The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.

Dacarbazine, an essential part of the four-drug standard of care for managing Hodgkin lymphoma, has been in short supply since last summer, prompting experts to search for a viable substitute.

In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.

“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.

Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.

Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.

In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.

“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.

According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
 

Finding a substitute

In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.

The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.

The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?

For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.

The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.

For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.

Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.

For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.

The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).

For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).

For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.

Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”

To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.

For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.

Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.

The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.

No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.

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

The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.

Dacarbazine, an essential part of the four-drug standard of care for managing Hodgkin lymphoma, has been in short supply since last summer, prompting experts to search for a viable substitute.

In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.

“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.

Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.

Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.

In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.

“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.

According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
 

Finding a substitute

In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.

The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.

The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?

For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.

The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.

For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.

Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.

For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.

The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).

For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).

For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.

Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”

To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.

For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.

Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.

The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.

No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.

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

The persistent shortage of dacarbazine has led to an “acute and unprecedented crisis” in the treatment of patients with advanced classical Hodgkin lymphoma, experts say.

Dacarbazine, an essential part of the four-drug standard of care for managing Hodgkin lymphoma, has been in short supply since last summer, prompting experts to search for a viable substitute.

In a recent review, oncologists scoured decades of data to find the best alternatives for a range of scenarios. For fit adults younger than 60, the group recommends the seven-drug regimen BEACOPP – bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone.

“Among all available regimens,” BEACOPP has “the most robust evidence” as a substitute for the four-drug standard ABVD, which includes doxorubicin, bleomycin, vinblastine, and dacarbazine, Pallawi Torka, MD, a hematologic oncologist at Roswell Park Comprehensive Cancer Center, Buffalo, N.Y., and colleagues wrote in JCO Oncology Practice.

Last October, the Food and Drug Administration posted a notice about the dacarbazine shortage. According to the notice, the shortage occurred because of “manufacturing delays” and a “demand increase” affecting three companies supplying the U.S. market – Fresenius Kabi USA, Hikma Pharmaceuticals, and Teva. In an update issued May 4, the FDA said that 100-mg and 200-mg vials of the drug are now available from Fresenius. An update from April 8 said that 200-mg vials were available from Hikma.

Dacarbazine is hardly the only oncology drug to fall into short supply. Recent data show that shortages of oncology drugs have become more common in the United States in recent years, particularly generic drugs and those targeting hematologic malignancies.

In a recent national survey of oncology pharmacists, researchers found that almost two-thirds of institutions reported at least one drug shortage in the past month, representing a 34% increase between 2018 and 2019.

“This shortage of [dacarbazine] is not the first shortage of oncolytic drugs, and it certainly will not be the last,” Nicole Soriano, PharmD, hematology/oncology clinical pharmacist at Northwestern Memorial Hospital, Chicago, and colleagues wrote in a commentary accompanying the review.

According to Dr. Soriano and coauthors, “some studies have found that shortages are significant across many oncology disciplines and may lead to delays, changes in therapy, interference with clinical research, increased risk of medication errors, adverse outcomes, and increased costs.”
 

Finding a substitute

In the current analysis, Dr. Torka and her team conducted an exhaustive literature review in which they examined studies going back decades.

The authors highlight more than 10 alternative regimens for treating advanced classical Hodgkin lymphoma. They also provide a detailed treatment algorithm to help oncologists choose the best option for their individual patients as well as strategies for reintegrating ABVD into patient care should the supply of dacarbazine return to normal.

The first considerations: Can patients tolerate intensive chemotherapy, and are patients younger than 60?

For fit adults younger than 60, Dr. Torka and colleagues conclude that the BEACOPP regimen is the “preferred” option. In trials comparing ABVD to BEACOPP, both regimens demonstrated similar overall survival. And while BEACOPP may provide slightly “better disease control,” this approach may also come with greater toxicities in the short and long term, compared with ABVD, depending on the dosing strategy.

The authors also propose an alternative treatment strategy in case the supply of dacarbazine returns to normal mid-treatment. In this scenario, patients could receive an escalated BEACOPP regimen for two cycles and then undergo an interim positron-emission tomography scan. If the scan is negative and dacarbazine is available, the patient’s regimen could be deescalated to ABVD for four cycles without affecting disease control.

For pediatric patients, the authors recommend the ABVE-PC regimen, which includes six drugs – doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide. Data show that the 5-year overall survival among pediatric patients receiving ABVE-PC is 95%.

Stanford V-C – cyclophosphamide, doxorubicin hydrochloride, vinblastine, vincristine, bleomycin, etoposide, and prednisone – is another “acceptable approach” for pediatric patients, the authors noted.

For older patients with advanced disease or those unfit for intensive chemotherapy, the authors suggest evaluating them for fitness for anthracyclines to determine whether doxorubicin, in particular, is an option.

The researchers suggest one of the following three strategies for those who are doxorubicin-eligible: PVAG (prednisone, vinblastine, doxorubicin, and gemcitabine), CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone), or EVA (etoposide, vinblastine, and doxorubicin).

For those unfit for anthracyclines, the options include COPP (cyclophosphamide, vincristine, procarbazine, and prednisone) or ChlVPP (chlorambucil, vinblastine, procarbazine, and prednisone).

For frail patients who are ineligible for chemotherapy, the team recommends brentuximab alone or in combination with nivolumab.

Given the limited availability of dacarbazine, the authors say that the “current supply should be triaged to prioritize patients whose therapy cannot be changed and those without alternative acceptable options.”

To stretch available dacarbazine supplies as much as possible, the researchers and editorialists advocate for rounding doses within 5%-10% of the prescribed dose.

For example, Dr. Torka and colleagues explained, rounding a dose from 750 mg down to 700 mg would save one vial of dacarbazine.

Vial sharing and using drugs beyond their use dates by compounding with closed-system transfer devices are other strategies to preserve the existing supply of dacarbazine.

The goal of this review “is to give as many patients as possible the most optimal and efficacious therapy even with the strain on supply,” the editorialists wrote.

No funding for the study was reported. Dr. Torka is an adviser for Genentech, ADC Therapeutics, and TG Therapeutics. Dr. Soriano has disclosed no relevant financial relationships.

