Clinician Reviews

Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.

This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI. 

In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.

They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.

Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.

“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.

“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.

Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.

There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
 

Nationally representative sample, six screening scenarios

In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.

And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.

The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m²) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”

Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)

First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m² and age 35-70 (2021 criteria) and BMI of at least 25 kg/m² and age 40-70 (2015 criteria).

They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.

The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).

Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.

Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m² and age 30-70, BMI of at least 25 kg/m² and age 18-70, age 35-70 and BMI of at least 23 kg/m², and age 35-70 and any BMI.

Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.

However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.

The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.

The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
 

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

Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.

This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI. 

In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.

They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.

Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.

“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.

“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.

Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.

There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
 

Nationally representative sample, six screening scenarios

In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.

And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.

The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m²) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”

Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)

First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m² and age 35-70 (2021 criteria) and BMI of at least 25 kg/m² and age 40-70 (2015 criteria).

They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.

The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).

Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.

Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m² and age 30-70, BMI of at least 25 kg/m² and age 18-70, age 35-70 and BMI of at least 23 kg/m², and age 35-70 and any BMI.

Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.

However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.

The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.

The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
 

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

Universal screening of all U.S. adults aged 35-70 years for prediabetes and type 2 diabetes, regardless of body mass index, would provide the fairest means of detection, according to a new analysis.

This would better detect prediabetes and diabetes in ethnic groups that have a higher risk of diabetes at lower cutoffs. Compared with White individuals, Black or Hispanic adults have a higher risk of developing type 2 diabetes at a younger age, and Asian, Hispanic, and Black Americans all have a higher risk of developing it at a lower BMI. 

In the new study, researchers examined six different screening scenarios in a nationally representative sample without diabetes.

They compared screening for prediabetes and type 2 diabetes using criteria from the 2021 U.S. Preventive Services Task Force (USPSTF) recommendations with the 2015 USPSTF recommendations, as well as four other screening thresholds with lower age or weight.

Universal screening for prediabetes and diabetes at age 35-70, regardless of BMI – which appears to be the sweet spot for most equitable detection in different races – may be easier to put into practice because it will mean clinicians don’t have to remember alternate cutoffs for different patient groups, the researchers suggested.

“All major racial and ethnic minority groups develop diabetes at lower weights than White adults, and it’s most pronounced for Asian Americans,” lead author Matthew J. O’Brien, MD, explained in a press release.

“If we make decisions about diabetes testing based on weight we will miss some people from racial and ethnic minority groups who are developing prediabetes and diabetes at lower weights,” said Dr. O’Brien, of Northwestern University, Chicago.

Going forward, to achieve equity in diagnosing prediabetes and diabetes “also requires addressing structural barriers [facing racial and ethnic minorities], which include not having a usual source of primary care, lacking health insurance, or having copays for screening tests based on insurance coverage,” the authors noted in their paper, published online in the American Journal of Preventive Medicine.

There is also a need for further study to examine the cost-effectiveness of any approach, and to study the impact of screening criteria on diagnosis, treatment, and outcomes in diverse populations.
 

Nationally representative sample, six screening scenarios

In the overall U.S. population, 81% of adults with prediabetes are unaware they have it, said Dr. O’Brien and colleagues, and 23% of diabetes cases are undiagnosed.

And Black, Hispanic, or Asian individuals have a nearly twofold higher prevalence of diabetes compared with White individuals.

The 2021 USPSTF recommendations state that clinicians should screen asymptomatic adults aged 35-70 years with overweight/obesity (BMI ≥ 25 kg/m²) and “should consider screening at an earlier age in persons from groups with disproportionately high incidence and prevalence (American Indian/Alaska Native, Asian American, Black, Hispanic/Latino, or Native Hawaiian/Pacific Islander persons) or in persons who have a family history of diabetes, a history of gestational diabetes, or a history of polycystic ovarian syndrome, and at a lower BMI in Asian American persons. Data suggest that a BMI of 23 or greater may be an appropriate cut point in Asian American persons.”

Dr. O’Brien and colleagues identified 3,243 nonpregnant adults without diagnosed diabetes who participated in the National Health and Nutrition Examination Survey (NHANES) in 2017-2020 and had an A1c blood test. (Half also had a fasting plasma glucose test.)

First, they compared screening using the more recent and earlier USPSTF criteria: BMI of at least 25 kg/m² and age 35-70 (2021 criteria) and BMI of at least 25 kg/m² and age 40-70 (2015 criteria).

They estimated that 13.9 million more adults would be eligible for screening using the 2021 versus the 2015 screening criteria.

The increases in screening eligibility were highest in Hispanic individuals (30.6%), followed by Asian individuals (17.9%), White individuals (14.0%), and Black individuals (13.9%).

Using the USPSTF 2021 versus 2015 screening criteria resulted in marginally higher sensitivity (58.6% vs. 52.9%) but lower specificity (69.3% vs. 76.4%) overall, as well as within each racial group.

Next, the researchers examined screening at two lower age cutoffs and two lower BMI cutoffs: BMI of at least 25 kg/m² and age 30-70, BMI of at least 25 kg/m² and age 18-70, age 35-70 and BMI of at least 23 kg/m², and age 35-70 and any BMI.

Screening at these lower age and weight thresholds resulted in even greater sensitivity and lower specificity than using the 2021 USPSTF criteria, especially among Hispanic, non-Hispanic Black, and Asian adults.

However, screening all adults aged 35-70 years regardless of BMI yielded the most equitable detection of prediabetes and diabetes – with a sensitivity of 67.8% and a specificity of 52.1% in the overall population, and a sensitivity of 70.1%, 70.4%, 68.4%, and 67.6%, and a specificity of 53.8%, 59.9%, 56.2%, and 48.9%, in the Asian, Black, Hispanic, and White subgroups, respectively.

The American Diabetes Association currently recommends screening all adults aged ≥ 35 years, or at any age if they have overweight/obesity and an additional diabetes risk factor, the researchers noted.

The study was partly funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. The authors have reported no relevant financial relationships.
 

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

Performing intimate exams under anesthesia (EUA) is a standard part of medical training. Yet, some researchers and opponents argue that pelvic and prostate exams too often occur without explicit patient consent, resulting in a professional breach of conduct that undermines institutional trust, leaves learners morally conflicted, raises racial equity concerns, and has more states stepping in to prohibit the practice.

“Whenever I talk about this at conferences around the country, people always come up to me and say it’s still happening at their institutions,” Lori Bruce, MA, MBE, HEC-C, associate director of the Interdisciplinary Center for Bioethics at Yale University, New Haven, Conn., told this news organization.

Most think this is a women’s issue, which occurs only in unconscious patients, she said. But Ms. Bruce found otherwise in a survey last year in which she polled the general public about their intimate exam experiences.

“Unconsented exams happen much more than we imagined, and they happen as often to men [having] prostate exams without consent as to women. Black [respondents] were nearly four times more likely to have reported receiving an unconsented intimate pelvic or prostate exam,” she said, based on her research. And Ms. Bruce believes it can happen across the economic spectrum.

Concern about unconsented EUAs arose in the early 2000s. In a study at that time, 75% of medical students reported that their patients had not given consent to be examined during surgical procedures. An ethics committee of the American College of Obstetricians and Gynecologists published guidelines for EUAs and states began passing legislation with patient protections and medical training consent policies.

California is believed to be the first to adopt legislation outlawing unconsented pelvic exams for training purposes in 2003, followed by Virginia in 2007, along with a handful of other states.

In 2019, on the heels of the #MeToo movement and renewed calls to end unconsented exams, more patients and providers began to speak publicly about their experiences with the practice. Some posted on social media using the #MeTooPelvic hashtag. In 2022, an award-winning documentary was also released about consent, “At Your Cervix.”More states subsequently passed legislation, and some medical schools strengthened their EUA consent policies.

Today, nearly half the states in the country have enacted laws against unconsented intimate EUAs, with some carrying misdemeanor charges for both the individual conducting the exam and the supervising physician. Other states leave open the option to fine the physician and revoke or suspend medical licenses.

Much of the new legislation requires explicit consent for intimate exams involving the pelvis, prostate, and rectum, with exceptions for emergency procedures and, in some cases, the collection of court-ordered forensic evidence. In addition, several states, including Colorado, Indiana, and Ohio, have pending or recently introduced bills. Last month, sister bills in Missouri passed the House and Senate, gaining more traction than previous legislative attempts. A similar bill was introduced in the Kansas House several times, including this year, and is expected to be on the agenda again in the next session. 

Intimate exams on patients without consent are “unethical and unacceptable,” said Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges. Although medical students learn sensitive procedures through simulation labs and gynecological teaching associates – individuals specifically trained to help students develop physical exam skills –  EUAs require strict adherence to widely accepted guidelines.

“Learners in the clinical setting should only perform such examinations for teaching purposes when the exam is explicitly consented to, related to the planned procedure, performed by a student who is recognized by the patient as a part of their care team, and done under direct supervision by an educator,” Dr. Whelan said.
 

Medical students bear moral burden

Arthur Caplan, PhD, director of medical ethics at New York University, has called unconsented intimate exams a “cousin issue” to abusive predatory behavior.

If the public is outraged that physicians “have misused their authority with athletes, then we should be equally outraged if that authority, even for a higher purpose [like] teaching and training, is still misused in terms of getting permission and consent,” he said in a video discussing Connecticut’s legislation to strengthen intimate exam requirements, which went into effect Jan. 1.   

Advocates of stricter EUA consent policies say the variability in consent practices destroys patient trust by ignoring the basic principles of respect and autonomy. Because patients are usually unaware a violation has occurred, reporting typically depends on medical students raising questions with educators and attendings, which they may hesitate to do for fear of repercussions.

Current practices, such as patients signing consent documents in the outpatient setting where students aren’t always privy to the discussion, contribute to the lack of transparency, Karampreet Kaur, MD, a 2nd-year ob.gyn. resident at the Hospital of the University of Pennsylvania, Philadelphia, said.

A 2019 survey of medical students by Elle magazine found that nearly half did not meet patients before conducting an intimate EUA. Of the 92% who performed a pelvic EUA, 61% reported doing so without obtaining explicit patient consent.

Dr. Kaur recently coauthored a survey of students from six medical schools and found that 84% completed at least one pelvic EUA during their ob.gyn. clerkships. About half of the students surveyed observed patients giving informed consent most or every time. Of those, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.

This burden weighs on the consciences of medical students. Respondents reported that they wanted to honor patient autonomy but felt they lacked the authority to object to pelvic EUAs when consent was unclear, which led to significant emotional distress.

“It’s not that physicians don’t care,” Dr. Kaur said. “I think most want to make sure patients feel safe and fully informed of the care they are receiving.”
 

To consent or not 

Incorporating a separate EUA consent form, typically signed during a preoperative visit but occasionally on the day of surgery, offers one potential solution as it ensures “clear and consistent language is used and forces documentation of this conversation,” said Dr. Kaur. At her current institution, providers and medical students must review charted EUA documentation, then that information is “made clear to attendings, fellows, residents, students, and even the OR staff,” she said.  

In Dr. Kaur’s survey, 11% of respondents supported a separate consent. Another study of 3rd- and 4th-year medical students published last year found that 45% agreed with having a separate signature line on the surgical consent form.

Legislation introduced recently in Colorado states that medical students must meet the patient, and patients must receive a written or electronic document titled, in at least 18-point bolded font, “consent for examination of breasts, pelvic region, rectum, and/or prostate.” The form must also include the names of medical students performing or observing an intimate exam for educational purposes.

Elizabeth Newman, MPP, public policy director at the Colorado Coalition Against Sexual Assault and supporter of the state’s intimate exam bill, said the legislation will allow medical students to learn the intricacies of these sensitive body systems and provide better patient care, particularly following the rollback of Roe v. Wade.

“Abortion is available and accessible in Colorado, and we are surrounded by states where it’s not,” said Ms. Newman. “Medical students in states where it’s outright banned are coming to Colorado to learn how to provide abortion care in their residencies and fellowships, so we want to maintain that access and not take those learning opportunities away with this law.”

Opponents of a separate form say it complicates the consent process. Dr. Kaur said she originally thought it would involve a lot of extra work, but it only takes 3-5 minutes. Few patients decline the exam after the conversation, and students benefit from the clear guidelines and transparency, she said.

“I had hoped that the many medical association guidelines [supporting] explicit consent would have influenced hospital policy, but it did not have that effect,” said Ms. Bruce, adding that recent legislative efforts have largely been driven by concerned bioethicists, lawmakers, and some medical students and physicians. “It all circles back to the patient having the right to refuse; it’s their body.”

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

Performing intimate exams under anesthesia (EUA) is a standard part of medical training. Yet, some researchers and opponents argue that pelvic and prostate exams too often occur without explicit patient consent, resulting in a professional breach of conduct that undermines institutional trust, leaves learners morally conflicted, raises racial equity concerns, and has more states stepping in to prohibit the practice.

