A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

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

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

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

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

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

A small, and likely decreasing, number of health care providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found.

Until now, producing an accurate count of abortion service providers in the United States has been difficult, leaving researchers to rely on indirect assessments of abortion clinics rather than counts of physicians who perform the procedure.

But the authors of a research letter published in JAMA Internal Medicine have come up with a number: Roughly 3,550 clinicians provide procedural and medication abortions, while 22,001 manage pregnancy loss with the same procedures and medications. More than half of all abortions in the United States now are achieved by medication.

The small number of providers is a cause for concern as a growing number of states move to restrict access to abortions, experts say.

“Abortions are only available if clinicians provide them,” said Julia Strasser, DrPH, MPH, senior research scientist at the George Washington University Milken Institute School of Public Health, Washington, D.C., who led the research. “This study finds that a variety of clinician types provide abortion care. But the number of abortion providers is low, and increasing restrictions will only make this worse.”

For their census, Dr. Strasser and her colleagues evaluated medical claims covering a full year from a private data company. They focused on two sets of services: medications (misoprostol and mifepristone) used in abortion care and pregnancy loss and procedures such as dilation and curettage and dilation and evacuation. Services were categorized as induced abortion or management by pregnancy loss on the basis of medical coding.

The researchers found that there were 3,550 abortion providers and 22,001 clinicians who managed pregnancy loss. Of those who induced abortions, 88% were physicians and 12% were advanced practice clinicians.

The clinicians who most frequently provided induced abortions were ob/gyns (72%), followed by family physicians (9%), advanced practice registered nurses (8%), and nurse midwives (3%). Several other specialists performed about 1% of abortions each.

Dr. Strasser said that 3,550 is an undercount because many providers do offer abortions but cannot or do not bill for them. Even so, the number likely will fall because fewer medical students are being trained for abortion procedures, according to Kaiser Health News.

Despite recommendations from the American College of Obstetricians and Gynecologists for standardized training on abortion care during medical residency, the number of programs that prohibit that training has surged in recent years, the report notes.
 

Restrictions looming

Compounding the problem, the researchers say, is the recent spate of state-level legislation regarding access to abortion. The U.S. Supreme Court is due to rule soon on a Mississippi law banning all abortions over 15 weeks’ gestational age, except in medical emergencies and in the case of severe fetal abnormalities.

Last May, Texas passed a law outlawing termination of pregnancy after 6 weeks of gestation – before many women know they’re pregnant. The law created a bounty system that permits essentially anyone in the United States to sue a woman in the state who seeks an abortion outside the law or anyone who assists her – including health care professionals. The Supreme Court in December refused to overturn the law – which reportedly has triggered a surge in women seeking abortion services in neighboring Oklahoma.

The legal environment is greatly increasing the risk that more clinicians will drop out of the workforce, Dr. Strasser told this news organization.

“As this happens, abortion care will undoubtedly become harder to access, especially for vulnerable populations,” she said. “Patients will have to travel farther, pay more money, or forgo necessary care.”

Another major variable is insurance coverage, the researchers found. Abortion coverage is highly restricted under private insurance and Medicaid, they note. Beyond increasingly restrictive payment issues, policies seen as punitive toward clinicians may cause many to stop offering medication and procedural services, Dr. Strasser said.

“The national political climate will likely see more barriers and less access to care in the coming months and years,” she told this news organization. “However, some states are taking concrete steps to protect abortion access for their residents and for others out of state. In supportive environments like these, enhanced training, expanded scope of practice, and improved reimbursement policies can increase access.”

If the Supreme Court overturns Roe v. Wade, Kaiser Health News reported, 26 states would likely ban abortion, triggering a flood of patients to states where the procedure remains more widely available.

According to the Center for Reproductive Rights, states that have expanded access are Washington, Oregon, California, New York, Vermont, Connecticut, and New Jersey. Another 12 states offer protected access, in which abortion is likely to remain legal even if Roe v. Wade is overturned, since in many of them, abortion is protected under their state constitutions.
 

Pivot to telehealth?

Another study, published in the same issue of JAMA Internal Medicine, evaluated health outcomes for 3,779 women. That study found that eligibility screening for medical abortions by history alone, without pelvic examination or ultrasonography, was safe and effective. That study found that medications were either dispensed in person or through the mail.

Taken together, the two studies suggest that more abortion services may shift toward telehealth, which could expand the number of health care professionals performing such services. Providers could include nurse practitioners, midwives, and physician assistants, said Melissa Grant, chief operating officer of carafem, a reproductive health and abortion service provider.

The service, which has offices in Atlanta, Chicago, Nashville, and Washington, D.C., has found that many patients prefer online appointments, especially if they live in rural areas, Ms. Grant said. The pandemic created a push toward online services.

“Even before the current breadth of restrictive legislation, we were seeing in increase because of COVID,” she said. “Most likely, abortion providers will continue to be pushed out of the profession, so having an option that’s widely available no matter where you live is essential. The United States is moving toward a system where the ZIP code you live in will foretell what care you get. That’s chilling.”

Those who currently provide abortion care have two advantages over what was available previously, Ms. Grant said. First, medical abortion is much more common, and data show that it is safe and effective for most pregnant people, as long as they undergo a health screening. Second, the boom in telehealth during the pandemic means providers are much more experienced in this type of service than before.

As more services such as carafem crop up, costs will drop, since a telehealth clinic – even one that uses health care professionals – has fewer expenses, such as for rent and equipment, than a physical facility.

“Because of the stigma around abortion, this is not likely to prompt a big rush of start-ups, but I do think we’re going to see a shake-up in the way services are being offered, and both patients and providers will likely turn toward technology,” Ms. Grant said. “An environment like this will require flexibility, innovation, and some real grit. We may take some time to get there, but it’s possible this moment is a pivot point in how abortion care is provided.”

Some of the researchers received grants from the Susan T. Buffett Foundation.

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

A small, and likely decreasing, number of health care providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found.

Until now, producing an accurate count of abortion service providers in the United States has been difficult, leaving researchers to rely on indirect assessments of abortion clinics rather than counts of physicians who perform the procedure.

But the authors of a research letter published in JAMA Internal Medicine have come up with a number: Roughly 3,550 clinicians provide procedural and medication abortions, while 22,001 manage pregnancy loss with the same procedures and medications. More than half of all abortions in the United States now are achieved by medication.

The small number of providers is a cause for concern as a growing number of states move to restrict access to abortions, experts say.

“Abortions are only available if clinicians provide them,” said Julia Strasser, DrPH, MPH, senior research scientist at the George Washington University Milken Institute School of Public Health, Washington, D.C., who led the research. “This study finds that a variety of clinician types provide abortion care. But the number of abortion providers is low, and increasing restrictions will only make this worse.”

For their census, Dr. Strasser and her colleagues evaluated medical claims covering a full year from a private data company. They focused on two sets of services: medications (misoprostol and mifepristone) used in abortion care and pregnancy loss and procedures such as dilation and curettage and dilation and evacuation. Services were categorized as induced abortion or management by pregnancy loss on the basis of medical coding.

The researchers found that there were 3,550 abortion providers and 22,001 clinicians who managed pregnancy loss. Of those who induced abortions, 88% were physicians and 12% were advanced practice clinicians.

The clinicians who most frequently provided induced abortions were ob/gyns (72%), followed by family physicians (9%), advanced practice registered nurses (8%), and nurse midwives (3%). Several other specialists performed about 1% of abortions each.

Dr. Strasser said that 3,550 is an undercount because many providers do offer abortions but cannot or do not bill for them. Even so, the number likely will fall because fewer medical students are being trained for abortion procedures, according to Kaiser Health News.

Despite recommendations from the American College of Obstetricians and Gynecologists for standardized training on abortion care during medical residency, the number of programs that prohibit that training has surged in recent years, the report notes.
 

Restrictions looming

Compounding the problem, the researchers say, is the recent spate of state-level legislation regarding access to abortion. The U.S. Supreme Court is due to rule soon on a Mississippi law banning all abortions over 15 weeks’ gestational age, except in medical emergencies and in the case of severe fetal abnormalities.

Last May, Texas passed a law outlawing termination of pregnancy after 6 weeks of gestation – before many women know they’re pregnant. The law created a bounty system that permits essentially anyone in the United States to sue a woman in the state who seeks an abortion outside the law or anyone who assists her – including health care professionals. The Supreme Court in December refused to overturn the law – which reportedly has triggered a surge in women seeking abortion services in neighboring Oklahoma.

The legal environment is greatly increasing the risk that more clinicians will drop out of the workforce, Dr. Strasser told this news organization.

“As this happens, abortion care will undoubtedly become harder to access, especially for vulnerable populations,” she said. “Patients will have to travel farther, pay more money, or forgo necessary care.”

Another major variable is insurance coverage, the researchers found. Abortion coverage is highly restricted under private insurance and Medicaid, they note. Beyond increasingly restrictive payment issues, policies seen as punitive toward clinicians may cause many to stop offering medication and procedural services, Dr. Strasser said.

“The national political climate will likely see more barriers and less access to care in the coming months and years,” she told this news organization. “However, some states are taking concrete steps to protect abortion access for their residents and for others out of state. In supportive environments like these, enhanced training, expanded scope of practice, and improved reimbursement policies can increase access.”

If the Supreme Court overturns Roe v. Wade, Kaiser Health News reported, 26 states would likely ban abortion, triggering a flood of patients to states where the procedure remains more widely available.

According to the Center for Reproductive Rights, states that have expanded access are Washington, Oregon, California, New York, Vermont, Connecticut, and New Jersey. Another 12 states offer protected access, in which abortion is likely to remain legal even if Roe v. Wade is overturned, since in many of them, abortion is protected under their state constitutions.
 

Pivot to telehealth?

Another study, published in the same issue of JAMA Internal Medicine, evaluated health outcomes for 3,779 women. That study found that eligibility screening for medical abortions by history alone, without pelvic examination or ultrasonography, was safe and effective. That study found that medications were either dispensed in person or through the mail.

Taken together, the two studies suggest that more abortion services may shift toward telehealth, which could expand the number of health care professionals performing such services. Providers could include nurse practitioners, midwives, and physician assistants, said Melissa Grant, chief operating officer of carafem, a reproductive health and abortion service provider.

The service, which has offices in Atlanta, Chicago, Nashville, and Washington, D.C., has found that many patients prefer online appointments, especially if they live in rural areas, Ms. Grant said. The pandemic created a push toward online services.

“Even before the current breadth of restrictive legislation, we were seeing in increase because of COVID,” she said. “Most likely, abortion providers will continue to be pushed out of the profession, so having an option that’s widely available no matter where you live is essential. The United States is moving toward a system where the ZIP code you live in will foretell what care you get. That’s chilling.”

Those who currently provide abortion care have two advantages over what was available previously, Ms. Grant said. First, medical abortion is much more common, and data show that it is safe and effective for most pregnant people, as long as they undergo a health screening. Second, the boom in telehealth during the pandemic means providers are much more experienced in this type of service than before.

As more services such as carafem crop up, costs will drop, since a telehealth clinic – even one that uses health care professionals – has fewer expenses, such as for rent and equipment, than a physical facility.

“Because of the stigma around abortion, this is not likely to prompt a big rush of start-ups, but I do think we’re going to see a shake-up in the way services are being offered, and both patients and providers will likely turn toward technology,” Ms. Grant said. “An environment like this will require flexibility, innovation, and some real grit. We may take some time to get there, but it’s possible this moment is a pivot point in how abortion care is provided.”

Some of the researchers received grants from the Susan T. Buffett Foundation.