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

When it comes to mammography recommendations state comprehensive cancer control (CCC) plans vary considerably and don’t always closely match the U.S. Preventive Services Task Force (USPSTF) recommendations for mammography frequency in women at average risk for breast cancer, according to a new cross-sectional study of CCC plans in all 50 states and the District of Columbia. The recommended age for initiation varied widely among CCC plans, and nearly one in five bore little resemblance at all to the USPTF recommendations.

According to the authors of the study, the variation among suggested ages of initiation may indicate a lack of consensus among state agencies. “For a recommendation tied to service coverage, this is a serious gap in public health policy,” they wrote in the study published online in JAMA Network Open.

CCC plans include goals, measurable objectives, and evidence-based strategies to combat cancers that are both common and preventable. They include input from multiple groups, frequently take 4-6 years to create, and should be updated regularly. Funding from the Centers for Disease Control and Prevention requires that the plans include data cancer screening prevalence rates and specific objectives and strategies.

Breast cancer is the most common cancer in women in the United States, and the second highest cause of cancer death. Regular, high-quality screening reduces breast cancer mortality by 25%-31% among women aged 50-69. As a result, the American Cancer Society, the USPSTF, the American College of Physicians, and the American Academy of Family Physicians have produced guidelines for mammography screening in women at average risk of breast cancer.

Although the benefits of screening are widely accepted, there is disagreement about the ages it should be initiated and ended. These inconsistencies stem from different evidence used to support recommendations, as well as different standards for benefits and harms from screening. Common concerns include overdiagnosis, false-positive results, and radiation damage from mammography.

Because these benefits and harms can vary based on age and values, there is an emphasis on shared decision-making between clinicians and women, especially those aged 40-49.

The most recent USPTF recommendation, issued in 2016, states that women aged 50-74 with average risk should be screened with mammography every 2 years. The choice of mammography in average-risk women under 50 should be approached on an individual basis. USPTF defines average risk as having no signs, symptoms, or previous diagnosis of breast cancer, and no family history or genetic causes for concern.

In the new study, researchers conducted a point-in-time evaluation of CCC plans from 50 states and the District of Columbia, between Nov. 1, 2019, and June 30, 2021.

Thirty-one percent of the plans included the complete USPTF recommendations of biennial mammography between ages 50 and 74; 51% included some, but not all of the USPTF recommendations; and 18% were not consistent at all with USPTF recommendations.

Overall, 59% of plans recommended initiation at age 50 and 37% at age 40, which is consistent with the older 2009 USPSTF recommendation. Eight percent of plans recommended starting at both 40 and 50, and 20% of plans had no recommended age of initiation.

Among the plans that were partially consistent with USPTF, 73% recommended initiation of mammography at age 40 and 31% at age 50. Eighty-five percent did not include an age to stop mammography; 15% did not include a recommended frequency; and 15% had an initiation age other than 40 or 50. Eighty-five percent of plans partially consistent with USPSTF included a recommendation that mammography should be conducted biennially.

The authors state that CCC plans could be improved by a unified emphasis on biennial screening of the general population of women aged 50-74, as well as clear differentiation between women at average risk and those at high risk, who could be screened at ages younger than 50 in consultation with their physician.

The study is limited by the fact that plans were reviewed a single time, while state CCC plans are updated with varying periodicity. The authors agree that implementation of population-based screening should be tailored to individual states and health care systems.

When it comes to mammography recommendations state comprehensive cancer control (CCC) plans vary considerably and don’t always closely match the U.S. Preventive Services Task Force (USPSTF) recommendations for mammography frequency in women at average risk for breast cancer, according to a new cross-sectional study of CCC plans in all 50 states and the District of Columbia. The recommended age for initiation varied widely among CCC plans, and nearly one in five bore little resemblance at all to the USPTF recommendations.

According to the authors of the study, the variation among suggested ages of initiation may indicate a lack of consensus among state agencies. “For a recommendation tied to service coverage, this is a serious gap in public health policy,” they wrote in the study published online in JAMA Network Open.

CCC plans include goals, measurable objectives, and evidence-based strategies to combat cancers that are both common and preventable. They include input from multiple groups, frequently take 4-6 years to create, and should be updated regularly. Funding from the Centers for Disease Control and Prevention requires that the plans include data cancer screening prevalence rates and specific objectives and strategies.

Breast cancer is the most common cancer in women in the United States, and the second highest cause of cancer death. Regular, high-quality screening reduces breast cancer mortality by 25%-31% among women aged 50-69. As a result, the American Cancer Society, the USPSTF, the American College of Physicians, and the American Academy of Family Physicians have produced guidelines for mammography screening in women at average risk of breast cancer.

Although the benefits of screening are widely accepted, there is disagreement about the ages it should be initiated and ended. These inconsistencies stem from different evidence used to support recommendations, as well as different standards for benefits and harms from screening. Common concerns include overdiagnosis, false-positive results, and radiation damage from mammography.

Because these benefits and harms can vary based on age and values, there is an emphasis on shared decision-making between clinicians and women, especially those aged 40-49.

The most recent USPTF recommendation, issued in 2016, states that women aged 50-74 with average risk should be screened with mammography every 2 years. The choice of mammography in average-risk women under 50 should be approached on an individual basis. USPTF defines average risk as having no signs, symptoms, or previous diagnosis of breast cancer, and no family history or genetic causes for concern.

In the new study, researchers conducted a point-in-time evaluation of CCC plans from 50 states and the District of Columbia, between Nov. 1, 2019, and June 30, 2021.

Thirty-one percent of the plans included the complete USPTF recommendations of biennial mammography between ages 50 and 74; 51% included some, but not all of the USPTF recommendations; and 18% were not consistent at all with USPTF recommendations.

Overall, 59% of plans recommended initiation at age 50 and 37% at age 40, which is consistent with the older 2009 USPSTF recommendation. Eight percent of plans recommended starting at both 40 and 50, and 20% of plans had no recommended age of initiation.

Among the plans that were partially consistent with USPTF, 73% recommended initiation of mammography at age 40 and 31% at age 50. Eighty-five percent did not include an age to stop mammography; 15% did not include a recommended frequency; and 15% had an initiation age other than 40 or 50. Eighty-five percent of plans partially consistent with USPSTF included a recommendation that mammography should be conducted biennially.

