concierge doctor,” she said. Two years ago, partly because of growing demand, she recruited another physician as an associate.

“People want a relationship with their doctor,” Dr. Serna added. “It’s hard to provide that in a regular practice.”

Todd Granger, MD, an internist who opened a DPC practice in Chapel Hill, N.C., in 2016, said new patients often mention feeling rushed through appointments with their previous doctors. Also, “it’s hard to get to see a doctor around here.”

Scott Bernstein, MD, an internist who runs a DPC practice in Scottsdale, Ariz., said he can arrange to have patients see specialists much faster than if they try to make appointments on their own. “I personally call specialists and then prep my patients on how to deal with the appointment,” he said.

Retainer-based practices tend to have a greater number of older and chronically ill patients, but they also attract patients who need less care. “The healthier patients find value in our proactive approach to prevention and wellness,” Dr. Serna said.

Some concierge physicians charge higher fees to patients who need more care, but many decide this is too complicated and charge everyone the same fee. Dr. Granger said he initially had a variable fee schedule, but when some lower-paying patients began to need more visits, he had to consider charging them extra. “Now I basically have just one fee,” he said.
 

Not a good fit for many physicians

Dr. Bauer said a lot of physicians are interested in retainer-based practice, but many of them might not make the income they had hoped for. Specialdocs interviews physicians who inquire about the model and ultimately doesn’t contract with 80% of them, Dr. Bauer said.

To be able to sign up and retain enough patients, the doctor’s attitude is important. “You have to be driven by the desire to go deep with patients -- to work hard with them and deal with their issues,” said Erika Bliss, MD, who runs a DPC practice in Seattle.

Dr. Bernstein said retainer-based physicians have to be interested in lifestyle issues, such as diet, exercise, and sleep. “I spend a lot of time dealing with issues like how to incorporate physical activity into daily routines,” he said. “Some doctors wouldn’t enjoy doing that.”

Also, concierge physicians have to be available all the time. “Patients have my cell phone number,” Dr. Granger said. “They could call in the middle of the night, but they usually don’t.”

To ensure that they get some time off, many concierge physicians have partners. Dr. Bernstein and another DPC doctor maintain separate practices but cover for each other. Each takes every other weekend off plus 6 weeks every year.
 

Can you attract enough patients?

A key challenge is finding enough patients to sustain a concierge practice. Planning the switch involves setting a target number of patients needed for the doctor to make a decent income after paying practice expenses. For example, a doctor charging $300 a month to 250 patients would gross $900,000 per year, and then pay practice expenses from that.

Attracting the target number of patients can take months or even years. After almost 6 years, Dr. Granger said, he has around 240 patients ― well below his target number of 440.

Partly because the practice model is not well known in North Carolina, Dr. Granger set his fee very low, at $60 a month, then raised it to $75. That means his practice has been grossing just $216,000 a year. But he is not about to give up. He plans to raise his fee in July and hopes that word of mouth will add more patients.

If physicians cannot earn enough in their concierge practice, Dr. Bauer said, they may moonlight at a local hospital or work for a telemedicine company. He hasn’t heard of physicians closing their concierge practice and returning to their previous practice model. “They didn’t like what they were doing before,” he said.
 

Opening up to lower-income patients

Dr. Granger’s $75 monthly fee is an example of how retainer-based medicine has transformed itself from a gold-plated service for rich people to a service that middle-class and even lower-income people can afford. DPC practices like Dr. Granger’s have dramatically lowered expenses by cutting out the need to bill insurance companies. Some DPC practices further reduce expenses by not having any staff and by renting out office space.

Dr. Forbush’s Pine Tree State patients are mostly blue-collar workers – electricians, plumbers, people who work in small businesses. He charges them $150 a month, which most patients who don’t have health insurance can afford. He said three-quarters of his patients lack health insurance, although some have back-up finances, such as health savings accounts.

Since his patients have to pay out of pocket for tests and specialists, Dr. Forbush keeps referrals in check by handling many problems himself. “Since I have more time to spend with the patient, I can often work out issues that other doctors might ask specialists to deal with,” he said.

He has learned some dermatologic procedures. “There are plenty of things I can handle on my own,” he said.

Dr. Granger adds that by examining patients during longer appointments, expensive diagnostic exams are not always necessary.
 

The challenges for this model

Many experts warn that retainer-based practices won’t work for doctors who want to leave employment or for doctors fresh out of residency. Not having your own patients to bring into the new practice is a big minus, because this is the best way to start the new practice.

Still, there are other ways to find patients. Dr. Bauer said physicians can advertise online, make themselves known by giving speeches in the community, or contract with small employers to treat their workers.

Dr. Bauer said some of his clients were employed physicians, and he thinks they will become a bigger factor now that fewer doctors remain in private practice. The chief barrier for employed physicians is the restrictive covenant that prevents them from setting up a practice nearby. But Dr. Bauer said some employers are willing to waive restrictive covenants for retainer-based doctors.

New physicians are also adopting the concierge model. Dr. Forbush said physicians straight out of residency have set up DPC practices in Maine. They signed up patients for their new practices even before they graduated, he said.

Retainer-based medicine is still mainly limited to primary care physicians, but according to Dr. Bauer, it can also work for specialists who have long-term relationships with patients, such as cardiologists, ob.gyns., rheumatologists, neurologists, and endocrinologists.
 

No going back

Most doctors who make the switch to retainer-based practice understand that there’s likely no going back. When Dr. Bernstein switched, he announced the change to patients and canceled insurance contracts. “It was make or break,” he said. “I had no parachute.”

