Feature

It’s no secret that the COVID-19 pandemic has disrupted medical practice and led to a surge in telemedicine visits. A new report issued by the health care social network Doximity in September predicts that these changes will be permanent, and that the telehealth industry will more than triple from $29 billion at the end of this year to about $106 billion by 2023.

The report, titled “2020 State of Telemedicine,” follows a similar 2019 publication and captures the changes created by the pandemic. “Obviously, telemedicine has been around for many years, but the pandemic around COVID-19 has really changed the game. Something that had been getting gradual adoption really rocketed to the forefront,” said Peter Alparin, MD, who is an internist in San Francisco and vice president of product at Doximity, in an interview. The report predicts that 20% of medical visits will be conducted through telemedicine by the end of 2020.

Gastroenterology is one of the top specialties to adopt telemedicine, ranking third behind endocrinology and rheumatology, and that should come as no surprise. “Chronic disease patients lend themselves well to telemedicine because they have ongoing relationships with their physicians, so they can be seen more often and it’s more convenient for them. The specialties that take care of patients with those sorts of illnesses were the ones that adopted it the most readily,” said Dr. Alparin.

That’s probably in part because specialists dealing with chronic conditions have been triaging patients with telephone calls for years, making it easier to tell when a patient needs to come in for a physical visit. “It’s a skill you learn, to tell when something is just a little bit different for a patient. It’s really a clinical judgment that has been honed over years of experience,” said Dr. Alparin. The report backs up that idea, as it found that the physician age groups that most often adopted telemedicine were those in their 40s, 50s, and 60s.

Telemedicine is popular with patients once they try it, and it can greatly expand a physician’s reach, according to Dr. Alparin. “If you’re a specialist, you can perhaps see patients in areas where that specialty is underrepresented, whether that’s the inner city or a very rural area,” he said. The most important barrier is high-speed Internet access, which remains a problem in many areas.

Doximity researchers surveyed more than 2,000 U.S. adults to get their opinions on telemedicine, and analyzed telemedicine adoption data from the platform’s own set of telemedicine tools, and compared it to data from the 2019 report. They also reviewed studies looking at disparities in medicine and patient access to telemedicine.

Telemedicine use among patients grew from 14% before the pandemic, to 35% who reported at least one telemedicine visit after COVID-19. A total of 23% said they planned to continue use of telemedicine after the pandemic ends, and 27% said they had become more comfortable using telemedicine. Among patients, 28% said telemedicine provides the same or better benefit as an in-person visit, and this rose to 53% among those with chronic illnesses.

Among physicians, telemedicine adoption rose by 20% between 2015 and 2018, but increased by 38% between 2019 and 2020. The highest percentage of physician telemedicine adopters were in large metro areas and East Coast states, led by Massachusetts, North Carolina, and New Jersey. None of the top 10 adopter states were west of Illinois.

Equity concerns remain: 64.3% of households with annual incomes of $25,000 or lower have access to broadband internet, compared with 93.5% of those with incomes of $50,000 or lower. In nonmetropolitan areas, 78.1% of households have access, compared with 86.7% of metropolitan households. The good news is that many patients prefer cell phone use for telemedicine, and nearly as many Black and Hispanic Americans own cell phones as White Americans. “That has really democratized access,” said Dr. Alperin.

A key to successful telemedicine appointments is to make sure that the patient is prepared, according to Dr. Alparin. Make sure the patient is in a relatively quiet, well-lit place, and that they have thought about the questions they want to ask. It’s possible to replicate some aspects of a physical appointment with the right conditions. “You can visualize how they move their arms and legs; you can see how they’re breathing. You can gain a lot of information by just watching somebody,” said Dr. Alparin. A physician might also spot clues in the patient’s surroundings. “If a patient is asthmatic and you see cats walking all over the place, or a patient is allergic to gluten and they have loaves of bread everywhere,” he added.

A big concern for telemedicine has been reimbursement. In response to the pandemic, the Centers for Medicare & Medicaid Services created a number of waivers to requirements for billing for telemedicine services, and private insurers followed suit. In August, the agency announced it would make some of those waivers permanent, though others such as removal of restrictions on the site of care, eligible providers, and nonrural areas will likely require an act of Congress to enshrine, CMS administrator Seema Verma told reporters at an August press conference.

SOURCE: 2020 State of Telemedicine Report.

It’s no secret that the COVID-19 pandemic has disrupted medical practice and led to a surge in telemedicine visits. A new report issued by the health care social network Doximity in September predicts that these changes will be permanent, and that the telehealth industry will more than triple from $29 billion at the end of this year to about $106 billion by 2023.

The report, titled “2020 State of Telemedicine,” follows a similar 2019 publication and captures the changes created by the pandemic. “Obviously, telemedicine has been around for many years, but the pandemic around COVID-19 has really changed the game. Something that had been getting gradual adoption really rocketed to the forefront,” said Peter Alparin, MD, who is an internist in San Francisco and vice president of product at Doximity, in an interview. The report predicts that 20% of medical visits will be conducted through telemedicine by the end of 2020.

Gastroenterology is one of the top specialties to adopt telemedicine, ranking third behind endocrinology and rheumatology, and that should come as no surprise. “Chronic disease patients lend themselves well to telemedicine because they have ongoing relationships with their physicians, so they can be seen more often and it’s more convenient for them. The specialties that take care of patients with those sorts of illnesses were the ones that adopted it the most readily,” said Dr. Alparin.

That’s probably in part because specialists dealing with chronic conditions have been triaging patients with telephone calls for years, making it easier to tell when a patient needs to come in for a physical visit. “It’s a skill you learn, to tell when something is just a little bit different for a patient. It’s really a clinical judgment that has been honed over years of experience,” said Dr. Alparin. The report backs up that idea, as it found that the physician age groups that most often adopted telemedicine were those in their 40s, 50s, and 60s.

Telemedicine is popular with patients once they try it, and it can greatly expand a physician’s reach, according to Dr. Alparin. “If you’re a specialist, you can perhaps see patients in areas where that specialty is underrepresented, whether that’s the inner city or a very rural area,” he said. The most important barrier is high-speed Internet access, which remains a problem in many areas.

Doximity researchers surveyed more than 2,000 U.S. adults to get their opinions on telemedicine, and analyzed telemedicine adoption data from the platform’s own set of telemedicine tools, and compared it to data from the 2019 report. They also reviewed studies looking at disparities in medicine and patient access to telemedicine.

Telemedicine use among patients grew from 14% before the pandemic, to 35% who reported at least one telemedicine visit after COVID-19. A total of 23% said they planned to continue use of telemedicine after the pandemic ends, and 27% said they had become more comfortable using telemedicine. Among patients, 28% said telemedicine provides the same or better benefit as an in-person visit, and this rose to 53% among those with chronic illnesses.

Among physicians, telemedicine adoption rose by 20% between 2015 and 2018, but increased by 38% between 2019 and 2020. The highest percentage of physician telemedicine adopters were in large metro areas and East Coast states, led by Massachusetts, North Carolina, and New Jersey. None of the top 10 adopter states were west of Illinois.

Equity concerns remain: 64.3% of households with annual incomes of $25,000 or lower have access to broadband internet, compared with 93.5% of those with incomes of $50,000 or lower. In nonmetropolitan areas, 78.1% of households have access, compared with 86.7% of metropolitan households. The good news is that many patients prefer cell phone use for telemedicine, and nearly as many Black and Hispanic Americans own cell phones as White Americans. “That has really democratized access,” said Dr. Alperin.

A key to successful telemedicine appointments is to make sure that the patient is prepared, according to Dr. Alparin. Make sure the patient is in a relatively quiet, well-lit place, and that they have thought about the questions they want to ask. It’s possible to replicate some aspects of a physical appointment with the right conditions. “You can visualize how they move their arms and legs; you can see how they’re breathing. You can gain a lot of information by just watching somebody,” said Dr. Alparin. A physician might also spot clues in the patient’s surroundings. “If a patient is asthmatic and you see cats walking all over the place, or a patient is allergic to gluten and they have loaves of bread everywhere,” he added.

A big concern for telemedicine has been reimbursement. In response to the pandemic, the Centers for Medicare & Medicaid Services created a number of waivers to requirements for billing for telemedicine services, and private insurers followed suit. In August, the agency announced it would make some of those waivers permanent, though others such as removal of restrictions on the site of care, eligible providers, and nonrural areas will likely require an act of Congress to enshrine, CMS administrator Seema Verma told reporters at an August press conference.

SOURCE: 2020 State of Telemedicine Report.

It’s no secret that the COVID-19 pandemic has disrupted medical practice and led to a surge in telemedicine visits. A new report issued by the health care social network Doximity in September predicts that these changes will be permanent, and that the telehealth industry will more than triple from $29 billion at the end of this year to about $106 billion by 2023.

The report, titled “2020 State of Telemedicine,” follows a similar 2019 publication and captures the changes created by the pandemic. “Obviously, telemedicine has been around for many years, but the pandemic around COVID-19 has really changed the game. Something that had been getting gradual adoption really rocketed to the forefront,” said Peter Alparin, MD, who is an internist in San Francisco and vice president of product at Doximity, in an interview. The report predicts that 20% of medical visits will be conducted through telemedicine by the end of 2020.

Gastroenterology is one of the top specialties to adopt telemedicine, ranking third behind endocrinology and rheumatology, and that should come as no surprise. “Chronic disease patients lend themselves well to telemedicine because they have ongoing relationships with their physicians, so they can be seen more often and it’s more convenient for them. The specialties that take care of patients with those sorts of illnesses were the ones that adopted it the most readily,” said Dr. Alparin.

That’s probably in part because specialists dealing with chronic conditions have been triaging patients with telephone calls for years, making it easier to tell when a patient needs to come in for a physical visit. “It’s a skill you learn, to tell when something is just a little bit different for a patient. It’s really a clinical judgment that has been honed over years of experience,” said Dr. Alparin. The report backs up that idea, as it found that the physician age groups that most often adopted telemedicine were those in their 40s, 50s, and 60s.

Telemedicine is popular with patients once they try it, and it can greatly expand a physician’s reach, according to Dr. Alparin. “If you’re a specialist, you can perhaps see patients in areas where that specialty is underrepresented, whether that’s the inner city or a very rural area,” he said. The most important barrier is high-speed Internet access, which remains a problem in many areas.

Doximity researchers surveyed more than 2,000 U.S. adults to get their opinions on telemedicine, and analyzed telemedicine adoption data from the platform’s own set of telemedicine tools, and compared it to data from the 2019 report. They also reviewed studies looking at disparities in medicine and patient access to telemedicine.

Telemedicine use among patients grew from 14% before the pandemic, to 35% who reported at least one telemedicine visit after COVID-19. A total of 23% said they planned to continue use of telemedicine after the pandemic ends, and 27% said they had become more comfortable using telemedicine. Among patients, 28% said telemedicine provides the same or better benefit as an in-person visit, and this rose to 53% among those with chronic illnesses.

Among physicians, telemedicine adoption rose by 20% between 2015 and 2018, but increased by 38% between 2019 and 2020. The highest percentage of physician telemedicine adopters were in large metro areas and East Coast states, led by Massachusetts, North Carolina, and New Jersey. None of the top 10 adopter states were west of Illinois.

Equity concerns remain: 64.3% of households with annual incomes of $25,000 or lower have access to broadband internet, compared with 93.5% of those with incomes of $50,000 or lower. In nonmetropolitan areas, 78.1% of households have access, compared with 86.7% of metropolitan households. The good news is that many patients prefer cell phone use for telemedicine, and nearly as many Black and Hispanic Americans own cell phones as White Americans. “That has really democratized access,” said Dr. Alperin.

A key to successful telemedicine appointments is to make sure that the patient is prepared, according to Dr. Alparin. Make sure the patient is in a relatively quiet, well-lit place, and that they have thought about the questions they want to ask. It’s possible to replicate some aspects of a physical appointment with the right conditions. “You can visualize how they move their arms and legs; you can see how they’re breathing. You can gain a lot of information by just watching somebody,” said Dr. Alparin. A physician might also spot clues in the patient’s surroundings. “If a patient is asthmatic and you see cats walking all over the place, or a patient is allergic to gluten and they have loaves of bread everywhere,” he added.

A big concern for telemedicine has been reimbursement. In response to the pandemic, the Centers for Medicare & Medicaid Services created a number of waivers to requirements for billing for telemedicine services, and private insurers followed suit. In August, the agency announced it would make some of those waivers permanent, though others such as removal of restrictions on the site of care, eligible providers, and nonrural areas will likely require an act of Congress to enshrine, CMS administrator Seema Verma told reporters at an August press conference.

SOURCE: 2020 State of Telemedicine Report.

Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.

Christina Chambers

This is good news for the growth of more information about the safety of biologics and other drugs during pregnancy. Pregnancy outcomes data are increasingly emerging – particularly for tumor necrosis factor (TNF) inhibitors – but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.

And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.

Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”

OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).

Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).

Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.

Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.

An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.

OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.

It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”

The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.

The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.

“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.

Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.

Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”

The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”

(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)

Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.

Oklahoma Medical Research Foundation

Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”

“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”

She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”

Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”

Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.

The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.


To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
 

Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.

Christina Chambers

This is good news for the growth of more information about the safety of biologics and other drugs during pregnancy. Pregnancy outcomes data are increasingly emerging – particularly for tumor necrosis factor (TNF) inhibitors – but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.

And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.

Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”

OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).

Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).

Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.

Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.

An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.

OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.

It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”

The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.

The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.

“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.

Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.

Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”

The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”

(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)

Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.

Oklahoma Medical Research Foundation

Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”

“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”

She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”

Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”

Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.

The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.


To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
 

Christina Chambers, PhD, MPH, who runs the MotherToBaby Pregnancy Studies research center at the University of California, San Diego, has found most pregnant women to be “entirely altruistic” about sharing their experiences with drug treatment during pregnancy.

Christina Chambers

This is good news for the growth of more information about the safety of biologics and other drugs during pregnancy. Pregnancy outcomes data are increasingly emerging – particularly for tumor necrosis factor (TNF) inhibitors – but dermatologists, rheumatologists, and their female patients with psoriasis and psoriatic arthritis (PsA) want much more.

And women’s participation in the MotherToBaby studies conducted by the nonprofit Organization of Teratology Information Specialists (OTIS) is key, say physicians who are treating women of reproductive age. OTIS is now listed in drug labeling as the “pregnancy registry” contact for many of the medications they may be discussing with patients.

Dr. Chambers said that most women appreciate “that participating in a study may not help her with her pregnancy, but it can help her sister or her friend or someone else who has these same questions in planning a pregnancy of ‘Can I stay on my treatment?’ or, in the case of an unplanned pregnancy, ‘Should I be concerned?’ ”

OTIS has enrolled women with psoriasis and/or PsA in studies of nine medications, most of them biologics (both TNF-alpha blockers and newer anti-interleukin agents).

Four of the studies – those evaluating etanercept (Enbrel), adalimumab (Humira), abatacept (Orencia), and ustekinumab (Stelara) – are now closed to enrollment with analyses either underway or completed. The other five are currently enrolling patients and involve treatment with certolizumab pegol (Cimzia), tildrakizumab (Ilumya), apremilast (Otezla), guselkumab (Tremfya), and tofacitinib (Xeljanz).

Lisa R. Sammaritano, MD, a rheumatologist at the Hospital for Special Surgery, New York, who led the development of the American College of Rheumatology’s first guideline for the management of reproductive health in rheumatic and musculoskeletal diseases, recommends to some of her patients that they contact OTIS. “Their pregnancy registry studies have added important information to the field over the years,” she said.

Most recently, a study of the anti–TNF-alpha medication adalimumab that began in 2004 in pregnant patients with RA and Crohn’s disease culminated in a 2019 PLOS ONE paper reporting no associations between exposure to the medication and an increased risk of adverse outcomes. The outcomes studied were major structural birth defects, minor defects, spontaneous abortion, preterm delivery, prenatal and postnatal growth deficiency, serious or opportunistic infections, and malignancies.