“Whenever I talk about this at conferences around the country, people always come up to me and say it’s still happening at their institutions,” Lori Bruce, MA, MBE, HEC-C, associate director of the Interdisciplinary Center for Bioethics at Yale University, New Haven, Conn., told this news organization.

Most think this is a women’s issue, which occurs only in unconscious patients, she said. But Ms. Bruce found otherwise in a survey last year in which she polled the general public about their intimate exam experiences.

“Unconsented exams happen much more than we imagined, and they happen as often to men [having] prostate exams without consent as to women. Black [respondents] were nearly four times more likely to have reported receiving an unconsented intimate pelvic or prostate exam,” she said, based on her research. And Ms. Bruce believes it can happen across the economic spectrum.

Concern about unconsented EUAs arose in the early 2000s. In a study at that time, 75% of medical students reported that their patients had not given consent to be examined during surgical procedures. An ethics committee of the American College of Obstetricians and Gynecologists published guidelines for EUAs and states began passing legislation with patient protections and medical training consent policies.

California is believed to be the first to adopt legislation outlawing unconsented pelvic exams for training purposes in 2003, followed by Virginia in 2007, along with a handful of other states.

In 2019, on the heels of the #MeToo movement and renewed calls to end unconsented exams, more patients and providers began to speak publicly about their experiences with the practice. Some posted on social media using the #MeTooPelvic hashtag. In 2022, an award-winning documentary was also released about consent, “At Your Cervix.”More states subsequently passed legislation, and some medical schools strengthened their EUA consent policies.

Today, nearly half the states in the country have enacted laws against unconsented intimate EUAs, with some carrying misdemeanor charges for both the individual conducting the exam and the supervising physician. Other states leave open the option to fine the physician and revoke or suspend medical licenses.

Much of the new legislation requires explicit consent for intimate exams involving the pelvis, prostate, and rectum, with exceptions for emergency procedures and, in some cases, the collection of court-ordered forensic evidence. In addition, several states, including Colorado, Indiana, and Ohio, have pending or recently introduced bills. Last month, sister bills in Missouri passed the House and Senate, gaining more traction than previous legislative attempts. A similar bill was introduced in the Kansas House several times, including this year, and is expected to be on the agenda again in the next session. 

Intimate exams on patients without consent are “unethical and unacceptable,” said Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges. Although medical students learn sensitive procedures through simulation labs and gynecological teaching associates – individuals specifically trained to help students develop physical exam skills –  EUAs require strict adherence to widely accepted guidelines.

“Learners in the clinical setting should only perform such examinations for teaching purposes when the exam is explicitly consented to, related to the planned procedure, performed by a student who is recognized by the patient as a part of their care team, and done under direct supervision by an educator,” Dr. Whelan said.
 

Medical students bear moral burden

Arthur Caplan, PhD, director of medical ethics at New York University, has called unconsented intimate exams a “cousin issue” to abusive predatory behavior.

If the public is outraged that physicians “have misused their authority with athletes, then we should be equally outraged if that authority, even for a higher purpose [like] teaching and training, is still misused in terms of getting permission and consent,” he said in a video discussing Connecticut’s legislation to strengthen intimate exam requirements, which went into effect Jan. 1.   

Advocates of stricter EUA consent policies say the variability in consent practices destroys patient trust by ignoring the basic principles of respect and autonomy. Because patients are usually unaware a violation has occurred, reporting typically depends on medical students raising questions with educators and attendings, which they may hesitate to do for fear of repercussions.

Current practices, such as patients signing consent documents in the outpatient setting where students aren’t always privy to the discussion, contribute to the lack of transparency, Karampreet Kaur, MD, a 2nd-year ob.gyn. resident at the Hospital of the University of Pennsylvania, Philadelphia, said.

A 2019 survey of medical students by Elle magazine found that nearly half did not meet patients before conducting an intimate EUA. Of the 92% who performed a pelvic EUA, 61% reported doing so without obtaining explicit patient consent.

Dr. Kaur recently coauthored a survey of students from six medical schools and found that 84% completed at least one pelvic EUA during their ob.gyn. clerkships. About half of the students surveyed observed patients giving informed consent most or every time. Of those, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.

This burden weighs on the consciences of medical students. Respondents reported that they wanted to honor patient autonomy but felt they lacked the authority to object to pelvic EUAs when consent was unclear, which led to significant emotional distress.

“It’s not that physicians don’t care,” Dr. Kaur said. “I think most want to make sure patients feel safe and fully informed of the care they are receiving.”
 

To consent or not 

Incorporating a separate EUA consent form, typically signed during a preoperative visit but occasionally on the day of surgery, offers one potential solution as it ensures “clear and consistent language is used and forces documentation of this conversation,” said Dr. Kaur. At her current institution, providers and medical students must review charted EUA documentation, then that information is “made clear to attendings, fellows, residents, students, and even the OR staff,” she said.  

In Dr. Kaur’s survey, 11% of respondents supported a separate consent. Another study of 3rd- and 4th-year medical students published last year found that 45% agreed with having a separate signature line on the surgical consent form.

Legislation introduced recently in Colorado states that medical students must meet the patient, and patients must receive a written or electronic document titled, in at least 18-point bolded font, “consent for examination of breasts, pelvic region, rectum, and/or prostate.” The form must also include the names of medical students performing or observing an intimate exam for educational purposes.

Elizabeth Newman, MPP, public policy director at the Colorado Coalition Against Sexual Assault and supporter of the state’s intimate exam bill, said the legislation will allow medical students to learn the intricacies of these sensitive body systems and provide better patient care, particularly following the rollback of Roe v. Wade.

“Abortion is available and accessible in Colorado, and we are surrounded by states where it’s not,” said Ms. Newman. “Medical students in states where it’s outright banned are coming to Colorado to learn how to provide abortion care in their residencies and fellowships, so we want to maintain that access and not take those learning opportunities away with this law.”

Opponents of a separate form say it complicates the consent process. Dr. Kaur said she originally thought it would involve a lot of extra work, but it only takes 3-5 minutes. Few patients decline the exam after the conversation, and students benefit from the clear guidelines and transparency, she said.

“I had hoped that the many medical association guidelines [supporting] explicit consent would have influenced hospital policy, but it did not have that effect,” said Ms. Bruce, adding that recent legislative efforts have largely been driven by concerned bioethicists, lawmakers, and some medical students and physicians. “It all circles back to the patient having the right to refuse; it’s their body.”

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

Performing intimate exams under anesthesia (EUA) is a standard part of medical training. Yet, some researchers and opponents argue that pelvic and prostate exams too often occur without explicit patient consent, resulting in a professional breach of conduct that undermines institutional trust, leaves learners morally conflicted, raises racial equity concerns, and has more states stepping in to prohibit the practice.

“Whenever I talk about this at conferences around the country, people always come up to me and say it’s still happening at their institutions,” Lori Bruce, MA, MBE, HEC-C, associate director of the Interdisciplinary Center for Bioethics at Yale University, New Haven, Conn., told this news organization.

Most think this is a women’s issue, which occurs only in unconscious patients, she said. But Ms. Bruce found otherwise in a survey last year in which she polled the general public about their intimate exam experiences.

“Unconsented exams happen much more than we imagined, and they happen as often to men [having] prostate exams without consent as to women. Black [respondents] were nearly four times more likely to have reported receiving an unconsented intimate pelvic or prostate exam,” she said, based on her research. And Ms. Bruce believes it can happen across the economic spectrum.

Concern about unconsented EUAs arose in the early 2000s. In a study at that time, 75% of medical students reported that their patients had not given consent to be examined during surgical procedures. An ethics committee of the American College of Obstetricians and Gynecologists published guidelines for EUAs and states began passing legislation with patient protections and medical training consent policies.

California is believed to be the first to adopt legislation outlawing unconsented pelvic exams for training purposes in 2003, followed by Virginia in 2007, along with a handful of other states.

In 2019, on the heels of the #MeToo movement and renewed calls to end unconsented exams, more patients and providers began to speak publicly about their experiences with the practice. Some posted on social media using the #MeTooPelvic hashtag. In 2022, an award-winning documentary was also released about consent, “At Your Cervix.”More states subsequently passed legislation, and some medical schools strengthened their EUA consent policies.

Today, nearly half the states in the country have enacted laws against unconsented intimate EUAs, with some carrying misdemeanor charges for both the individual conducting the exam and the supervising physician. Other states leave open the option to fine the physician and revoke or suspend medical licenses.

Much of the new legislation requires explicit consent for intimate exams involving the pelvis, prostate, and rectum, with exceptions for emergency procedures and, in some cases, the collection of court-ordered forensic evidence. In addition, several states, including Colorado, Indiana, and Ohio, have pending or recently introduced bills. Last month, sister bills in Missouri passed the House and Senate, gaining more traction than previous legislative attempts. A similar bill was introduced in the Kansas House several times, including this year, and is expected to be on the agenda again in the next session. 

Intimate exams on patients without consent are “unethical and unacceptable,” said Alison Whelan, MD, chief academic officer of the Association of American Medical Colleges. Although medical students learn sensitive procedures through simulation labs and gynecological teaching associates – individuals specifically trained to help students develop physical exam skills –  EUAs require strict adherence to widely accepted guidelines.

“Learners in the clinical setting should only perform such examinations for teaching purposes when the exam is explicitly consented to, related to the planned procedure, performed by a student who is recognized by the patient as a part of their care team, and done under direct supervision by an educator,” Dr. Whelan said.
 

Medical students bear moral burden

Arthur Caplan, PhD, director of medical ethics at New York University, has called unconsented intimate exams a “cousin issue” to abusive predatory behavior.

If the public is outraged that physicians “have misused their authority with athletes, then we should be equally outraged if that authority, even for a higher purpose [like] teaching and training, is still misused in terms of getting permission and consent,” he said in a video discussing Connecticut’s legislation to strengthen intimate exam requirements, which went into effect Jan. 1.   

Advocates of stricter EUA consent policies say the variability in consent practices destroys patient trust by ignoring the basic principles of respect and autonomy. Because patients are usually unaware a violation has occurred, reporting typically depends on medical students raising questions with educators and attendings, which they may hesitate to do for fear of repercussions.

Current practices, such as patients signing consent documents in the outpatient setting where students aren’t always privy to the discussion, contribute to the lack of transparency, Karampreet Kaur, MD, a 2nd-year ob.gyn. resident at the Hospital of the University of Pennsylvania, Philadelphia, said.

A 2019 survey of medical students by Elle magazine found that nearly half did not meet patients before conducting an intimate EUA. Of the 92% who performed a pelvic EUA, 61% reported doing so without obtaining explicit patient consent.

Dr. Kaur recently coauthored a survey of students from six medical schools and found that 84% completed at least one pelvic EUA during their ob.gyn. clerkships. About half of the students surveyed observed patients giving informed consent most or every time. Of those, 67% reported they never or rarely witnessed an explicit explanation that a medical student may perform a pelvic EUA.

This burden weighs on the consciences of medical students. Respondents reported that they wanted to honor patient autonomy but felt they lacked the authority to object to pelvic EUAs when consent was unclear, which led to significant emotional distress.

“It’s not that physicians don’t care,” Dr. Kaur said. “I think most want to make sure patients feel safe and fully informed of the care they are receiving.”
 

To consent or not 

Incorporating a separate EUA consent form, typically signed during a preoperative visit but occasionally on the day of surgery, offers one potential solution as it ensures “clear and consistent language is used and forces documentation of this conversation,” said Dr. Kaur. At her current institution, providers and medical students must review charted EUA documentation, then that information is “made clear to attendings, fellows, residents, students, and even the OR staff,” she said.  

In Dr. Kaur’s survey, 11% of respondents supported a separate consent. Another study of 3rd- and 4th-year medical students published last year found that 45% agreed with having a separate signature line on the surgical consent form.

Legislation introduced recently in Colorado states that medical students must meet the patient, and patients must receive a written or electronic document titled, in at least 18-point bolded font, “consent for examination of breasts, pelvic region, rectum, and/or prostate.” The form must also include the names of medical students performing or observing an intimate exam for educational purposes.

Elizabeth Newman, MPP, public policy director at the Colorado Coalition Against Sexual Assault and supporter of the state’s intimate exam bill, said the legislation will allow medical students to learn the intricacies of these sensitive body systems and provide better patient care, particularly following the rollback of Roe v. Wade.

“Abortion is available and accessible in Colorado, and we are surrounded by states where it’s not,” said Ms. Newman. “Medical students in states where it’s outright banned are coming to Colorado to learn how to provide abortion care in their residencies and fellowships, so we want to maintain that access and not take those learning opportunities away with this law.”

Opponents of a separate form say it complicates the consent process. Dr. Kaur said she originally thought it would involve a lot of extra work, but it only takes 3-5 minutes. Few patients decline the exam after the conversation, and students benefit from the clear guidelines and transparency, she said.