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

It took Michael Golden, MD, 5 years to decide to switch to a concierge practice, in which patients pay a monthly or annual fee for more personalized care. Dr. Golden, an internist in Beverly, Mass., changed course in 2021, during the COVID-19 pandemic.

“I’m not sure why I hesitated for so long,” said Dr. Golden.

Once they take the plunge into concierge practice or direct primary care (DPC) – a related form of retainer-based practice – many doctors are delighted with the change. But taking the plunge is a big step that they sometimes put off for years.

“The main factors for waiting are fear, uncertainty, and doubt,” said Leigh “Jack” Forbush, DO, a family physician who runs a DPC practice in Hampden, Maine, and mentors doctors contemplating the switch.

According to Dr. Forbush, the critical questions doctors ask themselves are, “Will I be able to find enough paying patients?” and – in the case of DPC practices, which cancel insurance – “Can I live without the money I get from insurers?”

Terry Bauer, CEO of Specialdocs Consultants in Highland Park, Ill., which helps doctors move to a concierge practice, said many of his clients put off the decision for as long as 15 years.

“Clients became progressively worn out – or even burnt out – by the demands of fee-for-service medicine,” said Dr. Bauer. “For women, the tipping point can be when their kids ask, ‘Mom, do you like your job better than me?’ For men, it may be more about feeling tired and unsatisfied with their work.”

But once these doctors make the switch, it’s with all their heart. “A client recently told me that if he couldn’t open a concierge practice, he might have to quit medicine,” Dr. Bauer said. “And he’s only 51.”
 

Few doctors regret switching

A 2020 survey of DPC physicians for the Society of Actuaries found that 99% reported having better or much better overall personal and professional satisfaction.

Retainer-based physicians report feeling much more relaxed after they start a concierge practice. On many workdays, Dr. Golden takes a walk on a trail in the woods behind his office. “That’s something I couldn’t do before,” he said. “And I go to my kids’ soccer games. I’m able to be present in their lives now.”

Since retainer-based doctors have markedly fewer patients, they can form personal relationships with each one. When Dr. Golden switched, he “went from having a couple of thousand patients to a few hundred,” he said.

“I know each patient now,” said Dorothy Cohen Serna, MD, an internist in Cypress, Tex., who moved to concierge in 2017. “I don’t need to look at their chart to know who they are.”

Dr. Serna said patients’ close relationship with her helped them get through the worst months of the pandemic. “They were scared, depressed, and concerned, and they needed a lot of individual attention,” she said.

Because they see fewer patients, concierge doctors can lengthen appointment times to about 30 minutes – or longer, if necessary. They no longer have a problem answering patients’ “doorknob questions” – wholly new concerns brought up at the end of the visit.

“The appointment might be for a sprained ankle, and then the patient might mention they haven’t been sleeping well,” Dr. Golden said. “I have time to talk about that without worrying that my schedule is getting backed up.”
 

Why patients sign up

Retainer-based practices are still an exotic concept in many areas, but patients are beginning to understand the value, said Shalini Kaneriya, MD, an internist in Herndon, Va,, who switched her practice to concierge in 2018.

Several hundred patients followed her into her new practice because “people realized their care would be better if they had a concierge doctor,” she said. Two years ago, partly because of growing demand, she recruited another physician as an associate.

“People want a relationship with their doctor,” Dr. Serna added. “It’s hard to provide that in a regular practice.”

Todd Granger, MD, an internist who opened a DPC practice in Chapel Hill, N.C., in 2016, said new patients often mention feeling rushed through appointments with their previous doctors. Also, “it’s hard to get to see a doctor around here.”

Scott Bernstein, MD, an internist who runs a DPC practice in Scottsdale, Ariz., said he can arrange to have patients see specialists much faster than if they try to make appointments on their own. “I personally call specialists and then prep my patients on how to deal with the appointment,” he said.

Retainer-based practices tend to have a greater number of older and chronically ill patients, but they also attract patients who need less care. “The healthier patients find value in our proactive approach to prevention and wellness,” Dr. Serna said.

Some concierge physicians charge higher fees to patients who need more care, but many decide this is too complicated and charge everyone the same fee. Dr. Granger said he initially had a variable fee schedule, but when some lower-paying patients began to need more visits, he had to consider charging them extra. “Now I basically have just one fee,” he said.
 

Not a good fit for many physicians

Dr. Bauer said a lot of physicians are interested in retainer-based practice, but many of them might not make the income they had hoped for. Specialdocs interviews physicians who inquire about the model and ultimately doesn’t contract with 80% of them, Dr. Bauer said.

To be able to sign up and retain enough patients, the doctor’s attitude is important. “You have to be driven by the desire to go deep with patients -- to work hard with them and deal with their issues,” said Erika Bliss, MD, who runs a DPC practice in Seattle.

Dr. Bernstein said retainer-based physicians have to be interested in lifestyle issues, such as diet, exercise, and sleep. “I spend a lot of time dealing with issues like how to incorporate physical activity into daily routines,” he said. “Some doctors wouldn’t enjoy doing that.”

Also, concierge physicians have to be available all the time. “Patients have my cell phone number,” Dr. Granger said. “They could call in the middle of the night, but they usually don’t.”

To ensure that they get some time off, many concierge physicians have partners. Dr. Bernstein and another DPC doctor maintain separate practices but cover for each other. Each takes every other weekend off plus 6 weeks every year.
 

Can you attract enough patients?

A key challenge is finding enough patients to sustain a concierge practice. Planning the switch involves setting a target number of patients needed for the doctor to make a decent income after paying practice expenses. For example, a doctor charging $300 a month to 250 patients would gross $900,000 per year, and then pay practice expenses from that.

Attracting the target number of patients can take months or even years. After almost 6 years, Dr. Granger said, he has around 240 patients ― well below his target number of 440.