An analysis is underway of adalimumab exposure in women with PsA – a patient subset that was added after the study started. But in the meantime, Dr. Chambers said, the 2019 research article is relevant to questions of drug safety across indications.

OTIS’s MothertoBaby studies are structured as prospective cohort studies. Dr. Chambers, a perinatal epidemiologist, is president of OTIS, which recruits women who have an exposure to the medication under study – at least one dose, for any length of time. And in most cases, it also recruits women with the underlying condition but no exposure and healthy women without the condition to represent the general population.

It’s the disease-matched comparison group that makes OTIS’s studies different from traditional pregnancy registries involving “a simple exposure series and outcomes that are described in the context of what you’d expect in the general population,” said Dr. Chambers, professor in the department of pediatrics, as well as family and preventative medicine, at UCSD and codirector of the Center for Better Beginnings at that university. “Many maternal conditions themselves [or their comorbidities] carry some risk of adverse outcomes in pregnancy.”

The OTIS studies typically involve at least 100 exposed pregnancies and a similar number of unexposed pregnancies; some have cohorts of 200-300.

The recently published study of adalimumab, for instance, included 257 women with exposure to the drug and 120 women in a disease comparison group with no exposure. In addition to finding no associations between drug exposure and adverse outcomes, the study found that women with RA or Crohn’s were at increased risk of preterm delivery, irrespective of adalimumab exposure.

“There’s insufficient [power with any of these numbers] to come to the conclusion that a drug is safe,” she said. “But what we have been able to say [through our studies] is that we’ve looked carefully at the whole array of outcomes ... and we don’t see anything unusual. That early view can be reassuring” until large population-based studies or claims analyses become possible.

Dr. Sammaritano, also with Weill Cornell Medicine, New York, said that she does not recommend registry participation for patients who stop biologics at the diagnosis of pregnancy. Since “the start of IgG antibody transfer during pregnancy is about 16 weeks,” she worries that including these patients might lead to falsely reassuring findings. “We are most interested in [knowing the outcomes of] patients who must continue the drugs through pregnancy,” she said.

Dr. Chambers, however, said that in her view, placental transfer is not a requirement for a medication to have some effect on the outcome of pregnancy. “The outcome could be influenced by an effect of the medication that doesn’t require placental transfer or require placental transfer in large amounts,” she said. “So it’s relevant to examine exposures that have occurred only in the first trimester, and this is especially true for the outcome of major birth defects, most of which are initiated in the first trimester.”

The MotherToBaby studies typically include both early, short exposures and longer exposures, she said. “And certainly, duration of use is a factor that we do consider in looking at specific outcomes such as growth, preterm delivery, and risk of serious or opportunistic infections.”

(In the published study of adalimumab, 65.3% of women in the medication-exposed cohort used the medication in all three trimesters, 10.5% in the first and second trimesters, and 22.4% in the first trimester only.)

Women participating in the MotherToBaby studies complete two to four interviews during pregnancy and may be interviewed again after delivery. They are asked for their permission to share a copy of their medical records – and their baby’s medical records – and their babies receive a follow-up pediatric exam by a pediatrician with expertise in dysmorphology/genetics (who is blinded to exposure status), most commonly in the participant’s home. Providers are not asked to enter any data.

Oklahoma Medical Research Foundation

Eliza Chakravarty, MD, a rheumatologist with the Oklahoma Medical Research Foundation in Oklahoma City who treats patients with PsA who are pregnant or considering pregnancy, said that her referrals for research participation “have been mostly to MothertoBaby.”

“Most drug companies [in the autoimmune space] are now contracting with them [for their pregnancy exposure research],” she said. “I really like that it’s become so centralized.”

She tells patients that many questions can be answered through research, that their experience matters, and that “there are benefits” to the extra pediatric examination. “I give them the information and let them decide whether or not they want to call [MotherToBaby],” she said. “I don’t want to impose. I want to make them aware.”

Dr. Chambers emphasizes to patients and physicians that the studies are strictly observational and do not require any changes in personal or medical regimens. “When people hear the word ‘research’ they think of clinical trials. We’re saying, you and your provider do everything you normally would do, just let us observe what happens during your pregnancy.”

Physicians should assure patients, moreover, that “just because the drug is being studied doesn’t mean there’s a known risk or even a suspected risk,” she said.

The MotherToBaby studies receive funding from the pharmaceutical companies, which are required by the Food and Drug Administration to conduct pregnancy exposure registries for medications used during pregnancy or in women of reproductive age. OTIS has an independent advisory board, however, and independently analyzes and publishes its findings. Progress reports are shared with the pharmaceutical companies, and in turn, the FDA, Dr. Chambers said.


To refer patients for MotherToBaby studies, physicians can use an online referral form found on the MothertoBaby web site, a service of OTIS, or call the pregnancy studies team at 877-311-8972 to provide them with the patient’s name or number. Patients may also be given the number and advised to consider calling. MotherToBaby offers medication fact sheets that answer questions about exposures during pregnancy and breastfeeding, and runs a free and confidential teratogen counseling service: 866-626-6847.
 

Jun Yang, MBBS, had watched as her father, who had battled hypertension for decades, ended up on four medications that still couldn’t bring his blood pressure to a healthy level. The cardiovascular endocrinologist then ran some tests, and soon thereafter her father had his blood pressure optimized on just one targeted medication.

Courtesy Dr. Jun Yang

Dr. Yang’s father was found to have a hormonal condition known as primary aldosteronism (PA) as the cause of his hypertension.

It turns out that PA is not as rare as once thought.

An eye-catching report in Annals of Internal Medicine this spring of an unexpectedly high prevalence of primary aldosteronism among a diverse cross section of U.S. patients with hypertension has raised issues that could dramatically change the way doctors in America, and elsewhere, assess and manage high blood pressure.

Foremost is the question of whether primary care physicians – the clinicians at the front line for diagnosing and initially treating most patients with hypertension – will absorb and act on this new evidence. For them, aldosteronism doesn’t automatically come to mind when they see high numbers on a BP monitor, and yet this latest research found that up to a third of all 726 patients in the study who were diagnosed with hypertension and with high urinary salt levels had PA.

That translates to a roughly three- to fivefold increase over standard prevalence estimates, and is a ”game changer” for how clinicians should approach hypertension management and PA diagnosis going forward, said John W. Funder, MD, in an editorial accompanying the Annals study.

Long considered relatively uncommon, hypertension driven by an excess of the hormone aldosterone, often because of an adenoma on the adrenal gland, is not the same as conventional “essential” hypertension. The former benefits from early diagnosis because its treatment is completely different – close to half of all PA patients can be treated definitively and quickly with surgical removal of an adenoma from one side of the adrenal gland.

For other PA patients, who have bilateral adrenal hyperplasia that is impossible to resolve surgically, treatment with drugs called mineralocorticoid receptor antagonists (MRAs), such as spironolactone, is needed because they target the hormonal cause of the high BP.

But what usually happens is that a patient with PA is mistakenly diagnosed with essential hypertension, in which the classic approach to treatment is to start with one regular antihypertensive drug, and add on further ones from different drug classes if blood pressure is not adequately controlled. When patients are taking three drugs, without adequate control, they are labeled as having “resistant hypertension.”

But in the case of PA, none of these conventional antihypertensives work, and the process of continuing to monitor and add different drugs wastes time, during which patients deteriorate.

“We need to change the culture of waiting for hypertension to be resistant and have patients riddled with end-organ damage,” due to years of persistently high BP and excess aldosterone “before we look for a secondary cause” like PA, declared Dr. Yang, of Hudson Institute of Medical Research and Monash University in Melbourne, during an interview.

So early diagnosis and prompt treatment of PA is key.

In addition to boosting the public health importance of early PA detection in hypertensive patients, the new up-sized PA prevalence numbers throw a spotlight on primary care physicians (PCPs) as key players who will need to apply the findings to practice on a public health scale.

These novel results create a need for “new guidelines, and a radically revised game plan with the key role of PCPs” emphasized in future management of patients with hypertension, said Dr. Funder, a professor of medicine at Monash University, in a second recent editorial in Hypertension.

“Buy-in by PCPs is essential,” agrees Robert M. Carey, MD, a cardiovascular endocrinologist and professor of medicine at the University of Virginia in Charlottesville, and a coauthor of the new study.

But he too acknowledges that this presents a major challenge. PCPs and internists, who diagnose a lot of hypertension, are “not used to thinking about aldosterone,” he said in an interview, encapsulating the key problem faced by proponents of earlier and more widespread PA assessment.

This dilemma looms as a “huge public health issue,” Dr. Carey warned.
 

‘We’re a long way from getting’ PCPs to buy in to PA screening

Will PCPs grow more comfortable with screening patients for PA themselves, or might they become more willing to refer hypertensive individuals for assessment at an expert center?

One skeptic is Ross D. Feldman, MD, a hypertension-management researcher and professor of medicine at the University of Manitoba in Winnipeg. The finding about high PA prevalence in patients with hypertension “is brand new, [and] the message needs to get to PCPs,” he said. But, “We’re a long way from getting it” to them. “I don’t know how to do that. It will be a tough sell.”

In addition, repositioning MRAs as an earlier option for many hypertensive patients won’t be easy either, because “we’ll never have outcome-trial data for MRAs,” given that they are now generic drugs, he noted.

“No clinical trial data show [MRAs] are first-line drugs,” said Dr. Feldman, who explained that, instead, MRAs are considered “go-to drugs” for patients with treatment-resistant hypertension, a niche therapeutic area. Results from the PATHWAY-2 trial published 5 years ago in Lancet showed “spironolactone was clearly the most effective treatment for the condition,” according to the report authors.

But even among patients with resistant hypertension, screening for PA dramatically lags despite being enshrined in guidelines.

“PCPs should start checking aldosterone-to-renin ratios [a widely used PA screen] in all patients with resistant hypertension or hypertension with hypokalemia, and then refer patients to specialists for testing and management,” said Jordana B. Cohen, MD, a nephrologist and hypertension researcher at the University of Pennsylvania in Philadelphia.

But recent studies of U.S. patient populations with clinical characteristics that meet existing criteria for PA screening showed that just 1%-2% of these individuals underwent an initial PA assessment, she noted, citing reports in the journals Surgery and Hypertension.

“We need to prioritize improving screening in these high-risk patients,” she stressed in an interview.

This illustrates that, in some respects, the new prevalence numbers are beside the point, because PA has been going unscreened and overlooked far too often even in the context of historical, lower prevalence rates, said Dr. Yang.

“The key point is that approximately 1 in 10 people with hypertension, and even more with resistant hypertension, have a form of the disease that is worse than essential hypertension but is routinely missed at present” and is also highly treatable.

“Evidence for the need for increased awareness of PA has been building for 2 decades,” stressed Dr. Yang, who has coauthored several commentaries and reviews that have bemoaned PA’s underappreciated status.
 

Interest in partnering with PCPs on guidance grows

One potential solution is to have endocrinologists and hypertension specialists’ partner with PCPs to come up with diagnostic and management recommendations. Both Dr. Funder and Dr. Carey are opinion leaders regarding the role of aldosterone in hypertension, and both were coauthors of the 2016 Endocrine Society guideline for PA assessment and management published in the Journal of Clinical Endocrinology & Metabolism , with Dr. Funder chairing the writing panel.

Now approaching its fifth year in effect, this guideline is “due for revision,” and “my hope is that we’ll be able to partner with one or more PCP organizations to come up with a version of the guideline targeted to PCPs,” Dr. Carey said.

He voiced interest in working on this with the American College of Physicians, which represents U.S. internal medicine physicians, and the American Academy of Family Physicians.

“We definitely need a partnership and educational efforts to get the word out from these organizations and not from a specialty society,” said Dr. Carey.

Dr. Funder said he has submitted a proposal to the Endocrine Society for a guidelines update he would chair with Dr. Carey’s assistance and with a diverse writing group that includes PCPs. Dr. Carey said that ideally this panel would write and release a revised guideline in 2021.

“Several of us are chomping at the bit to get this done,” he noted.

But participation by the ACP and AAFP remain uncertain as of September 2020. When approached about this, an ACP spokesperson said the organization had no comment. A spokesperson for the AAFP said, “It’s too early to tell if we will partner with any other organizations to develop guidelines specific to excess aldosterone, and how such guidelines might be received by our members.”

Recent history shows little cooperation between ACP, AAFP, and what might be termed the U.S. hypertension “establishment.” For example, when the American College of Cardiology and the American Heart Association released their most recent essential hypertension management guidelines in Hypertension in 2018, it was never adopted by ACP or AAFP.

The latter two organizations continue to endorse a higher BP threshold for diagnosing hypertension, and higher treatment targets set by alternative expert panels to those of the AHA/ACC.
 

Collaboration feasible, although PCPs overworked

Dr. Carey hopes that this episode will not preclude agreement over PA screening.

“I think it is still possible to partner with [the ACP and AAFP],” he observed, adding that he believes high PA prevalence among hypertensive patients and its consequences when unrecognized is “noncontentious.”

But he acknowledges that other, substantial hurdles also exist, notably the “overwhelming workload” that American PCPs already face.

David O’Gurek, MD, a family and community medicine physician at the Lewis Katz School of Medicine of Temple University in Philadelphia, agrees that a revamped approach to PA screening developed cooperatively between PCPs and specialists is an important goal and potentially feasible despite prior disagreements. “There has to be room for collaboration,” he said, but also emphasized the need for developing policies based on a systematic evidence review and a focus on patient-centered outcomes.

“We’re certainly missing patients with PA, but there needs to be greater clarity and standardization about the most appropriate screening approach and cutoff level” for flagging patients who need specialized assessment, Dr. O’Gurek said in an interview.

The current endocrinology literature also shows that experts remain divided on how best to accomplish this.

And some hypertension specialists question whether existing evidence is conclusive enough to warrant revised guidelines.

Dr. Cohen, the nephrologist and hypertension researcher, said that, while the recent prevalence report in Annals of Internal Medicine is “intriguing, hypothesis-generating information that suggests we are missing many cases of hyperaldosteronism in routine care,” she nevertheless believes that “we need additional data to be able to truly understand the breadth and implications of the findings.”

William C. Cushman, MD, a hypertension management specialist at the University of Tennessee Health Science Center in Memphis, agrees.

Changing existing practice guidelines “really needs randomized, controlled trials demonstrating a difference in long-term outcomes, ideally major cardiovascular outcomes,” that result from broader PA screening, he said.

Dr. Carey concurs that more evidence is needed to confirm the Annals report, but is confident this evidence will be in hand by the time a guideline-revision panel meets in 2021.
 

Australian model of PCPs screening for PA could be implemented in United States

An example of what might be possible when PCPs, endocrinologists, and hypertension specialists work together to make PA screening more accessible can be found in Melbourne, at the Endocrine Hypertension Service of Monash Health, in association with the Hudson Institute of Medical Research.

This began operating in July 2016, cofounded by Dr. Yang, whose experiences with her own father made her sensitive to the issue.

The service’s aim is to “address the underdiagnosis of PA, and to offer a streamlined diagnostic service for patients with hypertension,” with an “extensive outreach program” targeted to regional PCPs that, among other messages, encourages them to screen patients for PA when blood pressures exceed 140/90 mm Hg.

During its first 3 years of operation, the service saw 267 patients, with PA diagnosed in 135 and ruled out in 73 patients.

Notably, the proportion of these patients referred from PCPs jumped from 21% of 70 patients during the first year of operation to 47% of 70 patients during year 2, and 52% of 127 patients during the third year, ending in July 2019, said Dr. Yang, who continues to help run the service.

During the first year, a scant 3% of referred patients had recently diagnosed hypertension, but this rose to 14% during the second year, and to 19% during the most recent year with data available.

The median duration of diagnosed hypertension among referred patients fell from 11 years during year 1, to 7 years during year 3.