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

A small, and likely decreasing, number of health care providers in the United States perform abortions, and there is a risk that the count will be shrinking in the face of legislative attacks on the service, researchers have found.

Until now, producing an accurate count of abortion service providers in the United States has been difficult, leaving researchers to rely on indirect assessments of abortion clinics rather than counts of physicians who perform the procedure.

But the authors of a research letter published in JAMA Internal Medicine have come up with a number: Roughly 3,550 clinicians provide procedural and medication abortions, while 22,001 manage pregnancy loss with the same procedures and medications. More than half of all abortions in the United States now are achieved by medication.

The small number of providers is a cause for concern as a growing number of states move to restrict access to abortions, experts say.

“Abortions are only available if clinicians provide them,” said Julia Strasser, DrPH, MPH, senior research scientist at the George Washington University Milken Institute School of Public Health, Washington, D.C., who led the research. “This study finds that a variety of clinician types provide abortion care. But the number of abortion providers is low, and increasing restrictions will only make this worse.”

For their census, Dr. Strasser and her colleagues evaluated medical claims covering a full year from a private data company. They focused on two sets of services: medications (misoprostol and mifepristone) used in abortion care and pregnancy loss and procedures such as dilation and curettage and dilation and evacuation. Services were categorized as induced abortion or management by pregnancy loss on the basis of medical coding.

The researchers found that there were 3,550 abortion providers and 22,001 clinicians who managed pregnancy loss. Of those who induced abortions, 88% were physicians and 12% were advanced practice clinicians.

The clinicians who most frequently provided induced abortions were ob/gyns (72%), followed by family physicians (9%), advanced practice registered nurses (8%), and nurse midwives (3%). Several other specialists performed about 1% of abortions each.

Dr. Strasser said that 3,550 is an undercount because many providers do offer abortions but cannot or do not bill for them. Even so, the number likely will fall because fewer medical students are being trained for abortion procedures, according to Kaiser Health News.

Despite recommendations from the American College of Obstetricians and Gynecologists for standardized training on abortion care during medical residency, the number of programs that prohibit that training has surged in recent years, the report notes.
 

Restrictions looming

Compounding the problem, the researchers say, is the recent spate of state-level legislation regarding access to abortion. The U.S. Supreme Court is due to rule soon on a Mississippi law banning all abortions over 15 weeks’ gestational age, except in medical emergencies and in the case of severe fetal abnormalities.

Last May, Texas passed a law outlawing termination of pregnancy after 6 weeks of gestation – before many women know they’re pregnant. The law created a bounty system that permits essentially anyone in the United States to sue a woman in the state who seeks an abortion outside the law or anyone who assists her – including health care professionals. The Supreme Court in December refused to overturn the law – which reportedly has triggered a surge in women seeking abortion services in neighboring Oklahoma.

The legal environment is greatly increasing the risk that more clinicians will drop out of the workforce, Dr. Strasser told this news organization.

“As this happens, abortion care will undoubtedly become harder to access, especially for vulnerable populations,” she said. “Patients will have to travel farther, pay more money, or forgo necessary care.”

Another major variable is insurance coverage, the researchers found. Abortion coverage is highly restricted under private insurance and Medicaid, they note. Beyond increasingly restrictive payment issues, policies seen as punitive toward clinicians may cause many to stop offering medication and procedural services, Dr. Strasser said.

“The national political climate will likely see more barriers and less access to care in the coming months and years,” she told this news organization. “However, some states are taking concrete steps to protect abortion access for their residents and for others out of state. In supportive environments like these, enhanced training, expanded scope of practice, and improved reimbursement policies can increase access.”

If the Supreme Court overturns Roe v. Wade, Kaiser Health News reported, 26 states would likely ban abortion, triggering a flood of patients to states where the procedure remains more widely available.

According to the Center for Reproductive Rights, states that have expanded access are Washington, Oregon, California, New York, Vermont, Connecticut, and New Jersey. Another 12 states offer protected access, in which abortion is likely to remain legal even if Roe v. Wade is overturned, since in many of them, abortion is protected under their state constitutions.
 

Pivot to telehealth?

Another study, published in the same issue of JAMA Internal Medicine, evaluated health outcomes for 3,779 women. That study found that eligibility screening for medical abortions by history alone, without pelvic examination or ultrasonography, was safe and effective. That study found that medications were either dispensed in person or through the mail.

Taken together, the two studies suggest that more abortion services may shift toward telehealth, which could expand the number of health care professionals performing such services. Providers could include nurse practitioners, midwives, and physician assistants, said Melissa Grant, chief operating officer of carafem, a reproductive health and abortion service provider.

The service, which has offices in Atlanta, Chicago, Nashville, and Washington, D.C., has found that many patients prefer online appointments, especially if they live in rural areas, Ms. Grant said. The pandemic created a push toward online services.

“Even before the current breadth of restrictive legislation, we were seeing in increase because of COVID,” she said. “Most likely, abortion providers will continue to be pushed out of the profession, so having an option that’s widely available no matter where you live is essential. The United States is moving toward a system where the ZIP code you live in will foretell what care you get. That’s chilling.”

Those who currently provide abortion care have two advantages over what was available previously, Ms. Grant said. First, medical abortion is much more common, and data show that it is safe and effective for most pregnant people, as long as they undergo a health screening. Second, the boom in telehealth during the pandemic means providers are much more experienced in this type of service than before.

As more services such as carafem crop up, costs will drop, since a telehealth clinic – even one that uses health care professionals – has fewer expenses, such as for rent and equipment, than a physical facility.

“Because of the stigma around abortion, this is not likely to prompt a big rush of start-ups, but I do think we’re going to see a shake-up in the way services are being offered, and both patients and providers will likely turn toward technology,” Ms. Grant said. “An environment like this will require flexibility, innovation, and some real grit. We may take some time to get there, but it’s possible this moment is a pivot point in how abortion care is provided.”

Some of the researchers received grants from the Susan T. Buffett Foundation.

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

The past several weeks have been rather tumultuous for LGBTQ Americans, particularly transgender youth. The Texas attorney general penned a legal opinion stating that hormone therapy and puberty blockers for transgender youth constitute “child abuse” under Texas law. Following the statement, Texas governor Greg Abbott swiftly issued a directive to protective services to launch investigations into families providing such services to their children. Almost simultaneously, the Florida Senate approved the Parental Rights in Education bill (dubbed the “Don’t Say Gay” bill by opponents), which limits how sexual orientation and gender identity are taught in the classroom.

Despite the benefits of gender-affirming care for gender-diverse youth, 22 states have introduced legislation that bans the provision of gender-affirming medical care under the age of 18, even with the consent of parents or legal guardians.¹ Unfortunately, gender-diverse youth are more likely than are their cisgender peers to experience poverty, homelessness, depression, suicide, and violence.¹ As a result of ongoing stigma, many gender-diverse patients are hesitant to seek out professional medical care, which includes mental health care, routine health care, and gender-affirming therapies. The positive effects of gender-affirming care for transgender youth are clear, and life saving for many. Gender-affirming medical interventions improve social and mental health outcomes, such as decreased suicidal ideation, depression, and improved peer relations that last until adulthood.¹

As with all aspects in medicine, providers and families of gender-diverse youth need to balance the four ethical principles that guide decision-making and informed consent. For practitioners working with the pediatric/adolescent populations, the age at which pediatric or adolescent patients can truly provide consent or assent is still not determined.² This presents a unique set of challenges in the realm of gender-affirming care particularly when children/adolescents and their parents have differing perspectives on proposed treatment plans. For example, when discussing fertility preservation, a 16-year-old patient is much more likely to understand implications of future fertility than a 9-year-old patient. Furthermore, providers must find the delicate balance between maximizing treatment benefits (beneficence) while minimizing harm (nonmaleficence), while also discussing the uncertainty about the long-term risks of gender-affirming treatments.² The final obligation for health care providers is ensuring all patients have equitable access to care (justice) – which is why we must all oppose legislation that criminalizes treatment for gender-diverse youth, regardless of our individual opinions on gender-affirming care for patients.

Opponents of gender-affirming care for transgender youth often cite concern about permanent effects or psychological distress if a child begins gender-affirming therapy and then chooses to discontinue. While the medical community should be, and is alarmed about patients who detransition, the solution to limiting the number of patients who experience regret or detransition is most certainly not criminalizing or universally banning gender-affirming care for all patients.³ Experts in transgender medicine and surgery (some of whom are transgender themselves) have expressed apprehension regarding the evaluation of gender-diverse children and youth. The concern is not whether gender-diverse youth should receive gender-affirming treatments, but rather they questioned the assessments made by providers who may be less fully qualified to deliver treatment and who deviate from well-established standards of care.⁴ The logical solution would be to further improve upon the current standards of care, ensure providers have appropriate training, and to expand multidisciplinary models of gender-affirming centers for youth.

If politicians were truly worried about the welfare of gender-diverse children, there would be a shift in the allocation of funds or resources to improve research endeavors and establish effective multidisciplinary clinics to meet the needs of this marginalized patient population. While the medical community should carefully examine gender-affirming care in transgender youth, criminalizing care is unconscionable. Our community needs more evidence-based research, providers, and centers, not politics.

The LGBTQ community and providers are rightfully fearful of the repercussions of such legislation. And the politicians and supporters of such bills should be equally apprehensive of the negative consequences this legislation will have on the mental health of transgender youth.

While the model for gender-affirming medicine and surgery needs continual assessment to ensure all patients, regardless of age and goals of transition, are receiving evidence-based, quality care, these discussions and subsequent decision-making should occur among medical professionals, not among politicians and the lay press.⁴

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Hughes LD et al. ‘These laws will be devastating’: Provider perspectives on legislation banning gender-affirming care for transgender adolescents. J Adol Health;2021;69:976-82.

2. Kimberly LL et al. Ethical issues in gender-affirming care for youth. Pediatrics. Pediatrics;018;142(6)e20181537.

3. Ashley F. Psychol Sexual Orient Gender Divers. APA PsycNet. 2021.

4. Ault A. Transgender docs warn about gender-affirmative care for youth. WebMD. 2021 Nov. Accessed March 14, 2022.

The past several weeks have been rather tumultuous for LGBTQ Americans, particularly transgender youth. The Texas attorney general penned a legal opinion stating that hormone therapy and puberty blockers for transgender youth constitute “child abuse” under Texas law. Following the statement, Texas governor Greg Abbott swiftly issued a directive to protective services to launch investigations into families providing such services to their children. Almost simultaneously, the Florida Senate approved the Parental Rights in Education bill (dubbed the “Don’t Say Gay” bill by opponents), which limits how sexual orientation and gender identity are taught in the classroom.

Despite the benefits of gender-affirming care for gender-diverse youth, 22 states have introduced legislation that bans the provision of gender-affirming medical care under the age of 18, even with the consent of parents or legal guardians.¹ Unfortunately, gender-diverse youth are more likely than are their cisgender peers to experience poverty, homelessness, depression, suicide, and violence.¹ As a result of ongoing stigma, many gender-diverse patients are hesitant to seek out professional medical care, which includes mental health care, routine health care, and gender-affirming therapies. The positive effects of gender-affirming care for transgender youth are clear, and life saving for many. Gender-affirming medical interventions improve social and mental health outcomes, such as decreased suicidal ideation, depression, and improved peer relations that last until adulthood.¹

As with all aspects in medicine, providers and families of gender-diverse youth need to balance the four ethical principles that guide decision-making and informed consent. For practitioners working with the pediatric/adolescent populations, the age at which pediatric or adolescent patients can truly provide consent or assent is still not determined.² This presents a unique set of challenges in the realm of gender-affirming care particularly when children/adolescents and their parents have differing perspectives on proposed treatment plans. For example, when discussing fertility preservation, a 16-year-old patient is much more likely to understand implications of future fertility than a 9-year-old patient. Furthermore, providers must find the delicate balance between maximizing treatment benefits (beneficence) while minimizing harm (nonmaleficence), while also discussing the uncertainty about the long-term risks of gender-affirming treatments.² The final obligation for health care providers is ensuring all patients have equitable access to care (justice) – which is why we must all oppose legislation that criminalizes treatment for gender-diverse youth, regardless of our individual opinions on gender-affirming care for patients.