“I had hoped that the many medical association guidelines [supporting] explicit consent would have influenced hospital policy, but it did not have that effect,” said Ms. Bruce, adding that recent legislative efforts have largely been driven by concerned bioethicists, lawmakers, and some medical students and physicians. “It all circles back to the patient having the right to refuse; it’s their body.”

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

Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.

Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.

Ja'Crispy/iStock/Getty Images Plus

Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.

The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.

Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.

“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.

Overall, an increase of 10 mcg/m³ in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO₂, respectively (all P < .001).

The risks of dying from CVD were similar 1 and 2 days after the polluted day.

An increase in PM levels, but not NO₂, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO₂.

When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.

In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.

When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.

The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
 

Gender differences rooted in anatomy

When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.

The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.

The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
 

Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.

Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.

Ja&#039;Crispy/iStock/Getty Images Plus

Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.

The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.

Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.

“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.

Overall, an increase of 10 mcg/m³ in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO₂, respectively (all P < .001).

The risks of dying from CVD were similar 1 and 2 days after the polluted day.

An increase in PM levels, but not NO₂, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO₂.

When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.

In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.

When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.

The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
 

Gender differences rooted in anatomy

When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.

The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.

The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
 

Cardiovascular disease deaths were significantly more common on days of high pollution and for the following 2 days, compared with other days, based on data from nearly 88,000 deaths over a 5-year period.

Previous research has shown the harmful effect of air pollution on human health in highly polluted areas, but Eastern Poland, a region with so-called “Polish smog” has exceptionally high levels of pollution. However, the specific impact of Polish smog, caused primarily by burning coal, on cardiovascular disease (CVD) mortality has not been well studied, said Michal Swieczkowski, MD, of the Medical University of Bialystok (Poland) in a presentation at the annual congress of the European Association of Preventive Cardiology.

Ja&#039;Crispy/iStock/Getty Images Plus

Dr. Swieczkowski and colleagues reviewed all-cause deaths from five main cities in Eastern Poland during 2016-2020 for associations with pollution levels and days when deaths occurred. Mortality data were obtained from the Central Statistical Office. Air pollution concentrations for two types of particulate matter (PM2.5, PM10) and nitrogen oxide were collected from the Voivodeship Inspectorate for Environmental Protection. The main sources of the pollutants were road traffic and household heaters using coal or wood.

The final analysis included nearly 6 million person-years of follow-up. The researchers used a time-stratified case-crossover design. For each participant, the researchers compared levels of each pollutant on the day of the week a death occurred (such as a Wednesday) with pollutant levels on the same day of the week without any deaths in the same month (the remaining Wednesdays of that month). This design eliminated the potential confounding effects of participant characteristics, including other cardiovascular risk factors such as smoking and hyperlipidemia, and time trends. Essentially, participants “served as their own controls,” Dr. Swieczkowski said. The researchers conducted similar analyses for pollution levels 1 day and 2 days before a death occurred.

Overall, 87,990 deaths were identified during the study period; of these, 34,907 were from CVD, 9,688 from acute coronary syndromes, and 3,776 from ischemic stroke.

“Exposure to PM2.5 and PM10 was associated with increased mortality on the day of exposure, the next day, and up to 2 days after exposure,” said Dr. Swieczkowski.

Overall, an increase of 10 mcg/m³ in the three pollutants was significantly associated with increase in CVD mortality on the day of exposure to the increased pollution levels, with odds ratios of 1.034, 1.033, and 1.083 for PM2.5, PM10, and NO₂, respectively (all P < .001).

The risks of dying from CVD were similar 1 and 2 days after the polluted day.

An increase in PM levels, but not NO₂, was significantly associated with acute coronary syndrome (ACS) on the day of exposure to increased pollutants (ORs, 1.029 for PM2.5 [P = .002] and 1.015 [P = .049] for PM10). Both ischemic stroke and ACS mortality were significantly higher at 1 day after exposure, compared with other days. Ischemic stroke was associated with increases in PM2.5 and PM10, while ACS was associated with increases in PM2.5, PM10, and NO₂.

When stratified by gender, the effects were more noticeable in women, Dr. Swieczkowski said. “Exposure to both types of particulate caused increased mortality due to acute coronary syndrome as well as ischemic stroke.” Among men, only death from acute coronary syndrome was significantly associated with exposure to increased particulate matter.

In a head-to-head comparison, women were more vulnerable to air pollution by up to 2.5%, he added.

When stratified by age, the effects of all three pollutants were associated with increased risk of death from ischemic stroke and ACS in participants older than 65 years. For those aged 65 years and younger, the only significant association was between ACS-associated mortality and ischemic stroke.

The results suggest “a special need for developing calculators to estimate the risk of CVD incidence depending on the place of residence that could be used for everyday practice,” said Dr. Swieczkowski. “Systemic changes should become a priority for policy makers, and, simultaneously, we as physicians should educate and protect our patients, especially those with high risk of cardiovascular disease,” he said.
 

Gender differences rooted in anatomy

When asked for an explanation of the difference in the impact of pollution on mortality between men and women, Dr. Swieczkowski explained that women are likely more vulnerable because of differences in anatomy of the pharynx and larynx, and breathing patterns. Previous studies have shown that air pollution causes more oxidative stress in women. Also, in the current study, the mean age of the women was 8 to 9 years older, he said.

The study design was an “elegant way to take away the impact of other cardiovascular risk factors,” noted session moderator Maryam Kavousi, MD, of Erasmus University Medical Center, Rotterdam, the Netherlands.

The study was supported by the National Science Centre, Poland. The researchers had no financial conflicts to disclose.
 

The 30-second commercial, part of the government’s We Can Do This campaign, shows everyday people going about their lives, then reminds them that, “because COVID is still out there and so are you,” it might be time to update your vaccine.

But in real life, the message that COVID-19 is still a major concern is muffled if not absent for many. Many data tracking sources, both federal and others, are no longer reporting, as often, the number of COVID cases, hospitalizations, and deaths. 

The Department of Health & Human Services in February stopped updating its public COVID data site, instead directing all queries to the Centers for Disease Control and Prevention, which itself has been updating only weekly instead of daily since 2022. 

Nongovernmental sources, such as John Hopkins University, stopped reporting pandemic data in March, The New York Times also ended its COVID data-gathering project in March, stating that “the comprehensive real-time reporting that The Times has prioritized is no longer possible.” It will rely on reporting weekly CDC data moving forward. 

Along with the tracking sites, masking and social distancing mandates have mostly disappeared. President Joe Biden signed a bipartisan bill on April 10 that ended the national emergency for COVID. While some programs will stay in place for now, such as free vaccines, treatments, and tests, that too will go away when the federal public health emergency expires on May 11. The HHS already has issued its transition roadmap.

Many Americans, meanwhile, are still on the fence about the pandemic. A Gallup poll from March shows that about half of the American public say it’s over, and about half disagree. 

Are we closing up shop on COVID-19 too soon, or is it time? Not surprisingly, experts don’t agree. Some say the pandemic is now endemic – which broadly means the virus and its patterns are predictable and steady in designated regions – and that it’s critical to catch up on health needs neglected during the pandemic, such as screenings and other vaccinations

But others don’t think it’s reached that stage yet, saying that we are letting our guard down too soon and we can’t be blind to the possibility of another strong variant – or pandemic – emerging. Surveillance must continue, not decline, and be improved.
 

Time to move on?

In its transition roadmap released in February, the HHS notes that daily COVID reported cases are down over 90%, compared with the peak of the Omicron surge at the end of January 2022; deaths have declined by over 80%; and new hospitalizations caused by COVID have dropped by nearly 80%.

It is time to move on, said Ali Mokdad, PhD, a professor and chief strategy officer of population health at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. 

“Many people were delaying a lot of medical care, because they were afraid” during COVID’s height, he said, explaining that elective surgeries were postponed, prenatal care went down, as did screenings for blood pressure and diabetes.

His institute was tracking COVID projections every week but stopped in December.

As for emerging variants, “we haven’t seen a variant that scares us since Omicron” in November 2021, said Dr. Mokdad, who agrees that COVID is endemic now. The subvariants that followed it are very similar, and the current vaccines are working. 

“We can move on, but we cannot drop the ball on keeping an eye on the genetic sequencing of the virus,” he said. That will enable quick identification of new variants.

If a worrisome new variant does surface, Dr. Mokdad said, certain locations and resources will be able to gear up quickly, while others won’t be as fast, but overall the United States is in a much better position now. 

Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, also believes the pandemic phase is behind us

“This can’t be an emergency in perpetuity,” he said “Just because something is not a pandemic [anymore] does not mean that all activities related to it cease.”

COVID is highly unlikely to overwhelm hospitals again, and that was the main reason for the emergency declaration, he said. 

“It’s not all or none – collapsing COVID-related [monitoring] activities into the routine monitoring that is done for other infectious disease should be seen as an achievement in taming the virus,” he said.
 

Not endemic yet

Closing up shop too early could mean we are blindsided, said Rajendram Rajnarayanan, PhD, an assistant dean of research and associate professor at the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro. 

Already, he said, large labs have closed or scaled down as testing demand has declined, and many centers that offered community testing have also closed. Plus, home test results are often not reported.

Continued monitoring is key, he said. “You have to maintain a base level of sequencing for new variants,” he said. “Right now, the variant that is ‘top dog’ in the world is XBB.1.16.” 

That’s an Omicron subvariant that the World Health Organization is currently keeping its eye on, according to a media briefing on March 29. There are about 800 sequences of it from 22 countries, mostly India, and it’s been in circulation a few months. 

Dr. Rajnarayanan said he’s not overly worried about this variant, but surveillance must continue. His own breakdown of XBB.1.16 found the subvariant in 27 countries, including the United States, as of April 10.

Ideally, Dr. Rajnarayanan would suggest four areas to keep focusing on, moving forward:

• Active, random surveillance for new variants, especially in hot spots.
• Hospital surveillance and surveillance of long-term care, especially in congregate settings where people can more easily spread the virus.
• Travelers’ surveillance, now at , according to the CDC.
• Surveillance of animals such as mink and deer, because these animals can not only pick up the virus, but the virus can mutate in the animals, which could then transmit it back to people. 

With less testing, baseline surveillance for new variants has declined. The other three surveillance areas need improvement, too, he said, as the reporting is often delayed. 

Continued surveillance is crucial, agreed Katelyn Jetelina, PhD, an epidemiologist and data scientist who publishes a newsletter, Your Local Epidemiologist, updating developments in COVID and other pressing health issues. 

“It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars,” said Dr. Jetelina, who is also director of population health analytics for the Meadows Mental Health Policy Institute. “COVID-19 is still going to be here, it’s still going to mutate,” and still cause grief for those affected. “I’m most concerned about our ability to track the virus. It’s not clear what surveillance we will still have in the states and around the globe.” 

It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars.

For surveillance, she calls wastewater monitoring “the lowest-hanging fruit.” That’s because it “is not based on bias testing and has the potential to help with other outbreaks, too.” Hospitalization data is also essential, she said, as that information is the basis for public health decisions on updated vaccines and other protective measures.

While Dr. Jetelina is hopeful that COVID will someday be universally viewed as endemic, with predictable seasonal patterns, “I don’t think we are there yet. We still need to approach this virus with humility; that’s at least what I will continue to do.”

Dr. Rajnarayanan agreed that the pandemic has not yet reached endemic phase, though the situation is much improved. “Our vaccines are still protecting us from severe disease and hospitalization, and [the antiviral drug] Paxlovid is a great tool that works.”
 

Keeping tabs

While some data tracking has been eliminated, not all has, or will be. The CDC, as mentioned, continues to post cases, deaths, and a daily average of new hospital admissions weekly. The WHO’s dashboard tracks deaths, cases, and vaccine doses globally. 

In March, the WHO updated its working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest, with goals of evaluating the sublineages independently and to classify new variants more clearly when that’s needed. 

Still, WHO is considering ending its declaration of COVID as a public health emergency of international concern sometime in 2023.

Some public companies are staying vigilant. The drugstore chain Walgreens said it plans to maintain its COVID-19 Index, which launched in January 2022. 

“Data regarding spread of variants is important to our understanding of viral transmission and, as new variants emerge, it will be critical to continue to track this information quickly to predict which communities are most at risk,” Anita Patel, PharmD, vice president of pharmacy services development for Walgreens, said in a statement.

The data also reinforces the importance of vaccinations and testing in helping to stop the spread of COVID-19, she said.

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

The 30-second commercial, part of the government’s We Can Do This campaign, shows everyday people going about their lives, then reminds them that, “because COVID is still out there and so are you,” it might be time to update your vaccine.

But in real life, the message that COVID-19 is still a major concern is muffled if not absent for many. Many data tracking sources, both federal and others, are no longer reporting, as often, the number of COVID cases, hospitalizations, and deaths. 