Service clinicians diagnosed 37 patients with unilateral adenomas, and removed them from 23 patients with four more awaiting surgery and the remaining 10 opting instead for medical management. Another 95 patients went on therapy with a MRA, and during the most recent year studied all patients who began a MRA regimen had a partial or complete clinical response.

Dr. Carey said the “creative program represents a model for implementation in U.S. practice.

Dr. Funder, Dr. Carey, Dr. Feldman, Dr. Yang, Dr. Cohen, and Dr. O’Gurek had no relevant disclosures. Dr. Cushman has been a consultant to Novartis, received personal fees from Sanofi, and research funding from Eli Lilly.

mzoler@mdedge.com

Jun Yang, MBBS, had watched as her father, who had battled hypertension for decades, ended up on four medications that still couldn’t bring his blood pressure to a healthy level. The cardiovascular endocrinologist then ran some tests, and soon thereafter her father had his blood pressure optimized on just one targeted medication.

Courtesy Dr. Jun Yang

Dr. Yang’s father was found to have a hormonal condition known as primary aldosteronism (PA) as the cause of his hypertension.

It turns out that PA is not as rare as once thought.

An eye-catching report in Annals of Internal Medicine this spring of an unexpectedly high prevalence of primary aldosteronism among a diverse cross section of U.S. patients with hypertension has raised issues that could dramatically change the way doctors in America, and elsewhere, assess and manage high blood pressure.

Foremost is the question of whether primary care physicians – the clinicians at the front line for diagnosing and initially treating most patients with hypertension – will absorb and act on this new evidence. For them, aldosteronism doesn’t automatically come to mind when they see high numbers on a BP monitor, and yet this latest research found that up to a third of all 726 patients in the study who were diagnosed with hypertension and with high urinary salt levels had PA.

That translates to a roughly three- to fivefold increase over standard prevalence estimates, and is a ”game changer” for how clinicians should approach hypertension management and PA diagnosis going forward, said John W. Funder, MD, in an editorial accompanying the Annals study.

Long considered relatively uncommon, hypertension driven by an excess of the hormone aldosterone, often because of an adenoma on the adrenal gland, is not the same as conventional “essential” hypertension. The former benefits from early diagnosis because its treatment is completely different – close to half of all PA patients can be treated definitively and quickly with surgical removal of an adenoma from one side of the adrenal gland.

For other PA patients, who have bilateral adrenal hyperplasia that is impossible to resolve surgically, treatment with drugs called mineralocorticoid receptor antagonists (MRAs), such as spironolactone, is needed because they target the hormonal cause of the high BP.

But what usually happens is that a patient with PA is mistakenly diagnosed with essential hypertension, in which the classic approach to treatment is to start with one regular antihypertensive drug, and add on further ones from different drug classes if blood pressure is not adequately controlled. When patients are taking three drugs, without adequate control, they are labeled as having “resistant hypertension.”

But in the case of PA, none of these conventional antihypertensives work, and the process of continuing to monitor and add different drugs wastes time, during which patients deteriorate.

“We need to change the culture of waiting for hypertension to be resistant and have patients riddled with end-organ damage,” due to years of persistently high BP and excess aldosterone “before we look for a secondary cause” like PA, declared Dr. Yang, of Hudson Institute of Medical Research and Monash University in Melbourne, during an interview.

So early diagnosis and prompt treatment of PA is key.

In addition to boosting the public health importance of early PA detection in hypertensive patients, the new up-sized PA prevalence numbers throw a spotlight on primary care physicians (PCPs) as key players who will need to apply the findings to practice on a public health scale.

These novel results create a need for “new guidelines, and a radically revised game plan with the key role of PCPs” emphasized in future management of patients with hypertension, said Dr. Funder, a professor of medicine at Monash University, in a second recent editorial in Hypertension.

“Buy-in by PCPs is essential,” agrees Robert M. Carey, MD, a cardiovascular endocrinologist and professor of medicine at the University of Virginia in Charlottesville, and a coauthor of the new study.

But he too acknowledges that this presents a major challenge. PCPs and internists, who diagnose a lot of hypertension, are “not used to thinking about aldosterone,” he said in an interview, encapsulating the key problem faced by proponents of earlier and more widespread PA assessment.

This dilemma looms as a “huge public health issue,” Dr. Carey warned.
 

‘We’re a long way from getting’ PCPs to buy in to PA screening

Will PCPs grow more comfortable with screening patients for PA themselves, or might they become more willing to refer hypertensive individuals for assessment at an expert center?

One skeptic is Ross D. Feldman, MD, a hypertension-management researcher and professor of medicine at the University of Manitoba in Winnipeg. The finding about high PA prevalence in patients with hypertension “is brand new, [and] the message needs to get to PCPs,” he said. But, “We’re a long way from getting it” to them. “I don’t know how to do that. It will be a tough sell.”

In addition, repositioning MRAs as an earlier option for many hypertensive patients won’t be easy either, because “we’ll never have outcome-trial data for MRAs,” given that they are now generic drugs, he noted.

“No clinical trial data show [MRAs] are first-line drugs,” said Dr. Feldman, who explained that, instead, MRAs are considered “go-to drugs” for patients with treatment-resistant hypertension, a niche therapeutic area. Results from the PATHWAY-2 trial published 5 years ago in Lancet showed “spironolactone was clearly the most effective treatment for the condition,” according to the report authors.

But even among patients with resistant hypertension, screening for PA dramatically lags despite being enshrined in guidelines.

“PCPs should start checking aldosterone-to-renin ratios [a widely used PA screen] in all patients with resistant hypertension or hypertension with hypokalemia, and then refer patients to specialists for testing and management,” said Jordana B. Cohen, MD, a nephrologist and hypertension researcher at the University of Pennsylvania in Philadelphia.

But recent studies of U.S. patient populations with clinical characteristics that meet existing criteria for PA screening showed that just 1%-2% of these individuals underwent an initial PA assessment, she noted, citing reports in the journals Surgery and Hypertension.

“We need to prioritize improving screening in these high-risk patients,” she stressed in an interview.

This illustrates that, in some respects, the new prevalence numbers are beside the point, because PA has been going unscreened and overlooked far too often even in the context of historical, lower prevalence rates, said Dr. Yang.

“The key point is that approximately 1 in 10 people with hypertension, and even more with resistant hypertension, have a form of the disease that is worse than essential hypertension but is routinely missed at present” and is also highly treatable.

“Evidence for the need for increased awareness of PA has been building for 2 decades,” stressed Dr. Yang, who has coauthored several commentaries and reviews that have bemoaned PA’s underappreciated status.
 

Interest in partnering with PCPs on guidance grows

One potential solution is to have endocrinologists and hypertension specialists’ partner with PCPs to come up with diagnostic and management recommendations. Both Dr. Funder and Dr. Carey are opinion leaders regarding the role of aldosterone in hypertension, and both were coauthors of the 2016 Endocrine Society guideline for PA assessment and management published in the Journal of Clinical Endocrinology & Metabolism , with Dr. Funder chairing the writing panel.

Now approaching its fifth year in effect, this guideline is “due for revision,” and “my hope is that we’ll be able to partner with one or more PCP organizations to come up with a version of the guideline targeted to PCPs,” Dr. Carey said.

He voiced interest in working on this with the American College of Physicians, which represents U.S. internal medicine physicians, and the American Academy of Family Physicians.

“We definitely need a partnership and educational efforts to get the word out from these organizations and not from a specialty society,” said Dr. Carey.

Dr. Funder said he has submitted a proposal to the Endocrine Society for a guidelines update he would chair with Dr. Carey’s assistance and with a diverse writing group that includes PCPs. Dr. Carey said that ideally this panel would write and release a revised guideline in 2021.

“Several of us are chomping at the bit to get this done,” he noted.

But participation by the ACP and AAFP remain uncertain as of September 2020. When approached about this, an ACP spokesperson said the organization had no comment. A spokesperson for the AAFP said, “It’s too early to tell if we will partner with any other organizations to develop guidelines specific to excess aldosterone, and how such guidelines might be received by our members.”

Recent history shows little cooperation between ACP, AAFP, and what might be termed the U.S. hypertension “establishment.” For example, when the American College of Cardiology and the American Heart Association released their most recent essential hypertension management guidelines in Hypertension in 2018, it was never adopted by ACP or AAFP.

The latter two organizations continue to endorse a higher BP threshold for diagnosing hypertension, and higher treatment targets set by alternative expert panels to those of the AHA/ACC.
 

Collaboration feasible, although PCPs overworked

Dr. Carey hopes that this episode will not preclude agreement over PA screening.

“I think it is still possible to partner with [the ACP and AAFP],” he observed, adding that he believes high PA prevalence among hypertensive patients and its consequences when unrecognized is “noncontentious.”

But he acknowledges that other, substantial hurdles also exist, notably the “overwhelming workload” that American PCPs already face.

David O’Gurek, MD, a family and community medicine physician at the Lewis Katz School of Medicine of Temple University in Philadelphia, agrees that a revamped approach to PA screening developed cooperatively between PCPs and specialists is an important goal and potentially feasible despite prior disagreements. “There has to be room for collaboration,” he said, but also emphasized the need for developing policies based on a systematic evidence review and a focus on patient-centered outcomes.

“We’re certainly missing patients with PA, but there needs to be greater clarity and standardization about the most appropriate screening approach and cutoff level” for flagging patients who need specialized assessment, Dr. O’Gurek said in an interview.

The current endocrinology literature also shows that experts remain divided on how best to accomplish this.

And some hypertension specialists question whether existing evidence is conclusive enough to warrant revised guidelines.

Dr. Cohen, the nephrologist and hypertension researcher, said that, while the recent prevalence report in Annals of Internal Medicine is “intriguing, hypothesis-generating information that suggests we are missing many cases of hyperaldosteronism in routine care,” she nevertheless believes that “we need additional data to be able to truly understand the breadth and implications of the findings.”

William C. Cushman, MD, a hypertension management specialist at the University of Tennessee Health Science Center in Memphis, agrees.

Changing existing practice guidelines “really needs randomized, controlled trials demonstrating a difference in long-term outcomes, ideally major cardiovascular outcomes,” that result from broader PA screening, he said.

Dr. Carey concurs that more evidence is needed to confirm the Annals report, but is confident this evidence will be in hand by the time a guideline-revision panel meets in 2021.
 

Australian model of PCPs screening for PA could be implemented in United States

An example of what might be possible when PCPs, endocrinologists, and hypertension specialists work together to make PA screening more accessible can be found in Melbourne, at the Endocrine Hypertension Service of Monash Health, in association with the Hudson Institute of Medical Research.

This began operating in July 2016, cofounded by Dr. Yang, whose experiences with her own father made her sensitive to the issue.

The service’s aim is to “address the underdiagnosis of PA, and to offer a streamlined diagnostic service for patients with hypertension,” with an “extensive outreach program” targeted to regional PCPs that, among other messages, encourages them to screen patients for PA when blood pressures exceed 140/90 mm Hg.

During its first 3 years of operation, the service saw 267 patients, with PA diagnosed in 135 and ruled out in 73 patients.

Notably, the proportion of these patients referred from PCPs jumped from 21% of 70 patients during the first year of operation to 47% of 70 patients during year 2, and 52% of 127 patients during the third year, ending in July 2019, said Dr. Yang, who continues to help run the service.

During the first year, a scant 3% of referred patients had recently diagnosed hypertension, but this rose to 14% during the second year, and to 19% during the most recent year with data available.

The median duration of diagnosed hypertension among referred patients fell from 11 years during year 1, to 7 years during year 3.

Service clinicians diagnosed 37 patients with unilateral adenomas, and removed them from 23 patients with four more awaiting surgery and the remaining 10 opting instead for medical management. Another 95 patients went on therapy with a MRA, and during the most recent year studied all patients who began a MRA regimen had a partial or complete clinical response.

Dr. Carey said the “creative program represents a model for implementation in U.S. practice.

Dr. Funder, Dr. Carey, Dr. Feldman, Dr. Yang, Dr. Cohen, and Dr. O’Gurek had no relevant disclosures. Dr. Cushman has been a consultant to Novartis, received personal fees from Sanofi, and research funding from Eli Lilly.

mzoler@mdedge.com

Jun Yang, MBBS, had watched as her father, who had battled hypertension for decades, ended up on four medications that still couldn’t bring his blood pressure to a healthy level. The cardiovascular endocrinologist then ran some tests, and soon thereafter her father had his blood pressure optimized on just one targeted medication.

Courtesy Dr. Jun Yang

Dr. Yang’s father was found to have a hormonal condition known as primary aldosteronism (PA) as the cause of his hypertension.

It turns out that PA is not as rare as once thought.

An eye-catching report in Annals of Internal Medicine this spring of an unexpectedly high prevalence of primary aldosteronism among a diverse cross section of U.S. patients with hypertension has raised issues that could dramatically change the way doctors in America, and elsewhere, assess and manage high blood pressure.

Foremost is the question of whether primary care physicians – the clinicians at the front line for diagnosing and initially treating most patients with hypertension – will absorb and act on this new evidence. For them, aldosteronism doesn’t automatically come to mind when they see high numbers on a BP monitor, and yet this latest research found that up to a third of all 726 patients in the study who were diagnosed with hypertension and with high urinary salt levels had PA.

That translates to a roughly three- to fivefold increase over standard prevalence estimates, and is a ”game changer” for how clinicians should approach hypertension management and PA diagnosis going forward, said John W. Funder, MD, in an editorial accompanying the Annals study.

Long considered relatively uncommon, hypertension driven by an excess of the hormone aldosterone, often because of an adenoma on the adrenal gland, is not the same as conventional “essential” hypertension. The former benefits from early diagnosis because its treatment is completely different – close to half of all PA patients can be treated definitively and quickly with surgical removal of an adenoma from one side of the adrenal gland.

For other PA patients, who have bilateral adrenal hyperplasia that is impossible to resolve surgically, treatment with drugs called mineralocorticoid receptor antagonists (MRAs), such as spironolactone, is needed because they target the hormonal cause of the high BP.

But what usually happens is that a patient with PA is mistakenly diagnosed with essential hypertension, in which the classic approach to treatment is to start with one regular antihypertensive drug, and add on further ones from different drug classes if blood pressure is not adequately controlled. When patients are taking three drugs, without adequate control, they are labeled as having “resistant hypertension.”

But in the case of PA, none of these conventional antihypertensives work, and the process of continuing to monitor and add different drugs wastes time, during which patients deteriorate.

“We need to change the culture of waiting for hypertension to be resistant and have patients riddled with end-organ damage,” due to years of persistently high BP and excess aldosterone “before we look for a secondary cause” like PA, declared Dr. Yang, of Hudson Institute of Medical Research and Monash University in Melbourne, during an interview.

So early diagnosis and prompt treatment of PA is key.

In addition to boosting the public health importance of early PA detection in hypertensive patients, the new up-sized PA prevalence numbers throw a spotlight on primary care physicians (PCPs) as key players who will need to apply the findings to practice on a public health scale.

These novel results create a need for “new guidelines, and a radically revised game plan with the key role of PCPs” emphasized in future management of patients with hypertension, said Dr. Funder, a professor of medicine at Monash University, in a second recent editorial in Hypertension.

“Buy-in by PCPs is essential,” agrees Robert M. Carey, MD, a cardiovascular endocrinologist and professor of medicine at the University of Virginia in Charlottesville, and a coauthor of the new study.

But he too acknowledges that this presents a major challenge. PCPs and internists, who diagnose a lot of hypertension, are “not used to thinking about aldosterone,” he said in an interview, encapsulating the key problem faced by proponents of earlier and more widespread PA assessment.

This dilemma looms as a “huge public health issue,” Dr. Carey warned.
 

‘We’re a long way from getting’ PCPs to buy in to PA screening

Will PCPs grow more comfortable with screening patients for PA themselves, or might they become more willing to refer hypertensive individuals for assessment at an expert center?