Opponents of gender-affirming care for transgender youth often cite concern about permanent effects or psychological distress if a child begins gender-affirming therapy and then chooses to discontinue. While the medical community should be, and is alarmed about patients who detransition, the solution to limiting the number of patients who experience regret or detransition is most certainly not criminalizing or universally banning gender-affirming care for all patients.³ Experts in transgender medicine and surgery (some of whom are transgender themselves) have expressed apprehension regarding the evaluation of gender-diverse children and youth. The concern is not whether gender-diverse youth should receive gender-affirming treatments, but rather they questioned the assessments made by providers who may be less fully qualified to deliver treatment and who deviate from well-established standards of care.⁴ The logical solution would be to further improve upon the current standards of care, ensure providers have appropriate training, and to expand multidisciplinary models of gender-affirming centers for youth.

If politicians were truly worried about the welfare of gender-diverse children, there would be a shift in the allocation of funds or resources to improve research endeavors and establish effective multidisciplinary clinics to meet the needs of this marginalized patient population. While the medical community should carefully examine gender-affirming care in transgender youth, criminalizing care is unconscionable. Our community needs more evidence-based research, providers, and centers, not politics.

The LGBTQ community and providers are rightfully fearful of the repercussions of such legislation. And the politicians and supporters of such bills should be equally apprehensive of the negative consequences this legislation will have on the mental health of transgender youth.

While the model for gender-affirming medicine and surgery needs continual assessment to ensure all patients, regardless of age and goals of transition, are receiving evidence-based, quality care, these discussions and subsequent decision-making should occur among medical professionals, not among politicians and the lay press.⁴

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Hughes LD et al. ‘These laws will be devastating’: Provider perspectives on legislation banning gender-affirming care for transgender adolescents. J Adol Health;2021;69:976-82.

2. Kimberly LL et al. Ethical issues in gender-affirming care for youth. Pediatrics. Pediatrics;018;142(6)e20181537.

3. Ashley F. Psychol Sexual Orient Gender Divers. APA PsycNet. 2021.

4. Ault A. Transgender docs warn about gender-affirmative care for youth. WebMD. 2021 Nov. Accessed March 14, 2022.

The past several weeks have been rather tumultuous for LGBTQ Americans, particularly transgender youth. The Texas attorney general penned a legal opinion stating that hormone therapy and puberty blockers for transgender youth constitute “child abuse” under Texas law. Following the statement, Texas governor Greg Abbott swiftly issued a directive to protective services to launch investigations into families providing such services to their children. Almost simultaneously, the Florida Senate approved the Parental Rights in Education bill (dubbed the “Don’t Say Gay” bill by opponents), which limits how sexual orientation and gender identity are taught in the classroom.

Despite the benefits of gender-affirming care for gender-diverse youth, 22 states have introduced legislation that bans the provision of gender-affirming medical care under the age of 18, even with the consent of parents or legal guardians.¹ Unfortunately, gender-diverse youth are more likely than are their cisgender peers to experience poverty, homelessness, depression, suicide, and violence.¹ As a result of ongoing stigma, many gender-diverse patients are hesitant to seek out professional medical care, which includes mental health care, routine health care, and gender-affirming therapies. The positive effects of gender-affirming care for transgender youth are clear, and life saving for many. Gender-affirming medical interventions improve social and mental health outcomes, such as decreased suicidal ideation, depression, and improved peer relations that last until adulthood.¹

As with all aspects in medicine, providers and families of gender-diverse youth need to balance the four ethical principles that guide decision-making and informed consent. For practitioners working with the pediatric/adolescent populations, the age at which pediatric or adolescent patients can truly provide consent or assent is still not determined.² This presents a unique set of challenges in the realm of gender-affirming care particularly when children/adolescents and their parents have differing perspectives on proposed treatment plans. For example, when discussing fertility preservation, a 16-year-old patient is much more likely to understand implications of future fertility than a 9-year-old patient. Furthermore, providers must find the delicate balance between maximizing treatment benefits (beneficence) while minimizing harm (nonmaleficence), while also discussing the uncertainty about the long-term risks of gender-affirming treatments.² The final obligation for health care providers is ensuring all patients have equitable access to care (justice) – which is why we must all oppose legislation that criminalizes treatment for gender-diverse youth, regardless of our individual opinions on gender-affirming care for patients.

Opponents of gender-affirming care for transgender youth often cite concern about permanent effects or psychological distress if a child begins gender-affirming therapy and then chooses to discontinue. While the medical community should be, and is alarmed about patients who detransition, the solution to limiting the number of patients who experience regret or detransition is most certainly not criminalizing or universally banning gender-affirming care for all patients.³ Experts in transgender medicine and surgery (some of whom are transgender themselves) have expressed apprehension regarding the evaluation of gender-diverse children and youth. The concern is not whether gender-diverse youth should receive gender-affirming treatments, but rather they questioned the assessments made by providers who may be less fully qualified to deliver treatment and who deviate from well-established standards of care.⁴ The logical solution would be to further improve upon the current standards of care, ensure providers have appropriate training, and to expand multidisciplinary models of gender-affirming centers for youth.

If politicians were truly worried about the welfare of gender-diverse children, there would be a shift in the allocation of funds or resources to improve research endeavors and establish effective multidisciplinary clinics to meet the needs of this marginalized patient population. While the medical community should carefully examine gender-affirming care in transgender youth, criminalizing care is unconscionable. Our community needs more evidence-based research, providers, and centers, not politics.

The LGBTQ community and providers are rightfully fearful of the repercussions of such legislation. And the politicians and supporters of such bills should be equally apprehensive of the negative consequences this legislation will have on the mental health of transgender youth.

While the model for gender-affirming medicine and surgery needs continual assessment to ensure all patients, regardless of age and goals of transition, are receiving evidence-based, quality care, these discussions and subsequent decision-making should occur among medical professionals, not among politicians and the lay press.⁴

Dr. Brandt is an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Hughes LD et al. ‘These laws will be devastating’: Provider perspectives on legislation banning gender-affirming care for transgender adolescents. J Adol Health;2021;69:976-82.

2. Kimberly LL et al. Ethical issues in gender-affirming care for youth. Pediatrics. Pediatrics;018;142(6)e20181537.

3. Ashley F. Psychol Sexual Orient Gender Divers. APA PsycNet. 2021.

4. Ault A. Transgender docs warn about gender-affirmative care for youth. WebMD. 2021 Nov. Accessed March 14, 2022.

Premenopausal women with a family history of breast cancer have a greater volume of breast density observed during mammography, according to a new study of two retrospective cohorts published online Feb. 17 in JAMA Network Open. The findings suggest that breast density measured during mammography may have a genetic component, and suggest the importance of initiating early mammography in premenopausal women with a family history of breast cancer.

“We know that mammographic breast density is a very strong risk factor for breast cancer, probably one of the strongest risk factors, and it’s also a surrogate marker for breast cancer development, especially in premenopausal women. We also know that family history of breast cancer is a strong risk factor for breast cancer as well. Surprisingly, we have very limited information on how these risk factors are related to each other. There have been only two studies that have been done in this field in premenopausal women, and the studies are conflicting. So, we felt that we need to really understand how these two factors are related to each other and whether that would have an impact on modifying or refining mammographic screening in high-risk women,” Adetunji T. Toriola, MD, PhD, MPH, said in an interview. Dr. Toriola is professor of surgery at Washington University, St. Louis.

Previous research identified risk factors for dense breast tissue. A genome-wide association study found 31 genetic loci associated with dense breast tissue, and 17 had a known association with breast cancer risk.

In the JAMA Network Open study, the researchers included data from women who were treated at Washington University’s Joanne Knight Breast Health Center and Siteman Cancer Center. The discovery group included 375 premenopausal women who received annual mammography screening in 2016 and had dense volume and non-dense volume measured during each screen. The validation set drew from 14,040 premenopausal women seen at the centers between 2010 and 2015.

In the discovery group, women with a family history of breast cancer had greater volumetric percent density (odds ratio [OR], 1.25; P < .001). The validation set produced a similar result (OR, 1.30; 95% confidence interval, 1.17-1.45). Subanalyses revealed similar associations in non-Hispanic White and Black or African American women.

The current study included a higher percentage of women with a family history of breast cancer than previous studies, and also controlled for more variables. This may have removed confounding variables that could have affected previous studies.

“It reinforces the need to start mammogram screening early in women who have a family history of breast cancer,” Dr. Toriola said.

The study had some limitations, including a higher percentage of women with a family history of breast cancer than the National Health Interview Survey (23.2% and 15.3%, versus 8.4%), explained by the fact that women with a family history of breast cancer are more likely to seek out screening. The average age of women was on average 47 years, making them closer to perimenopausal than premenopausal.

The study was funded by the National Institutes of Health.

Premenopausal women with a family history of breast cancer have a greater volume of breast density observed during mammography, according to a new study of two retrospective cohorts published online Feb. 17 in JAMA Network Open. The findings suggest that breast density measured during mammography may have a genetic component, and suggest the importance of initiating early mammography in premenopausal women with a family history of breast cancer.

“We know that mammographic breast density is a very strong risk factor for breast cancer, probably one of the strongest risk factors, and it’s also a surrogate marker for breast cancer development, especially in premenopausal women. We also know that family history of breast cancer is a strong risk factor for breast cancer as well. Surprisingly, we have very limited information on how these risk factors are related to each other. There have been only two studies that have been done in this field in premenopausal women, and the studies are conflicting. So, we felt that we need to really understand how these two factors are related to each other and whether that would have an impact on modifying or refining mammographic screening in high-risk women,” Adetunji T. Toriola, MD, PhD, MPH, said in an interview. Dr. Toriola is professor of surgery at Washington University, St. Louis.

Previous research identified risk factors for dense breast tissue. A genome-wide association study found 31 genetic loci associated with dense breast tissue, and 17 had a known association with breast cancer risk.

In the JAMA Network Open study, the researchers included data from women who were treated at Washington University’s Joanne Knight Breast Health Center and Siteman Cancer Center. The discovery group included 375 premenopausal women who received annual mammography screening in 2016 and had dense volume and non-dense volume measured during each screen. The validation set drew from 14,040 premenopausal women seen at the centers between 2010 and 2015.

In the discovery group, women with a family history of breast cancer had greater volumetric percent density (odds ratio [OR], 1.25; P < .001). The validation set produced a similar result (OR, 1.30; 95% confidence interval, 1.17-1.45). Subanalyses revealed similar associations in non-Hispanic White and Black or African American women.

The current study included a higher percentage of women with a family history of breast cancer than previous studies, and also controlled for more variables. This may have removed confounding variables that could have affected previous studies.

“It reinforces the need to start mammogram screening early in women who have a family history of breast cancer,” Dr. Toriola said.

