Dual-physician marriages are becoming increasingly common. The estimated median age of first marriage has been increasing; the US Census Bureau reported a median age of 30.4 years for men and 28.6 years for women in early 2021.¹ According to the Association of American Medical Colleges 2020 Matriculating Student Questionnaire, the median age at matriculation for medical students was 23 years (N=16,956), and 92.4% (N=15,932) reported their marital status as single and never legally married.² Thus, it is likely that the majority of physicians get married at some point during medical school or residency training. A survey of over 10,000 physicians in more than 29 specialties showed that 24% of female physicians and 15% of male physicians are married to other physicians.³

Challenges

There are common challenges to all dual-career households, including coordinating demanding career schedules that compete with each other, balancing childrearing with career advancement, and harmonizing economic and personal goals. However, there are challenges that can be amplified in and unique to dual-physician marriages.

The Couples Match—Medical students, trainees, and even physicians in later stages of their careers may have less autonomy over their schedules compared to professionals in other fields. An early obstacle that many dual-physician marriages must overcome is navigating the National Resident Matching Program as a couple. The number of individuals participating as a couple in the 2022 Main Residency Match was 2444, and the postgraduate year 1 (PGY-1) match rate for individuals participating as a couple was 93.7%. The overall PGY-1 match rate for MD seniors in the United States was 92.9%.⁴ Thus, entering the match as a couple does not necessarily pose a disadvantage to successfully matching, but these statistics may be misleading. When applicants participate in the Match as a couple, their rank order lists form pairs of program choices that are processed by the matching algorithm to match the couple to the most preferred pair of programs on their rank order lists where each partner has been offered a position. Although many couples coordinate their rank order lists geographically, there is no guarantee that the couple will actually match together in the same city, let alone in the same time zone. Also, the statistics do not take into account if an individual in the couple is only partially matched (eg, if one applicant matches to a preliminary year position but not to an advanced dermatology position). The couples’ Match is only available to partners in the same application cycle, and couples that are not in sync may be more restricted when applying for residency positions.

Lack of Synchronization—Dual-physician couples are challenged to achieve synchronization not only in their day-to-day lives but also over the course of their careers. After matching to residency, the dual-physician couple faces additional scheduling stressors during training. Varied demanding patient schedules and competing call schedules may take a toll on the ability to spend time together. Coordination between both training programs to ensure weekend schedules and vacations are aligned can be helpful to try to maximize time together. If the couple’s education is staggered, their training schedules may not align when proceeding to fellowship or starting off with a new job as an attending. It is not uncommon for couples in medicine to be long-distance for a period of time, and partners may find themselves sacrificing ideal positions or self-restricting application to certain programs or jobs to secure a position near a partner who is already in training in a certain geographic location.

Domestic Work-Life Balance—Juxtaposing 2 highly demanding careers in the same household can be associated with certain tensions, as the weight of household and childrearing responsibilities as well as professional productivity and advancement is divided by the couple. In a 2008 survey of the American College of Surgeons on burnout, work-home conflict, and career satisfaction, surgeons in dual-physician relationships experienced a recent career conflict with their domestic partner and a work-home conflict more often than surgeons whose partners were working nonphysicians.⁵ The hours worked between men and women in dual-physician families differed according to a national sample of 9868 physicians in dual-physician relationships. The study showed that weekly hours worked by women with children were lower than among those without children, whereas similar differences were not observed among men.⁶ It is not understood if this suggests that women in dual-physician families work fewer hours due to the pressures of historical gender norms and increased household responsibilities. A 1988 survey of female physicians (N=382) in which 247 respondents indicated that they had domestic partners showed that women physicians whose partners also were physicians (n=91) were more than twice as likely to interrupt their own careers for their partners’ careers compared to female physicians whose partners were not physicians (n=156)(25% vs 11%, respectively). In contrast, the male partners who were not physicians were significantly more likely to interrupt their careers than male partners who were physicians (41% vs 15%, respectively, P<.05).⁷

Divorce—There have been mixed reports on the incidence of divorce in physicians compared to the general population, but studies suggest that physicians’ marriages tend to be more stable than those of other societal groups.⁸ Of 203 respondents of a survey of female physician members of the Minnesota Medical Association who were or had been married to another physician, 11.3% (22/203) were divorced, and medicine was reported to play a role in 69.6% of those separations.⁹ A retrospective analysis of nationally representative surveys by the US Census showed that divorce among physicians is less common than among non–health care workers and several other health professions.¹⁰

Rewards

The benefits of medical marriages are multifold and include increased job satisfaction, stability, financial security, shared passions, and mutual understanding. Common passions and interests form the foundation for many relationships, which is true for the dual-physician marriage. In a 2009 study, Perlman et al¹¹ performed qualitative interviews with 25 physicians and their partners—10 of which were in dual-physician relationships—about the challenges and strengths of their relationships. A key theme that emerged during the interviews was the acknowledgment of the benefits of being a physician to the relationship. Participants discussed both the financial security in a physician marriage and the security that medical knowledge adds to a relationship when caring for ill or injured family members. Other key themes identified were relying on mutual support in the relationship, recognizing the important role of each family member, and having shared values.¹¹

Financial Security—The financial security attributed to being in a medical marriage was highlighted in a series of interviews with physicians and their spouses.¹¹ A cross-sectional survey of a random sample of physicians showed that both men and women in dual-physician families had lower personal incomes than physicians married to nonphysicians. However, men and women in dual-physician families had spouses with higher incomes compared to spouses of physicians married to nonphysicians. Thus, the total family incomes were substantially higher in dual-physician households than the family incomes of physicians married to nonphysicians.¹²

Satisfaction—Dual-physician marriages benefit from a shared camaraderie and understanding of the joys and sacrifices that accompany pursuing a career in medicine. Medical spouses can communicate in mutually understood medical jargon. Compared to physicians married to nonphysicians, a statistically significant difference (P<.001) was found in physicians in dual-physicians families who more frequently reported enjoyment in discussing work with their spouses and more frequently reported satisfaction from shared work interests with their spouses.¹²

Final Thoughts

From the start of medical training, physicians and physicians-in-training experience unique benefits and challenges that are compounded in distinctive ways when 2 physicians get married. In an era where dual-physician marriage is becoming more common, it is important to acknowledge how this can both enrich and challenge the relationship.