The authors state that CCC plans could be improved by a unified emphasis on biennial screening of the general population of women aged 50-74, as well as clear differentiation between women at average risk and those at high risk, who could be screened at ages younger than 50 in consultation with their physician.

The study is limited by the fact that plans were reviewed a single time, while state CCC plans are updated with varying periodicity. The authors agree that implementation of population-based screening should be tailored to individual states and health care systems.

When it comes to mammography recommendations state comprehensive cancer control (CCC) plans vary considerably and don’t always closely match the U.S. Preventive Services Task Force (USPSTF) recommendations for mammography frequency in women at average risk for breast cancer, according to a new cross-sectional study of CCC plans in all 50 states and the District of Columbia. The recommended age for initiation varied widely among CCC plans, and nearly one in five bore little resemblance at all to the USPTF recommendations.

According to the authors of the study, the variation among suggested ages of initiation may indicate a lack of consensus among state agencies. “For a recommendation tied to service coverage, this is a serious gap in public health policy,” they wrote in the study published online in JAMA Network Open.

CCC plans include goals, measurable objectives, and evidence-based strategies to combat cancers that are both common and preventable. They include input from multiple groups, frequently take 4-6 years to create, and should be updated regularly. Funding from the Centers for Disease Control and Prevention requires that the plans include data cancer screening prevalence rates and specific objectives and strategies.

Breast cancer is the most common cancer in women in the United States, and the second highest cause of cancer death. Regular, high-quality screening reduces breast cancer mortality by 25%-31% among women aged 50-69. As a result, the American Cancer Society, the USPSTF, the American College of Physicians, and the American Academy of Family Physicians have produced guidelines for mammography screening in women at average risk of breast cancer.

Although the benefits of screening are widely accepted, there is disagreement about the ages it should be initiated and ended. These inconsistencies stem from different evidence used to support recommendations, as well as different standards for benefits and harms from screening. Common concerns include overdiagnosis, false-positive results, and radiation damage from mammography.

Because these benefits and harms can vary based on age and values, there is an emphasis on shared decision-making between clinicians and women, especially those aged 40-49.

The most recent USPTF recommendation, issued in 2016, states that women aged 50-74 with average risk should be screened with mammography every 2 years. The choice of mammography in average-risk women under 50 should be approached on an individual basis. USPTF defines average risk as having no signs, symptoms, or previous diagnosis of breast cancer, and no family history or genetic causes for concern.

In the new study, researchers conducted a point-in-time evaluation of CCC plans from 50 states and the District of Columbia, between Nov. 1, 2019, and June 30, 2021.

Thirty-one percent of the plans included the complete USPTF recommendations of biennial mammography between ages 50 and 74; 51% included some, but not all of the USPTF recommendations; and 18% were not consistent at all with USPTF recommendations.

Overall, 59% of plans recommended initiation at age 50 and 37% at age 40, which is consistent with the older 2009 USPSTF recommendation. Eight percent of plans recommended starting at both 40 and 50, and 20% of plans had no recommended age of initiation.

Among the plans that were partially consistent with USPTF, 73% recommended initiation of mammography at age 40 and 31% at age 50. Eighty-five percent did not include an age to stop mammography; 15% did not include a recommended frequency; and 15% had an initiation age other than 40 or 50. Eighty-five percent of plans partially consistent with USPSTF included a recommendation that mammography should be conducted biennially.

The authors state that CCC plans could be improved by a unified emphasis on biennial screening of the general population of women aged 50-74, as well as clear differentiation between women at average risk and those at high risk, who could be screened at ages younger than 50 in consultation with their physician.

The study is limited by the fact that plans were reviewed a single time, while state CCC plans are updated with varying periodicity. The authors agree that implementation of population-based screening should be tailored to individual states and health care systems.

A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.

On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.

Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.

Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”

The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”

Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.

Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.

Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
 

A glimpse at the future

The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.

The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.

“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”

But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”

She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. 
 

Spillover effect

Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.

“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”

Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.

“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.

Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.

“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”

Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.

Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
 

A looming ‘pipeline problem’

There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.

Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.

Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.

“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”

States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.

As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”

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

A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.

On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.

Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.

Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”

The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”

Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.

Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.

Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
 

A glimpse at the future

The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.

The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.

“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”

But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”

She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. 
 

Spillover effect

Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.

“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”

Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.

“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.

Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.

“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”

Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.

Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
 

A looming ‘pipeline problem’

There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.

Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.

Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.

“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”

States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.

As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”

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

A decision by the U.S. Supreme Court to overturn Roe v. Wade could have far-reaching impacts on residents in ob.gyn. medical programs across the country, from learning simple procedures like ultrasounds to how to manage miscarriages.

On Monday, Politico published a leaked initial draft majority opinion written by Justice Samuel Alito, which declares Roe unconstitutional. The actual opinion is due at the end of June. If all the justices keep their positions for that vote, the 1973 court case that legalized abortion rights in the United States would no longer keep states from banning the procedure before viability, which is defined as 24-26 weeks into a pregnancy.

Loss of federal protections provided by Roe would leave a patchwork of states where providers would have to change reproductive health practices. Medical schools in those states would also have to curtail any abortion care training, experts told this news organization.

Constance Bohon, MD, co-chair of the Legislative and Liability Committee of the American College of Obstetricians and Gynecologists (ACOG), said: “As a profession, we are concerned about the possibility that there will be ob.gyn. residents who graduate without the experience and training needed to care for a patient who has complications from an abortion or a missed abortion. We are very concerned that without adequate training and access to care for these patients, the maternal mortality rate will rise.”

The loss of Roe “means that sadly, and realistically, many residents just won’t get the training, or we will need to think about mitigation strategies, like providing simulation training,” said Kavita Vinekar, MD, MPH, assistant clinical professor in the department of obstetrics and gynecology at the David Geffen School of Medicine at UCLA. “I can assure you that without access to abortion training, the quality of ob.gyn. training will absolutely suffer.”

Twenty-two states, including large swaths of the south and Midwest, already have laws that would go into effect immediately to ban abortion in the absence of Roe. Four states, including Florida, Montana, and Indiana, would likely ban abortion, according to an analysis from the Guttmacher Institute.

Almost 45% of ob.gyn. obstetrics and gynecology residency programs are in these states, totaling 2,638 residents as of 2022, according to a study published in April by researchers at the UCLA.