The study had some limitations, including a higher percentage of women with a family history of breast cancer than the National Health Interview Survey (23.2% and 15.3%, versus 8.4%), explained by the fact that women with a family history of breast cancer are more likely to seek out screening. The average age of women was on average 47 years, making them closer to perimenopausal than premenopausal.

The study was funded by the National Institutes of Health.

Premenopausal women with a family history of breast cancer have a greater volume of breast density observed during mammography, according to a new study of two retrospective cohorts published online Feb. 17 in JAMA Network Open. The findings suggest that breast density measured during mammography may have a genetic component, and suggest the importance of initiating early mammography in premenopausal women with a family history of breast cancer.

“We know that mammographic breast density is a very strong risk factor for breast cancer, probably one of the strongest risk factors, and it’s also a surrogate marker for breast cancer development, especially in premenopausal women. We also know that family history of breast cancer is a strong risk factor for breast cancer as well. Surprisingly, we have very limited information on how these risk factors are related to each other. There have been only two studies that have been done in this field in premenopausal women, and the studies are conflicting. So, we felt that we need to really understand how these two factors are related to each other and whether that would have an impact on modifying or refining mammographic screening in high-risk women,” Adetunji T. Toriola, MD, PhD, MPH, said in an interview. Dr. Toriola is professor of surgery at Washington University, St. Louis.

Previous research identified risk factors for dense breast tissue. A genome-wide association study found 31 genetic loci associated with dense breast tissue, and 17 had a known association with breast cancer risk.

In the JAMA Network Open study, the researchers included data from women who were treated at Washington University’s Joanne Knight Breast Health Center and Siteman Cancer Center. The discovery group included 375 premenopausal women who received annual mammography screening in 2016 and had dense volume and non-dense volume measured during each screen. The validation set drew from 14,040 premenopausal women seen at the centers between 2010 and 2015.

In the discovery group, women with a family history of breast cancer had greater volumetric percent density (odds ratio [OR], 1.25; P < .001). The validation set produced a similar result (OR, 1.30; 95% confidence interval, 1.17-1.45). Subanalyses revealed similar associations in non-Hispanic White and Black or African American women.

The current study included a higher percentage of women with a family history of breast cancer than previous studies, and also controlled for more variables. This may have removed confounding variables that could have affected previous studies.

“It reinforces the need to start mammogram screening early in women who have a family history of breast cancer,” Dr. Toriola said.

The study had some limitations, including a higher percentage of women with a family history of breast cancer than the National Health Interview Survey (23.2% and 15.3%, versus 8.4%), explained by the fact that women with a family history of breast cancer are more likely to seek out screening. The average age of women was on average 47 years, making them closer to perimenopausal than premenopausal.

The study was funded by the National Institutes of Health.

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

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

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

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

One nurse is headed to federal prison and another faces a similar fate for participating in a pair of prison contraband schemes.

Former contract nurse Joseph Nwancha, RN, 41, of Baltimore, Maryland, was sentenced to 30 months in federal prison followed by 3 years of supervised release for his role in a scheme to smuggle narcotics, tobacco, cell phones, and other contraband into a state prison.

In his plea deal, Mr. Nwancha said that he was regularly the on-duty nurse during evenings and nights at Maryland Correctional Institute Jessup, which housed approximately 1,100 male inmates. This made it possible for him to have private contact with inmates without prison employees or other inmates observing the interactions.

According to court documents, beginning in September 2017, Corey Alston, an inmate at the medium-security prison, began bribing Mr. Nwancha to bring contraband into the prison. The inmate’s sister, Ashley Alston, discussed the bribe payments with Mr. Nwancha via text messages and later met with Mr. Nwancha to give him money. In his plea deal, Mr. Nwancha also admitted to having similar arrangements with other inmates.

On Nov. 28, 2017, Mr. Nwancha was stopped at MCIJ and was found to be in possession of approximately 230 g of K2, a synthetic cannabinoid, intended for Mr. Alston and other inmates, according to the court documents. A cell phone recovered from Mr. Nwancha contained text-message conversations discussing bribe payments and other details related to the smuggling operation. The next day, Mr. Nwancha fled to Dublin where he remained until his arrest and extradition, the document says.

According to the Maryland Board of Nursing, Mr. Nwancha earned his license to practice in 2013, and it expired in 2019.

The Washington Post reported that Mr. Nwancha was part of a smuggling ring involving at least 25 people, including corrections officers, in which conspirators would receive “bribes, kickbacks, and sexual favors” in exchange for smuggling contraband into the facility.

Jeane Arnette, RN, of Leavenworth, Kan., pleaded guilty to a scheme in which she used her role as a nurse to smuggle contraband, including cell phones, into the Leavenworth Detention Center.

Ms. Arnette, 61, pleaded guilty on Mach 10 to conspiracy to provide contraband to federal prison inmates. The Kansas City Star says Ms. Arnette worked at the prison from August 2020 through September 2021 and allegedly attempted to smuggle contraband on at least 15 occasions to one inmate. Investigators alleged she was paid through Cash App for the transactions.

She is scheduled to be sentenced June 9 and faces a maximum penalty of 5 years in prison.
 

New York nurse indicted in COVID-19 vaccine card scam

A New York licensed practical nurse faces charges of conspiring to defraud the U.S. Department of Health & Human Services and conspiring to commit forgery in a scheme to distribute and sell false COVID-19 vaccination cards.

According to the indictment, Steven Rodriguez, of Long Beach, N.Y., 27, a nurse at a Hempstead, N.Y.–based clinic, conspired with Jia Liu, 26, of New York, who is a member of the U.S. Marine Corps Reserve, to provide the fake vaccination cards. The cards were sold to unvaccinated Marine Corps reservists who did not want to comply with U.S. Department of Defense vaccination regulations.

In the scheme, Mr. Liu purchased stolen, blank COVID-19 vaccination cards from Mr. Rodriguez, then forged and distributed them for profit. Mr. Liu also directed buyers to meet Mr. Rodriguez in person at the health care clinic where, rather than administer the vaccination, Mr. Rodriguez would destroy the vial of vaccine intended for that patient, then provide a forged vaccination card. Mr. Rodriguez then made false entries in immunization databases indicating that the buyer had been vaccinated. Mr. Liu was also charged with one count of conspiring to defraud the Department of Defense, according to prosecutors.

Using code words such as “gift cards,” “Pokemon cards,” and “Cardi Bs,” the men sent messages on encrypted messaging apps and on social media to inform potential buyers of the opportunity to buy the fake cards, prosecutors said.

Overall, according to the indictment, Mr. Rodriguez and Mr. Liu distributed at least 300 stolen or false COVID-19 vaccination cards, created more than 70 false entries in immunization databases, and destroyed multiple doses of COVID-19 vaccine. “The defendants put military and other communities at risk of contracting a virus that has already claimed nearly one million lives in this country,” Breon Peace, U.S. Attorney for the Eastern District of New York, said when announcing the charges.

Mr. Rodriguez’s lawyer said in an email to The New York Times that the charges are “disturbing” but added, “This young man has no prior record and has a good family, which is why he was released on an unsecured signature bond with the consent of the government.”

Mr. Rodriguez acquired his LPN license in 2018, and it was valid as of press time, according to the New York Office of the Professions database.

Mr. Liu, who also faces charges in connection with the January 6 riot on Capitol Hill, was released on a $250,000 bond to home detention with GPS monitoring, according to the same report.

If convicted, the men could each face up to 10 years in prison.
 

Pennsylvania nurse practitioner faces 22 felony charges

A Bradford County, Pennsylvania, nurse practitioner is facing nearly two dozen felony violations of state law.

Stephanie King, CRNP, 45, of Ulster, Pennsylvania, is accused of prescribing medicines without a collaborating physician, as well as with multiple counts of false billing.

The felony charges include three violations of the state’s Controlled Substance, Drug, Device and Cosmetic Act; two counts of insurance fraud; six counts of Medicaid fraud; six counts of forgery; two counts of tampering with public records; and three counts of theft by deception.

According to local press reports, Ms. King was the owner and operator of the Center for Holistic and Integrative Mental Health in Athens, Pa. The charging documents allege that, beginning in November 2016, Ms. King entered into a sexual relationship with a patient and billed a private insurer for their trysts. Ms. King subsequently entered a relationship with another patient. Although she discontinued medical care for this patient after the affair began, she continued to prescribe controlled substances for him, according to the indictment.

In addition, prosecutors allege that Ms. King renewed previous collaboration agreements without the knowledge of her physician collaborators. Under Pennsylvania law, nurse practitioners are required to enter into collaborative agreements with Pennsylvania-licensed physicians in order to perform medical diagnoses and prescribe controlled substances.

The investigation found that Ms. King falsely billed more than $300,000 to private insurers and $100,000 to the Commonwealth of Pennsylvania for services that did not meet acceptable medical treatment standards. In addition, she is alleged to have written more than 3,750 prescriptions to patients during the time she did not meet the State of Pennsylvania’s requirements to prescribe.

Her license, originally obtained in 2011, was suspended on March 25, 2020.
 

Massachusetts nurse pleads guilty of tampering with patients’ fentanyl

A Massachusetts nurse was charged with and has agreed to plead guilty to one count of tampering with a controlled substance while working in the postsurgery recovery unit at a Massachusetts hospital as well as at an outpatient vascular surgery center.

According to the charging documents, Hugo Vieira, 41, of Berkley, Massachusetts, removed fentanyl from vials meant for patients undergoing or recovering from surgery. He then replaced the fentanyl with saline. Investigators identified 60 vials that had been tampered with at the vascular surgery center and two at the hospital.

Mr. Viera faces up to 10 years in prison followed by 3 years of supervised release and a fine of up to $250,000 for the tampering charge.

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

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

A vegetarian or vegan diet is said to be particularly popular among girls and young women. But despite what some people think, these diets, especially vegan diets, are not automatically healthy. A vegan diet can lead to nutritional deficits as a result of the limited choice of foods. These deficits can cause clinically relevant symptoms if they are not balanced out. One of the things to keep in mind is the need for a sufficient amount of vitamins B₁₂ and B₆, as well as vitamin D, explains nutritional scientist Bettina Dörr, PhD, from Munich, who specializes in how nutritional science is applied in everyday practice.

Vegetarian and vegan diets

According to Dr. Dörr, vegetarian diets can be categorized into the following main types:

• Ovo-lacto vegetarian (excludes meat and fish).
• Ovo vegetarian (excludes meat, fish, and dairy products).
• Lacto vegetarian (excludes meat, fish, and eggs).
• Vegan (excludes meat, fish, eggs, dairy products, and honey).
• Raw vegan (excludes meat, fish, eggs, dairy products, honey, and heated food).

The following are additional groups:

• Fruitarians want to eat only plant products that do not result in any damage to the plant itself (apples and nuts, for example, but not carrots or potatoes).
• Pescatarians exclude meat but still eat fish or seafood.
• Dirty vegetarians avoid meat and fish but, according to Dr. Dörr, they do not pay particular attention to their diet and eat lots of ready-made and confectionery products.
• Flexitarians value a balanced diet and eat meat or fish in moderation, but not particularly often.

Another diet is the orthorexic diet. Followers of this diet force themselves to have a healthy diet and are afraid of getting sick from unhealthy food. As the nutritional scientist explains, orthorexic persons set their own definitions of what is healthy. While some refrain from certain foods (e.g., household sugar), others eliminate whole food groups and eat nothing but raw food. Compulsive behavior can appear in specific methods of food preparation or adherence to fixed meal schedules.

The overwhelming majority of orthorexic persons are young women. As shown in a study from the University of Göttingen, orthorexic behavior is displayed above all in active women who play sports, particularly high-performance athletes. Children can also be affected by orthorexia if their parents are.