Partly because the practice model is not well known in North Carolina, Dr. Granger set his fee very low, at $60 a month, then raised it to $75. That means his practice has been grossing just $216,000 a year. But he is not about to give up. He plans to raise his fee in July and hopes that word of mouth will add more patients.

If physicians cannot earn enough in their concierge practice, Dr. Bauer said, they may moonlight at a local hospital or work for a telemedicine company. He hasn’t heard of physicians closing their concierge practice and returning to their previous practice model. “They didn’t like what they were doing before,” he said.
 

Opening up to lower-income patients

Dr. Granger’s $75 monthly fee is an example of how retainer-based medicine has transformed itself from a gold-plated service for rich people to a service that middle-class and even lower-income people can afford. DPC practices like Dr. Granger’s have dramatically lowered expenses by cutting out the need to bill insurance companies. Some DPC practices further reduce expenses by not having any staff and by renting out office space.

Dr. Forbush’s Pine Tree State patients are mostly blue-collar workers – electricians, plumbers, people who work in small businesses. He charges them $150 a month, which most patients who don’t have health insurance can afford. He said three-quarters of his patients lack health insurance, although some have back-up finances, such as health savings accounts.

Since his patients have to pay out of pocket for tests and specialists, Dr. Forbush keeps referrals in check by handling many problems himself. “Since I have more time to spend with the patient, I can often work out issues that other doctors might ask specialists to deal with,” he said.

He has learned some dermatologic procedures. “There are plenty of things I can handle on my own,” he said.

Dr. Granger adds that by examining patients during longer appointments, expensive diagnostic exams are not always necessary.
 

The challenges for this model

Many experts warn that retainer-based practices won’t work for doctors who want to leave employment or for doctors fresh out of residency. Not having your own patients to bring into the new practice is a big minus, because this is the best way to start the new practice.

Still, there are other ways to find patients. Dr. Bauer said physicians can advertise online, make themselves known by giving speeches in the community, or contract with small employers to treat their workers.

Dr. Bauer said some of his clients were employed physicians, and he thinks they will become a bigger factor now that fewer doctors remain in private practice. The chief barrier for employed physicians is the restrictive covenant that prevents them from setting up a practice nearby. But Dr. Bauer said some employers are willing to waive restrictive covenants for retainer-based doctors.

New physicians are also adopting the concierge model. Dr. Forbush said physicians straight out of residency have set up DPC practices in Maine. They signed up patients for their new practices even before they graduated, he said.

Retainer-based medicine is still mainly limited to primary care physicians, but according to Dr. Bauer, it can also work for specialists who have long-term relationships with patients, such as cardiologists, ob.gyns., rheumatologists, neurologists, and endocrinologists.
 

No going back

Most doctors who make the switch to retainer-based practice understand that there’s likely no going back. When Dr. Bernstein switched, he announced the change to patients and canceled insurance contracts. “It was make or break,” he said. “I had no parachute.”

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

It took Michael Golden, MD, 5 years to decide to switch to a concierge practice, in which patients pay a monthly or annual fee for more personalized care. Dr. Golden, an internist in Beverly, Mass., changed course in 2021, during the COVID-19 pandemic.

“I’m not sure why I hesitated for so long,” said Dr. Golden.

Once they take the plunge into concierge practice or direct primary care (DPC) – a related form of retainer-based practice – many doctors are delighted with the change. But taking the plunge is a big step that they sometimes put off for years.

“The main factors for waiting are fear, uncertainty, and doubt,” said Leigh “Jack” Forbush, DO, a family physician who runs a DPC practice in Hampden, Maine, and mentors doctors contemplating the switch.

According to Dr. Forbush, the critical questions doctors ask themselves are, “Will I be able to find enough paying patients?” and – in the case of DPC practices, which cancel insurance – “Can I live without the money I get from insurers?”

Terry Bauer, CEO of Specialdocs Consultants in Highland Park, Ill., which helps doctors move to a concierge practice, said many of his clients put off the decision for as long as 15 years.

“Clients became progressively worn out – or even burnt out – by the demands of fee-for-service medicine,” said Dr. Bauer. “For women, the tipping point can be when their kids ask, ‘Mom, do you like your job better than me?’ For men, it may be more about feeling tired and unsatisfied with their work.”

But once these doctors make the switch, it’s with all their heart. “A client recently told me that if he couldn’t open a concierge practice, he might have to quit medicine,” Dr. Bauer said. “And he’s only 51.”
 

Few doctors regret switching

A 2020 survey of DPC physicians for the Society of Actuaries found that 99% reported having better or much better overall personal and professional satisfaction.

Retainer-based physicians report feeling much more relaxed after they start a concierge practice. On many workdays, Dr. Golden takes a walk on a trail in the woods behind his office. “That’s something I couldn’t do before,” he said. “And I go to my kids’ soccer games. I’m able to be present in their lives now.”

Since retainer-based doctors have markedly fewer patients, they can form personal relationships with each one. When Dr. Golden switched, he “went from having a couple of thousand patients to a few hundred,” he said.

“I know each patient now,” said Dorothy Cohen Serna, MD, an internist in Cypress, Tex., who moved to concierge in 2017. “I don’t need to look at their chart to know who they are.”

Dr. Serna said patients’ close relationship with her helped them get through the worst months of the pandemic. “They were scared, depressed, and concerned, and they needed a lot of individual attention,” she said.

Because they see fewer patients, concierge doctors can lengthen appointment times to about 30 minutes – or longer, if necessary. They no longer have a problem answering patients’ “doorknob questions” – wholly new concerns brought up at the end of the visit.