Acknowledgment—The author thanks her husband Joshua L. Weinstock, MD (Camden, New Jersey), for his contribution to this article and their marriage.

Dual-physician marriages are becoming increasingly common. The estimated median age of first marriage has been increasing; the US Census Bureau reported a median age of 30.4 years for men and 28.6 years for women in early 2021.¹ According to the Association of American Medical Colleges 2020 Matriculating Student Questionnaire, the median age at matriculation for medical students was 23 years (N=16,956), and 92.4% (N=15,932) reported their marital status as single and never legally married.² Thus, it is likely that the majority of physicians get married at some point during medical school or residency training. A survey of over 10,000 physicians in more than 29 specialties showed that 24% of female physicians and 15% of male physicians are married to other physicians.³

Challenges

There are common challenges to all dual-career households, including coordinating demanding career schedules that compete with each other, balancing childrearing with career advancement, and harmonizing economic and personal goals. However, there are challenges that can be amplified in and unique to dual-physician marriages.

The Couples Match—Medical students, trainees, and even physicians in later stages of their careers may have less autonomy over their schedules compared to professionals in other fields. An early obstacle that many dual-physician marriages must overcome is navigating the National Resident Matching Program as a couple. The number of individuals participating as a couple in the 2022 Main Residency Match was 2444, and the postgraduate year 1 (PGY-1) match rate for individuals participating as a couple was 93.7%. The overall PGY-1 match rate for MD seniors in the United States was 92.9%.⁴ Thus, entering the match as a couple does not necessarily pose a disadvantage to successfully matching, but these statistics may be misleading. When applicants participate in the Match as a couple, their rank order lists form pairs of program choices that are processed by the matching algorithm to match the couple to the most preferred pair of programs on their rank order lists where each partner has been offered a position. Although many couples coordinate their rank order lists geographically, there is no guarantee that the couple will actually match together in the same city, let alone in the same time zone. Also, the statistics do not take into account if an individual in the couple is only partially matched (eg, if one applicant matches to a preliminary year position but not to an advanced dermatology position). The couples’ Match is only available to partners in the same application cycle, and couples that are not in sync may be more restricted when applying for residency positions.

Lack of Synchronization—Dual-physician couples are challenged to achieve synchronization not only in their day-to-day lives but also over the course of their careers. After matching to residency, the dual-physician couple faces additional scheduling stressors during training. Varied demanding patient schedules and competing call schedules may take a toll on the ability to spend time together. Coordination between both training programs to ensure weekend schedules and vacations are aligned can be helpful to try to maximize time together. If the couple’s education is staggered, their training schedules may not align when proceeding to fellowship or starting off with a new job as an attending. It is not uncommon for couples in medicine to be long-distance for a period of time, and partners may find themselves sacrificing ideal positions or self-restricting application to certain programs or jobs to secure a position near a partner who is already in training in a certain geographic location.

Domestic Work-Life Balance—Juxtaposing 2 highly demanding careers in the same household can be associated with certain tensions, as the weight of household and childrearing responsibilities as well as professional productivity and advancement is divided by the couple. In a 2008 survey of the American College of Surgeons on burnout, work-home conflict, and career satisfaction, surgeons in dual-physician relationships experienced a recent career conflict with their domestic partner and a work-home conflict more often than surgeons whose partners were working nonphysicians.⁵ The hours worked between men and women in dual-physician families differed according to a national sample of 9868 physicians in dual-physician relationships. The study showed that weekly hours worked by women with children were lower than among those without children, whereas similar differences were not observed among men.⁶ It is not understood if this suggests that women in dual-physician families work fewer hours due to the pressures of historical gender norms and increased household responsibilities. A 1988 survey of female physicians (N=382) in which 247 respondents indicated that they had domestic partners showed that women physicians whose partners also were physicians (n=91) were more than twice as likely to interrupt their own careers for their partners’ careers compared to female physicians whose partners were not physicians (n=156)(25% vs 11%, respectively). In contrast, the male partners who were not physicians were significantly more likely to interrupt their careers than male partners who were physicians (41% vs 15%, respectively, P<.05).⁷

Divorce—There have been mixed reports on the incidence of divorce in physicians compared to the general population, but studies suggest that physicians’ marriages tend to be more stable than those of other societal groups.⁸ Of 203 respondents of a survey of female physician members of the Minnesota Medical Association who were or had been married to another physician, 11.3% (22/203) were divorced, and medicine was reported to play a role in 69.6% of those separations.⁹ A retrospective analysis of nationally representative surveys by the US Census showed that divorce among physicians is less common than among non–health care workers and several other health professions.¹⁰

Rewards

The benefits of medical marriages are multifold and include increased job satisfaction, stability, financial security, shared passions, and mutual understanding. Common passions and interests form the foundation for many relationships, which is true for the dual-physician marriage. In a 2009 study, Perlman et al¹¹ performed qualitative interviews with 25 physicians and their partners—10 of which were in dual-physician relationships—about the challenges and strengths of their relationships. A key theme that emerged during the interviews was the acknowledgment of the benefits of being a physician to the relationship. Participants discussed both the financial security in a physician marriage and the security that medical knowledge adds to a relationship when caring for ill or injured family members. Other key themes identified were relying on mutual support in the relationship, recognizing the important role of each family member, and having shared values.¹¹