One skeptic is Ross D. Feldman, MD, a hypertension-management researcher and professor of medicine at the University of Manitoba in Winnipeg. The finding about high PA prevalence in patients with hypertension “is brand new, [and] the message needs to get to PCPs,” he said. But, “We’re a long way from getting it” to them. “I don’t know how to do that. It will be a tough sell.”

In addition, repositioning MRAs as an earlier option for many hypertensive patients won’t be easy either, because “we’ll never have outcome-trial data for MRAs,” given that they are now generic drugs, he noted.

“No clinical trial data show [MRAs] are first-line drugs,” said Dr. Feldman, who explained that, instead, MRAs are considered “go-to drugs” for patients with treatment-resistant hypertension, a niche therapeutic area. Results from the PATHWAY-2 trial published 5 years ago in Lancet showed “spironolactone was clearly the most effective treatment for the condition,” according to the report authors.

But even among patients with resistant hypertension, screening for PA dramatically lags despite being enshrined in guidelines.

“PCPs should start checking aldosterone-to-renin ratios [a widely used PA screen] in all patients with resistant hypertension or hypertension with hypokalemia, and then refer patients to specialists for testing and management,” said Jordana B. Cohen, MD, a nephrologist and hypertension researcher at the University of Pennsylvania in Philadelphia.

But recent studies of U.S. patient populations with clinical characteristics that meet existing criteria for PA screening showed that just 1%-2% of these individuals underwent an initial PA assessment, she noted, citing reports in the journals Surgery and Hypertension.

“We need to prioritize improving screening in these high-risk patients,” she stressed in an interview.

This illustrates that, in some respects, the new prevalence numbers are beside the point, because PA has been going unscreened and overlooked far too often even in the context of historical, lower prevalence rates, said Dr. Yang.

“The key point is that approximately 1 in 10 people with hypertension, and even more with resistant hypertension, have a form of the disease that is worse than essential hypertension but is routinely missed at present” and is also highly treatable.

“Evidence for the need for increased awareness of PA has been building for 2 decades,” stressed Dr. Yang, who has coauthored several commentaries and reviews that have bemoaned PA’s underappreciated status.
 

Interest in partnering with PCPs on guidance grows

One potential solution is to have endocrinologists and hypertension specialists’ partner with PCPs to come up with diagnostic and management recommendations. Both Dr. Funder and Dr. Carey are opinion leaders regarding the role of aldosterone in hypertension, and both were coauthors of the 2016 Endocrine Society guideline for PA assessment and management published in the Journal of Clinical Endocrinology & Metabolism , with Dr. Funder chairing the writing panel.

Now approaching its fifth year in effect, this guideline is “due for revision,” and “my hope is that we’ll be able to partner with one or more PCP organizations to come up with a version of the guideline targeted to PCPs,” Dr. Carey said.

He voiced interest in working on this with the American College of Physicians, which represents U.S. internal medicine physicians, and the American Academy of Family Physicians.

“We definitely need a partnership and educational efforts to get the word out from these organizations and not from a specialty society,” said Dr. Carey.

Dr. Funder said he has submitted a proposal to the Endocrine Society for a guidelines update he would chair with Dr. Carey’s assistance and with a diverse writing group that includes PCPs. Dr. Carey said that ideally this panel would write and release a revised guideline in 2021.

“Several of us are chomping at the bit to get this done,” he noted.

But participation by the ACP and AAFP remain uncertain as of September 2020. When approached about this, an ACP spokesperson said the organization had no comment. A spokesperson for the AAFP said, “It’s too early to tell if we will partner with any other organizations to develop guidelines specific to excess aldosterone, and how such guidelines might be received by our members.”

Recent history shows little cooperation between ACP, AAFP, and what might be termed the U.S. hypertension “establishment.” For example, when the American College of Cardiology and the American Heart Association released their most recent essential hypertension management guidelines in Hypertension in 2018, it was never adopted by ACP or AAFP.

The latter two organizations continue to endorse a higher BP threshold for diagnosing hypertension, and higher treatment targets set by alternative expert panels to those of the AHA/ACC.
 

Collaboration feasible, although PCPs overworked

Dr. Carey hopes that this episode will not preclude agreement over PA screening.

“I think it is still possible to partner with [the ACP and AAFP],” he observed, adding that he believes high PA prevalence among hypertensive patients and its consequences when unrecognized is “noncontentious.”

But he acknowledges that other, substantial hurdles also exist, notably the “overwhelming workload” that American PCPs already face.

David O’Gurek, MD, a family and community medicine physician at the Lewis Katz School of Medicine of Temple University in Philadelphia, agrees that a revamped approach to PA screening developed cooperatively between PCPs and specialists is an important goal and potentially feasible despite prior disagreements. “There has to be room for collaboration,” he said, but also emphasized the need for developing policies based on a systematic evidence review and a focus on patient-centered outcomes.

“We’re certainly missing patients with PA, but there needs to be greater clarity and standardization about the most appropriate screening approach and cutoff level” for flagging patients who need specialized assessment, Dr. O’Gurek said in an interview.

The current endocrinology literature also shows that experts remain divided on how best to accomplish this.

And some hypertension specialists question whether existing evidence is conclusive enough to warrant revised guidelines.

Dr. Cohen, the nephrologist and hypertension researcher, said that, while the recent prevalence report in Annals of Internal Medicine is “intriguing, hypothesis-generating information that suggests we are missing many cases of hyperaldosteronism in routine care,” she nevertheless believes that “we need additional data to be able to truly understand the breadth and implications of the findings.”

William C. Cushman, MD, a hypertension management specialist at the University of Tennessee Health Science Center in Memphis, agrees.

Changing existing practice guidelines “really needs randomized, controlled trials demonstrating a difference in long-term outcomes, ideally major cardiovascular outcomes,” that result from broader PA screening, he said.

Dr. Carey concurs that more evidence is needed to confirm the Annals report, but is confident this evidence will be in hand by the time a guideline-revision panel meets in 2021.
 

Australian model of PCPs screening for PA could be implemented in United States

An example of what might be possible when PCPs, endocrinologists, and hypertension specialists work together to make PA screening more accessible can be found in Melbourne, at the Endocrine Hypertension Service of Monash Health, in association with the Hudson Institute of Medical Research.

This began operating in July 2016, cofounded by Dr. Yang, whose experiences with her own father made her sensitive to the issue.

The service’s aim is to “address the underdiagnosis of PA, and to offer a streamlined diagnostic service for patients with hypertension,” with an “extensive outreach program” targeted to regional PCPs that, among other messages, encourages them to screen patients for PA when blood pressures exceed 140/90 mm Hg.

During its first 3 years of operation, the service saw 267 patients, with PA diagnosed in 135 and ruled out in 73 patients.

Notably, the proportion of these patients referred from PCPs jumped from 21% of 70 patients during the first year of operation to 47% of 70 patients during year 2, and 52% of 127 patients during the third year, ending in July 2019, said Dr. Yang, who continues to help run the service.

During the first year, a scant 3% of referred patients had recently diagnosed hypertension, but this rose to 14% during the second year, and to 19% during the most recent year with data available.

The median duration of diagnosed hypertension among referred patients fell from 11 years during year 1, to 7 years during year 3.

Service clinicians diagnosed 37 patients with unilateral adenomas, and removed them from 23 patients with four more awaiting surgery and the remaining 10 opting instead for medical management. Another 95 patients went on therapy with a MRA, and during the most recent year studied all patients who began a MRA regimen had a partial or complete clinical response.

Dr. Carey said the “creative program represents a model for implementation in U.S. practice.

Dr. Funder, Dr. Carey, Dr. Feldman, Dr. Yang, Dr. Cohen, and Dr. O’Gurek had no relevant disclosures. Dr. Cushman has been a consultant to Novartis, received personal fees from Sanofi, and research funding from Eli Lilly.

mzoler@mdedge.com

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

During normal times, the U.K.-based charity No Panic offers itself as an easily accessible service to those with anxiety disorders and phobias. Visitors to the website who can receive immediate, remote support from trained volunteers. But this spring was anything but normal, as the reality of COVID-19’s worldwide spread became terrifyingly clear.

COVID-19 cases peaked in the United Kingdom in early April. Nationwide lockdown efforts contributed to a gradual but ultimately substantial decline in cases, yet, despite the favorable trend lines, No Panic has remained busier than ever.

Beyond the physical symptoms associated with COVID-19, the psychological outcomes are vast and, it seems, prolonged. Researchers have now formalized a definition of the long-term mental maladies associated with the pandemic, collectively deeming them “coronaphobia.”

The term is a catch-all phrase for the fear and the emotional and social strain experienced by the general public in response to COVID-19. Obsessive behaviors, distress, avoidance reaction, panic, anxiety, hoarding, paranoia, and depression are some of the responses associated with coronaphobia. On the surface, these appear to be normal, somewhat fitting reactions to this surreal and frightening moment in time. However, for those experiencing coronaphobia, they are distinctly maladaptive and harmful.

“We had a serious rise in the use of our services, notably the helpline and email enquiries,” explained Sarah Floyd, No Panic’s volunteer advisor and social media coordinator. “It has been up and down all along, but more of an up since lockdown is easing.”

The group’s experience offers yet more evidence that the anxieties and fears caused by this global pandemic don’t flatten alongside the curve but instead linger as chronic problems requiring ongoing care.

“Every week in my clinic, I’m seeing people who are experiencing more anxiety and hopelessness and having an emotional response that is perhaps out of proportion to what one would expect, which is directly related to what is going on in the world right now with coronavirus,” said Gregory Scott Brown, MD, founder and director of the Center for Green Psychiatry in West Lake Hills, Tex. “Simply put, I think what we are looking at is adjustment disorder. That is probably how the DSM would define it.”

Adjustment disorder is one of the most frequently diagnosed mental health conditions, although it is also relatively understudied. It is really a set of disorders that follow in the wake of a significant stressor, which can vary from serious illness or the death of a loved one to relocating or experiencing work problems. The resulting dysfunction and distress that the person experiences are considered out of proportion in duration or scale with what would normally be expected. Diagnosing an adjustment disorder is made difficult by the lack of a valid and reliable screening measure.

Recent literature suggests that coronaphobia may be likely to occur in those who feel vulnerable to disease, are predisposed to anxiety, or are intolerant of uncertainty. Preexisting mental health conditions can also be exacerbated by periods of quarantine, self-isolation, and lockdown, which can lead to panic attacks, chronophobia (fear of passing time), and suicidality.

Although imperfect comparisons, findings from earlier 21st century disease outbreaks, such as severe acute respiratory syndrome and the Ebola virus, signal that containment efforts themselves play a role in deteriorating mental health. A recent rapid review found that, in studies comparing persons who had previously undergone quarantines and those who had not, the former were significantly more likely to experience acute stress disorder, posttraumatic stress symptoms, and depression. Quarantine was found to result in long-term behavioral changes, such as avoiding crowds, among the general public and health care practitioners.

That tremendous psychological morbidity should accompany a global pandemic of this scale is not surprising, according to Amit Anand, MD, vice chair for research for the Center for Behavioral Health and director of the Mood and Emotional Disorders Across the Life Span program at the Cleveland Clinic.

“The technical definition of anxiety is an impending sense of doom, and I think all of us are living with that,” Dr. Anand said. “The basic question then becomes, what is normal and when does it become abnormal?”

He added that most classifications of psychiatric disorders are set during periods of relative stability, which the current moment is most certainly not.

“This is such an unusual situation, so I think it will depend on case-by-case basis, keeping the whole context in mind as whether the patient is thinking or behaving with an abnormal amount of anxiety,” Dr. Anand said.

Investigators are currently trying to give clinicians the tools to better make that determination. In the first scientific study of this clinical condition, Sherman Lee, MD, reported that five symptoms – dizziness, sleep disturbances, tonic immobility, appetite loss, and nausea/abdominal distress – were strong factors for distinguishing coronaphobia from otherwise normal concerns about COVID-19 that did not result in functional impairment. Dr. Lee and colleagues have since published further evidence that coronaphobia “is a unique predictor of psychological distress during the COVID-19 crisis.” They are working on validating a self-reported mental health screener for this condition.

Having the tools to identify patients struggling with coronaphobia may go some ways toward addressing another area of declining health. At the outset of the COVID-19 pandemic, there was a question as to whether doctors would be beset by a surge of the “worried well” – persons mistakenly believing themselves to be infected. Now months into the pandemic, the converse phenomenon – a fear of contracting COVID-19 that is driving patients away from practitioners – appears to be the more valid concern.

In early spring, the pandemic’s first surge was accompanied by reports of approximately 40% and 60% drops in visits to EDs and ambulatory centers, respectively. Stories of acute stroke patients avoiding treatment began to appear in the press. Major U.S. cities saw noteworthy declines in 911 calls, indicating a hesitancy to be taken to a hospital. That COVID-19 has been accompanied by mass unemployment and subsequent loss of insurance complicates the notion that fear alone is keeping people from treatment. In other countries, it has been explicitly linked. Investigators in Singapore noted that coronaphobia played a role in reducing willingness to attend in-person visits among adolescents with eating disorders. Similarly, case reports in Israel suggest that coronaphobia has contributed to delays in diagnoses of common pediatric diseases.

There is also a concern, colloquially termed “reentry anxiety,” that mental health problems caused by the pandemic, the accompanying lockdown, self-isolation, and quarantine practices will prove alarmingly durable. Even after this challenging moment in history draws to a close, many people may face substantial stress in returning to the normal activities of life – social, professional, familial – once taken for granted.

“We are in the beginning phase of that now,” said Dr. Anand. “Lots of people are decompensating, getting depressed, and needing treatment. I think the longer it goes on for, the more difficult it will be.”

In the United States, that day may seem far away. Nonetheless, it is important to begin laying the therapeutic groundwork now, according to Dr. Brown.

“I am recommending unconventional therapies like meet-up groups, online forums,” he said. “Everything has shifted online, and so there are a lot of support groups that patients can participate to learn coping skills and really hear what other people are going through.”

Before reaching that stage, Dr. Brown recommends that clinicians first simply discuss such anxieties with their patients in order to normalize them.

“Realize that everyone essentially is going through some degree of this right now. The coronavirus pandemic is literally impacting every person on the face of the planet. Sometimes just pointing that out to people can really help,” he said.

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

Rural primary care doctors are facing a new set of obstacles to practicing in the COVID-19 pandemic. These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.

Courtesy Dr. Jacqueline W. Fincher

Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.

In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.

But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.

Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.

“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”

Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.

“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
 

Starting up telemedicine

Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.

As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.

“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.

Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.

G&P Productions

In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.

But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.

“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”

“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.

G&P Productions

Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.

“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.

The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
 

Treating political adversaries

Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.

Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.

Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.

“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”

In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.

“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.

Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.

Courtesy Dr. Clara Shin

He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.

“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”

“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.

The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.

“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.

Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.

“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.

“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.

Rural primary care doctors are facing a new set of obstacles to practicing in the COVID-19 pandemic. These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.

Courtesy Dr. Jacqueline W. Fincher

Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.

In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.

But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.

Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.

“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”

Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.

“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
 

Starting up telemedicine

Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.

As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.

“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.

Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.

G&P Productions

In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.

But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.

“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”

“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.

G&P Productions

Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.

“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.

The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
 

Treating political adversaries

Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.

Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.

Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.

“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”

In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.

“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.

Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.

Courtesy Dr. Clara Shin

He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.

“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”

“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.

The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.

“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.

Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.

“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.

“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.

Rural primary care doctors are facing a new set of obstacles to practicing in the COVID-19 pandemic. These include struggling with seeing patients virtually and treating patients who have politicized the virus. Additionally, the pandemic has exposed rural practices to greater financial difficulties.