Critical nutrients

When following a vegan diet, it is possible to ingest sufficient critical nutrients, even with plant-based foods, according to Dr. Dörr. The prerequisite for this is good knowledge regarding food and nutrients. However, it is increasingly the case that foods are “simply left out,” without consideration of the consequences. This factor should be considered when providing medical advice.

Some of the important nutrients in this respect are proteins and vitamins B₆, B₁₂, and D.

Proteins

Girls need 0.9 g/kg per day of protein. For a person whose body weight is 60 kg, this corresponds to 54 g. The daily protein requirement for a person who weighs 60 kg can be fulfilled through a vegan diet. According to Dr. Dörr, 54 g of protein is contained in 300 g of tofu, 350 g of cooked soybeans, 350 g of hazelnuts, 750 g of whole grain bread (15 slices at 50 g each), 750 g of cooked lentils, and 1 kg of white beans.

Vitamin B₆

Vitamin B₆ (pyridoxine) has, Dr. Dörr explains, multiple metabolic functions, especially in the metabolization of amino acids, and is important from a neurologic perspective. For girls, the vitamin is important for hormone metabolism. Data show that approximately 14% of girls aged 14-18 years ingest less than the recommended amount of vitamin B₆. For vegans, the percentage of those with insufficient intake is even higher, since vitamin B₆ has low bioavailability in plant-based foods. For girls, there is the additional factor of oral contraceptives. There are indications that those who use oral contraceptives containing estrogen have lower levels of pyridoxal-5’-phosphate (PLP), a marker for vitamin B₆. Since the PLP-dependent enzymes are essential for the synthesis of hormones such as serotonin, symptoms such as depressive moods, increased irritability, nervousness, and loss of libido can indicate a vitamin B₆ deficiency.

The daily B₆ requirement for girls is 1.4 mg and can be fulfilled, for example, by consuming 200 g of hazelnuts, 200 g of walnuts, 400 g of bananas (two to three bananas, depending on weight), 700 g of cooked green beans, 1 kg of cooked potatoes, and 1.4 kg of oats.

Vitamin B₁₂

Since vitamin B₁₂ is not present in plant-based food, following a vegan diet in the long term can result in deficiency unless dietary supplements are taken. When researching the choices of various dietary supplements, it should be taken into consideration that the utilization of vitamin B₁₂ from plant-based sources such as algae, seaweed, and fungi is not necessarily a given. Careful selection and regular monitoring of B₁₂ status is recommended.

Vitamin D

According to Dr. Dörr, evidence has increased in recent years that vitamin D is crucial not only for the bones but also for numerous metabolic processes. The fact is that foods are barely capable of covering the vitamin D requirement in amounts that can be expected to be consumed. Vegan foods are not able to contribute to the supply of vitamin D, since considerable amounts are present only in food of an animal origin. The decision to take supplements and in what amounts should be made on the basis of one’s condition.

Minerals

Calcium, iodine, iron, selenium, and zinc are not easily available in sufficient quantities from a purely plant-based diet. Plant-based foods usually contain lower quantities of these minerals than do foods of animal origin, and the minerals from plant-based sources have lower bioavailability. According to Dr. Dörr, current evidence suggests that a vegan diet can have negative effects on bone health. In an ongoing cross-sectional study, ultrasound measurements of the heel bone are being made, and biomarkers in the blood and urine are being measured. On average, people who follow a vegan diet have lower ultrasound readings than those of omnivores.

The European Prospective Investigation into Cancer and Nutrition (EPIC) study from Great Britain, which involved almost 55,000 people, revealed that vegans had a 43% higher risk of fracture, compared to meat eaters.

An important nutrient, especially for cell development, is choline, which, Dr. Dörr explains, can be absorbed mainly through eating eggs, fish, meat, and dairy products. There is increasing evidence that a vegan diet is not able to supply sufficient quantities of choline, particularly if requirements increase, such as during pregnancy and breastfeeding. Evidence has grown that women who wish to conceive a child benefit not only from a sufficient intake of folate intake for the prevention of neural tube defects and for favorable fetal development but also from sufficient quantities of choline (the recommended daily amount for pregnant women is 480 mg).

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

The vast majority of U.S. physicians regularly treat patients with socioeconomic challenges – from financial instability and a lack of transportation to eviction threats and domestic problems – but are deeply frustrated by their inability to adequately address these issues, a new survey has found.

The survey, conducted in February by The Physicians Foundation, queried 1,502 doctors (500 primary care physicians and 1,002 specialists) about their experience with social drivers – also known as determinants – of health (SDOH). Among the key findings: More than 60% of respondents said they had little or no time to effectively address the SDOH needs of their patients, yet nearly 9 in 10 (87%) said they would like to be able to do so in the future.

Most (63%) said they feel burned out when they try to help patients with their SDOH needs; and nearly 7 in 10 (68%) said managing SDOH for their patients has a “major impact” on their mental health and well-being.

This news organization spoke with Gary Price, MD, president of The Physicians Foundation, about the findings.

Q: These issues aren’t new. Why did you undertake this survey now?

The Physicians Foundation has surveyed America’s physicians for a decade on their practice and the broader health care environment, which included questions on SDOH. However, this is the first one we’ve done that concentrated entirely on SDOH. We think it’s particularly timely now.

The COVID-19 pandemic focused a very harsh spotlight on the tremendous impact SDOH can have on patient health, care outcomes, costs, physician burden, and the physician-patient relationship. It’s become increasingly apparent that for our country to achieve health equity and improve our health care system, including physician satisfaction, we must address the impact of SDOH on patients and physicians.

Even before the pandemic, we had an epidemic of physician burnout. That was driven in large part by the huge amount of time being wasted on administrative tasks such as pre-approvals, insurance forms, and working with electronic medical records. Now we’re recognizing that the causes of physician burnout are much larger than that.

Q: The results of the survey show that physicians are seeing the effects of SDOH no matter where they practice – rural (81%), urban (81%), suburban (73%) – how old they are, or their own racial or ethnic heritage. Is that surprising?

I was, in fact, surprised by the pervasiveness. Every physician is seeing the impact of social drivers on their patients every day. For a long time, physicians tried to ignore these problems because they couldn’t deal with them at the practice level; it was too big a task. But if we’re going to decrease the cost of health care and increase the quality of outcomes and decrease the enormous disparities we see, we’re going to have to deal with these SDOH.

I think the problem is grim, but physicians recognize this issue. It’s not one that they traditionally are trained to deal with – and, more importantly, they are not reimbursed on these issues. But despite that, they all want to help.

Q: The survey found that 83% of physicians believed their inability to adequately deal with SDOH moderately (60%) or significantly (23%) contributed to their feelings of burnout. Why do you think physicians find these problems so frustrating and stressful?

The definition of burnout is feeling that you’re being held responsible for things you no longer have any control or authority over. A patient’s inability to find transportation to get to an appointment, or who has financial instability that can lead them to have to make a choice between buying medicine or buying food for their family, isn’t something a physician can change. The overwhelming majority of physicians in our survey not only recognize that their patients have needs in these areas, but they don’t have time to be able to deal with them the way that they’d like to – either the resources aren’t there, or they aren’t effective, or they simply don’t know where to turn.

This phenomenon has been quantified by research. A 2020 study in JAMA, by the Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine, found that physicians who had a larger burden of patients with more social needs received lower quality scores from Medicare and were less likely to receive bonuses for the care they provided. But the lower scores were related to the patients’ socioeconomic environment and had nothing do with the quality of the care they received.

Q: Researchers have looked at the relationship between SDOH and burnout, and what happens when physicians incorporate resources to address social issues into their practice. And it seems that doing so can help ease burnout at least a little.

That makes perfect sense. You’re now giving them the ability to intervene and do something about a health-related issue that’s going to help their patients get better quicker. At the same time, addressing these social issues can reduce health care costs to the system while improving outcomes. For example, when a patient with diabetes who needs insulin has their electricity cut off, they can no longer refrigerate the insulin. So simply having their electricity restored could keep them from being hospitalized for a diabetic coma because they weren’t able to follow their treatment.

The Health Leads Grow and Catalyze project, which we helped fund in 2014-2018, trained college students to make lists of key resources patients might require – like food, electricity, or heat – and work with physicians in the emergency room to get a prescription for that need. We’ve seen a very excellent return on investment and it’s now in health systems all over the country.

Q: The survey does a good job of highlighting the nature and scope of the problem, but what about solutions? What, if anything, can physicians be doing now to reduce the burden of SDOH for their patients?

The most important thing we’re doing now is drawing attention to the problem, not only to the impact it’s having on patients’ health but the health and well-being of our physicians.

The greatest challenge physicians said they faced was not having enough time to address these issues in their practice, and that stems directly from a lot of time that gets wasted on other things – preapprovals, inefficient EHRs, checkboxes. Our doctors reported that even when they know where the resources exist, they are hard to access or unavailable when they want them.

Almost all these things are going to require innovative solutions, and in some cases might vary by the individual. With transportation, for example, maybe we need a system like Meals on Wheels, where part of the solution could be a system of volunteer drivers to take patients to appointments. Or we might need more funding for transportation directly aimed at people who don’t have access to a bus line. But when you think about how much a ride in an ambulance costs versus how much it would cost to get someone to the doctor before they got sick enough to require that ambulance, that kind of expenditure makes a lot of sense for driving down individual and system costs. 

Q: The problem of unconscious bias in medicine has been receiving increasing attention. Do you think this bias is related to the issues of SDOH the new survey reveals?

Discrimination and racism are examples of SDOH. Implicit bias can happen in any aspect of our lives and interactions with others – so for physicians this can happen with our patients. Our survey didn’t specifically dive into how bias plays a role in addressing the impact of SDOH, but as a society we can no longer ignore any factor that hinders a person from accessing high-quality, cost-effective health care, including our own unconscious bias.

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

The vast majority of U.S. physicians regularly treat patients with socioeconomic challenges – from financial instability and a lack of transportation to eviction threats and domestic problems – but are deeply frustrated by their inability to adequately address these issues, a new survey has found.

The survey, conducted in February by The Physicians Foundation, queried 1,502 doctors (500 primary care physicians and 1,002 specialists) about their experience with social drivers – also known as determinants – of health (SDOH). Among the key findings: More than 60% of respondents said they had little or no time to effectively address the SDOH needs of their patients, yet nearly 9 in 10 (87%) said they would like to be able to do so in the future.

Most (63%) said they feel burned out when they try to help patients with their SDOH needs; and nearly 7 in 10 (68%) said managing SDOH for their patients has a “major impact” on their mental health and well-being.

This news organization spoke with Gary Price, MD, president of The Physicians Foundation, about the findings.

Q: These issues aren’t new. Why did you undertake this survey now?

The Physicians Foundation has surveyed America’s physicians for a decade on their practice and the broader health care environment, which included questions on SDOH. However, this is the first one we’ve done that concentrated entirely on SDOH. We think it’s particularly timely now.

The COVID-19 pandemic focused a very harsh spotlight on the tremendous impact SDOH can have on patient health, care outcomes, costs, physician burden, and the physician-patient relationship. It’s become increasingly apparent that for our country to achieve health equity and improve our health care system, including physician satisfaction, we must address the impact of SDOH on patients and physicians.

Even before the pandemic, we had an epidemic of physician burnout. That was driven in large part by the huge amount of time being wasted on administrative tasks such as pre-approvals, insurance forms, and working with electronic medical records. Now we’re recognizing that the causes of physician burnout are much larger than that.