Financial Security—The financial security attributed to being in a medical marriage was highlighted in a series of interviews with physicians and their spouses.¹¹ A cross-sectional survey of a random sample of physicians showed that both men and women in dual-physician families had lower personal incomes than physicians married to nonphysicians. However, men and women in dual-physician families had spouses with higher incomes compared to spouses of physicians married to nonphysicians. Thus, the total family incomes were substantially higher in dual-physician households than the family incomes of physicians married to nonphysicians.¹²

Satisfaction—Dual-physician marriages benefit from a shared camaraderie and understanding of the joys and sacrifices that accompany pursuing a career in medicine. Medical spouses can communicate in mutually understood medical jargon. Compared to physicians married to nonphysicians, a statistically significant difference (P<.001) was found in physicians in dual-physicians families who more frequently reported enjoyment in discussing work with their spouses and more frequently reported satisfaction from shared work interests with their spouses.¹²

Final Thoughts

From the start of medical training, physicians and physicians-in-training experience unique benefits and challenges that are compounded in distinctive ways when 2 physicians get married. In an era where dual-physician marriage is becoming more common, it is important to acknowledge how this can both enrich and challenge the relationship.

Acknowledgment—The author thanks her husband Joshua L. Weinstock, MD (Camden, New Jersey), for his contribution to this article and their marriage.

Dual-physician marriages are becoming increasingly common. The estimated median age of first marriage has been increasing; the US Census Bureau reported a median age of 30.4 years for men and 28.6 years for women in early 2021.¹ According to the Association of American Medical Colleges 2020 Matriculating Student Questionnaire, the median age at matriculation for medical students was 23 years (N=16,956), and 92.4% (N=15,932) reported their marital status as single and never legally married.² Thus, it is likely that the majority of physicians get married at some point during medical school or residency training. A survey of over 10,000 physicians in more than 29 specialties showed that 24% of female physicians and 15% of male physicians are married to other physicians.³

Challenges

There are common challenges to all dual-career households, including coordinating demanding career schedules that compete with each other, balancing childrearing with career advancement, and harmonizing economic and personal goals. However, there are challenges that can be amplified in and unique to dual-physician marriages.

The Couples Match—Medical students, trainees, and even physicians in later stages of their careers may have less autonomy over their schedules compared to professionals in other fields. An early obstacle that many dual-physician marriages must overcome is navigating the National Resident Matching Program as a couple. The number of individuals participating as a couple in the 2022 Main Residency Match was 2444, and the postgraduate year 1 (PGY-1) match rate for individuals participating as a couple was 93.7%. The overall PGY-1 match rate for MD seniors in the United States was 92.9%.⁴ Thus, entering the match as a couple does not necessarily pose a disadvantage to successfully matching, but these statistics may be misleading. When applicants participate in the Match as a couple, their rank order lists form pairs of program choices that are processed by the matching algorithm to match the couple to the most preferred pair of programs on their rank order lists where each partner has been offered a position. Although many couples coordinate their rank order lists geographically, there is no guarantee that the couple will actually match together in the same city, let alone in the same time zone. Also, the statistics do not take into account if an individual in the couple is only partially matched (eg, if one applicant matches to a preliminary year position but not to an advanced dermatology position). The couples’ Match is only available to partners in the same application cycle, and couples that are not in sync may be more restricted when applying for residency positions.

Lack of Synchronization—Dual-physician couples are challenged to achieve synchronization not only in their day-to-day lives but also over the course of their careers. After matching to residency, the dual-physician couple faces additional scheduling stressors during training. Varied demanding patient schedules and competing call schedules may take a toll on the ability to spend time together. Coordination between both training programs to ensure weekend schedules and vacations are aligned can be helpful to try to maximize time together. If the couple’s education is staggered, their training schedules may not align when proceeding to fellowship or starting off with a new job as an attending. It is not uncommon for couples in medicine to be long-distance for a period of time, and partners may find themselves sacrificing ideal positions or self-restricting application to certain programs or jobs to secure a position near a partner who is already in training in a certain geographic location.

Domestic Work-Life Balance—Juxtaposing 2 highly demanding careers in the same household can be associated with certain tensions, as the weight of household and childrearing responsibilities as well as professional productivity and advancement is divided by the couple. In a 2008 survey of the American College of Surgeons on burnout, work-home conflict, and career satisfaction, surgeons in dual-physician relationships experienced a recent career conflict with their domestic partner and a work-home conflict more often than surgeons whose partners were working nonphysicians.⁵ The hours worked between men and women in dual-physician families differed according to a national sample of 9868 physicians in dual-physician relationships. The study showed that weekly hours worked by women with children were lower than among those without children, whereas similar differences were not observed among men.⁶ It is not understood if this suggests that women in dual-physician families work fewer hours due to the pressures of historical gender norms and increased household responsibilities. A 1988 survey of female physicians (N=382) in which 247 respondents indicated that they had domestic partners showed that women physicians whose partners also were physicians (n=91) were more than twice as likely to interrupt their own careers for their partners’ careers compared to female physicians whose partners were not physicians (n=156)(25% vs 11%, respectively). In contrast, the male partners who were not physicians were significantly more likely to interrupt their careers than male partners who were physicians (41% vs 15%, respectively, P<.05).⁷

Divorce—There have been mixed reports on the incidence of divorce in physicians compared to the general population, but studies suggest that physicians’ marriages tend to be more stable than those of other societal groups.⁸ Of 203 respondents of a survey of female physician members of the Minnesota Medical Association who were or had been married to another physician, 11.3% (22/203) were divorced, and medicine was reported to play a role in 69.6% of those separations.⁹ A retrospective analysis of nationally representative surveys by the US Census showed that divorce among physicians is less common than among non–health care workers and several other health professions.¹⁰