The Department of Health & Human Services in February stopped updating its public COVID data site, instead directing all queries to the Centers for Disease Control and Prevention, which itself has been updating only weekly instead of daily since 2022. 

Nongovernmental sources, such as John Hopkins University, stopped reporting pandemic data in March, The New York Times also ended its COVID data-gathering project in March, stating that “the comprehensive real-time reporting that The Times has prioritized is no longer possible.” It will rely on reporting weekly CDC data moving forward. 

Along with the tracking sites, masking and social distancing mandates have mostly disappeared. President Joe Biden signed a bipartisan bill on April 10 that ended the national emergency for COVID. While some programs will stay in place for now, such as free vaccines, treatments, and tests, that too will go away when the federal public health emergency expires on May 11. The HHS already has issued its transition roadmap.

Many Americans, meanwhile, are still on the fence about the pandemic. A Gallup poll from March shows that about half of the American public say it’s over, and about half disagree. 

Are we closing up shop on COVID-19 too soon, or is it time? Not surprisingly, experts don’t agree. Some say the pandemic is now endemic – which broadly means the virus and its patterns are predictable and steady in designated regions – and that it’s critical to catch up on health needs neglected during the pandemic, such as screenings and other vaccinations

But others don’t think it’s reached that stage yet, saying that we are letting our guard down too soon and we can’t be blind to the possibility of another strong variant – or pandemic – emerging. Surveillance must continue, not decline, and be improved.
 

Time to move on?

In its transition roadmap released in February, the HHS notes that daily COVID reported cases are down over 90%, compared with the peak of the Omicron surge at the end of January 2022; deaths have declined by over 80%; and new hospitalizations caused by COVID have dropped by nearly 80%.

It is time to move on, said Ali Mokdad, PhD, a professor and chief strategy officer of population health at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. 

“Many people were delaying a lot of medical care, because they were afraid” during COVID’s height, he said, explaining that elective surgeries were postponed, prenatal care went down, as did screenings for blood pressure and diabetes.

His institute was tracking COVID projections every week but stopped in December.

As for emerging variants, “we haven’t seen a variant that scares us since Omicron” in November 2021, said Dr. Mokdad, who agrees that COVID is endemic now. The subvariants that followed it are very similar, and the current vaccines are working. 

“We can move on, but we cannot drop the ball on keeping an eye on the genetic sequencing of the virus,” he said. That will enable quick identification of new variants.

If a worrisome new variant does surface, Dr. Mokdad said, certain locations and resources will be able to gear up quickly, while others won’t be as fast, but overall the United States is in a much better position now. 

Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, also believes the pandemic phase is behind us

“This can’t be an emergency in perpetuity,” he said “Just because something is not a pandemic [anymore] does not mean that all activities related to it cease.”

COVID is highly unlikely to overwhelm hospitals again, and that was the main reason for the emergency declaration, he said. 

“It’s not all or none – collapsing COVID-related [monitoring] activities into the routine monitoring that is done for other infectious disease should be seen as an achievement in taming the virus,” he said.
 

Not endemic yet

Closing up shop too early could mean we are blindsided, said Rajendram Rajnarayanan, PhD, an assistant dean of research and associate professor at the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro. 

Already, he said, large labs have closed or scaled down as testing demand has declined, and many centers that offered community testing have also closed. Plus, home test results are often not reported.

Continued monitoring is key, he said. “You have to maintain a base level of sequencing for new variants,” he said. “Right now, the variant that is ‘top dog’ in the world is XBB.1.16.” 

That’s an Omicron subvariant that the World Health Organization is currently keeping its eye on, according to a media briefing on March 29. There are about 800 sequences of it from 22 countries, mostly India, and it’s been in circulation a few months. 

Dr. Rajnarayanan said he’s not overly worried about this variant, but surveillance must continue. His own breakdown of XBB.1.16 found the subvariant in 27 countries, including the United States, as of April 10.

Ideally, Dr. Rajnarayanan would suggest four areas to keep focusing on, moving forward:

• Active, random surveillance for new variants, especially in hot spots.
• Hospital surveillance and surveillance of long-term care, especially in congregate settings where people can more easily spread the virus.
• Travelers’ surveillance, now at , according to the CDC.
• Surveillance of animals such as mink and deer, because these animals can not only pick up the virus, but the virus can mutate in the animals, which could then transmit it back to people. 

With less testing, baseline surveillance for new variants has declined. The other three surveillance areas need improvement, too, he said, as the reporting is often delayed. 

Continued surveillance is crucial, agreed Katelyn Jetelina, PhD, an epidemiologist and data scientist who publishes a newsletter, Your Local Epidemiologist, updating developments in COVID and other pressing health issues. 

“It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars,” said Dr. Jetelina, who is also director of population health analytics for the Meadows Mental Health Policy Institute. “COVID-19 is still going to be here, it’s still going to mutate,” and still cause grief for those affected. “I’m most concerned about our ability to track the virus. It’s not clear what surveillance we will still have in the states and around the globe.” 

It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars.

For surveillance, she calls wastewater monitoring “the lowest-hanging fruit.” That’s because it “is not based on bias testing and has the potential to help with other outbreaks, too.” Hospitalization data is also essential, she said, as that information is the basis for public health decisions on updated vaccines and other protective measures.

While Dr. Jetelina is hopeful that COVID will someday be universally viewed as endemic, with predictable seasonal patterns, “I don’t think we are there yet. We still need to approach this virus with humility; that’s at least what I will continue to do.”

Dr. Rajnarayanan agreed that the pandemic has not yet reached endemic phase, though the situation is much improved. “Our vaccines are still protecting us from severe disease and hospitalization, and [the antiviral drug] Paxlovid is a great tool that works.”
 

Keeping tabs

While some data tracking has been eliminated, not all has, or will be. The CDC, as mentioned, continues to post cases, deaths, and a daily average of new hospital admissions weekly. The WHO’s dashboard tracks deaths, cases, and vaccine doses globally. 

In March, the WHO updated its working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest, with goals of evaluating the sublineages independently and to classify new variants more clearly when that’s needed. 

Still, WHO is considering ending its declaration of COVID as a public health emergency of international concern sometime in 2023.

Some public companies are staying vigilant. The drugstore chain Walgreens said it plans to maintain its COVID-19 Index, which launched in January 2022. 

“Data regarding spread of variants is important to our understanding of viral transmission and, as new variants emerge, it will be critical to continue to track this information quickly to predict which communities are most at risk,” Anita Patel, PharmD, vice president of pharmacy services development for Walgreens, said in a statement.

The data also reinforces the importance of vaccinations and testing in helping to stop the spread of COVID-19, she said.

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

The 30-second commercial, part of the government’s We Can Do This campaign, shows everyday people going about their lives, then reminds them that, “because COVID is still out there and so are you,” it might be time to update your vaccine.

But in real life, the message that COVID-19 is still a major concern is muffled if not absent for many. Many data tracking sources, both federal and others, are no longer reporting, as often, the number of COVID cases, hospitalizations, and deaths. 

The Department of Health & Human Services in February stopped updating its public COVID data site, instead directing all queries to the Centers for Disease Control and Prevention, which itself has been updating only weekly instead of daily since 2022. 

Nongovernmental sources, such as John Hopkins University, stopped reporting pandemic data in March, The New York Times also ended its COVID data-gathering project in March, stating that “the comprehensive real-time reporting that The Times has prioritized is no longer possible.” It will rely on reporting weekly CDC data moving forward. 

Along with the tracking sites, masking and social distancing mandates have mostly disappeared. President Joe Biden signed a bipartisan bill on April 10 that ended the national emergency for COVID. While some programs will stay in place for now, such as free vaccines, treatments, and tests, that too will go away when the federal public health emergency expires on May 11. The HHS already has issued its transition roadmap.

Many Americans, meanwhile, are still on the fence about the pandemic. A Gallup poll from March shows that about half of the American public say it’s over, and about half disagree. 

Are we closing up shop on COVID-19 too soon, or is it time? Not surprisingly, experts don’t agree. Some say the pandemic is now endemic – which broadly means the virus and its patterns are predictable and steady in designated regions – and that it’s critical to catch up on health needs neglected during the pandemic, such as screenings and other vaccinations

But others don’t think it’s reached that stage yet, saying that we are letting our guard down too soon and we can’t be blind to the possibility of another strong variant – or pandemic – emerging. Surveillance must continue, not decline, and be improved.
 

Time to move on?

In its transition roadmap released in February, the HHS notes that daily COVID reported cases are down over 90%, compared with the peak of the Omicron surge at the end of January 2022; deaths have declined by over 80%; and new hospitalizations caused by COVID have dropped by nearly 80%.

It is time to move on, said Ali Mokdad, PhD, a professor and chief strategy officer of population health at the Institute for Health Metrics and Evaluation at the University of Washington, Seattle. 

“Many people were delaying a lot of medical care, because they were afraid” during COVID’s height, he said, explaining that elective surgeries were postponed, prenatal care went down, as did screenings for blood pressure and diabetes.

His institute was tracking COVID projections every week but stopped in December.

As for emerging variants, “we haven’t seen a variant that scares us since Omicron” in November 2021, said Dr. Mokdad, who agrees that COVID is endemic now. The subvariants that followed it are very similar, and the current vaccines are working. 

“We can move on, but we cannot drop the ball on keeping an eye on the genetic sequencing of the virus,” he said. That will enable quick identification of new variants.

If a worrisome new variant does surface, Dr. Mokdad said, certain locations and resources will be able to gear up quickly, while others won’t be as fast, but overall the United States is in a much better position now. 

Amesh Adalja, MD, a senior scholar at the Johns Hopkins Center for Health Security, Baltimore, also believes the pandemic phase is behind us

“This can’t be an emergency in perpetuity,” he said “Just because something is not a pandemic [anymore] does not mean that all activities related to it cease.”

COVID is highly unlikely to overwhelm hospitals again, and that was the main reason for the emergency declaration, he said. 

“It’s not all or none – collapsing COVID-related [monitoring] activities into the routine monitoring that is done for other infectious disease should be seen as an achievement in taming the virus,” he said.
 

Not endemic yet

Closing up shop too early could mean we are blindsided, said Rajendram Rajnarayanan, PhD, an assistant dean of research and associate professor at the New York Institute of Technology College of Osteopathic Medicine at Arkansas State University in Jonesboro. 

Already, he said, large labs have closed or scaled down as testing demand has declined, and many centers that offered community testing have also closed. Plus, home test results are often not reported.

Continued monitoring is key, he said. “You have to maintain a base level of sequencing for new variants,” he said. “Right now, the variant that is ‘top dog’ in the world is XBB.1.16.” 

That’s an Omicron subvariant that the World Health Organization is currently keeping its eye on, according to a media briefing on March 29. There are about 800 sequences of it from 22 countries, mostly India, and it’s been in circulation a few months. 

Dr. Rajnarayanan said he’s not overly worried about this variant, but surveillance must continue. His own breakdown of XBB.1.16 found the subvariant in 27 countries, including the United States, as of April 10.

Ideally, Dr. Rajnarayanan would suggest four areas to keep focusing on, moving forward:

• Active, random surveillance for new variants, especially in hot spots.
• Hospital surveillance and surveillance of long-term care, especially in congregate settings where people can more easily spread the virus.
• Travelers’ surveillance, now at , according to the CDC.
• Surveillance of animals such as mink and deer, because these animals can not only pick up the virus, but the virus can mutate in the animals, which could then transmit it back to people. 

With less testing, baseline surveillance for new variants has declined. The other three surveillance areas need improvement, too, he said, as the reporting is often delayed. 

Continued surveillance is crucial, agreed Katelyn Jetelina, PhD, an epidemiologist and data scientist who publishes a newsletter, Your Local Epidemiologist, updating developments in COVID and other pressing health issues. 

“It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars,” said Dr. Jetelina, who is also director of population health analytics for the Meadows Mental Health Policy Institute. “COVID-19 is still going to be here, it’s still going to mutate,” and still cause grief for those affected. “I’m most concerned about our ability to track the virus. It’s not clear what surveillance we will still have in the states and around the globe.” 

It’s a bit ironic to have a date for the end of a public health emergency; viruses don’t care about calendars.

For surveillance, she calls wastewater monitoring “the lowest-hanging fruit.” That’s because it “is not based on bias testing and has the potential to help with other outbreaks, too.” Hospitalization data is also essential, she said, as that information is the basis for public health decisions on updated vaccines and other protective measures.

While Dr. Jetelina is hopeful that COVID will someday be universally viewed as endemic, with predictable seasonal patterns, “I don’t think we are there yet. We still need to approach this virus with humility; that’s at least what I will continue to do.”