“The appointment might be for a sprained ankle, and then the patient might mention they haven’t been sleeping well,” Dr. Golden said. “I have time to talk about that without worrying that my schedule is getting backed up.”
 

Why patients sign up

Retainer-based practices are still an exotic concept in many areas, but patients are beginning to understand the value, said Shalini Kaneriya, MD, an internist in Herndon, Va,, who switched her practice to concierge in 2018.

Several hundred patients followed her into her new practice because “people realized their care would be better if they had a concierge doctor,” she said. Two years ago, partly because of growing demand, she recruited another physician as an associate.

“People want a relationship with their doctor,” Dr. Serna added. “It’s hard to provide that in a regular practice.”

Todd Granger, MD, an internist who opened a DPC practice in Chapel Hill, N.C., in 2016, said new patients often mention feeling rushed through appointments with their previous doctors. Also, “it’s hard to get to see a doctor around here.”

Scott Bernstein, MD, an internist who runs a DPC practice in Scottsdale, Ariz., said he can arrange to have patients see specialists much faster than if they try to make appointments on their own. “I personally call specialists and then prep my patients on how to deal with the appointment,” he said.

Retainer-based practices tend to have a greater number of older and chronically ill patients, but they also attract patients who need less care. “The healthier patients find value in our proactive approach to prevention and wellness,” Dr. Serna said.

Some concierge physicians charge higher fees to patients who need more care, but many decide this is too complicated and charge everyone the same fee. Dr. Granger said he initially had a variable fee schedule, but when some lower-paying patients began to need more visits, he had to consider charging them extra. “Now I basically have just one fee,” he said.
 

Not a good fit for many physicians

Dr. Bauer said a lot of physicians are interested in retainer-based practice, but many of them might not make the income they had hoped for. Specialdocs interviews physicians who inquire about the model and ultimately doesn’t contract with 80% of them, Dr. Bauer said.

To be able to sign up and retain enough patients, the doctor’s attitude is important. “You have to be driven by the desire to go deep with patients -- to work hard with them and deal with their issues,” said Erika Bliss, MD, who runs a DPC practice in Seattle.

Dr. Bernstein said retainer-based physicians have to be interested in lifestyle issues, such as diet, exercise, and sleep. “I spend a lot of time dealing with issues like how to incorporate physical activity into daily routines,” he said. “Some doctors wouldn’t enjoy doing that.”

Also, concierge physicians have to be available all the time. “Patients have my cell phone number,” Dr. Granger said. “They could call in the middle of the night, but they usually don’t.”

To ensure that they get some time off, many concierge physicians have partners. Dr. Bernstein and another DPC doctor maintain separate practices but cover for each other. Each takes every other weekend off plus 6 weeks every year.
 

Can you attract enough patients?

A key challenge is finding enough patients to sustain a concierge practice. Planning the switch involves setting a target number of patients needed for the doctor to make a decent income after paying practice expenses. For example, a doctor charging $300 a month to 250 patients would gross $900,000 per year, and then pay practice expenses from that.

Attracting the target number of patients can take months or even years. After almost 6 years, Dr. Granger said, he has around 240 patients ― well below his target number of 440.

Partly because the practice model is not well known in North Carolina, Dr. Granger set his fee very low, at $60 a month, then raised it to $75. That means his practice has been grossing just $216,000 a year. But he is not about to give up. He plans to raise his fee in July and hopes that word of mouth will add more patients.

If physicians cannot earn enough in their concierge practice, Dr. Bauer said, they may moonlight at a local hospital or work for a telemedicine company. He hasn’t heard of physicians closing their concierge practice and returning to their previous practice model. “They didn’t like what they were doing before,” he said.
 

Opening up to lower-income patients

Dr. Granger’s $75 monthly fee is an example of how retainer-based medicine has transformed itself from a gold-plated service for rich people to a service that middle-class and even lower-income people can afford. DPC practices like Dr. Granger’s have dramatically lowered expenses by cutting out the need to bill insurance companies. Some DPC practices further reduce expenses by not having any staff and by renting out office space.

Dr. Forbush’s Pine Tree State patients are mostly blue-collar workers – electricians, plumbers, people who work in small businesses. He charges them $150 a month, which most patients who don’t have health insurance can afford. He said three-quarters of his patients lack health insurance, although some have back-up finances, such as health savings accounts.

Since his patients have to pay out of pocket for tests and specialists, Dr. Forbush keeps referrals in check by handling many problems himself. “Since I have more time to spend with the patient, I can often work out issues that other doctors might ask specialists to deal with,” he said.

He has learned some dermatologic procedures. “There are plenty of things I can handle on my own,” he said.

Dr. Granger adds that by examining patients during longer appointments, expensive diagnostic exams are not always necessary.
 

The challenges for this model

Many experts warn that retainer-based practices won’t work for doctors who want to leave employment or for doctors fresh out of residency. Not having your own patients to bring into the new practice is a big minus, because this is the best way to start the new practice.

Still, there are other ways to find patients. Dr. Bauer said physicians can advertise online, make themselves known by giving speeches in the community, or contract with small employers to treat their workers.

Dr. Bauer said some of his clients were employed physicians, and he thinks they will become a bigger factor now that fewer doctors remain in private practice. The chief barrier for employed physicians is the restrictive covenant that prevents them from setting up a practice nearby. But Dr. Bauer said some employers are willing to waive restrictive covenants for retainer-based doctors.

New physicians are also adopting the concierge model. Dr. Forbush said physicians straight out of residency have set up DPC practices in Maine. They signed up patients for their new practices even before they graduated, he said.