Rewards

The benefits of medical marriages are multifold and include increased job satisfaction, stability, financial security, shared passions, and mutual understanding. Common passions and interests form the foundation for many relationships, which is true for the dual-physician marriage. In a 2009 study, Perlman et al¹¹ performed qualitative interviews with 25 physicians and their partners—10 of which were in dual-physician relationships—about the challenges and strengths of their relationships. A key theme that emerged during the interviews was the acknowledgment of the benefits of being a physician to the relationship. Participants discussed both the financial security in a physician marriage and the security that medical knowledge adds to a relationship when caring for ill or injured family members. Other key themes identified were relying on mutual support in the relationship, recognizing the important role of each family member, and having shared values.¹¹

Financial Security—The financial security attributed to being in a medical marriage was highlighted in a series of interviews with physicians and their spouses.¹¹ A cross-sectional survey of a random sample of physicians showed that both men and women in dual-physician families had lower personal incomes than physicians married to nonphysicians. However, men and women in dual-physician families had spouses with higher incomes compared to spouses of physicians married to nonphysicians. Thus, the total family incomes were substantially higher in dual-physician households than the family incomes of physicians married to nonphysicians.¹²

Satisfaction—Dual-physician marriages benefit from a shared camaraderie and understanding of the joys and sacrifices that accompany pursuing a career in medicine. Medical spouses can communicate in mutually understood medical jargon. Compared to physicians married to nonphysicians, a statistically significant difference (P<.001) was found in physicians in dual-physicians families who more frequently reported enjoyment in discussing work with their spouses and more frequently reported satisfaction from shared work interests with their spouses.¹²

Final Thoughts

From the start of medical training, physicians and physicians-in-training experience unique benefits and challenges that are compounded in distinctive ways when 2 physicians get married. In an era where dual-physician marriage is becoming more common, it is important to acknowledge how this can both enrich and challenge the relationship.

Acknowledgment—The author thanks her husband Joshua L. Weinstock, MD (Camden, New Jersey), for his contribution to this article and their marriage.

To the Editor:

In a 2010 landmark paper, researchers reported that the Preexposure Prophylaxis Initiative (iPrEx) trial demonstrated that once-daily pre-exposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate, which was approved by the US Food and Drug Administration (FDA) and packaged together as Truvada (Gilead Sciences, Inc), achieved a 44% reduction in the incidence of HIV infection compared to the placebo arm of the study (64/1248 HIV infections in the placebo group vs 36/1251 in the intervention group).¹ Subsequently, the US Department of Health and Human Services proposed an initiative to reduce new HIV infections by 90% by 2030.² The Centers for Disease Control and Prevention estimates that 1.1 million Americans have an indication for PrEP, yet only approximately 400,000 individuals currently take PrEP.^3,4

Increasing awareness of PrEP and its indications is essential because PrEP exerts its greatest benefit when used broadly. Awareness among primary care and infectious disease physicians was reported at 76%⁵; awareness among other medical specialists remains unknown. Awareness of PrEP among dermatologists is important because dermatologists play an important role in the diagnosis and treatment of many sexually transmitted infections (STIs), which are a risk factor for transmission of HIV. As providers who treat STIs, dermatologists are in a prime position to educate patients about PrEP, refer them for treatment, and prescribe the regimen. We conducted a survey to assess dermatologists’ knowledge about and attitudes toward PrEP. We also provide a brief summary of prescribing information about common PrEP regimens to fill in the knowledge gap among dermatologists as a way to promote its utilization.

An electronic survey was distributed to 486 members of the Association of Professors of Dermatology based in the United States using the web-based survey application REDCap. The study was approved by the New York University Grossman School of Medicine (New York, New York) institutional review board. Eighty-one anonymous survey responses were completed and returned (response rate, 16.6%). Data were analyzed using descriptive statistics.

The mean age (SD) of respondents was 39.1 (9.7) years; 49.4% (40/81) were male; and 74.1% (60/81) were attending physicians, with a mean (SD) of 9.4 (8.6) years of practice. Clinical practices were predominantly from the northeast (46.9% [38/81]) and mostly in an academic setting (74.1% [60/81]). As shown in Table 1, most surveyed dermatologists reported being aware of PrEP (93.8% [76/81]), but a minority (42.0% [34/81]) were familiar with indications for its use; even fewer (4.9% [4/81]) were current prescribers. Referral to other physicians for PrEP was reported by 58.0% (47/81) of respondents.

Despite respondents’ awareness of PrEP as a preventive measure (93.8% [76/81]) and their willingness to prescribe it (67.9% [55/81]), many reported being largely unfamiliar with its indications (58.0% [47/81]) and uncomfortable discussing its adverse effects (72.8% [59/81]), conducting appropriate laboratory monitoring (84.0% [68/81]), and refilling existing prescriptions (77.8% [63/81]). Respondents’ lack of education about PrEP was a barrier to prescribing (51.9% [42/81] to 59.3% [48/81]) and explains why a small minority (4.9% [4/81]) currently prescribe the regimen.

Our study sought to characterize current clinical knowledge about and practice patterns of PrEP among dermatologists. Dermatologists often encounter patients who present with an STI, which is a risk factor for HIV infection, but our survey respondents reported several barriers to utilizing PrEP. The difference in the degree of respondents’ willingness to prescribe PrEP (67.9%) and those who self-identified as prescribers (4.9%) suggests a role for dermatologists in prescribing or discussing PrEP with their patients—albeit a currently undefined role.

The results of our study suggested that half (41/81) of dermatologists believe that PrEP prescription is out of their scope of practice, likely due to a combination of scheduling, laboratory monitoring, and medicolegal concerns. For dermatologists who are interested in being PrEP prescribers, our results suggested that closing the knowledge gap around PrEP among dermatologists through training and education could improve comfort with this medication and lead to changes in practice to prevent the spread of HIV infection.