Q: The results of the survey show that physicians are seeing the effects of SDOH no matter where they practice – rural (81%), urban (81%), suburban (73%) – how old they are, or their own racial or ethnic heritage. Is that surprising?

I was, in fact, surprised by the pervasiveness. Every physician is seeing the impact of social drivers on their patients every day. For a long time, physicians tried to ignore these problems because they couldn’t deal with them at the practice level; it was too big a task. But if we’re going to decrease the cost of health care and increase the quality of outcomes and decrease the enormous disparities we see, we’re going to have to deal with these SDOH.

I think the problem is grim, but physicians recognize this issue. It’s not one that they traditionally are trained to deal with – and, more importantly, they are not reimbursed on these issues. But despite that, they all want to help.

Q: The survey found that 83% of physicians believed their inability to adequately deal with SDOH moderately (60%) or significantly (23%) contributed to their feelings of burnout. Why do you think physicians find these problems so frustrating and stressful?

The definition of burnout is feeling that you’re being held responsible for things you no longer have any control or authority over. A patient’s inability to find transportation to get to an appointment, or who has financial instability that can lead them to have to make a choice between buying medicine or buying food for their family, isn’t something a physician can change. The overwhelming majority of physicians in our survey not only recognize that their patients have needs in these areas, but they don’t have time to be able to deal with them the way that they’d like to – either the resources aren’t there, or they aren’t effective, or they simply don’t know where to turn.

This phenomenon has been quantified by research. A 2020 study in JAMA, by the Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine, found that physicians who had a larger burden of patients with more social needs received lower quality scores from Medicare and were less likely to receive bonuses for the care they provided. But the lower scores were related to the patients’ socioeconomic environment and had nothing do with the quality of the care they received.

Q: Researchers have looked at the relationship between SDOH and burnout, and what happens when physicians incorporate resources to address social issues into their practice. And it seems that doing so can help ease burnout at least a little.

That makes perfect sense. You’re now giving them the ability to intervene and do something about a health-related issue that’s going to help their patients get better quicker. At the same time, addressing these social issues can reduce health care costs to the system while improving outcomes. For example, when a patient with diabetes who needs insulin has their electricity cut off, they can no longer refrigerate the insulin. So simply having their electricity restored could keep them from being hospitalized for a diabetic coma because they weren’t able to follow their treatment.

The Health Leads Grow and Catalyze project, which we helped fund in 2014-2018, trained college students to make lists of key resources patients might require – like food, electricity, or heat – and work with physicians in the emergency room to get a prescription for that need. We’ve seen a very excellent return on investment and it’s now in health systems all over the country.

Q: The survey does a good job of highlighting the nature and scope of the problem, but what about solutions? What, if anything, can physicians be doing now to reduce the burden of SDOH for their patients?

The most important thing we’re doing now is drawing attention to the problem, not only to the impact it’s having on patients’ health but the health and well-being of our physicians.

The greatest challenge physicians said they faced was not having enough time to address these issues in their practice, and that stems directly from a lot of time that gets wasted on other things – preapprovals, inefficient EHRs, checkboxes. Our doctors reported that even when they know where the resources exist, they are hard to access or unavailable when they want them.

Almost all these things are going to require innovative solutions, and in some cases might vary by the individual. With transportation, for example, maybe we need a system like Meals on Wheels, where part of the solution could be a system of volunteer drivers to take patients to appointments. Or we might need more funding for transportation directly aimed at people who don’t have access to a bus line. But when you think about how much a ride in an ambulance costs versus how much it would cost to get someone to the doctor before they got sick enough to require that ambulance, that kind of expenditure makes a lot of sense for driving down individual and system costs. 

Q: The problem of unconscious bias in medicine has been receiving increasing attention. Do you think this bias is related to the issues of SDOH the new survey reveals?

Discrimination and racism are examples of SDOH. Implicit bias can happen in any aspect of our lives and interactions with others – so for physicians this can happen with our patients. Our survey didn’t specifically dive into how bias plays a role in addressing the impact of SDOH, but as a society we can no longer ignore any factor that hinders a person from accessing high-quality, cost-effective health care, including our own unconscious bias.

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

The vast majority of U.S. physicians regularly treat patients with socioeconomic challenges – from financial instability and a lack of transportation to eviction threats and domestic problems – but are deeply frustrated by their inability to adequately address these issues, a new survey has found.

The survey, conducted in February by The Physicians Foundation, queried 1,502 doctors (500 primary care physicians and 1,002 specialists) about their experience with social drivers – also known as determinants – of health (SDOH). Among the key findings: More than 60% of respondents said they had little or no time to effectively address the SDOH needs of their patients, yet nearly 9 in 10 (87%) said they would like to be able to do so in the future.

Most (63%) said they feel burned out when they try to help patients with their SDOH needs; and nearly 7 in 10 (68%) said managing SDOH for their patients has a “major impact” on their mental health and well-being.

This news organization spoke with Gary Price, MD, president of The Physicians Foundation, about the findings.

Q: These issues aren’t new. Why did you undertake this survey now?

The Physicians Foundation has surveyed America’s physicians for a decade on their practice and the broader health care environment, which included questions on SDOH. However, this is the first one we’ve done that concentrated entirely on SDOH. We think it’s particularly timely now.

The COVID-19 pandemic focused a very harsh spotlight on the tremendous impact SDOH can have on patient health, care outcomes, costs, physician burden, and the physician-patient relationship. It’s become increasingly apparent that for our country to achieve health equity and improve our health care system, including physician satisfaction, we must address the impact of SDOH on patients and physicians.

Even before the pandemic, we had an epidemic of physician burnout. That was driven in large part by the huge amount of time being wasted on administrative tasks such as pre-approvals, insurance forms, and working with electronic medical records. Now we’re recognizing that the causes of physician burnout are much larger than that.

Q: The results of the survey show that physicians are seeing the effects of SDOH no matter where they practice – rural (81%), urban (81%), suburban (73%) – how old they are, or their own racial or ethnic heritage. Is that surprising?

I was, in fact, surprised by the pervasiveness. Every physician is seeing the impact of social drivers on their patients every day. For a long time, physicians tried to ignore these problems because they couldn’t deal with them at the practice level; it was too big a task. But if we’re going to decrease the cost of health care and increase the quality of outcomes and decrease the enormous disparities we see, we’re going to have to deal with these SDOH.

I think the problem is grim, but physicians recognize this issue. It’s not one that they traditionally are trained to deal with – and, more importantly, they are not reimbursed on these issues. But despite that, they all want to help.

Q: The survey found that 83% of physicians believed their inability to adequately deal with SDOH moderately (60%) or significantly (23%) contributed to their feelings of burnout. Why do you think physicians find these problems so frustrating and stressful?

The definition of burnout is feeling that you’re being held responsible for things you no longer have any control or authority over. A patient’s inability to find transportation to get to an appointment, or who has financial instability that can lead them to have to make a choice between buying medicine or buying food for their family, isn’t something a physician can change. The overwhelming majority of physicians in our survey not only recognize that their patients have needs in these areas, but they don’t have time to be able to deal with them the way that they’d like to – either the resources aren’t there, or they aren’t effective, or they simply don’t know where to turn.

This phenomenon has been quantified by research. A 2020 study in JAMA, by the Physicians Foundation Center for the Study of Physician Practice and Leadership at Weill Cornell Medicine, found that physicians who had a larger burden of patients with more social needs received lower quality scores from Medicare and were less likely to receive bonuses for the care they provided. But the lower scores were related to the patients’ socioeconomic environment and had nothing do with the quality of the care they received.

Q: Researchers have looked at the relationship between SDOH and burnout, and what happens when physicians incorporate resources to address social issues into their practice. And it seems that doing so can help ease burnout at least a little.

That makes perfect sense. You’re now giving them the ability to intervene and do something about a health-related issue that’s going to help their patients get better quicker. At the same time, addressing these social issues can reduce health care costs to the system while improving outcomes. For example, when a patient with diabetes who needs insulin has their electricity cut off, they can no longer refrigerate the insulin. So simply having their electricity restored could keep them from being hospitalized for a diabetic coma because they weren’t able to follow their treatment.

The Health Leads Grow and Catalyze project, which we helped fund in 2014-2018, trained college students to make lists of key resources patients might require – like food, electricity, or heat – and work with physicians in the emergency room to get a prescription for that need. We’ve seen a very excellent return on investment and it’s now in health systems all over the country.

Q: The survey does a good job of highlighting the nature and scope of the problem, but what about solutions? What, if anything, can physicians be doing now to reduce the burden of SDOH for their patients?

The most important thing we’re doing now is drawing attention to the problem, not only to the impact it’s having on patients’ health but the health and well-being of our physicians.

The greatest challenge physicians said they faced was not having enough time to address these issues in their practice, and that stems directly from a lot of time that gets wasted on other things – preapprovals, inefficient EHRs, checkboxes. Our doctors reported that even when they know where the resources exist, they are hard to access or unavailable when they want them.

Almost all these things are going to require innovative solutions, and in some cases might vary by the individual. With transportation, for example, maybe we need a system like Meals on Wheels, where part of the solution could be a system of volunteer drivers to take patients to appointments. Or we might need more funding for transportation directly aimed at people who don’t have access to a bus line. But when you think about how much a ride in an ambulance costs versus how much it would cost to get someone to the doctor before they got sick enough to require that ambulance, that kind of expenditure makes a lot of sense for driving down individual and system costs. 

Q: The problem of unconscious bias in medicine has been receiving increasing attention. Do you think this bias is related to the issues of SDOH the new survey reveals?

Discrimination and racism are examples of SDOH. Implicit bias can happen in any aspect of our lives and interactions with others – so for physicians this can happen with our patients. Our survey didn’t specifically dive into how bias plays a role in addressing the impact of SDOH, but as a society we can no longer ignore any factor that hinders a person from accessing high-quality, cost-effective health care, including our own unconscious bias.

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

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the 2022 Gut Microbiota for Health World Summit, organized by the American Gastroenterological Association and the European Society of Neurogastroenterology and Motility.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting. “The answer now is totally yes.”

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), Dr. Khanna said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two that have completed phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroides and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with [ulcerative colitis] who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.

Help your patients understand their C. difficile diagnosis by sending them this resource from the AGA GI Patient Center.

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Get the latest information on the gut microbiome on the AGA website.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vedanta, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the 2022 Gut Microbiota for Health World Summit, organized by the American Gastroenterological Association and the European Society of Neurogastroenterology and Motility.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting. “The answer now is totally yes.”

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), Dr. Khanna said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two that have completed phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroides and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with [ulcerative colitis] who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.

Help your patients understand their C. difficile diagnosis by sending them this resource from the AGA GI Patient Center.

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Get the latest information on the gut microbiome on the AGA website.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vedanta, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

WASHINGTON – Research on standardized microbiome-based therapies designed to prevent the recurrence of Clostridioides difficile infection (CDI) is moving “with a lot of momentum,” according to one expert, and modulation of the gut microbiome may even enhance responses to immunotherapy and/or abrogate toxicity, according to another.

Several products for prevention of CDI recurrence are poised for either phase 3 trials or upcoming Food and Drug Administration approval, Sahil Khanna, MBBS, MS, professor of medicine, gastroenterology, and hepatology at the Mayo Clinic in Rochester, Minn., reported at the 2022 Gut Microbiota for Health World Summit, organized by the American Gastroenterological Association and the European Society of Neurogastroenterology and Motility.