Retainer-based medicine is still mainly limited to primary care physicians, but according to Dr. Bauer, it can also work for specialists who have long-term relationships with patients, such as cardiologists, ob.gyns., rheumatologists, neurologists, and endocrinologists.
 

No going back

Most doctors who make the switch to retainer-based practice understand that there’s likely no going back. When Dr. Bernstein switched, he announced the change to patients and canceled insurance contracts. “It was make or break,” he said. “I had no parachute.”

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.

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.

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.

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.

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.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

Racial residential segregation was significantly associated with poor glycemic control in Black adolescents with type 1 diabetes, according to data from 144 individuals.

Racial residential segregation is considered a form of systemic racism that involves limited access to resources, including health care resources, Deborah A. Ellis, MD, of Wayne State University, Detroit, and colleagues wrote in a poster presented at the annual meeting of the American Diabetes Association.

In the study, the researchers recruited youth aged 10-15 years with type 1 diabetes from seven pediatric clinics in two large U.S. cities. The mean age of the participants was 13.3 years, and the mean hemoglobin A1c was 11.5%.

Diabetes management was based on self-reports using the Diabetes Management Scale (DMS). Racial residential segregation, which refers to the separation of groups within a geographic area, was determined using data from the U.S. Census using Location Quotient (LQ) at the block group level; this showed the ratio of the Black population to the total population, compared with the same ratio in the metropolitan area.

The mean family income was $34,163, and the mean LQ was 3.04, “indicating residence in highly segregated neighborhoods,” the researchers wrote.

Overall, racial residential segregation was significantly associated with A1c (P = .001) but not with DMS (P = .311). The researchers also conducted a stepwise multiple regression analysis including age, insulin delivery method, neighborhood adversity (a 9-item composite with variables including percentage of persons living in poverty, percentage of households with no vehicle), and family income. They found that only age, insulin delivery method, and racial residential segregation had significant impacts of A1c levels.

The study was limited by several factors, including the use of self-reports.

However, the results are consistent with previous studies showing the potential negative health effects of structural racism, the researchers wrote. The findings suggest that racial residential segregation has an independent effect on glycemic control in Black youth with type 1 diabetes, and consequently, “advocacy and policy making to address such inequities could improve diabetes population health.”
 

Location makes a difference

“Poor neighborhoods have been associated with high rates of obesity, hypertension, type 2 diabetes and high cholesterol,” Romesh K. Khardori, MD, professor of medicine at Eastern Virginia Medical School, Norfolk, said in an interview. However, “not much is known about impact of racial segregation on type 1 diabetes,” said Dr. Khardori, who was not involved in the study.

Dr. Khardori was not surprised by the current study findings. “In our practice, Black youth coming from racially segregated or low-income housing projects often tend have poor diabetes control, with repeated admissions to local hospitals for managing acute/chronic complications of type 1 diabetes,” he said.

The current findings reflect Dr. Khardori’s clinical experience and highlight the need for clinicians to recognize the increased risk for poor glycemic control and poor outcomes in this vulnerable population.

More research is needed to expand the observations of the current study, Dr. Khardori said. Future researchers also should “involve community leaders and politicians to educate and garner more support for mitigation efforts.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Ellis and Dr. Khardori had no financial conflicts to disclose.

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

New data and a new documentary called “The Human Trial” together illuminate the hard work, sacrifice, and slow, iterative progress in the long search for a biological cure for type 1 diabetes.

Opening in select theaters on June 24, the film was written by Los Angeles filmmaker Lisa Hepner, who has type 1 diabetes, and codirected by Ms. Hepner and her husband Guy Mossman, who also filmed it. The couple co-own a film production company.

Abramorama

“The Human Trial” follows the personal journeys of two of the first participants in ViaCyte’s early phase 2 trial of stem cell–derived islet cell transplants, as well as those of the investigators and Ms. Hepner herself, who narrates and appears in the film, interweaving her own experience with type 1 diabetes while acting as a “bridge” between the trial’s participants and scientists. The film spans 7 years of the trial.

The timing of the film’s opening happens to follow presentations at two major medical meetings in early June of more recent islet cell transplantation data from ViaCyte and two other companies, Sernova and Vertex. Each is taking a different practical approach, with the most effective and safe technique yet to be determined.

But all are pursuing the same goal: A biological “cure” for type 1 diabetes with the aim of restoring fully functioning islet cells that can produce insulin and keep blood sugar levels in target range. Ultimately, the hope is to eliminate the need for both exogenous insulin and immunosuppression for all people with type 1 diabetes.

“Cell therapy is an attempt to drastically and substantially change the paradigm of how we actually treat type 1 diabetes,” Manasi S. Jaiman, MD, pediatric endocrinologist and chief medical officer at ViaCyte, said during a presentation at the annual meeting of the Endocrine Society.

Transplantation of cadaver-derived pancreatic islet cells to treat type 1 diabetes dates back more than 20 years to the landmark Edmonton Protocol, with many refinements since. About 1,500 recipients have received them, and roughly a quarter has maintained insulin independence after 10 years, Dr. Jaiman said.

More recently, islets derived from stem cells – either embryonic or autologous – have been used to address the supply and quality problems that arise from cadaveric (dead) donors.

Still, though, the need for lifelong immune suppression means the only current recipients are people with type 1 diabetes for whom the risk of diabetes outweighs that of immune suppression, such as those with hypoglycemic unawareness or extreme glucose swings.

Abramorama

Many research efforts are underway to counter the need for immune suppression by a variety of techniques including cell encapsulation or gene modification.

While the data thus far are encouraging, most of the reports align with what Ms. Hepner says in the film: “We all want stories with a beginning, middle, and end where all the loose pieces fit together. But clinical research is messy and hard. It doesn’t fit into a tidy headline, no matter how much you want it to.”
 