PrEP is indicated for HIV-negative patients who have HIV-positive sexual partners, utilize barrier protection methods inconsistently, or had a diagnosis of an STI in the last 6 months.⁶ In 2012, the FDA approved once-daily use of emtricitabine plus tenofovir for primary prevention of HIV infection. Post hoc analysis of iPrEx trial data revealed that once-daily PrEP taken regularly had a 92% to 100% protective effect against HIV.⁷

Regrettably, real-world uptake of PrEP has been slower than desired. The most recent data (2021) show that nearly 1 million individuals worldwide take PrEP; however, this represents only approximately one-third of those eligible.⁸ Utilization is notably lower among Black and Latino populations who stand to gain the most from PrEP given their higher risk of contracting HIV compared to their White counterparts.⁹ As such, improving access to PrEP through expanded provider awareness is essential to decrease the risk for HIV infection and transmission.

Emtricitabine plus tenofovir is safe and well tolerated; more common adverse effects are headache, nausea, vomiting, rash, and loss of appetite. Tenofovir likely decreases bone mineral density, even in HIV-negative patients¹⁰; mineralization seems to recover after the medication is discontinued.¹¹ Rarely, tenofovir can increase the level of creatinine and hepatic transaminases; a recent report on its long-term side effects has shown small nonprogressive decreases in glomerular filtration rate.¹² Monitoring kidney function is a component of prescribing PrEP (Table 2).

In 2019, emtricitabine plus tenofovir was reformulated with tenofovir alafenamide; the new combination regimen received FDA approval for once-daily PrEP under the brand name Descovy (Gilead Sciences, Inc). The new formulation results in a lower blood concentration of tenofovir and has been reported to present less of a risk for bone and kidney toxicity.^13,14

Notably, emtricitabine plus tenofovir alafenamide might accumulate faster in peripheral lymphatic tissue than emtricitabine plus tenofovir disoproxil fumarate. This property has led to a new regimen known as “on-demand PrEP,” which follows a 2-1-1 dosing regimen: Patients take a double dose 2 to 24 hours before sexual activity, 1 dose on the day of sexual activity, and 1 dose the day after sexual activity.¹⁵ Because some patients at risk for HIV infection might not be consistently sexually active, on-demand PrEP allows them to cycle on and off the medication. Barriers to implementing on-demand PrEP include requiring that sexual activity be planned and an adverse effect profile similar to daily-use PrEP.¹⁶

The FDA recently approved a long-acting, once-monthly combination injectable PrEP of cabotegravir and rilpivirine.¹⁷ The long duration of action of this PrEP will benefit patients who report problems with medication adherence.

Our study demonstrates low frequency in prescribing patterns of PrEP among dermatologists and suggests that an addressable barrier to such prescribing is the lack of knowledge on how to prescribe it safely, which warrants further clinical investigation. We summarize an approach to prescribing PrEP in Table 2. Our study was limited by a small sample of mostly academic dermatologists and selection bias, which may diminish the generalizability of findings. A study of a larger, more representative group of dermatologists likely would show different prescribing patterns and degrees of knowledge about PrEP. Research is needed to study the impact of educational interventions that aim to increase both knowledge and prescribing of PrEP among dermatologists.

To the Editor:

In a 2010 landmark paper, researchers reported that the Preexposure Prophylaxis Initiative (iPrEx) trial demonstrated that once-daily pre-exposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate, which was approved by the US Food and Drug Administration (FDA) and packaged together as Truvada (Gilead Sciences, Inc), achieved a 44% reduction in the incidence of HIV infection compared to the placebo arm of the study (64/1248 HIV infections in the placebo group vs 36/1251 in the intervention group).¹ Subsequently, the US Department of Health and Human Services proposed an initiative to reduce new HIV infections by 90% by 2030.² The Centers for Disease Control and Prevention estimates that 1.1 million Americans have an indication for PrEP, yet only approximately 400,000 individuals currently take PrEP.^3,4

Increasing awareness of PrEP and its indications is essential because PrEP exerts its greatest benefit when used broadly. Awareness among primary care and infectious disease physicians was reported at 76%⁵; awareness among other medical specialists remains unknown. Awareness of PrEP among dermatologists is important because dermatologists play an important role in the diagnosis and treatment of many sexually transmitted infections (STIs), which are a risk factor for transmission of HIV. As providers who treat STIs, dermatologists are in a prime position to educate patients about PrEP, refer them for treatment, and prescribe the regimen. We conducted a survey to assess dermatologists’ knowledge about and attitudes toward PrEP. We also provide a brief summary of prescribing information about common PrEP regimens to fill in the knowledge gap among dermatologists as a way to promote its utilization.

An electronic survey was distributed to 486 members of the Association of Professors of Dermatology based in the United States using the web-based survey application REDCap. The study was approved by the New York University Grossman School of Medicine (New York, New York) institutional review board. Eighty-one anonymous survey responses were completed and returned (response rate, 16.6%). Data were analyzed using descriptive statistics.

The mean age (SD) of respondents was 39.1 (9.7) years; 49.4% (40/81) were male; and 74.1% (60/81) were attending physicians, with a mean (SD) of 9.4 (8.6) years of practice. Clinical practices were predominantly from the northeast (46.9% [38/81]) and mostly in an academic setting (74.1% [60/81]). As shown in Table 1, most surveyed dermatologists reported being aware of PrEP (93.8% [76/81]), but a minority (42.0% [34/81]) were familiar with indications for its use; even fewer (4.9% [4/81]) were current prescribers. Referral to other physicians for PrEP was reported by 58.0% (47/81) of respondents.