Most reproductive health care training lasts between 1-2 months during residency and includes instruction on ultrasounds, best practices in managing pregnancy complications, learning how to safely evacuate a uterus in the event of a stillbirth or miscarriage, and counseling for family planning options.
 

A glimpse at the future

The potential for a new reality is already playing out in Texas, where a law banning abortions after 6 weeks in pregnancy took effect last Sept. 1. The Ryan Program, a national initiative to teach abortion care to medical school residents, started a pilot to match resident physicians in Texas with hospital programs in other states without abortion restrictions.

The Ryan Program has matched over 40 residents since the law took effect, according to Jody Steinauer, MD, PhD, who oversees the Ryan Program at the Bixby Center for Global Reproductive Health at the University of California, San Francisco. Matching students is an arduous and timely process because students have hectic schedules, and state licensure and other regulatory issues must be worked out, she said.

“It will take a while to get systems in place to really support resident travel, and not every resident is going to be able to travel, so I’m just worried about the future impacts on patient care,” Dr. Steinauer told this news organization. “We have hundreds of residents who are not learning the skills they need, and they’re not going be able to provide evidence-based, patient-centered care.”

But Dr. Bohon expressed skepticism that the Ryan Program and other initiatives to provide training for travel residents would be sufficient. “Unfortunately, it is anticipated that this program will not be sufficient to provide training for all of the ob.gyn. residents who do not have access to abortion training because of the state where their residency is,” she said. “There are residency programs that have the capacity to have ob.gyns. get training at their programs, but there is a limited number of these positions available as well.”

She added that the Council on Resident Education in Obstetrics and Gynecology is actively pursuing options to provide abortion training for residents for whom such training is not available. 
 

Spillover effect

Health care professionals in states without restrictive abortion laws will also see an increase in patients seeking abortion-related care. This spike already is happening in New Mexico, which borders not only Texas, but Oklahoma and Arizona – states that have severely restricted abortion rights.

“It’s difficult in the states that will be overloaded with additional abortion care to then incorporate learners on top of that,” said Eve Espey, MD, MPH, distinguished professor and chair of the department of obstetrics and gynecology at the University of New Mexico, Albuquerque. “Logistically, to fill that gap in care and train at the same time will be really challenging.”

Dr. Espey said the UNM Center for Reproductive Health has already seen patients from Texas who would likely fall under an exemption in that state’s law that allows abortions if a patient faces a medical emergency if the pregnancy continues.

“Providers are so afraid of these laws, and if they’re risk adverse, they’re always going to err on the side of not taking care of the patient if you think you can get in trouble,” Dr. Espey said, pointing to patients who presented with lethal fetal anomalies or ruptured fetal membranes early in pregnancy that might fall under the medical emergency exemption.

Dr. Steinauer with the Ryan Program said that many Texas residency program directors have told her they’ve heard from applicants who are giving low ranks to residency programs in the state.

“They’re saying, ‘if we want to be able to be trained as an ob.gyn., why would we want to go to a program with such significant restrictions?’” Dr. Steinauer said. “That is a real worry.”

Most ob.gyn. medical residency programs now provide built-in abortion training, which the Accreditation Council for Graduate Medical Education mandated in 1995. A small majority do not. According to a 2020 research letter from the ACOG, about 11% of ob.gyn. residents said their programs hypothetically offer training without a clear process to obtain it, and 8% reported that their programs offered no such training at all.

Residents can also opt out of abortion training, although students increasingly are choosing to only opt out of certain parts, such as training for abortions provided later in pregnancies, according to Dr. Steinauer.
 

A looming ‘pipeline problem’

There were about 3,550 abortion service clinicians in 2020, 72% of whom were ob.gyns., followed by family medicine doctors and advanced practice registered nurses, according to research published in March in JAMA Internal Medicine. This number is likely not an accurate tally, however, because the authors queried a national medical claims database that did not include self-pay patients.

Julia Strasser, DrPH, MPH, a senior research scientist at The George Washington University Milken Institute School of Public Health, Washington, D.C., who led the study, said states could create policies to broaden access to abortion for patients and training for medical residents.

Those include expanding laws to allow advanced practice clinicians to provide abortion care, allowing state Medicaid programs to opt-in for abortion payment, and establishing abortion care continuing medical education requirements for state boards of medicine for both ob.gyn. and primary care.

“Providers that practice in those restricted states will not only stop providing care there but also won’t be able to train the next generation of workforce to be able to provide that care,” Dr. Strasser said. “It’s a pipeline problem.”

States also could encourage their medical residency programs to not hold slots open for students who want to opt out of abortion care training. The University of Washington, Seattle, in 2000 eliminated slots it had been holding open for opt-out students because the state does not have restrictions on abortion.

As abortion becomes increasingly restricted across the country, Dr. Strasser said, for medical schools in “a state that continues to make abortion available, it’s essentially their duty to make that training available.”

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Seven physicians were among 12 medical professionals charged today by the U.S. Department of Justice with opioid distribution offenses.

In coordination with federal and state law enforcement, the DOJ charged the defendants for their involvement in the illegal distribution of opioids. At the time that they were charged with the alleged offenses, 12 of the defendants were medical professionals.

The 12 persons in eight federal districts across the country distributed more than 115 million controlled substances, including buprenorphine, clonazepam, dextroamphetamine-amphetamine, hydrocodone, morphine sulfate, oxycodone, oxymorphone, and Suboxone, per the DOJ.

“Doctors and health care professionals are entrusted with prescribing medicine responsibly and in the best interests of their patients. Today’s takedown targets medical providers across the country whose greed drove them to abandon this responsibility in favor of criminal profits,” said Anne Milgram, administrator of the Drug Enforcement Administration.
 