Dr. Rajnarayanan agreed that the pandemic has not yet reached endemic phase, though the situation is much improved. “Our vaccines are still protecting us from severe disease and hospitalization, and [the antiviral drug] Paxlovid is a great tool that works.”
 

Keeping tabs

While some data tracking has been eliminated, not all has, or will be. The CDC, as mentioned, continues to post cases, deaths, and a daily average of new hospital admissions weekly. The WHO’s dashboard tracks deaths, cases, and vaccine doses globally. 

In March, the WHO updated its working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest, with goals of evaluating the sublineages independently and to classify new variants more clearly when that’s needed. 

Still, WHO is considering ending its declaration of COVID as a public health emergency of international concern sometime in 2023.

Some public companies are staying vigilant. The drugstore chain Walgreens said it plans to maintain its COVID-19 Index, which launched in January 2022. 

“Data regarding spread of variants is important to our understanding of viral transmission and, as new variants emerge, it will be critical to continue to track this information quickly to predict which communities are most at risk,” Anita Patel, PharmD, vice president of pharmacy services development for Walgreens, said in a statement.

The data also reinforces the importance of vaccinations and testing in helping to stop the spread of COVID-19, she said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

Life expectancy in New York City fell to 78 years from 2019 to 2020, a 4.6-year drop mostly caused by the COVID-19 pandemic, NYC Health said in releasing its annual summary of vital statistics. 

Non-White demographic groups had the highest drops. Life expectancy fell to 73 years for Black New Yorkers (a 5.5-year drop from 2019) and 77.3 years for Hispanic/Latino New Yorkers (a 6-year drop.) For White New Yorkers life expectancy only fell to 80.1 years (about a 3-year drop.)

Overall, the city had a mortality rate of 241.3 deaths per 100,000 population in 2020. That’s even higher than the 228.9 deaths per 100,000 reported during the 2018 influenza pandemic, NYC Health said in a news release. 

“The sharp decline in life expectancy from 2019 was largely due to the COVID-19 pandemic,” said NYC Health Commissioner Ashwin Vasan, MD.

Another factor was a 42.2% rise in unintentional drug overdoses from 2019 to 2020. Again, racial disparities were highlighted, with the drug-related death rate highest among Black New Yorkers.

The pandemic also affected the premature death rate, meaning deaths before age 65. That rate went up 48.8% from 2019 to 2020. In the 8 previous years, from 2011 to 2019, it fell 8.6%“New Yorkers’ lifespans are falling, on top of years of relative flattening before COVID, and that cannot continue,” Dr. Vasan said in a news release. 

“It is the great challenge of our time, our city, and our Department to lay out an agenda for the next era of public health, to reverse these trends, and set us out on a new path where all New Yorkers can lead healthier, longer lives,” Dr. Vasan said.

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

A new study has shown a substantial variation in the blood pressure response to various antihypertensive medications between individuals, raising the possibility of future personalized therapy.

“We found that using the optimal antihypertensive drug for a particular patient resulted in an average of a 4.4 mm Hg greater reduction of blood pressure compared with a random choice of the other drugs. That is quite a substantial difference, and could be equivalent to adding in another drug,” lead author Johan Sundström, MD, Uppsala (Sweden) University Hospital, told this news organization.

Vishnu Kumar/Thinkstock

“These preliminary findings suggest that some people may be better treated with one antihypertensive drug rather than another. This is opening up the field of hypertension for personalized medicine,” he added.

The study was published online in the Journal of the American Medical Association.

The authors noted that despite global access to multiple classes of highly effective blood pressure-lowering drugs, only one in four women and one in five men with hypertension reach treatment targets. While most hypertension guidelines advocate combination pharmacotherapy, many patients in routine care continue to be treated with monotherapy, with adverse effects and nonadherence being important clinical problems.

“One drug often does not give enough blood pressure reduction, but patients are often reluctant to up-titrate to two drugs,” Dr. Sundström said. “While we know that the four recommended classes of antihypertensives lower blood pressure equally well on average, we don’t know if their efficacy is the same in individual patients.

“We wondered whether there could be different optimal drugs for different people, and if we could identify the optimal drug for each person then maybe more patients could get to target levels with just one drug,” he said.

The researchers conducted a randomized, double-blind, repeated crossover trial at an outpatient research clinic in Sweden, studying 280 men and women with grade 1 hypertension at low risk for cardiovascular events.

Each participant was scheduled for 2 months’ treatment in random order with each of four different classes of antihypertensive drugs: an ACE inhibitor, lisinopril; an angiotensin II blocker, candesartan; a thiazide diuretic, hydrochlorothiazide; a calcium channel blocker, amlodipine.

There were then repeated treatment periods for two drug classes to try to account for any effect of a particular event that might have affected the blood pressure at one point in time. Ambulatory daytime systolic blood pressure was measured at the end of each treatment period.

Results showed that variation in systolic blood pressure was large between treatments on average, between participants on average, within participants taking the same treatment, and between treatments in the same participant.

Overall, personalized treatment using the optimal single-drug therapy led to a 4.4–mm Hg lower systolic blood pressure in the trial population than a random choice of any of the other drug classes.

Taking into consideration that lisinopril was found to be on average the most efficacious of the drugs at the selected doses, personalized treatment compared with lisinopril still led to a 3.1–mm Hg improvement in systolic blood pressure.

The researchers noted that the mean additional blood pressure reduction achievable by using the optimal agent was of a magnitude twice that achieved by doubling the dose of a first drug, and more than half that of adding a second drug on average.

While there were only small differences between certain drugs (e.g., candesartan vs. lisinopril; amlodipine vs. hydrochlorothiazide), for all other comparisons tested, the choice was important, with particularly large gains to be made by personalizing the choice between candesartan vs. amlodipine and between lisinopril vs. amlodipine.

In addition, some people showed very large differences in response to different drugs, whereas others did not have much difference at all.
 

How to identify the optimal drug?

“The million-dollar question is how we identify the best drug for each individual patient,” Dr. Sundström said. “This study has opened Pandora’s box. We now need to figure out how to go forward and how we tailor treatment in each patient.”

In the study, the researchers suggest that personalizing therapy could be achieved either by identifying the phenotypic characteristics that are associated with enhanced response to one treatment vs. another or by directly measuring the individual’s responses to a series of treatments to ascertain which is most effective.

Addressing the first scenario, Dr. Sundström explained: “We can analyze the characteristics of patients who did best on each drug. There are many variables we can look at here such as age, diet, baseline blood pressure, exercise levels, smoking status, race, body weight, salt intake, and findings from genetic tests. We are going to try to look into these to see if we can find any predictors of response to various different drugs.”

For the second strategy, he suggested that patients starting pharmacologic therapy could try a few different treatments. “For example, we could give patients two different drugs and ask them to alternate treatment periods with each of them and measure their blood pressure with a home monitoring kit and record adverse effects.”

Nonadherence “is such a big problem with antihypertensives,” he added. “This approach may allow patients to be more empowered when choosing the right treatment, which should help adherence in the longer term.”
 

‘Proof-of-principle’

Commenting on the study in an accompanying editorial, Robert M. Carey, MD, University of Virginia Health System, Charlottesville, wrote: “At this stage, the findings are more theoretical than immediately practical for the implementation of personalized antihypertensive drug therapy, but the study does provide proof-of-principle and the authors suggest a few scenarios in which a personalized approach could be used in the future.”

He said the practical ramifications of personally targeted therapy remain unclear, given that determination of an individual’s response to a series of short test treatments before selecting long-term therapy may be considered too cumbersome, and currently few phenotypic markers are currently available that would be likely to accurately predict the individual response to a particular therapy.

Dr. Carey concluded that the results of this study “encourage the further pursuit of larger randomized trials using similar repeated crossover designs to validate this concept and eventually in trials with longer follow-up data to determine whether there is improvement in long-term clinical outcomes compared with current strategies.”

He added that the results support the possibility that personalized medical treatment of hypertension “may ultimately supplement or even supplant the current method of antihypertensive drug decision-making in the future.”

This study was supported by the Swedish Research Council; Kjell and Märta Beijer Foundation; and Anders Wiklöf. Dr. Sundström reported owning stock in Symptoms Europe AB and Anagram Kommunikation AB. Coauthor Emil Hagström, MD, PhD, reported receiving grants from Pfizer and Amgen and personal fees from Amgen, Novo Nordisk, Bayer, AstraZeneca, Amarin, and Novartis. Coauthor Ollie Östlund, PhD, reported fees from Uppsala University paid to his institution, Uppsala Clinical Research Center, for its participation in the PHYSIC trial during the conduct of the study. Dr. Carey reports no relevant financial relationships.
 

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

The Food and Drug Administration on April 13 cleared the first patch to reduce excessive underarm sweating for adults with primary axillary hyperhidrosis.

The single-use, disposable, prescription-only patch will be marketed as Brella. It consists of a sodium sheet with an adhesive overlay. A health care provider applies it to the patient’s underarm for up to 3 minutes and then repeats the process on the other underarm.

The developer, Candesant Biomedical, says the patch uses the company’s patented targeted alkali thermolysis (TAT) technology, which was built on the principle that heat is generated when sodium reacts with water in sweat. “The thermal energy created by the sodium sheet is precisely localized, microtargeting sweat glands to significantly reduce sweat production,” according to the company’s press release announcing the FDA decision.

FDA clearance was based on data from the pivotal randomized, double-blind, multicenter SAHARA study, which indicated that the product is effective and well tolerated.

Patients experienced a reduction in sweat that was maintained for 3 months or longer, according to trial results.

The SAHARA trial results were reported in a late-breaking abstract at the annual meeting of the American Academy of Dermatology in March.

The trial enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 (indicating frequent sweating or sweating that always interferes with daily activities). Trial participants were randomly assigned to receive either an active TAT or a sham patch, which was applied for up to 3 minutes.

At the meeting, lead investigator David M. Pariser, MD, a dermatologist practicing in Norfolk, Va., reported that at 4 weeks, 63.6% of patients in the active patch group achieved an HDSS score of 1 or 2, compared with 44.2% of those in the sham treatment group (P = .0332). Also, 43.2% of those in the active-patch group achieved an improvement of 2 points or greater on the HDSS, as compared with 16.3% of those in the sham treatment group (P = .0107) .

In addition, 9.1% of those in the active-patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” Dr. Pariser said at the meeting.

As for adverse events (AEs), 13 patients in the active-patch group experienced AEs at the treatment site. Six patients experienced erythema; four experienced erosion; two experienced burning, itching, or stinging; and one had underarm odor.

“The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” Dr. Pariser said. He noted that most AEs resolved in fewer than 2 weeks, and all AEs were mild to moderate.

According to the International Hyperhidrosis Society, about 1.3 million people in the United States have axillary hyperhidrosis, and about a third report that sweating is barely tolerable and frequently interferes with daily activities or is intolerable and always interferes with daily activities.

The patch will be available within months in select U.S. markets beginning in late summer. The company says the markets will be listed on its website.

A company representative told this news organization that because it is an in-office procedure, pricing will vary, depending on the practice. “With that said, Candesant expects doctors will charge about the same for one session of the Brella SweatControl Patch as they would for a high-end, in-office facial or chemical peel,” the representative said.

Dr. Pariser is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol-Myers Squibb, the Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

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

The Food and Drug Administration on April 13 cleared the first patch to reduce excessive underarm sweating for adults with primary axillary hyperhidrosis.

The single-use, disposable, prescription-only patch will be marketed as Brella. It consists of a sodium sheet with an adhesive overlay. A health care provider applies it to the patient’s underarm for up to 3 minutes and then repeats the process on the other underarm.

The developer, Candesant Biomedical, says the patch uses the company’s patented targeted alkali thermolysis (TAT) technology, which was built on the principle that heat is generated when sodium reacts with water in sweat. “The thermal energy created by the sodium sheet is precisely localized, microtargeting sweat glands to significantly reduce sweat production,” according to the company’s press release announcing the FDA decision.

FDA clearance was based on data from the pivotal randomized, double-blind, multicenter SAHARA study, which indicated that the product is effective and well tolerated.

Patients experienced a reduction in sweat that was maintained for 3 months or longer, according to trial results.

The SAHARA trial results were reported in a late-breaking abstract at the annual meeting of the American Academy of Dermatology in March.

The trial enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 (indicating frequent sweating or sweating that always interferes with daily activities). Trial participants were randomly assigned to receive either an active TAT or a sham patch, which was applied for up to 3 minutes.

At the meeting, lead investigator David M. Pariser, MD, a dermatologist practicing in Norfolk, Va., reported that at 4 weeks, 63.6% of patients in the active patch group achieved an HDSS score of 1 or 2, compared with 44.2% of those in the sham treatment group (P = .0332). Also, 43.2% of those in the active-patch group achieved an improvement of 2 points or greater on the HDSS, as compared with 16.3% of those in the sham treatment group (P = .0107) .