Companies use different approaches for transplanting islets

At ENDO 2022, Dr. Jaiman presented results for three patients who received pancreatic precursor (PEC-01) cells derived from ViaCyte’s proprietary pluripotent stem cell line. The cells are housed in an open delivery device about the size of a standard bandage to allow direct vascularization and are implanted in a patient’s forearm. An earlier version of the device was used in the two patients in “The Human Trial.”

All three patients experienced improved blood glucose levels with lower daily insulin doses and a rise from undetectable C-peptide to levels above 0.3 ng/mL. Of the three, the best results were seen in a 52-year-old woman with type 1 diabetes for 36 years complicated by hypoglycemic unawareness. At 1-year post transplant, her hemoglobin A1c dropped from 7.4% to 6.9%, and time in range [of ideal blood glucose] from 55% to 94%, plus she had a reduction in daily exogenous insulin use of 70%. However, at 18 months her time-in-range had dropped to about 75%.

“We are watching very closely to see what this means,” Dr. Jaiman said.

Further optimization of the approach is planned. “We’re still waiting on the bulk of the data and analyzing it ... We do realize this is a journey but we’re very excited by where we are,” she enthused.

In February 2022, ViaCyte announced it had teamed up with CRISPR Therapeutics to develop an allogeneic, gene-edited stem cell-derived product designed to produce insulin while at the same time evading the immune system.

Preliminary data from another company, Sernova, using a pouch device were presented at the 2022 annual scientific sessions of the American Diabetes Association by Piotr J. Bachul, MD, of the Transplantation Institute at the University of Chicago.

The Sernova Cell Pouch System containing cadaver islets was successfully transplanted into the abdominal wall of six of seven patients. After waiting a month to allow for vascularization, the cells are then placed into the pouch (as opposed to ViaCyte’s method where they are implanted together). The first three patients achieved islet cell graft function – with positive C-peptide – for up to 1 year, although all also required supplemental transplants into the portal vein to achieve insulin independence.

In May 2022, Sernova announced a partnership with Evotec to develop a product that will combine induced pluripotent stem cell (iPSC)-based beta cells for use with the Cell Pouch System.

Clinical testing is scheduled to begin in 2024, a Sernova representative told this news organization.

And as reported earlier in June, findings from Vertex Pharmaceuticals showed success in two patients who received that company›s investigational allogeneic stem-cell derived islets (VX-880), with the first person completely insulin independent 9 months post transplant.

In contrast to the other two companies, Vertex’s approach is to transplant the cells directly to the hepatic portal vein rather than into a subcutaneous pouch.

“The only space that has ever worked efficiently for islets is the liver because they immediately get blood. ... The subcutaneous space is an interesting place, but the problem is it’s not very well vascularized,” James F. Markmann, MD, PhD, chief of the division of transplant surgery at Massachusetts General Hospital, Boston, who worked on the Vertex trials, told this news organization.

However, the Sernova representative countered: “With the Cell Pouch transplant, not only can surgeons avoid the risks associated with [hepatic] portal vein infusion – including immediate blood-mediated inflammatory reaction, which is known to kill a large proportion of infused islets – but also liver pathologies.”

Furthermore, the cells remaining in the pouch “may be entirely removed from the patient in the event of a subsequently detected cell quality issue,” which isn’t possible with cells delivered into the portal vein.

“I think it will be interesting how it plays out,” Dr. Markmann said, referring to the field as a whole.

‘The Human Trial’ spotlights the real people behind the data

“The Human Trial” ties together the lives of two young adult study participants: a mother named Maren Badger, who qualified for the study because she regularly experienced severe low blood sugar accompanied by seizures, and Greg Romero, a father who has sight-threatening diabetic retinopathy and other complications, as well as financial hardship.

The film chronicles their experiences over 7 years after receiving the transplant. It’s not easy for either of them to undergo all the implantation and explantation procedures as well as cope with the uncertainty as to whether the transplanted cells are working.

At the same time, the researchers’ emotional and sometimes frustrating journey is shown, as are scenes following company executives to Saudi Arabia and Japan in their pursuit of trial funding.

Ms. Hepner herself is featured pursuing the film’s storyline by frequently questioning company executives, in person and virtually, as well as telling her own story.

A visit to the Banting House Historic Site in London, Ontario, with her young son gives Ms. Hepner the opportunity to explain that after Canadian surgeon Frederick Banting discovered insulin, he sold the patent to the University of Toronto for one dollar.

“One hundred years ago, insulin wasn’t a business. It was a medical breakthrough that saved millions of lives. When Banting accepted his Nobel [Prize], he famously said: ‘Insulin doesn’t belong to me, it belongs to the world.’ ... Now, there’s a $245 billion industry designed to manage our disease,” Ms. Hepner says in the film.

But, she adds: “There’s a catch-22: Biotech needs big pharma’s profits to fund clinical trials. Without that support the researchers wouldn’t have gotten this far. Like most relationships, it’s complicated.”

Nonetheless, the film ultimately uplifts. As one company executive says: “Data show the product is producing insulin in patients for the first time. ... This is a big deal. We know now that the cells work.

“We didn’t know that 5 years ago. All the pieces are there, it’s just a matter of completing the puzzle.”

The ViaCyte work presented by Dr. Jaiman received funding from the European Commission Horizon 2020, the California Institute for Regenerative Medicine, and the JDRF. Jaiman is an employee of ViaCyte. The Sernova work was funded by Sernova and JDRF. Dr. Markmann has reported serving on advisory boards for iTolerance, eGenesis, and Qihan Biotech, and being a consultant for Vertex Pharmaceuticals. Ms. Hepner and Mr. Mossman run LA-based Vox Pop Films, a production company specializing in nonfiction content and commercials. “The Human Trial” was made in collaboration with the nonprofit Beyond Type 1.