Jennifer A. Wargo, MD, MMSc, of the University of Texas MD Anderson Cancer Center, Houston, described her investigations of microbiome modulation’s role in cancer treatment. “I used to say yes [we can do this] somewhat enthusiastically without data, but now we have data to support this,” she said at the meeting. “The answer now is totally yes.”

New approaches for CDI

“Based on how the field is moving, we might be able to [offer our patients] earlier microbiome restoration” than is currently afforded with fecal microbiota transplantation (FMT), Dr. Khanna said. “Right now the [Food and Drug Administration] and our clinical guidelines say we should do FMT after three or more episodes [of CDI] – that’s heartbreaking for patients.”

Several of the microbiome-based therapies under investigation – including two that have completed phase 3 trials – have shown efficacy after a second episode of CDI, and one of these two has also had positive results after one episode of CDI in patients 65 at older, a group at particularly high risk of recurrence, said Dr. Khanna.

The value of standardized, mostly pill-form microbiome therapies has been heightened during the pandemic. “We’ve been doing conventional FMT for recurrent C. difficile for over a decade now, and it’s probably the most effective treatment we have,” said Colleen R. Kelly, MD, associate professor of medicine at Brown University, Providence, R.I., and moderator of the session on microbiota-based therapies.

Prepandemic “it got really hard, with issues of identifying donors, and quality control and safety ... And then when COVID hit the stool banks shut down,” she said in an interview after the meeting. With stool testing for SARS-CoV-2 now in place, some stool is again available, “but it made me realize how fragile our current system is,” Dr. Kelly said. “The fact that companies are putting these products through the FDA pipeline and investigating them in rigorous, scientific randomized controlled trials is really good for the field.”

The products vary in composition; some are live multi-strain biotherapeutics derived from donor stool, for instance, while others are defined live bacterial consortia not from stool. Most are oral formulations, given one or multiple times, that do not require any bowel preparation.

One of the products most advanced in the pipeline, RBX2660 (Rebiotix, Ferring Pharmaceuticals) is stool derived and rectally administered. In phase 3 research, 70.5% of patients who received one active enema after having had two or more CDI recurrences and standard-of-care antibiotic treatment had no additional recurrence at 8 weeks compared to 58.1% in the placebo group, Dr. Khanna said.

The other product with positive phase 3 results, SER-109 (Seres Therapeutics), is a donor stool-derived oral formulation of purified Firmicutes spores that is administered after bowel prep. In results published earlier this year, the percentage of patients with recurrence of CDI up to 8 weeks after standard antibiotic treatment was 12% in the SER-109 group and 40% in the placebo group.

Patients in this trial were required to have had three episodes of CDI, and interestingly, Dr. Khanna said, the diagnosis of CDI was made only by toxin enzyme immunoassay (EIA). Earlier phase 2 research, which allowed either toxin EIA or polymerase chain reaction testing for the diagnosis of CDI (as other trials have done), produced negative results, leading investigators to surmise that some of the included patients had been colonized with C. difficile rather than being actively infected, Dr. Khanna said.

Researchers of these trials are documenting not only resolution of CDI but what they believe are positive shifts in the gut microbiota after microbiome-based therapy, he said. For instance, a phase 1 trial he led of the product RBX7455 (Rebiotix, Ferring Pharmaceuticals) – an oral capsule of lyophilized stool-based bacteria that can be kept for several days at room temperature – showed increases in Bacteroides and Clostridia.

And other trials’ analyses of microbiome engraftment have demonstrated that “you can restore [species] even when these bacteria aren’t [included in the therapy],” he noted. “As the milieu of the gut improves, species that were not detected start coming back up.”

Asked about rates of efficacy in the trials’ placebo arms, Dr. Khanna said that “we’ve become smarter with our antibiotic regimens ... the placebo response rate is the response to newer guideline-based therapies.”

In addition to CDI, microbiome-based therapies are being studied, mostly in phase 1 research, for indications such as Crohn’s disease, ulcerative colitis, autism spectrum disorder, hepatitis B, and hepatic encephalopathy, Dr. Khanna noted.

Dr. Kelly, whose own research has focused on FMT for CDI, said she anticipates an expansion of research into other indications once products to prevent CDI recurrence are on the market. “There have been a couple of promising ulcerative colitis trials that haven’t gone anywhere clinically yet,” she said in the interview. “But will we now identify patients with [ulcerative colitis] who may be more sensitive to microbial manipulation, for whom we can use these microbial therapies along with a biologic?”

Some of her patients with IBD and CDI who are treated with FMT have not only had their CDI eradicated but have subsequently seen improvements in their IBD, she noted.

The role of traditional FMT and of stool banks will likely change in the future with new standardized oral microbiome-based therapies that can be approved and regulated by the FDA, she said. However, “we think the stool banks will still have some value,” she said, certainly for clinical research and probably for some treatment purposes as well. Regarding new therapies, “I just really hope they’re affordable,” she said.

Help your patients understand their C. difficile diagnosis by sending them this resource from the AGA GI Patient Center.

Gut microbiome manipulation for cancer

Dr. Wargo’s research at MD Anderson has focused on metastatic breast cancer and immunotherapeutic checkpoint blockade. By sequencing microbiota samples and performing immune profiling in hundreds of patients, her team found that responders to PD-1 blockage have a greater diversity of gut bacteria and that “favorable signatures in the gut microbiome” are associated with enhanced immune responses in the tumor microenvironment.

Studies published last year in Science from investigators in Israel (2021 Feb 5;371[6529]:602-9) and Pittsburgh (2021 Feb 5;371[6529]:595-602), demonstrated that FMT promotes response in immunotherapy-refractory melanoma patients. In one study, FMT provided clinical benefit in 6 of 15 patients whose cancer had progressed on prior anti-PD-1 therapy, “which is pretty remarkable,” Dr. Wargo said.

Both research groups, she noted, saw favorable changes in the gut microbiome and immune cell infiltrates both at the level of the colon and the tumor.

Current research on FMT and other microbiome modulation strategies for cancer is guided in part by knowledge that tumors have microbial signatures – these signatures are now being identified across all tumor types – and by findings of “cross talk” between the gut and tumor microbiomes, she explained.

“Researchers are working hard to identify optimal consortia to enhance immune responses in the cancer setting, with promising work in preclinical models,” she said, and clinical trials are in progress. The role of diet in modulating the microbiome and enhancing anti-tumor immunity, with a focus on high dietary fiber intake, is also being investigated, she said.

Get the latest information on the gut microbiome on the AGA website.

Dr. Wargo reported that she serves on the advisory boards and is a paid speaker of numerous pharmaceutical and biotechnology companies, and is the coinventor of a patent submitted by the Texas MD Anderson Cancer Center on modulating the microbiome to enhance response to checkpoint blockade, and another related patent. Dr. Khanna reported that he is involved in research with Ferring/Rebiotix, Finch, Seres, Pfizer and Vedanta, and does consulting for Immuron and several other companies. Dr. Kelly said she serves as an unpaid adviser for OpenBiome, a nonprofit stool bank, and that her site has enrolled patients in two of the trials testing products for CDI.

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.

The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”

The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.

The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.

Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.

Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at [email protected] to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at [email protected]. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.

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

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.

The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”

The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.

The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.

Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.

Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at [email protected] to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at [email protected]. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.

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

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.

The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”

The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.

The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.

Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.

Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at [email protected] to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at [email protected]. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.

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

As the controversial Alzheimer’s disease (AD) drug aducanumab (Aduhelm) begins its integration into clinical practice, some physicians are concerned the drug’s prescribing label does not include adequate brain imaging recommendations to detect amyloid-related imaging abnormalities (ARIA).

Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem is the trial data used for the drug’s approval by the U.S. Food and Drug Administration included five MRIs to screen for ARIA.

“We recommend proceeding as per the clinical trials,” said Meghan Riddle, MD, associate director, Memory and Aging program, Butler Hospital, and assistant professor of psychiatry and human behavior, Brown University, Providence, R.I.

Dr. Riddle shared her team’s clinical experience with aducanumab, as well as information on four ARIA cases from their clinic, during a presentation at the American Association for Geriatric Psychiatry (AAGP) 2022 Annual Meeting.
 

Significant safety risk?

As previously reported by this news organization, the FDA granted accelerated approval of aducanumab for AD last year.

ARIA is the most common risk associated with aducanumab and has two types: ARIA-E (with edema) and ARIA-H (with hemosiderin). These can co-occur, particularly in areas of high amyloid burden, Dr. Riddle noted during her presentation.

ARIA is often detected incidentally via MRI. Patients are usually asymptomatic, but when they do have symptoms, headache, dizziness, and vision changes are the most common complaints. However, these are generally mild, said Dr. Riddle.

Nevertheless, in some cases, there can be severe sequelae, including severe edema or bleeding and seizures, she added.

A major risk factor for ARIA is apolipoprotein 4 (APOE ε4) status. Carriers are twice as likely to develop ARIA as non-carriers.

“If you’re heterozygote for APOE ε4, you have about a 40% chance of developing ARIA, and if you’re homozygote, you have about a 66% chance of developing ARIA,” Dr. Riddle said.

Given the high rate of ARIA in APOE ε4 carriers, the team from Butler Hospital recommends APOE testing prior to treatment with aducanumab.

The risk for developing ARIA is highest within the year of dose titration, Dr. Riddle noted. The current FDA label recommends obtaining a recent brain MRI, within 1 year, and then scans before the 7th and 12th infusions. However, the protocol during the clinical trials of aducanumab included MRI at baseline and prior to the 5th, 7th, 9th, and 12th infusions.

Dr. Riddle’s group has opted to continue the research protocol with new patients. “There’s concern that the decreased MRI monitoring based on the current FDA label may pose a significant safety risk, particularly among those who we know are already at a higher risk of developing ARIA,” she said.

Dr. Riddle also shared how her team selects aducanumab candidates. They need to have mild cognitive impairment (MCI), a mini-mental state examination (MMSE) score of 24 to 30, and a recent MRI to review for eligibility and APOE testing.

The most common reason for treatment exclusion is advanced disease and comorbidity, such as stroke.

Once approved for treatment, patients receive monthly infusions titrated over 6 months – 1 mg/kg for 2 months, 3 mg/kg for 2 months, 6 mg/kg for 2 months, then 10 mg/kg.

Patients are monitored to ensure safety and tolerability and regular review of MRI findings. In addition, patients and their families receive ongoing education about the drug.

Dr. Riddle and her team permanently discontinue the aducanumab if patients develop microhemorrhage, more than one area of superficial siderosis, more than 10 microhemorrhages, more than two episodes of ARIA, or severe symptoms of ARIA.
 

Four cases

Of the 11 patients who were candidates for aducanumab treatment, four developed ARIA. All are APOE ε4 carriers, with two homozygotes and two heterozygotes. All had severe radiographic ARIA-E, with one developing ARIA-H.

“Importantly, they were all initially asymptomatic and the ARIA was just picked up on their regular surveillance MRI,” said Dr. Riddle. She added that the drug was discontinued in all four cases.

Three of the ARIA cases were detected prior to the 5th scan, which is “concerning,” said Dr. Riddle. “Based on the current FDA label of safety monitoring, they don’t recommend doing that MRI. So [clinicians] would have dosed through that ARIA, which could put someone at much greater risk of developing severe symptoms.”

In addition, 14 patients at the center are receiving treatment with aducanumab. However, at this point they have not yet received their first MRI screen.

Dr. Riddle noted that when patients are told they are not candidates for treatment, or when treatment is discontinued, they are upset. However, she added, there is also a substantial level of understanding.

“We have a very layered discussion that includes the simple fact that we still aren’t sure if this is going to provide any clinical benefit, that this decision [to approve the drug] was accelerated, and that data are still being gathered,” Dr. Riddle added.