In addition, 9.1% of those in the active-patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” Dr. Pariser said at the meeting.

As for adverse events (AEs), 13 patients in the active-patch group experienced AEs at the treatment site. Six patients experienced erythema; four experienced erosion; two experienced burning, itching, or stinging; and one had underarm odor.

“The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” Dr. Pariser said. He noted that most AEs resolved in fewer than 2 weeks, and all AEs were mild to moderate.

According to the International Hyperhidrosis Society, about 1.3 million people in the United States have axillary hyperhidrosis, and about a third report that sweating is barely tolerable and frequently interferes with daily activities or is intolerable and always interferes with daily activities.

The patch will be available within months in select U.S. markets beginning in late summer. The company says the markets will be listed on its website.

A company representative told this news organization that because it is an in-office procedure, pricing will vary, depending on the practice. “With that said, Candesant expects doctors will charge about the same for one session of the Brella SweatControl Patch as they would for a high-end, in-office facial or chemical peel,” the representative said.

Dr. Pariser is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol-Myers Squibb, the Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

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

The Food and Drug Administration on April 13 cleared the first patch to reduce excessive underarm sweating for adults with primary axillary hyperhidrosis.

The single-use, disposable, prescription-only patch will be marketed as Brella. It consists of a sodium sheet with an adhesive overlay. A health care provider applies it to the patient’s underarm for up to 3 minutes and then repeats the process on the other underarm.

The developer, Candesant Biomedical, says the patch uses the company’s patented targeted alkali thermolysis (TAT) technology, which was built on the principle that heat is generated when sodium reacts with water in sweat. “The thermal energy created by the sodium sheet is precisely localized, microtargeting sweat glands to significantly reduce sweat production,” according to the company’s press release announcing the FDA decision.

FDA clearance was based on data from the pivotal randomized, double-blind, multicenter SAHARA study, which indicated that the product is effective and well tolerated.

Patients experienced a reduction in sweat that was maintained for 3 months or longer, according to trial results.

The SAHARA trial results were reported in a late-breaking abstract at the annual meeting of the American Academy of Dermatology in March.

The trial enrolled 110 individuals with Hyperhidrosis Disease Severity Scale (HDSS) scores of 3 or 4 (indicating frequent sweating or sweating that always interferes with daily activities). Trial participants were randomly assigned to receive either an active TAT or a sham patch, which was applied for up to 3 minutes.

At the meeting, lead investigator David M. Pariser, MD, a dermatologist practicing in Norfolk, Va., reported that at 4 weeks, 63.6% of patients in the active patch group achieved an HDSS score of 1 or 2, compared with 44.2% of those in the sham treatment group (P = .0332). Also, 43.2% of those in the active-patch group achieved an improvement of 2 points or greater on the HDSS, as compared with 16.3% of those in the sham treatment group (P = .0107) .

In addition, 9.1% of those in the active-patch group achieved a 3-point improvement on the HDSS, compared with none in the sham group. “That’s an amazing improvement; you’re basically going from moderate or severe to none,” Dr. Pariser said at the meeting.

As for adverse events (AEs), 13 patients in the active-patch group experienced AEs at the treatment site. Six patients experienced erythema; four experienced erosion; two experienced burning, itching, or stinging; and one had underarm odor.

“The two procedure-related AEs in the TAT-treated group were compensatory sweating and irritant contact dermatitis due to the adhesive,” Dr. Pariser said. He noted that most AEs resolved in fewer than 2 weeks, and all AEs were mild to moderate.

According to the International Hyperhidrosis Society, about 1.3 million people in the United States have axillary hyperhidrosis, and about a third report that sweating is barely tolerable and frequently interferes with daily activities or is intolerable and always interferes with daily activities.

The patch will be available within months in select U.S. markets beginning in late summer. The company says the markets will be listed on its website.

A company representative told this news organization that because it is an in-office procedure, pricing will vary, depending on the practice. “With that said, Candesant expects doctors will charge about the same for one session of the Brella SweatControl Patch as they would for a high-end, in-office facial or chemical peel,” the representative said.

Dr. Pariser is a consultant or investigator for Bickel Biotechnology, Biofrontera AG, Bristol-Myers Squibb, the Celgene Corporation, Novartis Pharmaceuticals, Pfizer, Regeneron, and Sanofi.

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

Although an elevated and pigmented lesion should be considered for possible melanoma, this one had prominent telangiectasias and was proven to be a basal cell carcinoma (BCC) on biopsy.

While the literature often focuses on light-colored skin types and the high risk of skin cancers, individuals with darker skin can also get melanoma and nonmelanoma skin cancer. Half of the BCCs in African American people are pigmented BCCs, compared to less than 10% for Caucasian individuals. Individuals who are Hispanic have twice the likelihood of pigmented BCCs as those who are Caucasian.¹ Pigmented BCCs manifest as darker lesions, as occurred in this individual. Nonpigmented BCCs tend to be pink or pale in color.

Typically, superficial and very small, nodular BCCs can be successfully treated with 2 cycles of electrodesiccation and curettage. EDC should, however, be avoided in low-risk BCCs when these lesions occur in areas of secondary hair growth, such as the beard or scalp. This is because the epidermis follows the hair follicle, and in sites with deep hair follicles, EDC would have to get down to the subcutis to effectively clear the tumor.

For larger, nodular BCCs, full-thickness excision with adequate margins is warranted. For high-risk types, and those in high-risk areas near the nose, eyes, mouth, and ears, Mohs micrographic surgery is recommended to maximize the likelihood of complete excision while minimizing the loss of normal tissue.

Since the physician suspected this was a pigmented BCC, he performed a superficial shave biopsy on a small representative area of the lesion for diagnosis. This patient’s biopsy confirmed a nodular-type pigmented BCC. The lesion was removed in the office with 5-mm margins oriented along the resting skin tension lines with good closure and cosmetic results.

The patient was advised to have routine skin evaluations every 6 months due to the high risk of additional cancers. He was also advised to take oral niacinamide 500 mg twice daily, which can reduce the risk of actinic keratoses and nonmelanoma skin cancers by 15% and 23%, respectively, in those who have had lesions.²

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Although an elevated and pigmented lesion should be considered for possible melanoma, this one had prominent telangiectasias and was proven to be a basal cell carcinoma (BCC) on biopsy.

While the literature often focuses on light-colored skin types and the high risk of skin cancers, individuals with darker skin can also get melanoma and nonmelanoma skin cancer. Half of the BCCs in African American people are pigmented BCCs, compared to less than 10% for Caucasian individuals. Individuals who are Hispanic have twice the likelihood of pigmented BCCs as those who are Caucasian.¹ Pigmented BCCs manifest as darker lesions, as occurred in this individual. Nonpigmented BCCs tend to be pink or pale in color.

Typically, superficial and very small, nodular BCCs can be successfully treated with 2 cycles of electrodesiccation and curettage. EDC should, however, be avoided in low-risk BCCs when these lesions occur in areas of secondary hair growth, such as the beard or scalp. This is because the epidermis follows the hair follicle, and in sites with deep hair follicles, EDC would have to get down to the subcutis to effectively clear the tumor.

For larger, nodular BCCs, full-thickness excision with adequate margins is warranted. For high-risk types, and those in high-risk areas near the nose, eyes, mouth, and ears, Mohs micrographic surgery is recommended to maximize the likelihood of complete excision while minimizing the loss of normal tissue.

Since the physician suspected this was a pigmented BCC, he performed a superficial shave biopsy on a small representative area of the lesion for diagnosis. This patient’s biopsy confirmed a nodular-type pigmented BCC. The lesion was removed in the office with 5-mm margins oriented along the resting skin tension lines with good closure and cosmetic results.

The patient was advised to have routine skin evaluations every 6 months due to the high risk of additional cancers. He was also advised to take oral niacinamide 500 mg twice daily, which can reduce the risk of actinic keratoses and nonmelanoma skin cancers by 15% and 23%, respectively, in those who have had lesions.²

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Although an elevated and pigmented lesion should be considered for possible melanoma, this one had prominent telangiectasias and was proven to be a basal cell carcinoma (BCC) on biopsy.

While the literature often focuses on light-colored skin types and the high risk of skin cancers, individuals with darker skin can also get melanoma and nonmelanoma skin cancer. Half of the BCCs in African American people are pigmented BCCs, compared to less than 10% for Caucasian individuals. Individuals who are Hispanic have twice the likelihood of pigmented BCCs as those who are Caucasian.¹ Pigmented BCCs manifest as darker lesions, as occurred in this individual. Nonpigmented BCCs tend to be pink or pale in color.

Typically, superficial and very small, nodular BCCs can be successfully treated with 2 cycles of electrodesiccation and curettage. EDC should, however, be avoided in low-risk BCCs when these lesions occur in areas of secondary hair growth, such as the beard or scalp. This is because the epidermis follows the hair follicle, and in sites with deep hair follicles, EDC would have to get down to the subcutis to effectively clear the tumor.

For larger, nodular BCCs, full-thickness excision with adequate margins is warranted. For high-risk types, and those in high-risk areas near the nose, eyes, mouth, and ears, Mohs micrographic surgery is recommended to maximize the likelihood of complete excision while minimizing the loss of normal tissue.

Since the physician suspected this was a pigmented BCC, he performed a superficial shave biopsy on a small representative area of the lesion for diagnosis. This patient’s biopsy confirmed a nodular-type pigmented BCC. The lesion was removed in the office with 5-mm margins oriented along the resting skin tension lines with good closure and cosmetic results.

The patient was advised to have routine skin evaluations every 6 months due to the high risk of additional cancers. He was also advised to take oral niacinamide 500 mg twice daily, which can reduce the risk of actinic keratoses and nonmelanoma skin cancers by 15% and 23%, respectively, in those who have had lesions.²

‌

Photo and text courtesy of Daniel Stulberg, MD, FAAFP, Professor and Chair, Department of Family and Community Medicine, Western Michigan University Homer Stryker, MD School of Medicine, Kalamazoo.

Filmmaker Gez Medinger and immunologist Danny Altmann have been dubbed by British media as “COVID’s odd couple,” and they don’t mind at all. Discussing their recent book, The Long COVID Handbook, the authors lean into their animated roles: Medinger is a passionate patient-researcher and “guinea pig” (his words) in search of his own healing, and Altmann is a no-nonsense, data-driven scientist and “Professor Boring” (as he puts it).

And the message they have about the impact of long COVID is stunning.

“The clinical burden [of long COVID] is somewhere on par with the whole of heart disease all over again, or the whole of oncology all over again, which are our biggest clinical bills concurrently,” Altmann said.

The pair met early in the pandemic, after Medinger became infected during the first wave and interviewed Altmann for his YouTube channel, which has more than 5 million views. 

“Danny was one of the first people from the medical establishment to sort of stand up on the parapet and wave a flag and say, ‘Hey, guys, there’s a problem here.’ And that was incredibly validating for 2 million people in the U.K. alone who were suffering with long COVID,” Medinger said. 

Their relationship works, not just for publishing one of the first definitive guides to long COVID, but also as a model for how patients with lived experiences can lead the way in medicine – from giving the condition its name to driving the medical establishment for recognition, clinical research, and therapeutic answers. 

With Altmann currently leading a major research project at Imperial College London on long COVID and Medinger’s social media platform and communication skills, they’re both advancing the world’s understanding of the disease in their own way.

“We’re now more than 3 years into this completely mysterious, uncharted disease process with a whole globe full of really desperate people,” said Altmann. “It’s a living, organic thing, and yet that also demands some kind of order and collation and pulling together into some kind of sense. So I was very pleased when Gez approached me to help him with the book.”

In it, they translate everything they’ve learned about the condition that’s “scattered in 100,000 places around the globe” into a digestible format. It tells two sides of the same story: the anecdotal experiences Medinger has undergone or observed in the long COVID community through more than a dozen of his own patient-led studies, as well the hard science and research that’s amassing in the medical world. 

In an interview, Medinger and Altmann discussed how their book can help both patients and clinicians, and the next steps needed to combat long COVID.
 

What are the book’s key takeaways for you?

Medinger: “I would say we put together an incredibly comprehensive couple of chapters on the hypotheses, big picture, what’s causing long COVID. And then the nitty-gritty research for everything that we’ve found out that is going on. ... And the other part of the book that I think is particularly important, beyond the tips for managing symptoms, is the content on mental health and the impact on your emotional state and your capacity and just how huge that is. ... That has been the most powerful thing for patients when they’ve read it. And they’ve said that they’ve just been crying all the way through those chapters because suddenly they feel heard and seen.”

Altmann: “Obviously, you’d expect me to say that the parts of the book that I love most are the kind of hard-nosed, medical, mechanistic bits. ... We’ve got 150 million-plus desperate people deciding or not deciding to go and see their general practitioner, getting a fair hearing or not getting a fair hearing. And the poor doctor has never learned this in medical school, has never read a textbook on it, and hasn’t a clue what’s coming through the door. 