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

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

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

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

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

The U.S. Supreme Court has voted to overturn the federal constitutional right to abortion, which will now leave the issue to be decided on a state-by-state basis.

According to some estimates, about 25 million women of reproductive age will now live in states that ban or severely restrict abortion. Twenty-six states are “certain or likely” to ban abortion, according to the Guttmacher Institute, which supports abortion rights.

Thirteen states have so-called trigger laws that will ban abortion almost immediately, while nine other states are now likely to try to enforce near-total bans or severe restrictions that have been blocked by courts pending the outcome of the just-issued decision in Dobbs v. Jackson Women’s Health Organization. Four states also have a history or have shown a recent desire to prohibit abortion, according to the Guttmacher Institute.

Doctors and others who provide abortion services, or in some states “aid or abet” an abortion, could be fined thousands of dollars or sent to prison.

The court voted in favor of Mississippi and its 2018 law that outlawed abortion after 15 weeks. Jackson Women’s Health, the state’s sole remaining abortion provider, sued to block the law soon after it passed.

The Supreme Court decision is not a surprise, as the justices indicated they were leaning that way during oral arguments in December. The majority’s thoughts were further revealed when a draft of the opinion was leaked to the news outlet Politico on May 2. 

In the final opinion, Justice Samuel Alito, writing for the majority, “It is time to heed the Constitution and return the issue of abortion to the people’s elected representatives.”

The decision strikes down both precedent-setting rulings that established a right to abortion until the point of viability, long considered to be 24 weeks: Roe v. Wade (1973) and Planned Parenthood v. Casey (1992).

Twenty-five medical professional societies – representing OB/GYNs, family medicine doctors, fertility specialists, geneticists, hospitalists, internists, pediatricians, psychiatrists, nurses, nurse practitioners, and midwives – had urged the court to throw out the Mississippi law. And more than 2,500 medical professionals signed on to a petition in June, urging the court to uphold the right to abortion.

The number of abortions has recently increased from what had been a long decline. The Guttmacher Institute estimates there were there were 930,160 abortion procedures in 2020 (compared to 3.6 million births), an 8% increase from 2017. The number does not include self-managed abortions. The organization said the increase was potentially due to expanded Medicaid coverage and reduced access to contraception due to Trump administration policies.
 

Trigger laws and bans

When trigger laws and new restrictions go into effect, women in the South, Midwest, and Inter-Mountain West will likely have to drive hundreds of miles for an abortion, according to Guttmacher. Women in Louisiana, for instance, would have to drive 660 miles to get to the nearest provider in Illinois.

University of Utah researchers estimated that almost half of women will see a big increase in the distance to abortion care, from a median distance of 39 miles to 113 miles. State bans will disproportionately impact women of color, those living in poverty, and people with less education, they said.

The CDC has reported that Black women are three times more likely to die from a pregnancy-related cause than white women.

Doctors and other abortion providers could face serious penalties. The maximum penalty in Texas is life in prison, and the sentence could be 10 to 15 years in 11 other states, according to an article in the medical journal JAMA by attorneys Rebecca B. Reingold and Lawrence O. Gostin.

“Threats of prosecution undermine clinicians’ ability to provide safe, evidence-based care and to counsel patients honestly, impeding the patient-physician relationship,” they wrote. “Given harsh penalties, physicians may cease treating pregnancy loss, with no clear line between treating miscarriages and abortions.”

In preparing for these attacks on patients and doctors, New York Gov. Kathy Hochul on June 13 signed a bill that immediately protects anyone who has an abortion and medical professionals in the state who provide them from legal retaliation by states that restrict or prohibit abortion.

Even while Roe was still the law, Mississippi had banned most abortions after 20 weeks, and 16 states prohibited abortion after 22 weeks. A Texas ban on abortion after 6 weeks – which also allows private citizens to sue abortion providers – was allowed to stay in place while it was being challenged.

On May 26, Oklahoma Gov. Kevin Stitt signed  a bill banning abortion from the moment of conception. Just as in Texas, the Oklahoma law allows what critics have called “bounty hunting” of abortion providers.

Four states have a constitutional amendment declaring that the state constitution does not secure or protect the right to abortion or allow the use of public funds for abortion: Alabama, Louisiana, Tennessee, and West Virginia.
 

Some states protecting rights

At least 16 states have proactively protected a right to an abortion, according to Guttmacher, while The New York Times reports that Washington, DC, has laws that protect abortion, along with 20 states: Alaska, Colorado, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Mexico, Rhode Island, California, Connecticut, Delaware, Hawaii, Maryland, New Jersey, New York, Oregon, Vermont, and Washington.

Some of these states are gearing up for a potential influx of patients. Washington Gov. Jay Inslee signed a law that authorizes physician assistants, advanced registered nurse practitioners, and other providers acting within their scope of practice to perform abortions. And the Maryland Legislature overrode a veto by Gov. Larry Hogan of a law that expands who can perform abortions.

Wisconsin Gov. Tony Evers in early June called a special legislative session to repeal the state’s 173-year-old dormant ban on abortion. But the majority Republican legislature vowed to take no action.

B. Jessie Hill, JD, associate dean for academic affairs and a professor at the Case Western Reserve University School of Law, says she expects anti-abortion groups to challenge these protective laws, “by saying that fetuses are persons under the Constitution with a right to life and therefore that the state has to protect them.”

But, she says, “there’s going to be big, big challenges with those lawsuits,” and they will not be “winners off the bat.”
 