Dr. Riddle noted that the risk of ARIA is highest during the dose titration period: “There’s a signal that once you get to the 10 mg/kg dose, that plateaus.”

None of the patients at her center have reached that 12-month treatment mark. “The current plan is to do the MRI at 12 months then to give serial MRIs but less frequently, and whether that’s at 6 months or annually is yet to be determined.”

“We’re kind of writing these protocols as information evolves,” Dr. Riddle said.

The Memory and Aging Program receives grants from NIH-ADNI, Alzheimer’s Association, Fain Family Foundation, Joukowsky Family Foundation, Winter Family, Rhode Island Foundation, Goodman Family Foundation, and Global Alzheimer Platform Foundation; and clinical trials include: Lilly, Biogen, Genentech, Avid, Roche, Eisai, and Novartis. Dr. Riddle has disclosed no relevant financial relationships.

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

As the controversial Alzheimer’s disease (AD) drug aducanumab (Aduhelm) begins its integration into clinical practice, some physicians are concerned the drug’s prescribing label does not include adequate brain imaging recommendations to detect amyloid-related imaging abnormalities (ARIA).

Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem is the trial data used for the drug’s approval by the U.S. Food and Drug Administration included five MRIs to screen for ARIA.

“We recommend proceeding as per the clinical trials,” said Meghan Riddle, MD, associate director, Memory and Aging program, Butler Hospital, and assistant professor of psychiatry and human behavior, Brown University, Providence, R.I.

Dr. Riddle shared her team’s clinical experience with aducanumab, as well as information on four ARIA cases from their clinic, during a presentation at the American Association for Geriatric Psychiatry (AAGP) 2022 Annual Meeting.
 

Significant safety risk?

As previously reported by this news organization, the FDA granted accelerated approval of aducanumab for AD last year.

ARIA is the most common risk associated with aducanumab and has two types: ARIA-E (with edema) and ARIA-H (with hemosiderin). These can co-occur, particularly in areas of high amyloid burden, Dr. Riddle noted during her presentation.

ARIA is often detected incidentally via MRI. Patients are usually asymptomatic, but when they do have symptoms, headache, dizziness, and vision changes are the most common complaints. However, these are generally mild, said Dr. Riddle.

Nevertheless, in some cases, there can be severe sequelae, including severe edema or bleeding and seizures, she added.

A major risk factor for ARIA is apolipoprotein 4 (APOE ε4) status. Carriers are twice as likely to develop ARIA as non-carriers.

“If you’re heterozygote for APOE ε4, you have about a 40% chance of developing ARIA, and if you’re homozygote, you have about a 66% chance of developing ARIA,” Dr. Riddle said.

Given the high rate of ARIA in APOE ε4 carriers, the team from Butler Hospital recommends APOE testing prior to treatment with aducanumab.

The risk for developing ARIA is highest within the year of dose titration, Dr. Riddle noted. The current FDA label recommends obtaining a recent brain MRI, within 1 year, and then scans before the 7th and 12th infusions. However, the protocol during the clinical trials of aducanumab included MRI at baseline and prior to the 5th, 7th, 9th, and 12th infusions.

Dr. Riddle’s group has opted to continue the research protocol with new patients. “There’s concern that the decreased MRI monitoring based on the current FDA label may pose a significant safety risk, particularly among those who we know are already at a higher risk of developing ARIA,” she said.

Dr. Riddle also shared how her team selects aducanumab candidates. They need to have mild cognitive impairment (MCI), a mini-mental state examination (MMSE) score of 24 to 30, and a recent MRI to review for eligibility and APOE testing.

The most common reason for treatment exclusion is advanced disease and comorbidity, such as stroke.

Once approved for treatment, patients receive monthly infusions titrated over 6 months – 1 mg/kg for 2 months, 3 mg/kg for 2 months, 6 mg/kg for 2 months, then 10 mg/kg.

Patients are monitored to ensure safety and tolerability and regular review of MRI findings. In addition, patients and their families receive ongoing education about the drug.

Dr. Riddle and her team permanently discontinue the aducanumab if patients develop microhemorrhage, more than one area of superficial siderosis, more than 10 microhemorrhages, more than two episodes of ARIA, or severe symptoms of ARIA.
 

Four cases

Of the 11 patients who were candidates for aducanumab treatment, four developed ARIA. All are APOE ε4 carriers, with two homozygotes and two heterozygotes. All had severe radiographic ARIA-E, with one developing ARIA-H.

“Importantly, they were all initially asymptomatic and the ARIA was just picked up on their regular surveillance MRI,” said Dr. Riddle. She added that the drug was discontinued in all four cases.

Three of the ARIA cases were detected prior to the 5th scan, which is “concerning,” said Dr. Riddle. “Based on the current FDA label of safety monitoring, they don’t recommend doing that MRI. So [clinicians] would have dosed through that ARIA, which could put someone at much greater risk of developing severe symptoms.”

In addition, 14 patients at the center are receiving treatment with aducanumab. However, at this point they have not yet received their first MRI screen.

Dr. Riddle noted that when patients are told they are not candidates for treatment, or when treatment is discontinued, they are upset. However, she added, there is also a substantial level of understanding.

“We have a very layered discussion that includes the simple fact that we still aren’t sure if this is going to provide any clinical benefit, that this decision [to approve the drug] was accelerated, and that data are still being gathered,” Dr. Riddle added.

Dr. Riddle noted that the risk of ARIA is highest during the dose titration period: “There’s a signal that once you get to the 10 mg/kg dose, that plateaus.”

None of the patients at her center have reached that 12-month treatment mark. “The current plan is to do the MRI at 12 months then to give serial MRIs but less frequently, and whether that’s at 6 months or annually is yet to be determined.”

“We’re kind of writing these protocols as information evolves,” Dr. Riddle said.

The Memory and Aging Program receives grants from NIH-ADNI, Alzheimer’s Association, Fain Family Foundation, Joukowsky Family Foundation, Winter Family, Rhode Island Foundation, Goodman Family Foundation, and Global Alzheimer Platform Foundation; and clinical trials include: Lilly, Biogen, Genentech, Avid, Roche, Eisai, and Novartis. Dr. Riddle has disclosed no relevant financial relationships.

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

As the controversial Alzheimer’s disease (AD) drug aducanumab (Aduhelm) begins its integration into clinical practice, some physicians are concerned the drug’s prescribing label does not include adequate brain imaging recommendations to detect amyloid-related imaging abnormalities (ARIA).

Specifically, the drug’s label calls for three MRI brain scans before, and during, the titration period. The problem is the trial data used for the drug’s approval by the U.S. Food and Drug Administration included five MRIs to screen for ARIA.

“We recommend proceeding as per the clinical trials,” said Meghan Riddle, MD, associate director, Memory and Aging program, Butler Hospital, and assistant professor of psychiatry and human behavior, Brown University, Providence, R.I.

Dr. Riddle shared her team’s clinical experience with aducanumab, as well as information on four ARIA cases from their clinic, during a presentation at the American Association for Geriatric Psychiatry (AAGP) 2022 Annual Meeting.
 

Significant safety risk?

As previously reported by this news organization, the FDA granted accelerated approval of aducanumab for AD last year.

ARIA is the most common risk associated with aducanumab and has two types: ARIA-E (with edema) and ARIA-H (with hemosiderin). These can co-occur, particularly in areas of high amyloid burden, Dr. Riddle noted during her presentation.

ARIA is often detected incidentally via MRI. Patients are usually asymptomatic, but when they do have symptoms, headache, dizziness, and vision changes are the most common complaints. However, these are generally mild, said Dr. Riddle.

Nevertheless, in some cases, there can be severe sequelae, including severe edema or bleeding and seizures, she added.

A major risk factor for ARIA is apolipoprotein 4 (APOE ε4) status. Carriers are twice as likely to develop ARIA as non-carriers.

“If you’re heterozygote for APOE ε4, you have about a 40% chance of developing ARIA, and if you’re homozygote, you have about a 66% chance of developing ARIA,” Dr. Riddle said.

Given the high rate of ARIA in APOE ε4 carriers, the team from Butler Hospital recommends APOE testing prior to treatment with aducanumab.

The risk for developing ARIA is highest within the year of dose titration, Dr. Riddle noted. The current FDA label recommends obtaining a recent brain MRI, within 1 year, and then scans before the 7th and 12th infusions. However, the protocol during the clinical trials of aducanumab included MRI at baseline and prior to the 5th, 7th, 9th, and 12th infusions.

Dr. Riddle’s group has opted to continue the research protocol with new patients. “There’s concern that the decreased MRI monitoring based on the current FDA label may pose a significant safety risk, particularly among those who we know are already at a higher risk of developing ARIA,” she said.

Dr. Riddle also shared how her team selects aducanumab candidates. They need to have mild cognitive impairment (MCI), a mini-mental state examination (MMSE) score of 24 to 30, and a recent MRI to review for eligibility and APOE testing.

The most common reason for treatment exclusion is advanced disease and comorbidity, such as stroke.

Once approved for treatment, patients receive monthly infusions titrated over 6 months – 1 mg/kg for 2 months, 3 mg/kg for 2 months, 6 mg/kg for 2 months, then 10 mg/kg.

Patients are monitored to ensure safety and tolerability and regular review of MRI findings. In addition, patients and their families receive ongoing education about the drug.

Dr. Riddle and her team permanently discontinue the aducanumab if patients develop microhemorrhage, more than one area of superficial siderosis, more than 10 microhemorrhages, more than two episodes of ARIA, or severe symptoms of ARIA.
 

Four cases

Of the 11 patients who were candidates for aducanumab treatment, four developed ARIA. All are APOE ε4 carriers, with two homozygotes and two heterozygotes. All had severe radiographic ARIA-E, with one developing ARIA-H.

“Importantly, they were all initially asymptomatic and the ARIA was just picked up on their regular surveillance MRI,” said Dr. Riddle. She added that the drug was discontinued in all four cases.

Three of the ARIA cases were detected prior to the 5th scan, which is “concerning,” said Dr. Riddle. “Based on the current FDA label of safety monitoring, they don’t recommend doing that MRI. So [clinicians] would have dosed through that ARIA, which could put someone at much greater risk of developing severe symptoms.”

In addition, 14 patients at the center are receiving treatment with aducanumab. However, at this point they have not yet received their first MRI screen.

Dr. Riddle noted that when patients are told they are not candidates for treatment, or when treatment is discontinued, they are upset. However, she added, there is also a substantial level of understanding.

“We have a very layered discussion that includes the simple fact that we still aren’t sure if this is going to provide any clinical benefit, that this decision [to approve the drug] was accelerated, and that data are still being gathered,” Dr. Riddle added.

Dr. Riddle noted that the risk of ARIA is highest during the dose titration period: “There’s a signal that once you get to the 10 mg/kg dose, that plateaus.”

None of the patients at her center have reached that 12-month treatment mark. “The current plan is to do the MRI at 12 months then to give serial MRIs but less frequently, and whether that’s at 6 months or annually is yet to be determined.”

“We’re kind of writing these protocols as information evolves,” Dr. Riddle said.

The Memory and Aging Program receives grants from NIH-ADNI, Alzheimer’s Association, Fain Family Foundation, Joukowsky Family Foundation, Winter Family, Rhode Island Foundation, Goodman Family Foundation, and Global Alzheimer Platform Foundation; and clinical trials include: Lilly, Biogen, Genentech, Avid, Roche, Eisai, and Novartis. Dr. Riddle has disclosed no relevant financial relationships.

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