Despite respondents’ awareness of PrEP as a preventive measure (93.8% [76/81]) and their willingness to prescribe it (67.9% [55/81]), many reported being largely unfamiliar with its indications (58.0% [47/81]) and uncomfortable discussing its adverse effects (72.8% [59/81]), conducting appropriate laboratory monitoring (84.0% [68/81]), and refilling existing prescriptions (77.8% [63/81]). Respondents’ lack of education about PrEP was a barrier to prescribing (51.9% [42/81] to 59.3% [48/81]) and explains why a small minority (4.9% [4/81]) currently prescribe the regimen.

Our study sought to characterize current clinical knowledge about and practice patterns of PrEP among dermatologists. Dermatologists often encounter patients who present with an STI, which is a risk factor for HIV infection, but our survey respondents reported several barriers to utilizing PrEP. The difference in the degree of respondents’ willingness to prescribe PrEP (67.9%) and those who self-identified as prescribers (4.9%) suggests a role for dermatologists in prescribing or discussing PrEP with their patients—albeit a currently undefined role.

The results of our study suggested that half (41/81) of dermatologists believe that PrEP prescription is out of their scope of practice, likely due to a combination of scheduling, laboratory monitoring, and medicolegal concerns. For dermatologists who are interested in being PrEP prescribers, our results suggested that closing the knowledge gap around PrEP among dermatologists through training and education could improve comfort with this medication and lead to changes in practice to prevent the spread of HIV infection.

PrEP is indicated for HIV-negative patients who have HIV-positive sexual partners, utilize barrier protection methods inconsistently, or had a diagnosis of an STI in the last 6 months.⁶ In 2012, the FDA approved once-daily use of emtricitabine plus tenofovir for primary prevention of HIV infection. Post hoc analysis of iPrEx trial data revealed that once-daily PrEP taken regularly had a 92% to 100% protective effect against HIV.⁷

Regrettably, real-world uptake of PrEP has been slower than desired. The most recent data (2021) show that nearly 1 million individuals worldwide take PrEP; however, this represents only approximately one-third of those eligible.⁸ Utilization is notably lower among Black and Latino populations who stand to gain the most from PrEP given their higher risk of contracting HIV compared to their White counterparts.⁹ As such, improving access to PrEP through expanded provider awareness is essential to decrease the risk for HIV infection and transmission.

Emtricitabine plus tenofovir is safe and well tolerated; more common adverse effects are headache, nausea, vomiting, rash, and loss of appetite. Tenofovir likely decreases bone mineral density, even in HIV-negative patients¹⁰; mineralization seems to recover after the medication is discontinued.¹¹ Rarely, tenofovir can increase the level of creatinine and hepatic transaminases; a recent report on its long-term side effects has shown small nonprogressive decreases in glomerular filtration rate.¹² Monitoring kidney function is a component of prescribing PrEP (Table 2).

In 2019, emtricitabine plus tenofovir was reformulated with tenofovir alafenamide; the new combination regimen received FDA approval for once-daily PrEP under the brand name Descovy (Gilead Sciences, Inc). The new formulation results in a lower blood concentration of tenofovir and has been reported to present less of a risk for bone and kidney toxicity.^13,14

Notably, emtricitabine plus tenofovir alafenamide might accumulate faster in peripheral lymphatic tissue than emtricitabine plus tenofovir disoproxil fumarate. This property has led to a new regimen known as “on-demand PrEP,” which follows a 2-1-1 dosing regimen: Patients take a double dose 2 to 24 hours before sexual activity, 1 dose on the day of sexual activity, and 1 dose the day after sexual activity.¹⁵ Because some patients at risk for HIV infection might not be consistently sexually active, on-demand PrEP allows them to cycle on and off the medication. Barriers to implementing on-demand PrEP include requiring that sexual activity be planned and an adverse effect profile similar to daily-use PrEP.¹⁶

The FDA recently approved a long-acting, once-monthly combination injectable PrEP of cabotegravir and rilpivirine.¹⁷ The long duration of action of this PrEP will benefit patients who report problems with medication adherence.

Our study demonstrates low frequency in prescribing patterns of PrEP among dermatologists and suggests that an addressable barrier to such prescribing is the lack of knowledge on how to prescribe it safely, which warrants further clinical investigation. We summarize an approach to prescribing PrEP in Table 2. Our study was limited by a small sample of mostly academic dermatologists and selection bias, which may diminish the generalizability of findings. A study of a larger, more representative group of dermatologists likely would show different prescribing patterns and degrees of knowledge about PrEP. Research is needed to study the impact of educational interventions that aim to increase both knowledge and prescribing of PrEP among dermatologists.

To the Editor:

In a 2010 landmark paper, researchers reported that the Preexposure Prophylaxis Initiative (iPrEx) trial demonstrated that once-daily pre-exposure prophylaxis (PrEP) with emtricitabine plus tenofovir disoproxil fumarate, which was approved by the US Food and Drug Administration (FDA) and packaged together as Truvada (Gilead Sciences, Inc), achieved a 44% reduction in the incidence of HIV infection compared to the placebo arm of the study (64/1248 HIV infections in the placebo group vs 36/1251 in the intervention group).¹ Subsequently, the US Department of Health and Human Services proposed an initiative to reduce new HIV infections by 90% by 2030.² The Centers for Disease Control and Prevention estimates that 1.1 million Americans have an indication for PrEP, yet only approximately 400,000 individuals currently take PrEP.^3,4

Increasing awareness of PrEP and its indications is essential because PrEP exerts its greatest benefit when used broadly. Awareness among primary care and infectious disease physicians was reported at 76%⁵; awareness among other medical specialists remains unknown. Awareness of PrEP among dermatologists is important because dermatologists play an important role in the diagnosis and treatment of many sexually transmitted infections (STIs), which are a risk factor for transmission of HIV. As providers who treat STIs, dermatologists are in a prime position to educate patients about PrEP, refer them for treatment, and prescribe the regimen. We conducted a survey to assess dermatologists’ knowledge about and attitudes toward PrEP. We also provide a brief summary of prescribing information about common PrEP regimens to fill in the knowledge gap among dermatologists as a way to promote its utilization.