How are they expected to know what to do? So I think the least we can do in some of those chapters is feed into their knowledge of general medicine and give them some clues. ... I think if we can explain to people what might be going on in them, and to their doctors, what on earth they might do about it, what kind of tests they might order, that helps a bit.”
 

How did you balance the more controversial parts of the book, including the chapter about so-called “treatments”? For instance, the book recounts Gez’s harrowing experience with ivermectin as a frightening warning. But Danny, you were nervous about even mentioning unproven and potentially dangerous treatments as things people have tried and have looked into. 

Medinger: “We had to try and work out how to handle the topic, how to handle those points of view, whilst at the same time still being informative. I think the book is stronger for that chapter, too. The other thing would certainly have been to just not address the subject, but it’s one of the things that people want to know the most about. And there’s also a lot of bad information floating around out there about certain treatments. Ivermectin, for example, and this is what happened to me when I tried it. ‘Don’t do it. It’s not recommended. Please don’t.’ 

I think it was also very important to include because that cautionary tale really applies to every single one of those treatments that people might be hearing about that hasn’t been backed up by efficacy and safety studies.”

Altmann: “I think Gez has been quite diplomatic. That chapter was, I think, a testament to the power of the book. And the biggest test of our marriage as ‘the odd couple.’ Because when I first read the first draft of what Gez had written, I said, ‘my name can’t even be on this book. Otherwise, I’ll be sacked.’ 

And we had to find marriage counseling after that, and a way back to write a version of that chapter that expressed both halves of those concerns in a way that did justice to those different viewpoints. And I think that makes it quite a strong chapter.”
 

What do you think are the most urgent next steps in the search for solving long COVID?

Medinger: “I would personally like to try and get some sort of answer on viral persistence. ... If there’s one thing that feels like it would be treatable in theory, and would make sense why we’re still getting all of these symptoms this whole time later, it’s that, so I would like to try and establish or eliminate viral persistence. So if you gave me Elon Musk’s wealth, that’s what I would throw a bunch of the money at, trying to either eliminate or establish that. 

And then, you know, the other important thing is a diagnostic test. Danny always talks about how important it is. Once you have that, it helps you suddenly open the doors to all these other things that you can do. And treatment trials. Let’s throw some meds at this so that we have an educated guess at what might work and put them into high-powered, randomized, controlled trials and see if anything comes out because from the patient perspective, I don’t think any of us wants to wait for 5 years for that stuff to start happening.”

Altmann: “I completely agree. If you go to a website, like clinicaltrials.gov, you’ll find an immense number of clinical trials on COVID. There isn’t really a shortage of them, some of them better-powered to get an answer than others.”

How do you think public policy needs to adapt for long COVID, including social safety nets such as workers’ compensation and disability benefits?

Medinger: “In terms of public policy, what I would like would be some public acknowledgment that it’s real from government sources. Just the acknowledgment that it’s real and it remains a risk even now.”

Altmann: “Nobody in politics asks my opinion. I think they’d hate to hear it. Because if I went to see them and said, well, actually, if you thought the COVID pandemic was bad, wait till you see what’s on the table now. We’ve created a disabled population in our country of 2 million, at least a portion if not more of people who are not fully contributory to the workforce anymore ... [with] legal wrangles about retirement and health insurance and pensions, and a human right to adequate health care. Which means, ideally, a purpose-built clinic where they can have their respiratory opinion and their rheumatology opinion and their endocrine opinion and their neurology opinion, all under one roof.”

You’ve both shown so much optimism. Why is that?

Altmann: “I’ve been an immunologist for a long time now, and written all my decades of grant applications, where as a community we made what, at the time, were kind of wild promises and wildly optimistic projections of how our knowledge of tumor immunity would revolutionize cancer care, and how knowledge of autoimmunity would revolutionize care of all the autoimmune diseases. 

And weirdly almost every word we wrote over those 25 or 30 years came true. Cancer immunotherapy was revolutionized, and biologics for diabetes, multiple sclerosis, and arthritis were revolutionized. So if I have faith that those things came true, I have complete faith in this as well.”

Medinger: “From the patient perspective, what I would say is that we are seeing people who’ve been ill for more than 2 years recover. People are suddenly turning the corner when they might not have expected to. 

And while we don’t quite know exactly why yet, and it’s not everyone, every single time I hear the story of someone saying, ‘I’m pretty much back to where I was, I feel like I’ve recovered,’ I feel great. Even if I haven’t. Because I know that every single time I hear someone say that, that just increases the probability that I will, too.”
 

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

Filmmaker Gez Medinger and immunologist Danny Altmann have been dubbed by British media as “COVID’s odd couple,” and they don’t mind at all. Discussing their recent book, The Long COVID Handbook, the authors lean into their animated roles: Medinger is a passionate patient-researcher and “guinea pig” (his words) in search of his own healing, and Altmann is a no-nonsense, data-driven scientist and “Professor Boring” (as he puts it).

And the message they have about the impact of long COVID is stunning.

“The clinical burden [of long COVID] is somewhere on par with the whole of heart disease all over again, or the whole of oncology all over again, which are our biggest clinical bills concurrently,” Altmann said.

The pair met early in the pandemic, after Medinger became infected during the first wave and interviewed Altmann for his YouTube channel, which has more than 5 million views. 

“Danny was one of the first people from the medical establishment to sort of stand up on the parapet and wave a flag and say, ‘Hey, guys, there’s a problem here.’ And that was incredibly validating for 2 million people in the U.K. alone who were suffering with long COVID,” Medinger said. 

Their relationship works, not just for publishing one of the first definitive guides to long COVID, but also as a model for how patients with lived experiences can lead the way in medicine – from giving the condition its name to driving the medical establishment for recognition, clinical research, and therapeutic answers. 

With Altmann currently leading a major research project at Imperial College London on long COVID and Medinger’s social media platform and communication skills, they’re both advancing the world’s understanding of the disease in their own way.

“We’re now more than 3 years into this completely mysterious, uncharted disease process with a whole globe full of really desperate people,” said Altmann. “It’s a living, organic thing, and yet that also demands some kind of order and collation and pulling together into some kind of sense. So I was very pleased when Gez approached me to help him with the book.”

In it, they translate everything they’ve learned about the condition that’s “scattered in 100,000 places around the globe” into a digestible format. It tells two sides of the same story: the anecdotal experiences Medinger has undergone or observed in the long COVID community through more than a dozen of his own patient-led studies, as well the hard science and research that’s amassing in the medical world. 

In an interview, Medinger and Altmann discussed how their book can help both patients and clinicians, and the next steps needed to combat long COVID.
 

What are the book’s key takeaways for you?

Medinger: “I would say we put together an incredibly comprehensive couple of chapters on the hypotheses, big picture, what’s causing long COVID. And then the nitty-gritty research for everything that we’ve found out that is going on. ... And the other part of the book that I think is particularly important, beyond the tips for managing symptoms, is the content on mental health and the impact on your emotional state and your capacity and just how huge that is. ... That has been the most powerful thing for patients when they’ve read it. And they’ve said that they’ve just been crying all the way through those chapters because suddenly they feel heard and seen.”

Altmann: “Obviously, you’d expect me to say that the parts of the book that I love most are the kind of hard-nosed, medical, mechanistic bits. ... We’ve got 150 million-plus desperate people deciding or not deciding to go and see their general practitioner, getting a fair hearing or not getting a fair hearing. And the poor doctor has never learned this in medical school, has never read a textbook on it, and hasn’t a clue what’s coming through the door. 

How are they expected to know what to do? So I think the least we can do in some of those chapters is feed into their knowledge of general medicine and give them some clues. ... I think if we can explain to people what might be going on in them, and to their doctors, what on earth they might do about it, what kind of tests they might order, that helps a bit.”
 

How did you balance the more controversial parts of the book, including the chapter about so-called “treatments”? For instance, the book recounts Gez’s harrowing experience with ivermectin as a frightening warning. But Danny, you were nervous about even mentioning unproven and potentially dangerous treatments as things people have tried and have looked into. 

Medinger: “We had to try and work out how to handle the topic, how to handle those points of view, whilst at the same time still being informative. I think the book is stronger for that chapter, too. The other thing would certainly have been to just not address the subject, but it’s one of the things that people want to know the most about. And there’s also a lot of bad information floating around out there about certain treatments. Ivermectin, for example, and this is what happened to me when I tried it. ‘Don’t do it. It’s not recommended. Please don’t.’ 

I think it was also very important to include because that cautionary tale really applies to every single one of those treatments that people might be hearing about that hasn’t been backed up by efficacy and safety studies.”

Altmann: “I think Gez has been quite diplomatic. That chapter was, I think, a testament to the power of the book. And the biggest test of our marriage as ‘the odd couple.’ Because when I first read the first draft of what Gez had written, I said, ‘my name can’t even be on this book. Otherwise, I’ll be sacked.’ 

And we had to find marriage counseling after that, and a way back to write a version of that chapter that expressed both halves of those concerns in a way that did justice to those different viewpoints. And I think that makes it quite a strong chapter.”
 

What do you think are the most urgent next steps in the search for solving long COVID?

Medinger: “I would personally like to try and get some sort of answer on viral persistence. ... If there’s one thing that feels like it would be treatable in theory, and would make sense why we’re still getting all of these symptoms this whole time later, it’s that, so I would like to try and establish or eliminate viral persistence. So if you gave me Elon Musk’s wealth, that’s what I would throw a bunch of the money at, trying to either eliminate or establish that. 

And then, you know, the other important thing is a diagnostic test. Danny always talks about how important it is. Once you have that, it helps you suddenly open the doors to all these other things that you can do. And treatment trials. Let’s throw some meds at this so that we have an educated guess at what might work and put them into high-powered, randomized, controlled trials and see if anything comes out because from the patient perspective, I don’t think any of us wants to wait for 5 years for that stuff to start happening.”

Altmann: “I completely agree. If you go to a website, like clinicaltrials.gov, you’ll find an immense number of clinical trials on COVID. There isn’t really a shortage of them, some of them better-powered to get an answer than others.”

How do you think public policy needs to adapt for long COVID, including social safety nets such as workers’ compensation and disability benefits?

Medinger: “In terms of public policy, what I would like would be some public acknowledgment that it’s real from government sources. Just the acknowledgment that it’s real and it remains a risk even now.”

Altmann: “Nobody in politics asks my opinion. I think they’d hate to hear it. Because if I went to see them and said, well, actually, if you thought the COVID pandemic was bad, wait till you see what’s on the table now. We’ve created a disabled population in our country of 2 million, at least a portion if not more of people who are not fully contributory to the workforce anymore ... [with] legal wrangles about retirement and health insurance and pensions, and a human right to adequate health care. Which means, ideally, a purpose-built clinic where they can have their respiratory opinion and their rheumatology opinion and their endocrine opinion and their neurology opinion, all under one roof.”

You’ve both shown so much optimism. Why is that?

Altmann: “I’ve been an immunologist for a long time now, and written all my decades of grant applications, where as a community we made what, at the time, were kind of wild promises and wildly optimistic projections of how our knowledge of tumor immunity would revolutionize cancer care, and how knowledge of autoimmunity would revolutionize care of all the autoimmune diseases. 

And weirdly almost every word we wrote over those 25 or 30 years came true. Cancer immunotherapy was revolutionized, and biologics for diabetes, multiple sclerosis, and arthritis were revolutionized. So if I have faith that those things came true, I have complete faith in this as well.”

Medinger: “From the patient perspective, what I would say is that we are seeing people who’ve been ill for more than 2 years recover. People are suddenly turning the corner when they might not have expected to. 

And while we don’t quite know exactly why yet, and it’s not everyone, every single time I hear the story of someone saying, ‘I’m pretty much back to where I was, I feel like I’ve recovered,’ I feel great. Even if I haven’t. Because I know that every single time I hear someone say that, that just increases the probability that I will, too.”
 

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

Filmmaker Gez Medinger and immunologist Danny Altmann have been dubbed by British media as “COVID’s odd couple,” and they don’t mind at all. Discussing their recent book, The Long COVID Handbook, the authors lean into their animated roles: Medinger is a passionate patient-researcher and “guinea pig” (his words) in search of his own healing, and Altmann is a no-nonsense, data-driven scientist and “Professor Boring” (as he puts it).

And the message they have about the impact of long COVID is stunning.

“The clinical burden [of long COVID] is somewhere on par with the whole of heart disease all over again, or the whole of oncology all over again, which are our biggest clinical bills concurrently,” Altmann said.

The pair met early in the pandemic, after Medinger became infected during the first wave and interviewed Altmann for his YouTube channel, which has more than 5 million views. 

“Danny was one of the first people from the medical establishment to sort of stand up on the parapet and wave a flag and say, ‘Hey, guys, there’s a problem here.’ And that was incredibly validating for 2 million people in the U.K. alone who were suffering with long COVID,” Medinger said. 