Courtesy Dr. Jacqueline W. Fincher

Before the pandemic some rurally based primary care physicians were already working through big challenges, such as having few local medical colleagues to consult and working in small practices with lean budgets. In fact, data gathered by the National Rural Health Association showed that there are only 40 primary care physicians per 100,000 patients in rural regions, compared with 53 in urban areas – and the number of physicians overall is 13 per 10,000 in rural areas, compared with 31 in cities.

In the prepandemic world, for some doctors, the challenges were balanced by the benefits of practicing in these sparsely populated communities with scenic, low-traffic roads. Some perks of practicing in rural areas touted by doctors included having a fast commute, being able to swim in a lake near the office before work, having a low cost of living, and feeling like they are making a difference in their communities as they treat generations of the families they see around town.

But today, new hurdles to practicing medicine in rural America created by the COVID-19 pandemic have caused the hardships to feel heavier than the joys at times for some physicians interviewed by MDedge.

Many independent rural practices in need of assistance were not able to get much from the federal Provider Relief Funds, said John M. Westfall, MD, who is director of the Robert Graham Center for Policy Studies in Family Medicine and Primary Care, in an interview.

“Rural primary care doctors function independently or in smaller critical access hospitals and community health centers,” said Dr. Westfall, who previously practiced family medicine in a small town in Colorado. “Many of these have much less financial reserves so are at risk of cutbacks and closure.”

Jacqueline W. Fincher, MD, an internist based in a tiny Georgia community along the highway between Atlanta and Augusta, said her small practice works on really thin margins and doesn’t have much cushion. At the beginning of the pandemic, all visits were down, and her practice operated at a loss. To help, Dr. Fincher and her colleagues applied for funding from the Small Business Administration’s Paycheck Protection Program (PPP) through the CARES Act.

“COVID-19 has had a tremendous impact especially on primary care practices. We live and die by volume. … Our volume in mid-March to mid-May really dropped dramatically,” explained Dr. Fincher, who is also president of the American College of Physicians. “The PPP sustained us for 2 months, enabling us to pay our staff and to remain open and get us up and running on telehealth.”
 

Starting up telemedicine

Experiencing spotty or no access to broadband Internet is nothing new to rural physicians, but having this problem interfere with their ability to provide care to patients is.

As much of the American health system rapidly embraced telehealth during the pandemic, obtaining access to high-speed Internet has been a major challenge for rural patients, noted Dr. Westfall.

“Some practices were able to quickly adopt some telehealth capacity with phone and video. Changes in payment for telehealth helped. But in some rural communities there was not adequate Internet bandwidth for quality video connections. And some patients did not have the means for high-speed video connections,” Dr. Westfall said.

Indeed, according to a 2019 Pew Research Center survey, 63% of rural Americans say they can access the Internet through a broadband connection at home, compared with 75% and 79% in suburban and urban areas, respectively.

G&P Productions

In the Appalachian town of Zanesville, Ohio, for example, family physician Shelly L. Dunmyer, MD, and her colleagues discovered that many patients don’t have Internet access at home. Dr. Fincher has to go to the office to conduct telehealth visits because her own Internet access at home is unpredictable. As for patients, it may take 15 minutes for them to work out technical glitches and find good Internet reception, said Dr. Fincher. For internist Y. Ki Shin, MD, who practices in the coastal town of Montesano in Washington state, about 25% of his practice’s telehealth visits must be conducted by phone because of limitations on video, such as lack of high-speed access.

But telephone visits are often insufficient replacements for appointments via video, according to several rural physicians interviewed for this piece.

“Telehealth can be frustrating at times due to connectivity issues which can be difficult at times in the rural areas,” said Dr. Fincher. “In order for telehealth to be reasonably helpful to patients and physicians to care for people with chronic problems, the patients must have things like blood pressure monitors, glucometers, and scales to address problems like hypertension, diabetes myelitis, and congestive heart failure.”

“If you have the audio and video and the data from these devices, you’re good. If you don’t have these data, and/or don’t have the video you just can’t provide good care,” she explained.

G&P Productions

Dr. Dunmyer and her colleagues at Medical Home Primary Care Center in Zanesville, Ohio, found a way to get around the problem of patients not being able to access Internet to participate in video visits from their homes. This involved having her patients drive into her practice’s parking lot to participate in modified telehealth visits. Staffers gave iPads to patients in their cars, and Dr. Dunmyer conducted visits from her office, about 50 yards away.

“We were even doing Medicare wellness visits: Instead of asking them to get up and move around the room, we would sit at the window and wave at them, ask them to get out, walk around the car. We were able to check mobility and all kinds of things that we’d normally do in the office,” Dr. Dunmyer explained in an interview.

The family physician noted that her practice is now conducting fewer parking lot visits since her office is allowing in-person appointments, but that they’re still an option for her patients.
 

Treating political adversaries

Some rural physicians have experienced strained relationships with patients for reasons other than technology – stark differences in opinion over the pandemic itself. Certain patients are following President Trump’s lead and questioning everything from the pandemic death toll to preventive measures recommended by scientists and medical experts, physicians interviewed by MDedge said.

Patients everywhere share these viewpoints, of course, but research and election results confirm that rural areas are more receptive to conservative viewpoints. In 2018, a Pew Research Center survey reported that rural and urban areas are “becoming more polarized politically,” and “rural areas tend to have a higher concentration of Republicans and Republican-leaning independents.” For example, 40% of rural respondents reported “very warm” or “somewhat warm” feelings toward Donald Trump, compared with just 19% in urban areas.

Dr. Shin has struggled to cope with patients who want to argue about pandemic safety precautions like wearing masks and seem to question whether systemic racism exists.

“We are seeing a lot more people who feel that this pandemic is not real, that it’s a political and not-true infection,” he said in an interview. “We’ve had patients who were angry at us because we made them wear masks, and some were demanding hydroxychloroquine and wanted to have an argument because we’re not going to prescribe it for them.”

In one situation, which he found especially disturbing, Dr. Shin had to leave the exam room because a patient wouldn’t stop challenging him regarding the pandemic. Things have gotten so bad that Dr. Shin has even questioned whether he wants to continue his long career in his small town because of local political attitudes such as opposition to mask-wearing and social distancing.

“Mr. Trump’s misinformation on this pandemic made my job much more difficult. As a minority, I feel less safe in my community than ever,” said Dr. Shin, who described himself as Asian American.

Despite these new stressors, Dr. Shin has experienced some joyful moments while practicing medicine in the pandemic.

Courtesy Dr. Clara Shin

He said a recent home visit to a patient who had been hospitalized for over 3 months and nearly died helped him put political disputes with his patients into perspective.

“He was discharged home but is bedbound. He had gangrene on his toes, and I could not fully examine him using video,” Dr. Shin recalled. “It was tricky to find the house, but a very large Trump sign was very helpful in locating it. It was a good visit: He was happy to see me, and I was happy to see that he was doing okay at home.”

“I need to remind myself that supporting Mr. Trump does not always mean that my patient supports Mr. Trump’s view on the pandemic and the race issues in our country,” Dr. Shin added.

The Washington-based internist said he also tells himself that, even if his patients refuse to follow his strong advice regarding pandemic precautions, it does not mean he has failed as a doctor.

“I need to continue to educate patients about the dangers of COVID infection but cannot be angry if they don’t choose to follow my recommendations,” he noted.

Dr. Fincher says her close connection with patients has allowed her to smooth over politically charged claims about the pandemic in the town of Thomson, Georgia, with a population 6,800.

“I have a sense that, even though we may differ in our understanding of some basic facts, they appreciate what I say since we have a long-term relationship built on trust,” she said. This kind of trust, Dr. Fincher suggested, may be more common than in urban areas where there’s a larger supply of physicians, and patients don’t see the same doctors for long periods of time.

“It’s more meaningful when it comes from me, rather than doctors who are [new to patients] every year when their employer changes their insurance,” she noted.

The National Academies of Science, Engineering, and Medicine have just released a 522-page report, but it’s not the usual compilation of guidelines for treatment of a disease. Instead, the authors of “Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action” argue in stark terms that the American society has colossally failed individuals living with sickle cell disease (SCD), who are mostly Black or Brown. A dramatic overhaul of the country’s medical and societal priorities is needed to turn things around to improve health and longevity among this rare disease population.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

The findings from the NASEM report are explicit: “There has been substantial success in increasing the survival of children with SCD, but this success had not been translated to similar success as they become adults.” One factor posited to contribute to the slow progress in the improvement of quality and quantity of life for adults living with this disease is the fact that “SCD is largely a disease of African Americans, and as such exists in a context of racial discrimination, health and other societal disparities, mistrust of the health care system, and the effects of poverty.” The report also cites the substantial evidence that those with SCD may receive poorer quality of care.

The report’s 14 authors were made up of an ad hoc committee formed at the request of the Department of Health & Human Services’ Office of Minority Health. The office asked NASEM to convene the committee to develop a strategic plan and blueprint for the United States and others regarding SCD.

The NASEM SCD committee members “realized that we can’t address the medical components of SCD if we don’t explore societal issues and why it’s been so hard to get good care for people with sickle cell disease,” hematologist and report coauthor Ifeyinwa (Ify) Osunkwo, MD, professor of medicine and pediatrics at Atrium Health and director of the Sickle Cell Disease Enterprise, Levine Cancer Institute, Charlotte, N.C., said in an interview. Dr. Osunkwo is also the medical editor of Hematology News.

“After almost a year of meetings and digging into the background and history of SCD care, we came out with very comprehensive summary of where we were and where we want to be,” she said. “The report provides short-, intermediate- and long-term recommendations and identifies which entity and organization should be responsible for implementing them.”

The report authors, led by pediatrician and committee chair Marie Clare McCormick, MD, of the Harvard School of Public Health, Boston, stated that about 100,000 people in the United States and millions worldwide live with SCD. The disease kills more than 700 people per year in the United States, and treatment costs an estimated $2 billion a year.

When judged by disability-adjusted life-years lost – a measurement of expected healthy years of life without an illness – the impact of SCD on individuals is estimated to be greater than a long list of other diseases such as Alzheimer’s disease, breast cancer, type 1 diabetes, and AIDS/HIV, the report noted.

“The health care needs of individuals living with SCD have been neglected by the U.S. and global health care systems, causing them and their families to suffer,” the report said. “Many of the complications that afflict individuals with SCD, particularly pain, are invisible. Pain is only diagnosed by self-reports, and in SCD there are few to no external indicators of the pain experience. Nevertheless, the pain can be excruciatingly severe and requires treatment with strong analgesics.”

There’s even more misery to the story of SCD, the report said, and Dr. Osunkwo agreed. “It’s not just about pain. These individuals suffer from multiple organ-system complications that are physical but also psychological and societal. They experience a lot of disparities in every aspect of their lives. You’re sick, so then you can’t get a job or health insurance, you can’t get Social Security benefits. You can’t get the type of health care you need nor can you access the other forms of support you need and often you are judged as a drug seeker for complaining of pain or repeatedly seeking acute care for unresolved pain.”

Multiple factors exacerbate the experience of people living with SCD in America, the report said. “Because of systemic racism, unconscious bias, and the stigma associated with the diagnosis, the disease brings with it a much broader burden.”

Dr. Osunkwo put it this way: “SCD is a disease that mostly affects Brown and Black people, and that gets layered into the whole discrimination issues that Black and Brown people face compounding the health burden from their disease.”

The report added that “the SCD community has developed a significant lack of trust in the health care system due to the nearly universal stigma and lack of belief in their reports of pain, a lack of trust that has been further reinforced by historical events, such as the Tuskegee experiment.”

The report highlighted research that finds that Blacks “are more likely to receive a lower quality of pain management than white patients and may be perceived as having drug-seeking behavior.”

The report also identified gaps in treatment, noting that “many SCD complications are not restricted to any one organ system, and the impact of the disease on [quality of life] can be profound but hard to define and compartmentalize.”

Dr. Osunkwo said medical professionals often fail to understand the full breadth of the disease. “There’s no particular look to SCD. When you have cancer, you come in, and you look like you’re sick because you’re bald. Everyone clues into that cancer look and knows it’s lethal, that you’re may likely die early. We don’t have that “look that generates empathy” for SCD, and people don’t understand the burden on those affected. They don’t understand or appreciate that SCD shortens your lifespan as well ... that people living with SCD die 3 decades earlier than their ethnically matched peers. Also, SCD is associated with a lot of pain, and pain and the treatment of pain with opioids makes people [health care providers] uncomfortable unless it’s cancer pain.”

She added: “People also assume that, if it’s not pain, it’s not SCD even though SCD can cause leg ulcers and blood clots and even affect the tonsils, or lead to a stroke. When a disease complexity is too difficult for providers to understand, they either avoid it or don’t do anything for the patient.”

Screening and surveillance for SCD and sickle cell trait is insufficient, the report said, and the potential cost of missed childhood cases is large. Detecting the condition at birth allows the implementation of appropriate comprehensive care and treatment to prevent early death from infections and strokes. As the authors noted, “tremendous strides have been made in the past few decades in the care of children with SCD, which have led to almost all children in high-income settings surviving to adulthood.” However, there remains gaps in care coordination and follow-up of babies screened at birth and even bigger gaps in translating these life span gains to adults particularly around the period of transition from pediatrics to adult care when there appears to be a spike in morbidity and mortality.

Dr_Microbe/Thinkstock

The report summarized current treatments for SCD and noted “an influx of pipeline products” after years of little progress and identifies “a need for targeted SCD therapies that address the underlying cause of the disease.”

While treatment recommendations exist, Dr. Osunkwo said, “the evidence for them is very poor and many SCD complications have no evidence-based guidelines for providers to follow. We need more research to provide high quality evidence to make guidelines for SCD treatment stronger and more robust.”

In its final section, the report offers a “strategic plan and blueprint for sickle cell disease action.” It offers several strategies to achieve the vision of “long healthy productive lives for those living with sickle cell disease and sickle cell trait”:

• Establish and fund a research agenda to inform effective programs and policies across the life span.
• Implement efforts to advance understanding of the full impact of sickle cell trait on individuals and society.
• Address barriers to accessing current and pipeline therapies for SCD.
• Improve SCD awareness and strengthen advocacy efforts.
• Increase the number of qualified health professionals providing SCD care.
• Strengthen the evidence base for interventions and disease management and implement widespread efforts to monitor the quality of SCD care.
• Establish organized systems of care assuring both clinical and nonclinical supportive services to all persons living with SCD.
• Establish a national system to collect and link data to characterize the burden of disease, outcomes, and the needs of those with SCD across the life span.

“Right now, the average lifespan for SCD is in the mid-40s to mid-50s,” Dr. Osunkwo said. “That’s a horrible statistic. Even if we just take up half of these recommendations, people will live longer with SCD, and they’ll be more productive and contribute more to society. If we value a cancer life the same as a sickle cell life, we’ll be halfway across the finish line. But the stigma of SCD being a Black and Brown problem is going to be the hardest to confront as it requires a systemic change in our culture as a country and a health care system.”

Still, she said, the commissioning of the report “shows that there is a desire to understand the issue in better detail and try to mitigate it.”

Dr. Osunkwo and Dr. McCormick had no relevant disclosures.

SOURCE: National Academies of Sciences, Engineering, and Medicine. Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action. Washington, D.C.: National Academies Press, 2020.

The National Academies of Science, Engineering, and Medicine have just released a 522-page report, but it’s not the usual compilation of guidelines for treatment of a disease. Instead, the authors of “Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action” argue in stark terms that the American society has colossally failed individuals living with sickle cell disease (SCD), who are mostly Black or Brown. A dramatic overhaul of the country’s medical and societal priorities is needed to turn things around to improve health and longevity among this rare disease population.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

The findings from the NASEM report are explicit: “There has been substantial success in increasing the survival of children with SCD, but this success had not been translated to similar success as they become adults.” One factor posited to contribute to the slow progress in the improvement of quality and quantity of life for adults living with this disease is the fact that “SCD is largely a disease of African Americans, and as such exists in a context of racial discrimination, health and other societal disparities, mistrust of the health care system, and the effects of poverty.” The report also cites the substantial evidence that those with SCD may receive poorer quality of care.