An electronic survey was distributed to 486 members of the Association of Professors of Dermatology based in the United States using the web-based survey application REDCap. The study was approved by the New York University Grossman School of Medicine (New York, New York) institutional review board. Eighty-one anonymous survey responses were completed and returned (response rate, 16.6%). Data were analyzed using descriptive statistics.

The mean age (SD) of respondents was 39.1 (9.7) years; 49.4% (40/81) were male; and 74.1% (60/81) were attending physicians, with a mean (SD) of 9.4 (8.6) years of practice. Clinical practices were predominantly from the northeast (46.9% [38/81]) and mostly in an academic setting (74.1% [60/81]). As shown in Table 1, most surveyed dermatologists reported being aware of PrEP (93.8% [76/81]), but a minority (42.0% [34/81]) were familiar with indications for its use; even fewer (4.9% [4/81]) were current prescribers. Referral to other physicians for PrEP was reported by 58.0% (47/81) of respondents.

Despite respondents’ awareness of PrEP as a preventive measure (93.8% [76/81]) and their willingness to prescribe it (67.9% [55/81]), many reported being largely unfamiliar with its indications (58.0% [47/81]) and uncomfortable discussing its adverse effects (72.8% [59/81]), conducting appropriate laboratory monitoring (84.0% [68/81]), and refilling existing prescriptions (77.8% [63/81]). Respondents’ lack of education about PrEP was a barrier to prescribing (51.9% [42/81] to 59.3% [48/81]) and explains why a small minority (4.9% [4/81]) currently prescribe the regimen.

Our study sought to characterize current clinical knowledge about and practice patterns of PrEP among dermatologists. Dermatologists often encounter patients who present with an STI, which is a risk factor for HIV infection, but our survey respondents reported several barriers to utilizing PrEP. The difference in the degree of respondents’ willingness to prescribe PrEP (67.9%) and those who self-identified as prescribers (4.9%) suggests a role for dermatologists in prescribing or discussing PrEP with their patients—albeit a currently undefined role.

The results of our study suggested that half (41/81) of dermatologists believe that PrEP prescription is out of their scope of practice, likely due to a combination of scheduling, laboratory monitoring, and medicolegal concerns. For dermatologists who are interested in being PrEP prescribers, our results suggested that closing the knowledge gap around PrEP among dermatologists through training and education could improve comfort with this medication and lead to changes in practice to prevent the spread of HIV infection.

PrEP is indicated for HIV-negative patients who have HIV-positive sexual partners, utilize barrier protection methods inconsistently, or had a diagnosis of an STI in the last 6 months.⁶ In 2012, the FDA approved once-daily use of emtricitabine plus tenofovir for primary prevention of HIV infection. Post hoc analysis of iPrEx trial data revealed that once-daily PrEP taken regularly had a 92% to 100% protective effect against HIV.⁷

Regrettably, real-world uptake of PrEP has been slower than desired. The most recent data (2021) show that nearly 1 million individuals worldwide take PrEP; however, this represents only approximately one-third of those eligible.⁸ Utilization is notably lower among Black and Latino populations who stand to gain the most from PrEP given their higher risk of contracting HIV compared to their White counterparts.⁹ As such, improving access to PrEP through expanded provider awareness is essential to decrease the risk for HIV infection and transmission.

Emtricitabine plus tenofovir is safe and well tolerated; more common adverse effects are headache, nausea, vomiting, rash, and loss of appetite. Tenofovir likely decreases bone mineral density, even in HIV-negative patients¹⁰; mineralization seems to recover after the medication is discontinued.¹¹ Rarely, tenofovir can increase the level of creatinine and hepatic transaminases; a recent report on its long-term side effects has shown small nonprogressive decreases in glomerular filtration rate.¹² Monitoring kidney function is a component of prescribing PrEP (Table 2).

In 2019, emtricitabine plus tenofovir was reformulated with tenofovir alafenamide; the new combination regimen received FDA approval for once-daily PrEP under the brand name Descovy (Gilead Sciences, Inc). The new formulation results in a lower blood concentration of tenofovir and has been reported to present less of a risk for bone and kidney toxicity.^13,14

Notably, emtricitabine plus tenofovir alafenamide might accumulate faster in peripheral lymphatic tissue than emtricitabine plus tenofovir disoproxil fumarate. This property has led to a new regimen known as “on-demand PrEP,” which follows a 2-1-1 dosing regimen: Patients take a double dose 2 to 24 hours before sexual activity, 1 dose on the day of sexual activity, and 1 dose the day after sexual activity.¹⁵ Because some patients at risk for HIV infection might not be consistently sexually active, on-demand PrEP allows them to cycle on and off the medication. Barriers to implementing on-demand PrEP include requiring that sexual activity be planned and an adverse effect profile similar to daily-use PrEP.¹⁶

The FDA recently approved a long-acting, once-monthly combination injectable PrEP of cabotegravir and rilpivirine.¹⁷ The long duration of action of this PrEP will benefit patients who report problems with medication adherence.

Our study demonstrates low frequency in prescribing patterns of PrEP among dermatologists and suggests that an addressable barrier to such prescribing is the lack of knowledge on how to prescribe it safely, which warrants further clinical investigation. We summarize an approach to prescribing PrEP in Table 2. Our study was limited by a small sample of mostly academic dermatologists and selection bias, which may diminish the generalizability of findings. A study of a larger, more representative group of dermatologists likely would show different prescribing patterns and degrees of knowledge about PrEP. Research is needed to study the impact of educational interventions that aim to increase both knowledge and prescribing of PrEP among dermatologists.