Medication abortions, travel next battle

Some states are also trying to outlaw or severely restrict the use of RU-486, the abortion pill. A Tennessee law that goes into effect in 2023 would ban delivery of pills by mail and require a patient to have two doctor visits – one consultation and one to pick up the pills.

Mississippi has also enacted restrictions including the requirement that women meet with a doctor  first – and is being sued by pill maker GenBioPro.

Guttmacher estimates that medication abortion accounted for 39% of all abortions in the U.S. in 2017 and 60% of all abortions that occurred before 10 weeks’ gestation.

Some states have floated the idea of prohibiting anyone from traveling to another state for an abortion.

George Mason University law professor Ilya Somin, JD, has written that such a law would likely violate the Dormant Commerce Clause, “which forbids state regulations that specifically restrict interstate commerce or discriminate against it.”

He also wrote that states lack the authority to regulate activity that takes place beyond their borders and that such bans “are open to challenge because they violate the constitutional right to travel.”

Hill also said a travel ban would be problematic, noting that it might be difficult to prosecute someone for “something you did completely in another state.”

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

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.

How much does the risk of new-onset type 2 diabetes (T2D) increase in patients who have had a mild SARS-CoV-2 (COVID-19) infection?

Dr. Jain: We are now finding many associations between COVID-19 and T2D. Recently, there have been studies, especially from the United States and Germany, showing that even after mild COVID-19, the occurrence of new onset T2D is greater than what we thought previously. For instance, we are now seeing that the rate of new-onset T2D in adults who have had mild COVID-19 is about 18 additional adults per 1000 people. These people have about a 46% higher risk of developing T2D compared to those who did not have COVID-19. This is something we must keep in mind moving forward when it comes to screening for diabetes.

How have you navigated through the diagnostic components of T2D and COVID-19?

Dr. Jain: When people were exclusively doing virtual appointments during the COVID-19 lockdowns, there wasn't enough screening for retinopathy, worsening blood pressure, or even basic lab testing, for instance. We could not perform electrocardiography screenings for our patients with diabetes; we had to defer it unless people were symptomatic. This was not the ideal situation, as many people with diabetes may have “silent” coronary artery disease, making screening crucial even in those patients who are not symptomatic. The impact of this is anyone’s guess at this time. Unfortunately, there is no literature that has looked at the impact of deferred screenings during the pandemic.

However, in my own practice, we are now transitioning back to in-person appointments and making sure that all of these screening visits are being conducted in a timely manner so that we can catch the micro- and macrovascular complications of diabetes sooner.

Although data on the long-term impact are not available, what studies have been done regarding the treatment of T2D during the pandemic?

Dr. Jain: There are some observational studies. There was a claims database analysis that looked at patient visits, screening tests, filling of medications, and glycated hemoglobin (A1C) levels in 2020 vs 2019 in the United States. There was no significant difference between the A1C levels and medication fills. I think one reason for this is that we all were able to adapt to the changes required from us, and we were able to incorporate the virtual appointments. That's reassuring. I think we still need some more data to make any definitive assumptions about what the overall care of diabetes has been as we are coming out of the pandemic.

Have you seen any particular characteristics or disparities in those patients who have been impacted by T2D and COVID-19?

Dr. Jain: With the mask mandate, physical distancing requirements, and differing vaccination rates across parts of the world, we have seen disparities in the impact of COVID-19, especially for those that are the most vulnerable. This includes people with multiple comorbidities.

We also know that, even at baseline, patients with T2D are often prone to multiple cardiovascular issues and dialysis requirements. These individuals still have to be extremely cautious. I have seen that those patients who actually need the most attention are still not able to go out and get the care. It is important that we are inclusive in our understanding of the requirements of people at high risk for T2D and other comorbidities. Necessary requirements to reduce infection risk include following physical distancing and masking requirements as appropriate and ensuring timely screening for retinopathy, nephropathy, and coronary artery disease as well as getting foot exams.

We have to give them all the care and access to healthcare that they need. Expert consensus suggests that we ensure optimization of vaccination status, glycemic control, cardiovascular risk, and weight control. We also need to ensure that these high-risk individuals have not slipped through the cracks and have appropriate appointment follow-ups, labs, etc. booked in a timely manner.

What guidelines and standards do you rely upon to ensure that patients are getting the most out of their treatment?

Dr. Jain: COVID-19 aside, we still want to make sure that the management of T2D is not glucose-centric. We now understand that diabetes requires 360-degree care, and that involves not only controlling the blood sugars but also making sure that we are mitigating risk factors for vascular complications. That includes ensuring blood pressure is well controlled and that cholesterol levels are in target range for patients who either have history of heart attacks, strokes, heart failure, kidney disease, or who are at future risk for these events.

We are using medications that can help protect the heart and the kidneys. Considering that T2D and obesity are so closely interlinked, we are using medications that help with overcoming the weight aspect as well. I think that a patient-centric, multidisciplinary approach is the most crucial and the most reliable way of getting that 360-degree comprehensive care for patients with diabetes.

Is there anything else you would like to share with your colleagues or peers?

Dr. Jain: As we are coming out of the pandemic, we still we need to realize that the repercussions of COVID-19 will still stay with us for a long, long time. We do know that COVID-19 infection leads to a tsunami of inflammation in the body. This can have long-lasting effects, including chronic conditions.

It is important that we continue to screen for diabetes given that there is a higher incidence of T2D in those with even mild COVID-19, and especially those at highest risk, such as people with obesity. We need to make sure that we are not missing any pieces of the puzzle there, especially because diabetes is a silent disease. We should not rely on symptoms to determine when we should screen; instead, we must be proactive about screening and management.