Medical professionals, others across six states charged

One former nurse, one business manager, and one individual who practiced medicine without a medical credential are among those listed in the indictment. These include the following:

• Eskender Getachew, MD, a Columbus, Ohio, sleep medicine specialist, was charged with unlawful distribution of controlled substances outside the use of professional practice and not for a legitimate medical practice.
• Charles Kistler, DO, an Upper Arlington, Ohio, family practice physician, was charged with unlawful distribution of controlled substances for unlawful prescribing at Midtown Family Practice Clinic in Columbus.
• Yogeshwar Gil, MBBS, a Manchester, Tenn., family medicine doctor and owner of a medical practice, was charged with conspiracy to unlawfully distribute controlled substances and maintaining a drug-involved premises. Dr. Gil was charged in connection with an alleged scheme to distribute opioids and Suboxone outside the usual course of professional practice and without a legitimate medical purpose.
• Contessa Holley, RN, a Pulaski, Tenn., former nurse and clinical director, was charged with wire fraud, aggravated identity theft, and possession of a controlled substance with intent to distribute. She’s alleged to be connected with a scheme to unlawfully obtain opioids by filling fraudulent prescriptions in the names of current and former patients who were in hospice. The indictment alleged that Ms. Holley used the patients’ hospice benefits to cover the opioids’ costs while keeping the drugs for her own use and for further distribution.
• Francene Aretha Gayle, MD, an Orlando, Fla., physician, was charged with conspiracy to unlawfully distribute controlled substances, conspiracy to commit health care fraud, health care fraud, and several substantive counts of illegally issuing opioid prescriptions. Dr. Gayle was charged along with Schara Monique Davis, a Huntsville, Ala.–based business manager. Per the indictment, Dr. Gayle and Ms. Davis operated three medical clinics in Alabama, where Dr. Gayle was the sole physician. The medical clinics billed health insurers for millions of dollars in patient visits that Dr. Gayle had supposedly conducted but during which she was allegedly absent from the clinics; other staff members conducted the visits instead. It’s alleged that Dr. Gayle presigned prescriptions for opioids that were given to patients.
• Robert Taffet, MD, a Haddonfield, N.J., orthopedic surgeon and owner of a medical practice in Sicklerville, N.J., was charged with conspiracy to unlawfully distribute controlled substances. The indictment alleges that he falsified patient files to state that he interacted with patients when he didn’t and that he issued prescriptions for opioids and other controlled substances without assessing the patients in person or by telemedicine. It’s alleged that Dr. Taffett issued prescriptions for more than 179,000 pills that were dispensed by New Jersey pharmacies between April 2020 and December 2021.
• Hau La, MD, a Brentwood, Tenn., family medicine physician and the operator of Absolute Medical Care in Smyrna, Tenn., was charged with sixteen counts of unlawful distribution of a controlled substance. The physician is alleged to have unlawfully prescribed opioids to eight patients outside the usual course of practice and without a legitimate medical purpose.
• Frederick De Mesa, of War, W.Va., practiced as a physician and used a DEA registration number that allowed him to prescribe controlled substances. Mr. De Mesa prescribed these substances without a medical license and didn’t have an active DEA registration number, according to the indictment.
• Loey Kousa, a former internist from Paintsville, Ky., was charged with unlawful distribution of controlled substances, healthcare fraud, and making false statements in connection with the delivery of health care services. The indictment alleges that the former physician issued prescriptions for opioids outside the usual course of professional practice and without a legitimate medical purpose in his capacity as owner and operator of East KY Clinic in Paintsville. He is alleged to have issued the unlawful prescriptions for patients whose treatments were covered by taxpayer-funded programs such as Medicare and Medicaid; he also billed these programs for medically unnecessary procedures for these patients.

Also included in the indictment were Jay Sadrinia, DMD, a Villa Hills, Ky., dentist, who was charged with four counts of illegal distribution of oxycodone and morphine sulfate and one count of illegal distribution of morphine sulfate that resulted in death or serious bodily injury; and Casey Kelleher, an owner-operator of Neighborhood Pharmacy in Boynton Beach, Fla., who allegedly sold large amounts of oxycodone and hydromorphone on the black market.

The Centers for Medicare & Medicaid Services’ Center for Program Integrity has taken six administrative actions against health care providers for their alleged involvement in these offenses, per the DOJ’s announcement.

“Patient care and safety are top priorities for us, and CMS has taken administrative action against six providers to protect critical resources entrusted to Medicare while also safeguarding people with Medicare,” said CMS Administrator Chiquita Brooks-LaSure.

“These actions to combat fraud, waste, and abuse in our federal programs would not be possible without the close and successful partnership of the Centers for Medicare & Medicaid Services, the Department of Justice, and the U.S. Department of Health and Human Services Office of Inspector General,” she added.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

Takotsubo syndrome, a condition that’s also been called “broken heart syndrome,” can be triggered by both positive and negative life stressors, especially in men, a new study suggests.

The findings show that although Takotsubo syndrome, a type of acute heart failure related to atypical patterns of transient left ventricular contraction abnormalities, is often triggered by negative emotional stressors, it can also stem from positive life events, something the researchers are calling “happy heart syndrome.”

In this registry study, males were more likely to experience Takotsubo syndrome from a positive life event, as were those with atypical, nonapical ballooning, reported Thomas Stiermaier, MD, of University Hospital Schleswig-Holstein in Lübeck, Germany, and colleagues.

Patients with negative and positive emotional triggers experienced similar short- and long-term outcomes, they found.

The results were published online in JACC: Heart Failure.

Previous studies have shown that Takotsubo syndrome can be related to negative emotional triggers, physical triggers such as heavy physical activity, or medical procedures (or, in some cases, neither of these), or even a combination of emotional and physical triggers, the authors said. Research shows that physical triggers are most often linked to poor outcomes.

A vast number of clinical scenarios may lead up to Takotsubo syndrome, noted Jason H. Rogers, MD, professor of cardiovascular medicine at the University of California, Davis, who commented on these findings.

“Examples would include other medical illness, such as infection or recent surgery, having a heated argument with someone, running to catch a flight at the airport, and even being awakened suddenly by a sick pet,” Dr. Rogers told this news organization.

But not all patients experience unhappy life stressors before these events occur, he added. “It is possible for patients to have happy life stressors that can lead to Takotsubo syndrome also.”

For this analysis, the research team evaluated 2,482 patients using data from the multicenter German-Italian-Spanish Takotsubo (GEIST) Registry, one of the largest of its kind. Of these patients, 910 experienced an emotional trigger; of these, 873 had negative preceding events, and 37 had pleasant preceding events. The mean age was 70 years in both groups.

The study team then compared patients with negative emotional triggers to those with positive emotional triggers, which included weddings, the birth of grandchildren, birthday parties, or anticipation of a trip or Christmas.

There was a 1.5% incidence of pleasant emotional triggers among all Takotsubo syndrome patients.