The report’s 14 authors were made up of an ad hoc committee formed at the request of the Department of Health & Human Services’ Office of Minority Health. The office asked NASEM to convene the committee to develop a strategic plan and blueprint for the United States and others regarding SCD.

The NASEM SCD committee members “realized that we can’t address the medical components of SCD if we don’t explore societal issues and why it’s been so hard to get good care for people with sickle cell disease,” hematologist and report coauthor Ifeyinwa (Ify) Osunkwo, MD, professor of medicine and pediatrics at Atrium Health and director of the Sickle Cell Disease Enterprise, Levine Cancer Institute, Charlotte, N.C., said in an interview. Dr. Osunkwo is also the medical editor of Hematology News.

“After almost a year of meetings and digging into the background and history of SCD care, we came out with very comprehensive summary of where we were and where we want to be,” she said. “The report provides short-, intermediate- and long-term recommendations and identifies which entity and organization should be responsible for implementing them.”

The report authors, led by pediatrician and committee chair Marie Clare McCormick, MD, of the Harvard School of Public Health, Boston, stated that about 100,000 people in the United States and millions worldwide live with SCD. The disease kills more than 700 people per year in the United States, and treatment costs an estimated $2 billion a year.

When judged by disability-adjusted life-years lost – a measurement of expected healthy years of life without an illness – the impact of SCD on individuals is estimated to be greater than a long list of other diseases such as Alzheimer’s disease, breast cancer, type 1 diabetes, and AIDS/HIV, the report noted.

“The health care needs of individuals living with SCD have been neglected by the U.S. and global health care systems, causing them and their families to suffer,” the report said. “Many of the complications that afflict individuals with SCD, particularly pain, are invisible. Pain is only diagnosed by self-reports, and in SCD there are few to no external indicators of the pain experience. Nevertheless, the pain can be excruciatingly severe and requires treatment with strong analgesics.”

There’s even more misery to the story of SCD, the report said, and Dr. Osunkwo agreed. “It’s not just about pain. These individuals suffer from multiple organ-system complications that are physical but also psychological and societal. They experience a lot of disparities in every aspect of their lives. You’re sick, so then you can’t get a job or health insurance, you can’t get Social Security benefits. You can’t get the type of health care you need nor can you access the other forms of support you need and often you are judged as a drug seeker for complaining of pain or repeatedly seeking acute care for unresolved pain.”

Multiple factors exacerbate the experience of people living with SCD in America, the report said. “Because of systemic racism, unconscious bias, and the stigma associated with the diagnosis, the disease brings with it a much broader burden.”

Dr. Osunkwo put it this way: “SCD is a disease that mostly affects Brown and Black people, and that gets layered into the whole discrimination issues that Black and Brown people face compounding the health burden from their disease.”

The report added that “the SCD community has developed a significant lack of trust in the health care system due to the nearly universal stigma and lack of belief in their reports of pain, a lack of trust that has been further reinforced by historical events, such as the Tuskegee experiment.”

The report highlighted research that finds that Blacks “are more likely to receive a lower quality of pain management than white patients and may be perceived as having drug-seeking behavior.”

The report also identified gaps in treatment, noting that “many SCD complications are not restricted to any one organ system, and the impact of the disease on [quality of life] can be profound but hard to define and compartmentalize.”

Dr. Osunkwo said medical professionals often fail to understand the full breadth of the disease. “There’s no particular look to SCD. When you have cancer, you come in, and you look like you’re sick because you’re bald. Everyone clues into that cancer look and knows it’s lethal, that you’re may likely die early. We don’t have that “look that generates empathy” for SCD, and people don’t understand the burden on those affected. They don’t understand or appreciate that SCD shortens your lifespan as well ... that people living with SCD die 3 decades earlier than their ethnically matched peers. Also, SCD is associated with a lot of pain, and pain and the treatment of pain with opioids makes people [health care providers] uncomfortable unless it’s cancer pain.”

She added: “People also assume that, if it’s not pain, it’s not SCD even though SCD can cause leg ulcers and blood clots and even affect the tonsils, or lead to a stroke. When a disease complexity is too difficult for providers to understand, they either avoid it or don’t do anything for the patient.”

Screening and surveillance for SCD and sickle cell trait is insufficient, the report said, and the potential cost of missed childhood cases is large. Detecting the condition at birth allows the implementation of appropriate comprehensive care and treatment to prevent early death from infections and strokes. As the authors noted, “tremendous strides have been made in the past few decades in the care of children with SCD, which have led to almost all children in high-income settings surviving to adulthood.” However, there remains gaps in care coordination and follow-up of babies screened at birth and even bigger gaps in translating these life span gains to adults particularly around the period of transition from pediatrics to adult care when there appears to be a spike in morbidity and mortality.

Dr_Microbe/Thinkstock

The report summarized current treatments for SCD and noted “an influx of pipeline products” after years of little progress and identifies “a need for targeted SCD therapies that address the underlying cause of the disease.”

While treatment recommendations exist, Dr. Osunkwo said, “the evidence for them is very poor and many SCD complications have no evidence-based guidelines for providers to follow. We need more research to provide high quality evidence to make guidelines for SCD treatment stronger and more robust.”

In its final section, the report offers a “strategic plan and blueprint for sickle cell disease action.” It offers several strategies to achieve the vision of “long healthy productive lives for those living with sickle cell disease and sickle cell trait”:

• Establish and fund a research agenda to inform effective programs and policies across the life span.
• Implement efforts to advance understanding of the full impact of sickle cell trait on individuals and society.
• Address barriers to accessing current and pipeline therapies for SCD.
• Improve SCD awareness and strengthen advocacy efforts.
• Increase the number of qualified health professionals providing SCD care.
• Strengthen the evidence base for interventions and disease management and implement widespread efforts to monitor the quality of SCD care.
• Establish organized systems of care assuring both clinical and nonclinical supportive services to all persons living with SCD.
• Establish a national system to collect and link data to characterize the burden of disease, outcomes, and the needs of those with SCD across the life span.

“Right now, the average lifespan for SCD is in the mid-40s to mid-50s,” Dr. Osunkwo said. “That’s a horrible statistic. Even if we just take up half of these recommendations, people will live longer with SCD, and they’ll be more productive and contribute more to society. If we value a cancer life the same as a sickle cell life, we’ll be halfway across the finish line. But the stigma of SCD being a Black and Brown problem is going to be the hardest to confront as it requires a systemic change in our culture as a country and a health care system.”

Still, she said, the commissioning of the report “shows that there is a desire to understand the issue in better detail and try to mitigate it.”

Dr. Osunkwo and Dr. McCormick had no relevant disclosures.

SOURCE: National Academies of Sciences, Engineering, and Medicine. Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action. Washington, D.C.: National Academies Press, 2020.

The National Academies of Science, Engineering, and Medicine have just released a 522-page report, but it’s not the usual compilation of guidelines for treatment of a disease. Instead, the authors of “Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action” argue in stark terms that the American society has colossally failed individuals living with sickle cell disease (SCD), who are mostly Black or Brown. A dramatic overhaul of the country’s medical and societal priorities is needed to turn things around to improve health and longevity among this rare disease population.

Courtesy Wikimedia Commons/Osaro Erhabor/Creative Commons License

The findings from the NASEM report are explicit: “There has been substantial success in increasing the survival of children with SCD, but this success had not been translated to similar success as they become adults.” One factor posited to contribute to the slow progress in the improvement of quality and quantity of life for adults living with this disease is the fact that “SCD is largely a disease of African Americans, and as such exists in a context of racial discrimination, health and other societal disparities, mistrust of the health care system, and the effects of poverty.” The report also cites the substantial evidence that those with SCD may receive poorer quality of care.

The report’s 14 authors were made up of an ad hoc committee formed at the request of the Department of Health & Human Services’ Office of Minority Health. The office asked NASEM to convene the committee to develop a strategic plan and blueprint for the United States and others regarding SCD.

The NASEM SCD committee members “realized that we can’t address the medical components of SCD if we don’t explore societal issues and why it’s been so hard to get good care for people with sickle cell disease,” hematologist and report coauthor Ifeyinwa (Ify) Osunkwo, MD, professor of medicine and pediatrics at Atrium Health and director of the Sickle Cell Disease Enterprise, Levine Cancer Institute, Charlotte, N.C., said in an interview. Dr. Osunkwo is also the medical editor of Hematology News.

“After almost a year of meetings and digging into the background and history of SCD care, we came out with very comprehensive summary of where we were and where we want to be,” she said. “The report provides short-, intermediate- and long-term recommendations and identifies which entity and organization should be responsible for implementing them.”

The report authors, led by pediatrician and committee chair Marie Clare McCormick, MD, of the Harvard School of Public Health, Boston, stated that about 100,000 people in the United States and millions worldwide live with SCD. The disease kills more than 700 people per year in the United States, and treatment costs an estimated $2 billion a year.

When judged by disability-adjusted life-years lost – a measurement of expected healthy years of life without an illness – the impact of SCD on individuals is estimated to be greater than a long list of other diseases such as Alzheimer’s disease, breast cancer, type 1 diabetes, and AIDS/HIV, the report noted.

“The health care needs of individuals living with SCD have been neglected by the U.S. and global health care systems, causing them and their families to suffer,” the report said. “Many of the complications that afflict individuals with SCD, particularly pain, are invisible. Pain is only diagnosed by self-reports, and in SCD there are few to no external indicators of the pain experience. Nevertheless, the pain can be excruciatingly severe and requires treatment with strong analgesics.”

There’s even more misery to the story of SCD, the report said, and Dr. Osunkwo agreed. “It’s not just about pain. These individuals suffer from multiple organ-system complications that are physical but also psychological and societal. They experience a lot of disparities in every aspect of their lives. You’re sick, so then you can’t get a job or health insurance, you can’t get Social Security benefits. You can’t get the type of health care you need nor can you access the other forms of support you need and often you are judged as a drug seeker for complaining of pain or repeatedly seeking acute care for unresolved pain.”

Multiple factors exacerbate the experience of people living with SCD in America, the report said. “Because of systemic racism, unconscious bias, and the stigma associated with the diagnosis, the disease brings with it a much broader burden.”

Dr. Osunkwo put it this way: “SCD is a disease that mostly affects Brown and Black people, and that gets layered into the whole discrimination issues that Black and Brown people face compounding the health burden from their disease.”

The report added that “the SCD community has developed a significant lack of trust in the health care system due to the nearly universal stigma and lack of belief in their reports of pain, a lack of trust that has been further reinforced by historical events, such as the Tuskegee experiment.”

The report highlighted research that finds that Blacks “are more likely to receive a lower quality of pain management than white patients and may be perceived as having drug-seeking behavior.”

The report also identified gaps in treatment, noting that “many SCD complications are not restricted to any one organ system, and the impact of the disease on [quality of life] can be profound but hard to define and compartmentalize.”

Dr. Osunkwo said medical professionals often fail to understand the full breadth of the disease. “There’s no particular look to SCD. When you have cancer, you come in, and you look like you’re sick because you’re bald. Everyone clues into that cancer look and knows it’s lethal, that you’re may likely die early. We don’t have that “look that generates empathy” for SCD, and people don’t understand the burden on those affected. They don’t understand or appreciate that SCD shortens your lifespan as well ... that people living with SCD die 3 decades earlier than their ethnically matched peers. Also, SCD is associated with a lot of pain, and pain and the treatment of pain with opioids makes people [health care providers] uncomfortable unless it’s cancer pain.”

She added: “People also assume that, if it’s not pain, it’s not SCD even though SCD can cause leg ulcers and blood clots and even affect the tonsils, or lead to a stroke. When a disease complexity is too difficult for providers to understand, they either avoid it or don’t do anything for the patient.”

Screening and surveillance for SCD and sickle cell trait is insufficient, the report said, and the potential cost of missed childhood cases is large. Detecting the condition at birth allows the implementation of appropriate comprehensive care and treatment to prevent early death from infections and strokes. As the authors noted, “tremendous strides have been made in the past few decades in the care of children with SCD, which have led to almost all children in high-income settings surviving to adulthood.” However, there remains gaps in care coordination and follow-up of babies screened at birth and even bigger gaps in translating these life span gains to adults particularly around the period of transition from pediatrics to adult care when there appears to be a spike in morbidity and mortality.

Dr_Microbe/Thinkstock

The report summarized current treatments for SCD and noted “an influx of pipeline products” after years of little progress and identifies “a need for targeted SCD therapies that address the underlying cause of the disease.”

While treatment recommendations exist, Dr. Osunkwo said, “the evidence for them is very poor and many SCD complications have no evidence-based guidelines for providers to follow. We need more research to provide high quality evidence to make guidelines for SCD treatment stronger and more robust.”

In its final section, the report offers a “strategic plan and blueprint for sickle cell disease action.” It offers several strategies to achieve the vision of “long healthy productive lives for those living with sickle cell disease and sickle cell trait”:

• Establish and fund a research agenda to inform effective programs and policies across the life span.
• Implement efforts to advance understanding of the full impact of sickle cell trait on individuals and society.
• Address barriers to accessing current and pipeline therapies for SCD.
• Improve SCD awareness and strengthen advocacy efforts.
• Increase the number of qualified health professionals providing SCD care.
• Strengthen the evidence base for interventions and disease management and implement widespread efforts to monitor the quality of SCD care.
• Establish organized systems of care assuring both clinical and nonclinical supportive services to all persons living with SCD.
• Establish a national system to collect and link data to characterize the burden of disease, outcomes, and the needs of those with SCD across the life span.

“Right now, the average lifespan for SCD is in the mid-40s to mid-50s,” Dr. Osunkwo said. “That’s a horrible statistic. Even if we just take up half of these recommendations, people will live longer with SCD, and they’ll be more productive and contribute more to society. If we value a cancer life the same as a sickle cell life, we’ll be halfway across the finish line. But the stigma of SCD being a Black and Brown problem is going to be the hardest to confront as it requires a systemic change in our culture as a country and a health care system.”

Still, she said, the commissioning of the report “shows that there is a desire to understand the issue in better detail and try to mitigate it.”

Dr. Osunkwo and Dr. McCormick had no relevant disclosures.

SOURCE: National Academies of Sciences, Engineering, and Medicine. Addressing Sickle Cell Disease: A Strategic Plan and Blueprint for Action. Washington, D.C.: National Academies Press, 2020.

In September, an advisory board to the National Cancer Institute overwhelmingly voted to form a working group to review the continued funding and running of its largest cancer screening trial. But the lone abstaining board member suggested that the reevaluation was a smoke screen for ending the $100 million Tomosynthesis Mammography Imaging Screening Trial (TMIST).

“We’re going to have a working group to kill the trial,” Peter Adamson, MD, of Sanofi, commented in an interpretation of the NCI’s intent. The randomized trial, which began enrolling women in 2017, is comparing tomosynthesis, or three-dimensional (3-D) mammography, with older, less expensive 2-D technology.

The NCI’s move to reevaluate TMIST comes 6 months after Medscape Medical News reported that the projected 165,000-women study was lagging in enrollment of both patients and participating sites/physicians.

Enlisting sites is difficult, in part because radiologists – informed by their experience and previous research results – already believe that the 3-D technology is superior, commented two TMIST study investigators at that time.

Furthermore, experts who were quoted in the Medscape story said that radiology practice in the United States has substantially transitioned to 3-D and will continue to do so. This point was supported by a review of imaging market data.

At the September virtual meeting of the National Cancer Advisory Board, which was first reported by the Cancer Letter, Philip Castle, PhD, MPH, director of the NCI’s division of cancer prevention, said it was “time to reevaluate TMIST’s feasibility and relevance.”

There is also a need to “examine the utility of TMIST, given the unanticipated challenges due to the pandemic,” he said, referring to low accrual of patients in 2020.