Their relationship works, not just for publishing one of the first definitive guides to long COVID, but also as a model for how patients with lived experiences can lead the way in medicine – from giving the condition its name to driving the medical establishment for recognition, clinical research, and therapeutic answers. 

With Altmann currently leading a major research project at Imperial College London on long COVID and Medinger’s social media platform and communication skills, they’re both advancing the world’s understanding of the disease in their own way.

“We’re now more than 3 years into this completely mysterious, uncharted disease process with a whole globe full of really desperate people,” said Altmann. “It’s a living, organic thing, and yet that also demands some kind of order and collation and pulling together into some kind of sense. So I was very pleased when Gez approached me to help him with the book.”

In it, they translate everything they’ve learned about the condition that’s “scattered in 100,000 places around the globe” into a digestible format. It tells two sides of the same story: the anecdotal experiences Medinger has undergone or observed in the long COVID community through more than a dozen of his own patient-led studies, as well the hard science and research that’s amassing in the medical world. 

In an interview, Medinger and Altmann discussed how their book can help both patients and clinicians, and the next steps needed to combat long COVID.
 

What are the book’s key takeaways for you?

Medinger: “I would say we put together an incredibly comprehensive couple of chapters on the hypotheses, big picture, what’s causing long COVID. And then the nitty-gritty research for everything that we’ve found out that is going on. ... And the other part of the book that I think is particularly important, beyond the tips for managing symptoms, is the content on mental health and the impact on your emotional state and your capacity and just how huge that is. ... That has been the most powerful thing for patients when they’ve read it. And they’ve said that they’ve just been crying all the way through those chapters because suddenly they feel heard and seen.”

Altmann: “Obviously, you’d expect me to say that the parts of the book that I love most are the kind of hard-nosed, medical, mechanistic bits. ... We’ve got 150 million-plus desperate people deciding or not deciding to go and see their general practitioner, getting a fair hearing or not getting a fair hearing. And the poor doctor has never learned this in medical school, has never read a textbook on it, and hasn’t a clue what’s coming through the door. 

How are they expected to know what to do? So I think the least we can do in some of those chapters is feed into their knowledge of general medicine and give them some clues. ... I think if we can explain to people what might be going on in them, and to their doctors, what on earth they might do about it, what kind of tests they might order, that helps a bit.”
 

How did you balance the more controversial parts of the book, including the chapter about so-called “treatments”? For instance, the book recounts Gez’s harrowing experience with ivermectin as a frightening warning. But Danny, you were nervous about even mentioning unproven and potentially dangerous treatments as things people have tried and have looked into. 

Medinger: “We had to try and work out how to handle the topic, how to handle those points of view, whilst at the same time still being informative. I think the book is stronger for that chapter, too. The other thing would certainly have been to just not address the subject, but it’s one of the things that people want to know the most about. And there’s also a lot of bad information floating around out there about certain treatments. Ivermectin, for example, and this is what happened to me when I tried it. ‘Don’t do it. It’s not recommended. Please don’t.’ 

I think it was also very important to include because that cautionary tale really applies to every single one of those treatments that people might be hearing about that hasn’t been backed up by efficacy and safety studies.”

Altmann: “I think Gez has been quite diplomatic. That chapter was, I think, a testament to the power of the book. And the biggest test of our marriage as ‘the odd couple.’ Because when I first read the first draft of what Gez had written, I said, ‘my name can’t even be on this book. Otherwise, I’ll be sacked.’ 

And we had to find marriage counseling after that, and a way back to write a version of that chapter that expressed both halves of those concerns in a way that did justice to those different viewpoints. And I think that makes it quite a strong chapter.”
 

What do you think are the most urgent next steps in the search for solving long COVID?

Medinger: “I would personally like to try and get some sort of answer on viral persistence. ... If there’s one thing that feels like it would be treatable in theory, and would make sense why we’re still getting all of these symptoms this whole time later, it’s that, so I would like to try and establish or eliminate viral persistence. So if you gave me Elon Musk’s wealth, that’s what I would throw a bunch of the money at, trying to either eliminate or establish that. 

And then, you know, the other important thing is a diagnostic test. Danny always talks about how important it is. Once you have that, it helps you suddenly open the doors to all these other things that you can do. And treatment trials. Let’s throw some meds at this so that we have an educated guess at what might work and put them into high-powered, randomized, controlled trials and see if anything comes out because from the patient perspective, I don’t think any of us wants to wait for 5 years for that stuff to start happening.”

Altmann: “I completely agree. If you go to a website, like clinicaltrials.gov, you’ll find an immense number of clinical trials on COVID. There isn’t really a shortage of them, some of them better-powered to get an answer than others.”

How do you think public policy needs to adapt for long COVID, including social safety nets such as workers’ compensation and disability benefits?

Medinger: “In terms of public policy, what I would like would be some public acknowledgment that it’s real from government sources. Just the acknowledgment that it’s real and it remains a risk even now.”

Altmann: “Nobody in politics asks my opinion. I think they’d hate to hear it. Because if I went to see them and said, well, actually, if you thought the COVID pandemic was bad, wait till you see what’s on the table now. We’ve created a disabled population in our country of 2 million, at least a portion if not more of people who are not fully contributory to the workforce anymore ... [with] legal wrangles about retirement and health insurance and pensions, and a human right to adequate health care. Which means, ideally, a purpose-built clinic where they can have their respiratory opinion and their rheumatology opinion and their endocrine opinion and their neurology opinion, all under one roof.”

You’ve both shown so much optimism. Why is that?

Altmann: “I’ve been an immunologist for a long time now, and written all my decades of grant applications, where as a community we made what, at the time, were kind of wild promises and wildly optimistic projections of how our knowledge of tumor immunity would revolutionize cancer care, and how knowledge of autoimmunity would revolutionize care of all the autoimmune diseases. 

And weirdly almost every word we wrote over those 25 or 30 years came true. Cancer immunotherapy was revolutionized, and biologics for diabetes, multiple sclerosis, and arthritis were revolutionized. So if I have faith that those things came true, I have complete faith in this as well.”

Medinger: “From the patient perspective, what I would say is that we are seeing people who’ve been ill for more than 2 years recover. People are suddenly turning the corner when they might not have expected to. 

And while we don’t quite know exactly why yet, and it’s not everyone, every single time I hear the story of someone saying, ‘I’m pretty much back to where I was, I feel like I’ve recovered,’ I feel great. Even if I haven’t. Because I know that every single time I hear someone say that, that just increases the probability that I will, too.”
 

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

Vaccines for the world’s most deadly diseases, like cancer and heart disease, will likely be ready by 2030 and could save millions of lives, according to the top doctor at one of the world’s leading drug companies.

The announcement is yet another sign of what many are calling “the golden age” of vaccine development, which is largely credited to the pandemic’s use of mRNA technology to create COVID-19 vaccines.

“I think what we have learned in recent months is that if you ever thought that mRNA was just for infectious diseases, or just for COVID, the evidence now is that that’s absolutely not the case,” Moderna Chief Medical Officer Paul Burton, MD, PhD, told The Guardian. “It can be applied to all sorts of disease areas; we are in cancer, infectious disease, cardiovascular disease, autoimmune diseases, rare disease. We have studies in all of those areas, and they have all shown tremendous promise.”

The U.S. Food and Drug Administration recently designated two new Moderna vaccines as breakthrough therapies: a shot that prevents respiratory syncytial virus (RSV) in older people and a shot that helps prevent the recurrence of melanoma. The FDA’s breakthrough designation is given when a new treatment’s early trial results are substantially better than an existing therapy.

The mRNA vaccine technology that made headlines for its role in COVID-19 vaccines works by teaching the body how to make a specific protein to help the immune system prevent or target a certain disease.

Dr. Burton anticipates that mRNA technology will result in breakthroughs such as a cancer vaccine that can be personalized based on the features of a specific tumor.

“I think we will have mRNA-based therapies for rare diseases that were previously undruggable, and I think that 10 years from now, we will be approaching a world where you truly can identify the genetic cause of a disease and, with relative simplicity, go and edit that out and repair it using mRNA-based technology,” he said. 

The Moderna executive made the statements before its annual update on its vaccine pipeline projects, which the company calls “Vaccines Day.” The Massachusetts-based drugmaker said it has given someone the first dose of a “next-generation” COVID-19 vaccine in a phase III trial, has made progress on a Lyme disease shot, and is developing a vaccine for the highly contagious norovirus.

In all, Moderna expects “six major vaccine product launches in the next few years,” the company said in a statement, adding that it expects the COVID-19 booster market alone to be valued at $15 billion.

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

Vaccines for the world’s most deadly diseases, like cancer and heart disease, will likely be ready by 2030 and could save millions of lives, according to the top doctor at one of the world’s leading drug companies.

The announcement is yet another sign of what many are calling “the golden age” of vaccine development, which is largely credited to the pandemic’s use of mRNA technology to create COVID-19 vaccines.

“I think what we have learned in recent months is that if you ever thought that mRNA was just for infectious diseases, or just for COVID, the evidence now is that that’s absolutely not the case,” Moderna Chief Medical Officer Paul Burton, MD, PhD, told The Guardian. “It can be applied to all sorts of disease areas; we are in cancer, infectious disease, cardiovascular disease, autoimmune diseases, rare disease. We have studies in all of those areas, and they have all shown tremendous promise.”

The U.S. Food and Drug Administration recently designated two new Moderna vaccines as breakthrough therapies: a shot that prevents respiratory syncytial virus (RSV) in older people and a shot that helps prevent the recurrence of melanoma. The FDA’s breakthrough designation is given when a new treatment’s early trial results are substantially better than an existing therapy.

The mRNA vaccine technology that made headlines for its role in COVID-19 vaccines works by teaching the body how to make a specific protein to help the immune system prevent or target a certain disease.

Dr. Burton anticipates that mRNA technology will result in breakthroughs such as a cancer vaccine that can be personalized based on the features of a specific tumor.

“I think we will have mRNA-based therapies for rare diseases that were previously undruggable, and I think that 10 years from now, we will be approaching a world where you truly can identify the genetic cause of a disease and, with relative simplicity, go and edit that out and repair it using mRNA-based technology,” he said. 

The Moderna executive made the statements before its annual update on its vaccine pipeline projects, which the company calls “Vaccines Day.” The Massachusetts-based drugmaker said it has given someone the first dose of a “next-generation” COVID-19 vaccine in a phase III trial, has made progress on a Lyme disease shot, and is developing a vaccine for the highly contagious norovirus.

In all, Moderna expects “six major vaccine product launches in the next few years,” the company said in a statement, adding that it expects the COVID-19 booster market alone to be valued at $15 billion.

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

Vaccines for the world’s most deadly diseases, like cancer and heart disease, will likely be ready by 2030 and could save millions of lives, according to the top doctor at one of the world’s leading drug companies.

The announcement is yet another sign of what many are calling “the golden age” of vaccine development, which is largely credited to the pandemic’s use of mRNA technology to create COVID-19 vaccines.

“I think what we have learned in recent months is that if you ever thought that mRNA was just for infectious diseases, or just for COVID, the evidence now is that that’s absolutely not the case,” Moderna Chief Medical Officer Paul Burton, MD, PhD, told The Guardian. “It can be applied to all sorts of disease areas; we are in cancer, infectious disease, cardiovascular disease, autoimmune diseases, rare disease. We have studies in all of those areas, and they have all shown tremendous promise.”

The U.S. Food and Drug Administration recently designated two new Moderna vaccines as breakthrough therapies: a shot that prevents respiratory syncytial virus (RSV) in older people and a shot that helps prevent the recurrence of melanoma. The FDA’s breakthrough designation is given when a new treatment’s early trial results are substantially better than an existing therapy.

The mRNA vaccine technology that made headlines for its role in COVID-19 vaccines works by teaching the body how to make a specific protein to help the immune system prevent or target a certain disease.

Dr. Burton anticipates that mRNA technology will result in breakthroughs such as a cancer vaccine that can be personalized based on the features of a specific tumor.

“I think we will have mRNA-based therapies for rare diseases that were previously undruggable, and I think that 10 years from now, we will be approaching a world where you truly can identify the genetic cause of a disease and, with relative simplicity, go and edit that out and repair it using mRNA-based technology,” he said. 

The Moderna executive made the statements before its annual update on its vaccine pipeline projects, which the company calls “Vaccines Day.” The Massachusetts-based drugmaker said it has given someone the first dose of a “next-generation” COVID-19 vaccine in a phase III trial, has made progress on a Lyme disease shot, and is developing a vaccine for the highly contagious norovirus.

In all, Moderna expects “six major vaccine product launches in the next few years,” the company said in a statement, adding that it expects the COVID-19 booster market alone to be valued at $15 billion.

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