Among patients with positive prior triggers, there was a higher incidence of atypical ballooning (27.0% vs. 12.5%; P = .01), and a higher percentage of these patients were male (18.9% vs. 5.0%; P < .01) in comparison with those with negative events prior to Takotsubo syndrome.

Long-term death rates (8.8% vs. 2.7%; P = .20) and rates of in-hospital complication outcomes, including cardiogenic shock, stroke, death, or pulmonary edema (12.3% vs. 8.1%; P = .45), were similar for patients with negative preceding events and for those with positive preceding events.

Study limitations included that it cannot provide insight into the specific mechanisms of Takotsubo syndrome, it was observational, the sample size of patients in the positive events group was small, and the contributing research facilities assessed cardiac biomarker levels differently.

“Additional research efforts are needed to explore whether numerically lower cardiac-related event rates in patients with happy heart syndrome would be statistically significant in a larger sample size,” the researchers concluded.

Dr. Stiermaier reports no relevant financial relationships.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The use of isotretinoin to treat acne was not associated with an increase in adverse neuropsychiatric outcomes, compared with the use of oral antibiotics, in a large retrospective cohort study published in the British Journal of Dermatology.

Although severe neuropsychiatric effects associated with isotretinoin therapy in patients with acne have been reported, “the evidence base ... is mixed and inconclusive,” and many studies are small, Seena Fazel, MBChB, MD, of the department of psychiatry, Oxford University, England, and co-authors write in the study.

The study results suggest that isotretinoin is conferring protection against adverse neuropsychiatric outcomes, particularly when compared with using oral antibiotics to treat acne, Dr. Fazel, professor of forensic psychiatry at Oxford University and the study’s senior author, said in an interview.

In the study, the investigators reviewed electronic health records (2013-2019) from a primarily United States–based dataset (TriNetX) of patients with acne aged 12-27 who had been followed for up to 1 year after their prescriptions had been dispensed.

There were four arms: those prescribed isotretinoin (30,866), oral antibiotics (44,748), topical anti-acne treatments (108,367), and those who had not been prescribed any acne treatment (78,666). The primary outcomes were diagnoses of a neuropsychiatric disorder (psychotic, mood, anxiety, personality, behavioral, and sleep disorders; and non-fatal self-harm) within one year of being prescribed treatment.

After using propensity score matching to adjust for confounders at baseline, the investigators determined that the odds ratio for any incident neuropsychiatric outcomes among patients with acne treated with isotretinoin was 0.80 (95% confidence interval, 0.74-0.87), compared with patients on oral antibiotics; 0.94 (95% CI, 0.87-1.02), compared with patients on topical anti-acne medications; and 1.06 (95% CI, 0.97-1.16), compared with those without a prescription for anti-acne medicines.

Side effects of isotretinoin – such as headache, dry mouth, and fatigue – were higher among those on isotretinoin than in the other three groups.

The authors concluded that isotretinoin was not independently linked to excess adverse neuropsychiatric outcomes at a population level. “We observed a consistent association between increasing acne severity as indicated by anti-acne treatment options and incidence of adverse neuropsychiatric outcomes, but the findings showed that isotretinoin exposure did not add to the risk of neuropsychiatric adverse outcomes over and above what was associated with oral antibiotics,” they write.

Isotretinoin treatment “appeared to mitigate the excess neuropsychiatric risk associated with recalcitrant moderate-to-severe acne,” they add.

The dermatology community has been interested in the impact isotretinoin has on mental health, and “I think clinically, they see that people get better on isotretinoin and their mental health improves,” Dr. Fazel told this news organization.

Asked to comment on the study results, John Barbieri, MD, MBA, director of the Advanced Acne Therapeutics Clinic, Brigham and Women’s Hospital, Boston, commended the investigators for the design of the trial.

“One of the strengths of this study is that they use a technique called propensity-score matching, where you try to make the groups of patients similar with respect to their other characteristics to minimize the risks of confounding and bias in the study, which I think is a real strength,” he told this news organization. “The other thing that they do, which I think is a strength, is to think about the impact of acne severity on these outcomes, because we know acne itself is associated with depression and risk for suicide and other neuropsychiatric outcomes.”

Including a cohort of patients who had acne and received oral antibiotics for comparison “is a nice way to address the potential for confounding by severity and confounding by indication,” Dr. Barbieri said. “Those who get antibiotics usually have more severe acne. They may not have it as severely as those who get isotretinoin, but it is a nice approach to account for background levels of depression and neuropsychiatric outcomes in patients with acne. I think that is a real strength of the study. This is one of the best studies to have looked at this question.” 

However, although the study found that isotretinoin decreased the excess psychiatric risk associated with refractory moderate-to-severe acne, it does not rule out the possibility that individuals may experience an adverse psychiatric outcome while on isotretinoin, Dr. Barbieri said.

“While I think on a population level, we absolutely can feel reassured by these data, I do think there are individual patients who have idiosyncratic, unpredictable reactions to isotretinoin where they have mood changes, whether it be irritability, depression, or other mood changes,” he cautioned. “Given the association of acne itself with mental health comorbidities, it is important to screen for comorbidities such as depression in all patients with acne.”

The study was funded by the Wellcome Trust, which provided Dr. Fazel and the first author with financial support for the study. One author is an employee of TriNetX; the other authors had no relevant disclosures. Dr. Barbieri reported no financial disclosures. He is cochair of the AAD’s Acne Guidelines Workgroup and associate editor at JAMA Dermatology.

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

The Food and Drug Administration has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD).

The Lumipulse G β-Amyloid Ratio 1-42/1-40 (Fujirebio Diagnostics) test detects amyloid plaques associated with AD in adults age 55 or older who are under investigation for AD and other causes of cognitive decline.

“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive [positron emission tomography (PET)] scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” he added.

In its statement, the FDA notes that there is an “unmet need for a reliable and safe test that can accurately identify patients with amyloid plaques consistent with Alzheimer’s disease.”

The agency goes on to state that this new test may eliminate the need to use PET brain scans, a “potentially costly and cumbersome option” to visualize amyloid plaques for the diagnosis of AD.

The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid (CSF). A positive Lumipulse G β-amyloid Ratio (1-42/1-40) test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.

However, the FDA notes that the test is not a stand-alone assay and should be used in conjunction with other clinical evaluations and additional tests to determine treatment options.