TMIST is “a huge budget item,” and accrual has been a problem “for years – essentially since the trial began,” added Ned Sharpless, MD, director of the NCI.

Fourteen advisory board members voted in favor of creating the working group to review the trial. The lone abstention, as noted above, was from Dr. Adamson, who is global head of oncology development and pediatric innovation at Sanofi and is also professor emeritus, University of Pennsylvania, Philadelphia.

Dr. Adamson said that he was “not denying the impact” of COVID-19 but speculated that other clinical trials have had the same problem.

He also wondered whether COVID-19 was an “excuse” for bringing TMIST to a “public forum” and objected to the fact that TMIST investigators were not present and had not been invited to offer “an action plan” to remedy their trial’s woes.

Dr. Castle explained that COVID-19 had reduced TMIST’s monthly patient accrual by 50% from March to August, compared with recent preceding months. The underaccrual “will likely result in delayed outcomes and escalating costs.”

However, TMIST was staggeringly behind in accrual even before COVID-19. The trial has averaged less than 1,500 women a month over the past 2 years, yet it needed to average 5,500 a month to meet accrual goals, Dr. Castle noted.

Further, Dr. Castle suggested that TMIST’s contribution to mammography practice may be negligible, citing three factors: changes in the imaging market, earlier research results, and other ongoing major trials of 3-D mammography.

“[The] relevance of the [TMIST] data by the completion of the trial is uncertain because of 3-D market ... penetrance by the conclusion of the trial,” Dr. Castle said. Even with optimistic accrual projections, study completion and reporting would occur somewhere between 2029 and 2032 – not in 2025, as originally planned.

Currently, 68% of certified mammography facilities in the United States have one or more 3-D units, and 40% of all units are 3-D, he noted. (However, as previously reported, this latter statistic on total units is likely an undercount because all 3-D units have a built-in 2-D function, but the two components in a single machine are equally counted by the Food and Drug Administration – even when 3-D is exclusively used.)

Dr. Castle also summarized earlier observational and randomized trial data on tomosynthesis mammography: “Evidence is already available suggesting that 3-D is no worse and probably better than 2-D.”

Additionally, he reviewed three other European mammography trials involving 3-D technology (in the United Kingdom, Germany, and Norway) and said that they will contribute “additional informative data.”

Notably, Dr. Adamson did not object to these critical points but said the “approach” taken by the NCI advisory board at this meeting was “incredibly disturbing.”

Dr. Castle defended himself, saying “nowhere” in his presentation was there any mention that the trial would be “shut down.”

Dr. Sharpless then interjected: “There is no easy way to do this. TMIST is the most troubled of our trials [in prevention and screening] from an accrual point of view.”
 

TMIST investigators respond

A pair of TMIST investigators commented about the NCI’s planned reevaluation – and what it means.

Etta D. Pisano, MD, the study’s principal investigator, accented the positive: “We have heard nothing of suspending TMIST and are ready to work with NCI to reach TMIST endpoints more efficiently,” she said in an interview.

She also offered a positive spin on TMIST enrollment and trial site enlistment. “Enrollment quadrupled and trial sites doubled in the 14 months prior to the COVID-19 pandemic. An unheard of 19% of the 30,000 women enrolled at 99 sites are African American.”

The trial has “momentum,” said Dr. Pisano, who is also chief research officer at the American College of Radiology.

Dr. Castle, however, noted that enrollment is far behind schedule; the 30,000 women who have been enrolled so far represent less than a quarter of the planned enrollment of 165,000 women, due by the end of 2020.

TMIST is designed to learn whether 3-D mammography is better at finding – and reducing the rate of – potentially lethal cancers than older 2-D technology.

Most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). This allows radiologists to flip through the images like pages in a book and is considered to offer a superior read of the breast.

TMIST uses “advanced” breast cancers as a novel surrogate outcome. The trial period is 4.5 years, during which women are screened annually to determine which imaging technology results in fewer advanced cancers. These include larger HER2-positive and triple-negative malignancies; those associated with positive nodes; and metastatic disease.

These malignancies correlate with breast cancer mortality, Dr. Pisano said.

“We need this trial to help us learn how to improve the process for identifying high-risk patients and how to utilize both of these technologies better,” said Mitchell Schnall, MD, PhD, from the University of Pennsylvania. He is cochair of the ECOG-ACRIN trial group, which is corunning TMIST.

“Look, we all know that 3-D sees more lesions, but consequently, more women are having additional procedures, including biopsies and excisions. The question that TMIST asks is whether that huge expenditure of time, money, and psychological stress is worth it in terms of better outcomes for each person who has the experience,” Dr. Schnall said in an interview.

“One size should not fit all in breast cancer screening, and the TMIST trial can show the way to a precision approach to screening,” he said.

But, earlier this year, Daniel Kopans, MD, professor of radiology, Harvard Medical School, Boston, said in an interview that TMIST is a “huge waste of money.”

He believes that “radiologists who are experienced in using [3-D] for screening will not go back.

“It would be malpractice since they know there are cancers that they will miss on [2-D] that they can find on tomosynthesis,” said Dr. Kopans. He was involved in the development of the first 3-D unit but no longer profits from its sales because his group’s patent has expired.

TMIST was conceived before 3-D mammogram took off clinically, which may explain the trial’s enrollment and site participation woes. In the lag time between the initial trial design (2012) and study start date (2017), clinical practice in the United States and Canada shifted quickly to embrace the newer technology.

This article first appeared on Medscape.com.

In September, an advisory board to the National Cancer Institute overwhelmingly voted to form a working group to review the continued funding and running of its largest cancer screening trial. But the lone abstaining board member suggested that the reevaluation was a smoke screen for ending the $100 million Tomosynthesis Mammography Imaging Screening Trial (TMIST).

“We’re going to have a working group to kill the trial,” Peter Adamson, MD, of Sanofi, commented in an interpretation of the NCI’s intent. The randomized trial, which began enrolling women in 2017, is comparing tomosynthesis, or three-dimensional (3-D) mammography, with older, less expensive 2-D technology.

The NCI’s move to reevaluate TMIST comes 6 months after Medscape Medical News reported that the projected 165,000-women study was lagging in enrollment of both patients and participating sites/physicians.

Enlisting sites is difficult, in part because radiologists – informed by their experience and previous research results – already believe that the 3-D technology is superior, commented two TMIST study investigators at that time.

Furthermore, experts who were quoted in the Medscape story said that radiology practice in the United States has substantially transitioned to 3-D and will continue to do so. This point was supported by a review of imaging market data.

At the September virtual meeting of the National Cancer Advisory Board, which was first reported by the Cancer Letter, Philip Castle, PhD, MPH, director of the NCI’s division of cancer prevention, said it was “time to reevaluate TMIST’s feasibility and relevance.”

There is also a need to “examine the utility of TMIST, given the unanticipated challenges due to the pandemic,” he said, referring to low accrual of patients in 2020.

TMIST is “a huge budget item,” and accrual has been a problem “for years – essentially since the trial began,” added Ned Sharpless, MD, director of the NCI.

Fourteen advisory board members voted in favor of creating the working group to review the trial. The lone abstention, as noted above, was from Dr. Adamson, who is global head of oncology development and pediatric innovation at Sanofi and is also professor emeritus, University of Pennsylvania, Philadelphia.

Dr. Adamson said that he was “not denying the impact” of COVID-19 but speculated that other clinical trials have had the same problem.

He also wondered whether COVID-19 was an “excuse” for bringing TMIST to a “public forum” and objected to the fact that TMIST investigators were not present and had not been invited to offer “an action plan” to remedy their trial’s woes.

Dr. Castle explained that COVID-19 had reduced TMIST’s monthly patient accrual by 50% from March to August, compared with recent preceding months. The underaccrual “will likely result in delayed outcomes and escalating costs.”

However, TMIST was staggeringly behind in accrual even before COVID-19. The trial has averaged less than 1,500 women a month over the past 2 years, yet it needed to average 5,500 a month to meet accrual goals, Dr. Castle noted.

Further, Dr. Castle suggested that TMIST’s contribution to mammography practice may be negligible, citing three factors: changes in the imaging market, earlier research results, and other ongoing major trials of 3-D mammography.

“[The] relevance of the [TMIST] data by the completion of the trial is uncertain because of 3-D market ... penetrance by the conclusion of the trial,” Dr. Castle said. Even with optimistic accrual projections, study completion and reporting would occur somewhere between 2029 and 2032 – not in 2025, as originally planned.

Currently, 68% of certified mammography facilities in the United States have one or more 3-D units, and 40% of all units are 3-D, he noted. (However, as previously reported, this latter statistic on total units is likely an undercount because all 3-D units have a built-in 2-D function, but the two components in a single machine are equally counted by the Food and Drug Administration – even when 3-D is exclusively used.)

Dr. Castle also summarized earlier observational and randomized trial data on tomosynthesis mammography: “Evidence is already available suggesting that 3-D is no worse and probably better than 2-D.”

Additionally, he reviewed three other European mammography trials involving 3-D technology (in the United Kingdom, Germany, and Norway) and said that they will contribute “additional informative data.”

Notably, Dr. Adamson did not object to these critical points but said the “approach” taken by the NCI advisory board at this meeting was “incredibly disturbing.”

Dr. Castle defended himself, saying “nowhere” in his presentation was there any mention that the trial would be “shut down.”

Dr. Sharpless then interjected: “There is no easy way to do this. TMIST is the most troubled of our trials [in prevention and screening] from an accrual point of view.”
 

TMIST investigators respond

A pair of TMIST investigators commented about the NCI’s planned reevaluation – and what it means.

Etta D. Pisano, MD, the study’s principal investigator, accented the positive: “We have heard nothing of suspending TMIST and are ready to work with NCI to reach TMIST endpoints more efficiently,” she said in an interview.

She also offered a positive spin on TMIST enrollment and trial site enlistment. “Enrollment quadrupled and trial sites doubled in the 14 months prior to the COVID-19 pandemic. An unheard of 19% of the 30,000 women enrolled at 99 sites are African American.”

The trial has “momentum,” said Dr. Pisano, who is also chief research officer at the American College of Radiology.

Dr. Castle, however, noted that enrollment is far behind schedule; the 30,000 women who have been enrolled so far represent less than a quarter of the planned enrollment of 165,000 women, due by the end of 2020.

TMIST is designed to learn whether 3-D mammography is better at finding – and reducing the rate of – potentially lethal cancers than older 2-D technology.

Most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). This allows radiologists to flip through the images like pages in a book and is considered to offer a superior read of the breast.

TMIST uses “advanced” breast cancers as a novel surrogate outcome. The trial period is 4.5 years, during which women are screened annually to determine which imaging technology results in fewer advanced cancers. These include larger HER2-positive and triple-negative malignancies; those associated with positive nodes; and metastatic disease.

These malignancies correlate with breast cancer mortality, Dr. Pisano said.

“We need this trial to help us learn how to improve the process for identifying high-risk patients and how to utilize both of these technologies better,” said Mitchell Schnall, MD, PhD, from the University of Pennsylvania. He is cochair of the ECOG-ACRIN trial group, which is corunning TMIST.

“Look, we all know that 3-D sees more lesions, but consequently, more women are having additional procedures, including biopsies and excisions. The question that TMIST asks is whether that huge expenditure of time, money, and psychological stress is worth it in terms of better outcomes for each person who has the experience,” Dr. Schnall said in an interview.

“One size should not fit all in breast cancer screening, and the TMIST trial can show the way to a precision approach to screening,” he said.

But, earlier this year, Daniel Kopans, MD, professor of radiology, Harvard Medical School, Boston, said in an interview that TMIST is a “huge waste of money.”

He believes that “radiologists who are experienced in using [3-D] for screening will not go back.

“It would be malpractice since they know there are cancers that they will miss on [2-D] that they can find on tomosynthesis,” said Dr. Kopans. He was involved in the development of the first 3-D unit but no longer profits from its sales because his group’s patent has expired.

TMIST was conceived before 3-D mammogram took off clinically, which may explain the trial’s enrollment and site participation woes. In the lag time between the initial trial design (2012) and study start date (2017), clinical practice in the United States and Canada shifted quickly to embrace the newer technology.

This article first appeared on Medscape.com.

In September, an advisory board to the National Cancer Institute overwhelmingly voted to form a working group to review the continued funding and running of its largest cancer screening trial. But the lone abstaining board member suggested that the reevaluation was a smoke screen for ending the $100 million Tomosynthesis Mammography Imaging Screening Trial (TMIST).

“We’re going to have a working group to kill the trial,” Peter Adamson, MD, of Sanofi, commented in an interpretation of the NCI’s intent. The randomized trial, which began enrolling women in 2017, is comparing tomosynthesis, or three-dimensional (3-D) mammography, with older, less expensive 2-D technology.

The NCI’s move to reevaluate TMIST comes 6 months after Medscape Medical News reported that the projected 165,000-women study was lagging in enrollment of both patients and participating sites/physicians.

Enlisting sites is difficult, in part because radiologists – informed by their experience and previous research results – already believe that the 3-D technology is superior, commented two TMIST study investigators at that time.

Furthermore, experts who were quoted in the Medscape story said that radiology practice in the United States has substantially transitioned to 3-D and will continue to do so. This point was supported by a review of imaging market data.

At the September virtual meeting of the National Cancer Advisory Board, which was first reported by the Cancer Letter, Philip Castle, PhD, MPH, director of the NCI’s division of cancer prevention, said it was “time to reevaluate TMIST’s feasibility and relevance.”

There is also a need to “examine the utility of TMIST, given the unanticipated challenges due to the pandemic,” he said, referring to low accrual of patients in 2020.

TMIST is “a huge budget item,” and accrual has been a problem “for years – essentially since the trial began,” added Ned Sharpless, MD, director of the NCI.

Fourteen advisory board members voted in favor of creating the working group to review the trial. The lone abstention, as noted above, was from Dr. Adamson, who is global head of oncology development and pediatric innovation at Sanofi and is also professor emeritus, University of Pennsylvania, Philadelphia.

Dr. Adamson said that he was “not denying the impact” of COVID-19 but speculated that other clinical trials have had the same problem.

He also wondered whether COVID-19 was an “excuse” for bringing TMIST to a “public forum” and objected to the fact that TMIST investigators were not present and had not been invited to offer “an action plan” to remedy their trial’s woes.

Dr. Castle explained that COVID-19 had reduced TMIST’s monthly patient accrual by 50% from March to August, compared with recent preceding months. The underaccrual “will likely result in delayed outcomes and escalating costs.”

However, TMIST was staggeringly behind in accrual even before COVID-19. The trial has averaged less than 1,500 women a month over the past 2 years, yet it needed to average 5,500 a month to meet accrual goals, Dr. Castle noted.

Further, Dr. Castle suggested that TMIST’s contribution to mammography practice may be negligible, citing three factors: changes in the imaging market, earlier research results, and other ongoing major trials of 3-D mammography.

“[The] relevance of the [TMIST] data by the completion of the trial is uncertain because of 3-D market ... penetrance by the conclusion of the trial,” Dr. Castle said. Even with optimistic accrual projections, study completion and reporting would occur somewhere between 2029 and 2032 – not in 2025, as originally planned.

Currently, 68% of certified mammography facilities in the United States have one or more 3-D units, and 40% of all units are 3-D, he noted. (However, as previously reported, this latter statistic on total units is likely an undercount because all 3-D units have a built-in 2-D function, but the two components in a single machine are equally counted by the Food and Drug Administration – even when 3-D is exclusively used.)

Dr. Castle also summarized earlier observational and randomized trial data on tomosynthesis mammography: “Evidence is already available suggesting that 3-D is no worse and probably better than 2-D.”

Additionally, he reviewed three other European mammography trials involving 3-D technology (in the United Kingdom, Germany, and Norway) and said that they will contribute “additional informative data.”

Notably, Dr. Adamson did not object to these critical points but said the “approach” taken by the NCI advisory board at this meeting was “incredibly disturbing.”