The FDA reports that it evaluated the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank.

The samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.

The risks associated with the Lumipulse G β-amyloid Ratio (1-42/1-40) test are mainly the possibility of false-positive and false-negative test results.

False-positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for AD.

False-negative test results could result in additional unnecessary diagnostic tests and potential delay in effective treatment for AD.

The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

The agency says this action “creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through FDA’s 510(k) premarket process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.”

The Lumipulse G β-amyloid Ratio (1-42/1-40) was granted Breakthrough Device designation, a process designed to expedite the development and review of devices that may provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. 

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

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

A rise in esophageal adenocarcinoma (EAC) cases and deaths showcases a need for noninvasive screening methods that can be performed by nonendoscopists, such as nurses or technicians, according to a presentation at the 2022 AGA Tech Summit that reviewed the new approaches. AGA’s annual innovation summit is sponsored by the AGA Center for GI Innovation and Technology.

Mortality rates are high, because the cancer is usually found after obstructive symptoms. Screening for Barrett’s esophagus (BE) and associated dysplasia could lead to earlier diagnosis and better prognoses, but endoscopic screening is costly and invasive, and few at-risk patients take advantage of it.

Some new approaches have the potential to screen more patients and detect earlier stages of disease, according to Prasad Iyer, MD, director of the esophageal interest group in the division of gastroenterology and hepatology at the Mayo Clinic in Rochester, Minn.

The estimated rise in EAC ranges from 400% to 600% between 1975 and 2000. The 5-year survival of EAC hovers at around 20%. “Not only is the incidence increasing, but the mortality associated with the disease is also increasing at a similar pace,” said Dr. Iyer during his presentation.

The only known precursor to EAC is BE, which has made the condition a focal point in screening. “If we can screen those with risk factors, we can identify those with prevalent Barrett’s. We then can put those with known Barrett’s into surveillance to detect cancer or high-grade or low-grade dysplasia. And then we when we find dysplasia or early cancer, we can intervene hopefully endoscopically to prevent or treat this progression from Barrett’s to adenocarcinoma,” said Dr. Iyer.

Endoscopic treatment of dysplasia achieves similar long-term survival outcomes to esophagectomy,Dr. Iyer said. Clinical studies have shown that radiofrequency ablation of high-grade and low-grade dysplasia reduces progression to cancer.
 

Low screening rates miss at-risk patients

Unfortunately, only 10%-12% of esophageal cancers are detected during surveillance, partly because many with BE are unaware of the condition and therefore don’t enter surveillance. “Two-thirds of the patients with Barrett’s are not under surveillance, so it’s not surprising that most esophageal cancers, unfortunately, are still being diagnosed after the onset of obstructive symptoms,” said Dr. Iyer.

A key issue is that sedated endoscopy is the only available screening tool, and it is expensive and invasive. “Only 10% of those who should get evaluated for the presence of Barrett’s are currently getting evaluated,” said Dr. Iyer.

Those issues have led to a movement to develop noninvasive methods for screening that could be performed by nonendoscopists, such as nurses or technicians. Dr. Iyer noted the importance of sensitivity and specificity of any test, but access to the test and participation are often overlooked factors.

“We hope that, by developing a nonendoscopic, minimally invasive test, we can increase access by allowing nonphysicians to perform this test. By keeping the costs low, we make this strategy cost effective, and hopefully get buy in for reimbursement from payers,” said Dr. Iyer.
 

New screening methods on horizon

He reviewed several noninvasive screening methodologies in development.

Unsedated transnasal endoscopy has been used successfully to diagnose BE, but the technique has not gained much traction in the United States.

Some devices collect esophageal cells, and then test them for various biomarkers. These include EsophaCap, CytoSponge, and the ESOCHEK Balloon. The procedure requires the patient to swallow a device, which is attached to a string or cord. After a few minutes, the device expands into a sphere or balloon, and the operator pulls it out through the esophagus, collecting 3-4 million esophageal cells in the process.

Biomarker analysis of the cells can include the protein trefoil factor 3 and methylated DNA markers. Case-control studies have shown this approach can achieve sensitivities of 76%-94%, and specificities of 62%-92%. “At least in case-control studies, this technology has been shown in thousands of patients now to be well tolerated, very safe, with a low risk of detachment, and can be done by a nurse in an office setting in less than 10 minutes,” said Dr. Iyer.
 

Earlier detection of Barrett’s

He summarized a randomized, controlled trial, published in 2020 in The Lancet, which tested this approach in patients who had taken proton pump inhibitors for at least 6 months. It compared 6,983 patients screened using the CytoSponge/TFF3 with 6,531 usual-care patients who only underwent screening if their physicians recommended it.

In the screening group, 140 patients were diagnosed with Barrett’s Esophagus, compared with 13 in the usual-care group. There were nine cases of dysplastic Barrett’s and five cases of stage I EAC in the screening group, versus no dysplastic Barrett’s and three advanced stage EAC cases in the usual care group. “You can see how we can shift the spectrum of patients with Barrett’s if we go for early detection,” said Dr. Iyer.

Another noninvasive strategy relies on sensors to detect exhaled volatile organic compounds. After a patient breathes into the detector for about 5 minutes, an artificial neural network distinguishes molecular patterns indicative of the presence or absence of BE. The technique had just moderate sensitivity and specificity, “But this is very noninvasive and even less invasive than [sponge or balloon]-based technology,” said Dr. Iyer.

Other efforts are underway to identify plasma biomarkers for screening. Dr. Iyer and colleagues have developed methylated DNA markers for EAC and squamous cell cancer. So far, they have achieved sensitivity and specificity just above 80%. “Not where we would want it to be, but certainly not terrible,” said Dr. Iyer, adding that they are performing a larger prospective study.

He described a potential screening program that could draw from electronic medical records or even apps to identify patients with risk above a defined threshold who would then be tested with minimally invasive techniques. Those with positive results would go on to confirmatory endoscopy. His group found that such a strategy would be cost effective even if reflux was not used as a qualifying criterion for screening.

Answering audience questions after the talk, Dr. Iyer was asked if noninvasive methods would directly compete with endoscopy, or if some patients would be better candidates for one or the other.

“That’s something we need to think through. It’s going to be very difficult for us to say every patient at risk should get an endoscopy. I just don’t think that strategy is probably practical or cost effective. On the other hand, I think an all-of-the-above strategy is probably just fine. It’s like elections. You have to be very local, your message has to be cost effective, available, and have adequate patient as well as provider buy-in,” he said.

Dr. Iyer has received research funding from Exact Sciences, Pentax Medical, and Cernostics. He has consulted for Exact Sciences, Pentax Medical, Medtronic, Ambu, Cernostics, CDx Diagnostics, and Symple Surgical. The 2022 AGA Tech Summit was supported by independent grants from Castle Biosciences, Medtronic, Boston Scientific, Exact Sciences, Olympus, 3-D Matrix, Apollo Endosurgery, Motus GI Holdings, STERIS Endoscopy, Cook Medical, FUJIFILM Healthcare Americas, and Virgo.

This article was updated 5/10/22.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

Single-use endoscopes are becoming increasingly common, and economic and regulatory factors are driving growth and innovation in this field. Those were some of the messages presented at a session on innovations in endoscope devices at the 2022 AGA Tech Summit, sponsored by the AGA Center for GI Innovation and Technology.

“We’ve seen a shift in the need for more disposable technologies to support overall environmental parameters,” Brian Sanders, director of market development for GI at Ambu, explained during his presentation. “The more complicated these designs became, the more challenging they became to clean.”

Mr. Sanders highlighted some of the advantages of single-use scopes. There are no repair costs, and fewer storage and supply costs. They are more convenient since there is no need to wait for a scope to be cleaned. And the Food and Drug Administration has supported moving to single-use duodenoscopes. He also surmised that consumers might prefer single-use endoscopes since the risk of infection is likely to be lower than with reusable endoscopes.

Still, it can be difficult to get a full understanding of the costs of reusable versus single-use devices. Costs may be spread out across departments within a facility, and can include capital costs, repairs, reprocessing, consumables, and opportunity costs that occur due to delays. “[Many] categories are not transparent because they are hosted with cross-lateral budgets throughout the facility, so this is a messy web,” said Mr. Sanders.

Furthermore, findings from a meta-analysis of bronchoscopes indicate a 15.2% contamination rate, and an infection rate attributable to reusable bronchoscopes of 2.8%, with an average treatment cost of $11,788.

“When you consider all of the drivers we’re seeing in the endoscope arena, it’s our strong belief that, within the next 10 years, most endoscopes being utilized in medical practice will turn to single use,” Mr. Sanders continued.

During the Q&A period following the presentation, the discussion turned to the environmental impact of single-use devices. “We do a lot of endoscopies. If we start moving into single-use gastroscopes and colonoscopes, how do we process them? Can we recycle them?” asked panel moderator Sushovan Guha, MD, PhD, professor of medicine at McGovern Medical School and codirector of the Center for Interventional Gastroenterology at UTHealth Science Center, Houston.

The question drew a response from panelist Katie Eckerline, EUS group manager at Boston Scientific. She noted that the water and chemicals used in reprocessing the company’s EXALT single-use duodenoscope device are important, as is the requirement for personal protective equipment. “[T]here’s an underappreciated environmental impact that comes along with scope reprocessing because it’s not happening directly in the rooms, and this is often overlooked,” replied Ms. Eckerline.

She noted that Boston Scientific has taken steps to make EXALT duodenoscopes recyclable. The company sends used scopes to a third-party company that autoclaves them and separates the plastic from the electronics and metals. The electronics and metals can be repurposed for nonmedical use, and the plastic is recycled.

However, while Boston Scientific offers this recycling option for free, and hospital administrators and physicians often bring up the issue of environmental impact during negotiations, “only about 25% or 30% of the customers who are using EXALT choose to implement [recycling],” Ms. Eckerline explained.

Sanders noted that the FDA updated its guidance on April 4, encouraging transition to duodenoscopes that are fully disposable or have disposable components. The revision was based on new interim information from postmarketing surveillance studies, which showed that duodenoscopes with a removable component to facilitate cleaning had a contamination rate of 0.5%, compared with rates as high as 6% in older models. “It’s really almost forcing our hand at this point to move to some type of disposable option,” said Mr. Sanders.

Dr. Guha has consulted for Medtronic.

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).

The findings of smooth, round alopecia occurring rapidly without associated scarring, pain, or itching, is consistent with the diagnosis of alopecia areata.

Alopecia areata is a common autoimmune disease caused by T lymphocytes targeting hair follicles and resulting in rapid and nonscarring hair loss. It is usually self-resolving and about 2% of all individuals are affected at some point during their lifetime, with an average age of onset of 33 years.¹ Some patients may progress to loss of all scalp hair (alopecia totalis) or all hair on the scalp and body (alopecia universalis).¹

It is important to inspect a patient’s scalp, face, and body for more subtle areas of loss that could signal other disorders, such as lichen planopilaris, discoid lupus, or telogen effluvium. It is worth noting that alopecia areata is not associated with scalp lesions, crusting, or scars without follicles. Such findings should be further investigated with a 4-mm punch biopsy of affected and adjacent follicular units. Carefully labeling biopsy specimens as scalp specimens for hair loss will aid in a correct histopathologic diagnosis.

Systematic data comparing treatments for alopecia areata are lacking. For localized disease, topical or intradermal triamcinolone injections at a concentration of 5 to 10 mg/mL, with about 0.1 mL to 0.05 mL injected every square centimeter of affected area (up to 40 mg per visit), can provide rapid regrowth.¹ Within 4 months of the monthly injections, 63% of patients experience complete regrowth.¹ Despite this favorable outcome, there is also a high rate of recurrence.

For more widespread disease, contact immunotherapy with squaric acid dibutyl ester or diphencyprone can provoke a low-grade contact allergy and induce antigenic completion. This therapy is painless but can be itchy; medications must be compounded and titrated to activity.

The patient in this case opted to receive monthly triamcinolone injections in an undiluted concentration of 10 mg/mL for 3 months, at which point she experienced excellent hair regrowth. A small patch of recurrence was noted a year later and treated twice with monthly triamcinolone injections.

‌

Text courtesy of Jonathan Karnes, MD, medical director, MDFMR Dermatology Services, Augusta, ME. Photos courtesy of Jonathan Karnes, MD (copyright retained).