Dr. Castle defended himself, saying “nowhere” in his presentation was there any mention that the trial would be “shut down.”

Dr. Sharpless then interjected: “There is no easy way to do this. TMIST is the most troubled of our trials [in prevention and screening] from an accrual point of view.”
 

TMIST investigators respond

A pair of TMIST investigators commented about the NCI’s planned reevaluation – and what it means.

Etta D. Pisano, MD, the study’s principal investigator, accented the positive: “We have heard nothing of suspending TMIST and are ready to work with NCI to reach TMIST endpoints more efficiently,” she said in an interview.

She also offered a positive spin on TMIST enrollment and trial site enlistment. “Enrollment quadrupled and trial sites doubled in the 14 months prior to the COVID-19 pandemic. An unheard of 19% of the 30,000 women enrolled at 99 sites are African American.”

The trial has “momentum,” said Dr. Pisano, who is also chief research officer at the American College of Radiology.

Dr. Castle, however, noted that enrollment is far behind schedule; the 30,000 women who have been enrolled so far represent less than a quarter of the planned enrollment of 165,000 women, due by the end of 2020.

TMIST is designed to learn whether 3-D mammography is better at finding – and reducing the rate of – potentially lethal cancers than older 2-D technology.

Most 3-D systems are used in conjunction with 2-D. First, two static images of the breast are taken (2-D), and then the unit moves in an arc, taking multiple images of the breast (3-D). This allows radiologists to flip through the images like pages in a book and is considered to offer a superior read of the breast.

TMIST uses “advanced” breast cancers as a novel surrogate outcome. The trial period is 4.5 years, during which women are screened annually to determine which imaging technology results in fewer advanced cancers. These include larger HER2-positive and triple-negative malignancies; those associated with positive nodes; and metastatic disease.

These malignancies correlate with breast cancer mortality, Dr. Pisano said.

“We need this trial to help us learn how to improve the process for identifying high-risk patients and how to utilize both of these technologies better,” said Mitchell Schnall, MD, PhD, from the University of Pennsylvania. He is cochair of the ECOG-ACRIN trial group, which is corunning TMIST.

“Look, we all know that 3-D sees more lesions, but consequently, more women are having additional procedures, including biopsies and excisions. The question that TMIST asks is whether that huge expenditure of time, money, and psychological stress is worth it in terms of better outcomes for each person who has the experience,” Dr. Schnall said in an interview.

“One size should not fit all in breast cancer screening, and the TMIST trial can show the way to a precision approach to screening,” he said.

But, earlier this year, Daniel Kopans, MD, professor of radiology, Harvard Medical School, Boston, said in an interview that TMIST is a “huge waste of money.”

He believes that “radiologists who are experienced in using [3-D] for screening will not go back.

“It would be malpractice since they know there are cancers that they will miss on [2-D] that they can find on tomosynthesis,” said Dr. Kopans. He was involved in the development of the first 3-D unit but no longer profits from its sales because his group’s patent has expired.

TMIST was conceived before 3-D mammogram took off clinically, which may explain the trial’s enrollment and site participation woes. In the lag time between the initial trial design (2012) and study start date (2017), clinical practice in the United States and Canada shifted quickly to embrace the newer technology.

This article first appeared on Medscape.com.

Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 38,516 child cases reported during the week ending Sept. 17 bring the cumulative number to 587,948, which is 10.3% of all COVID-19 cases. The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.

Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.

The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.

Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.

rfranki@mdedge.com

Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 38,516 child cases reported during the week ending Sept. 17 bring the cumulative number to 587,948, which is 10.3% of all COVID-19 cases. The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.

Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.

The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.

Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.

rfranki@mdedge.com

Children continue to represent an increasing proportion of reported COVID-19 cases in the United States, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

The 38,516 child cases reported during the week ending Sept. 17 bring the cumulative number to 587,948, which is 10.3% of all COVID-19 cases. The previous week, children represented 10.0% of all cases, and that proportion has continued to rise throughout the pandemic, the AAP and CHA report shows.

Looking at just new cases for the latest week, the 38,000+ pediatric cases made up almost 17% of the 228,396 cases reported for all ages, compared with 16% and 15% the two previous weeks. For the weeks ending Aug. 13 and Aug. 6, the corresponding figures were 8% and 13%, based on the data in the AAP/CHA report, which cover 49 states (New York City but not New York state), the District of Columbia, Puerto Rico, and Guam.

The state with the highest proportion of child COVID-19 cases as of Sept. 17 was Wyoming, with 20.6%, followed by North Dakota at 18.3% and Tennessee at 17.9%. New York City has a cumulative rate of just 3.4%, but New Jersey is the state with the lowest rate at 3.6%. Florida comes in at 5.9% but is using an age range of 0-14 years for children, and Texas has a rate of 6.0% but has reported ages for only 8% of confirmed cases, the AAP and CHA noted.

Severe illness, however, continues to be rare in children. The overall hospitalization rate for children was down to 1.7% among the 26 jurisdictions providing ages as Sept. 17 – down from 1.8% the week before and 2.3% on Aug. 20. The death rate is just 0.02% among 43 jurisdictions, the report said.

rfranki@mdedge.com

More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.

kate_sept2004/E+

Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.

Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
 

Specialist pay gap narrows slightly

As in the past 10 years of the survey, female physicians continue to make less than their male colleagues. The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).

The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.

The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).

“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.

“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.

Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.

The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.

An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.

Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
 

Women more likely than men to live above their means

More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).

Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.

Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.

Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).

Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.

This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).

Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.

Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).

Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
 

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

More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.

kate_sept2004/E+

Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.

Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
 

Specialist pay gap narrows slightly

As in the past 10 years of the survey, female physicians continue to make less than their male colleagues. The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).

The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.

The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).

“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.

“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.

Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.

The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.

An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.

Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
 

Women more likely than men to live above their means

More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).

Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.

Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.

Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).

Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.

This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).

Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.

Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).

Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
 

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

More female physicians are becoming specialists, a Medscape survey finds, and five specialties have seen particularly large increases during the last 5 years.

kate_sept2004/E+

Obstetrician/gynecologists and pediatricians had the largest female representation at 58% and those percentages were both up from 50% in 2015, according to the Medscape Female Physician Compensation Report 2020.

Rheumatology saw a dramatic jump in numbers of women from 29% in 2015 to 54% now. Dermatology increased from 32% to 49%, and family medicine rose from 35% to 43% during that time.
 

Specialist pay gap narrows slightly

As in the past 10 years of the survey, female physicians continue to make less than their male colleagues. The gender gap was the same this year in primary care — women made 25% less ($212,000 vs. $264,000).

The gap in specialists narrowed slightly. Women made 31% less this year ($286,000 vs $375,000) instead of the 33% less reported in last year’s survey, a difference of $89,000 this year.

The gender pay gap was consistent across all race and age groups and was consistent in responses about net worth. Whereas 57% of male physicians had a net worth of $1 million or more, only 40% of female physicians did. Twice as many male physicians as female physicians had a net worth of more than $5 million (10% vs. 5%).

“Many physicians expect the gender pay gap to narrow in the coming years,” John Prescott, MD, chief academic officer of the Association of American Medical Colleges, said in an interview.

“Yet, it is a challenging task, requiring an institutional commitment to transparency, cross-campus collaboration, ongoing communication, dedicated resources, and enlightened leadership,” he said.

Female physicians working in office-based, solo practices made the most overall at $290,000; women in outpatient settings made the least at $223,000.

The survey included more than 4,500 responses. The responses were collected during the early part of the year and do not reflect changes in income expected from the COVID-19 pandemic.

An analysis in Health Affairs, for instance, predicted that primary care practices would lose $67,774 in gross revenue per full-time-equivalent physician in calendar year 2020 because of the pandemic.

Most physicians did not experience a significant financial loss in 2019, but COVID-19 may, at least temporarily, change those answers in next year’s report, physicians predicted.
 

Women more likely than men to live above their means

More women this year (39%) said they live below their means than answered that way last year (31%). Female physicians were more likely to say they lived above their means than were their male counterparts (8% vs. 6%).

Greenwald Wealth Management in St. Louis Park, Minn., says aiming for putting away 20% of total gross salary is a good financial goal.

Women in this year’s survey spent about 7% less time seeing patients than did their male counterparts (35.9 hours a week vs. 38.8). The average for all physicians was 37.8 hours a week. Add the 15.6 average hours per week physicians spend on paperwork, and they are putting in 53-hour workweeks on average overall.

Asked what parts of their job they found most rewarding, women were more likely than were men to say “gratitude/relationships with patients” (31% vs. 25%). They were less likely than were men to answer that the most rewarding part was “being very good at what I do/finding answers/diagnoses” (22% vs. 25%) or “making good money at a job I like” (9% vs. 13%).

Most female physicians — and physicians overall — said they would choose medicine again. But two specialties saw a substantial increase in that answer.

This year, 79% of those in physical medicine and rehabilitation said they would choose medicine again (compared with 66% last year) and 84% of gastroenterologists answered that way (compared with 76% in 2019).

Psychiatrists, however, were in the group least likely to say they would choose their specialty again along with those in internal medicine, family medicine, and diabetes and endocrinology.

Female physicians in orthopedics, radiology, and dermatology were most likely to choose their specialties again (91% - 92%).

Female physicians were less likely to use physician assistants in their practices than were their male colleagues (31% vs. 38%) but more likely to use NPs (52% vs. 50%). More than a third (38%) of male and female physicians reported they use neither.
 

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

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.

Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.

AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.

Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.

AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

President Donald Trump, who seems intent on announcing a COVID-19 vaccine before Election Day, could legally authorize a vaccine over the objections of experts, officials at the Food and Drug Administration and even vaccine manufacturers, who have pledged not to release any vaccine unless it’s proved safe and effective.

In podcasts, public forums, social media and medical journals, a growing number of prominent health leaders say they fear that Mr. Trump – who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA – will take matters into his own hands, running roughshod over the usual regulatory process.

It would reflect another attempt by a norm-breaking administration, poised to ram through a Supreme Court nominee opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions. Mr. Trump has repeatedly contradicted the advice of senior scientists on COVID-19 while pushing controversial treatments for the disease.

If the executive branch were to overrule the FDA’s scientific judgment, a vaccine of limited efficacy and, worse, unknown side effects could be rushed to market.

The worries intensified over the weekend, after Alex Azar, the administration’s secretary of Health & Human Services, asserted his agency’s rule-making authority over the FDA. HHS spokesperson Caitlin Oakley said Mr. Azar’s decision had no bearing on the vaccine approval process.

Vaccines are typically approved by the FDA. Alternatively, Mr. Azar – who reports directly to Mr. Trump – can issue an emergency use authorization, even before any vaccines have been shown to be safe and effective in late-stage clinical trials.

“Yes, this scenario is certainly possible legally and politically,” said Jerry Avorn, MD, a professor of medicine at Harvard Medical School, who outlined such an event in the New England Journal of Medicine. He said it “seems frighteningly more plausible each day.”

Vaccine experts and public health officials are particularly vexed by the possibility because it could ruin the fragile public confidence in a COVID-19 vaccine. It might put scientific authorities in the position of urging people not to be vaccinated after years of coaxing hesitant parents to ignore baseless fears.

Physicians might refuse to administer a vaccine approved with inadequate data, said Preeti Malani, MD, chief health officer and professor of medicine at the University of Michigan in Ann Arbor, in a recent webinar. “You could have a safe, effective vaccine that no one wants to take.” A recent KFF poll found that 54% of Americans would not submit to a COVID-19 vaccine authorized before Election Day.

After this story was published, an HHS official said that Mr. Azar “will defer completely to the FDA” as the agency weighs whether to approve a vaccine produced through the government’s Operation Warp Speed effort.

“The idea the Secretary would approve or authorize a vaccine over the FDA’s objections is preposterous and betrays ignorance of the transparent process that we’re following for the development of the OWS vaccines,” HHS chief of staff Brian Harrison wrote in an email.

White House spokesperson Judd Deere dismissed the scientists’ concerns, saying Trump cared only about the public’s safety and health. “This false narrative that the media and Democrats have created that politics is influencing approvals is not only false but is a danger to the American public,” he said.

Usually, the FDA approves vaccines only after companies submit years of data proving that a vaccine is safe and effective. But a 2004 law allows the FDA to issue an emergency use authorization with much less evidence, as long as the vaccine “may be effective” and its “known and potential benefits” outweigh its “known and potential risks.”

Many scientists doubt a vaccine could meet those criteria before the election. But the terms might be legally vague enough to allow the administration to take such steps.

Moncef Slaoui, chief scientific adviser to Operation Warp Speed, the government program aiming to more quickly develop COVID-19 vaccines, said it’s “extremely unlikely” that vaccine trial results will be ready before the end of October.

Mr. Trump, however, has insisted repeatedly that a vaccine to fight the pandemic that has claimed 200,000 American lives will be distributed starting next month. He reiterated that claim Saturday at a campaign rally in Fayetteville, N.C.

The vaccine will be ready “in a matter of weeks,” he said. “We will end the pandemic from China.”

Although pharmaceutical companies have launched three clinical trials in the United States, no one can say with certainty when those trials will have enough data to determine whether the vaccines are safe and effective.

Officials at Moderna, whose vaccine is being tested in 30,000 volunteers, have said their studies could produce a result by the end of the year, although the final analysis could take place next spring.

Pfizer executives, who have expanded their clinical trial to 44,000 participants, boast that they could know their vaccine works by the end of October.

AstraZeneca’s U.S. vaccine trial, which was scheduled to enroll 30,000 volunteers, is on hold pending an investigation of a possible vaccine-related illness.

Scientists have warned for months that the Trump administration could try to win the election with an “October surprise,” authorizing a vaccine that hasn’t been fully tested. “I don’t think people are crazy to be thinking about all of this,” said William Schultz, a partner in a Washington, D.C., law firm who served as a former FDA commissioner for policy and as general counsel for HHS.

“You’ve got a president saying you’ll have an approval in October. Everybody’s wondering how that could happen.”

In an opinion piece published in the Wall Street Journal, conservative former FDA commissioners Scott Gottlieb and Mark McClellan argued that presidential intrusion was unlikely because the FDA’s “thorough and transparent process doesn’t lend itself to meddling. Any deviation would quickly be apparent.”

But the administration has demonstrated a willingness to bend the agency to its will. The FDA has been criticized for issuing emergency authorizations for two COVID-19 treatments that were boosted by the president but lacked strong evidence to support them: hydroxychloroquine and convalescent plasma.

Mr. Azar has sidelined the FDA in other ways, such as by blocking the agency from regulating lab-developed tests, including tests for the novel coronavirus.

Although FDA Commissioner Stephen Hahn told the Financial Times he would be willing to approve emergency use of a vaccine before large-scale studies conclude, agency officials also have pledged to ensure the safety of any COVID-19 vaccines.

A senior FDA official who oversees vaccine approvals, Peter Marks, MD, has said he will quit if his agency rubber-stamps an unproven COVID-19 vaccine.

“I think there would be an outcry from the public health community second to none, which is my worst nightmare – my worst nightmare – because we will so confuse the public,” said Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, in his weekly podcast.

Still, “even if a company did not want it to be done, even if the FDA did not want it to be done, he could still do that,” said Dr. Osterholm, in his podcast. “I hope that we’d never see that happen, but we have to entertain that’s a possibility.”

In the New England Journal editorial, Dr. Avorn and coauthor Aaron Kesselheim, MD, wondered whether Mr. Trump might invoke the 1950 Defense Production Act to force reluctant drug companies to manufacture their vaccines.

But Mr. Trump would have to sue a company to enforce the Defense Production Act, and the company would have a strong case in refusing, said Lawrence Gostin, director of Georgetown’s O’Neill Institute for National and Global Health Law.

Also, he noted that Mr. Trump could not invoke the Defense Production Act unless a vaccine were “scientifically justified and approved by the FDA.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.