This discussion was recorded on Aug. 31, 2022. This transcript has been edited for clarity.

Robert Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have Dr. Paul Christo, a pain specialist in the Division of Pain Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and host of the national radio show Aches and Gains on SiriusXM Radio, joining us to discuss the ongoing and worsening fentanyl crisis in the U.S.

Welcome, Dr Christo.

Paul J. Christo, MD, MBA: Thanks so much for having me.

Dr. Glatter: I want to begin with a sobering statistic regarding overdoses. There were over 107,000 overdose deaths in the U.S. from 2020 to 2021, of which over two thirds involved the synthetic opiate fentanyl, based on recent data from the CDC.

Let’s start by having you explain how deadly fentanyl is in terms of its potency compared with morphine and heroin.

Dr. Christo: Fentanyl is considered a synthetic opioid. It’s not a naturally occurring opioid like morphine, for example, or codeine. We use this drug, fentanyl, often in the anesthesia well. We’ve used it for many years as an anesthetic for surgery very safely. In the chronic pain world, we’ve used it to help reduce chronic pain in the form of a patch.

What we’re seeing now, though, is something entirely different, which is the use of synthetic fentanyl as a mind- and mood-altering substance for those who don’t have pain, and essentially those who are buying this off the street. Fentanyl is about 80-100 times more potent than morphine, so you can put that in perspective in terms of its danger.

Dr. Glatter: Let me have you take us through an evolution of the opioid crisis from the 1990s, from long-acting opioid OxyContin, which was approved in 1995, to where we are now. There are different phases. If you could, educate our audience on how we got to where fentanyl is now the most common opiate involved in drug overdoses.

Dr. Christo: It really stems from the epidemic related to chronic pain. We have over 100 million people in the United States alone who suffer from chronic pain. Most chronic pain, sadly, is undertreated or untreated. In the ‘90s, in the quest to reduce chronic pain to a better extent, we saw more and more literature and studies related to the use of opioids for noncancer pain (e.g., for lower back pain).

There were many primary care doctors and pain specialists who started using opioids, probably for patients who didn’t really need it. I think it was done out of good conscience in the sense that they were trying to reduce pain. We have other methods of pain relief, but we needed more. At that time, in the ‘90s, we had a greater use of opioids to treat noncancer pain.

Then from that point, we transitioned to the use of heroin. Again, this isn’t among the chronic pain population, but it was the nonchronic pain population that starting using heroin. Today we see synthetic fentanyl.
 

Addressing the synthetic opioid crisis

Dr. Glatter: With fentanyl being the most common opiate we’re seeing, we’re having problems trying to save patients. We’re trying to use naloxone, but obviously in increasing amounts, and sometimes it’s not adequate and we have to intubate patients.

In terms of addressing this issue of supply, the fentanyl is coming from Mexico, China, and it’s manufactured here in the United States. How do we address this crisis? What are the steps that you would recommend we take?

Dr. Christo: I think that we need to better support law enforcement to crack down on those who are manufacturing fentanyl in the United States, and also to crack down on those who are transporting it from, say, Mexico – I think it’s primarily coming from Mexico – but from outside the United States to the United States. I feel like that’s important to do.

Two, we need to better educate those who are using these mind- and mood-altering substances. We’re seeing more and more that it’s the young-adult population, those between the ages of 13 and 25, who are starting to use these substances, and they’re very dangerous.

Dr. Glatter: Are these teens seeking out heroin and it happens to be laced with fentanyl, or are they actually seeking pure fentanyl? Are they trying to buy the colorful pills that we know about? What’s your experience in terms of the population you’re treating and what you could tell us?

Dr. Christo: I think it’s both. We’re seeing young adults who are interested in the use of fentanyl as a mind- and mood-altering substance. We’re also seeing young and older adults use other drugs, like cocaine and heroin, that are laced with fentanyl, and they don’t know it. That’s exponentially more dangerous.

Fentanyl test strips

Dr. Glatter: People are unaware that there is fentanyl in what they’re using, and it is certainly leading to overdoses and deaths. I think that parents really need to be aware of this.

Dr. Christo: Yes, for sure. I think we need better educational methods in the schools to educate that population that we’re talking about (between the ages of 13 and 25). Let them know the dangers, because I don’t think they’re aware of the danger, and how potent fentanyl is in terms of its lethality, and that you don’t need very much to take in a form of a pill or to inhale or to inject intravenously to kill yourself. That is key – education at that level – and to let those who are going to use these substances (specifically, synthetic fentanyl) know that they should consider the use of fentanyl test strips.

Fentanyl test strips would be primarily used for those who are thinking that they’re using heroin but there may be fentanyl in there, or methamphetamine and there may be fentanyl, and they don’t know. The test strip gives them that knowledge.

The other harm reduction strategies would be the use of naloxone, known as Narcan. That’s a lifesaver. You just have to spritz it into the nostril. You don’t do it yourself if you’re using the substance, but you’ve got others who can do it for you. No question, that’s a lifesaver. We need to make sure that there’s greater availability of that throughout the entire country, and we’re seeing some of that in certain states. In certain states, you don’t need a prescription to get naloxone from the pharmacy.

Dr. Glatter: I think it’s so important that it should be widely available. Certainly, the COVID-19 pandemic exacerbated the number of overdoses we saw. Are overdoses coming down or are we still at a level that’s close to 2020?

Dr. Christo: Unfortunately, we’re still seeing the same level, if not seeing it escalate. Certainly, the pandemic, because of the economic cost associated with the pandemic – loss of employment, underemployment – as well as the emotional stress of the pandemic led many people to use substances on the street in order to cope. They’re coping mechanisms, and we really haven’t seen it abate quite yet.

Dr. Glatter: Do you have a message for the lawmakers on Capitol Hill as to what we can do regarding the illegal manufacturing and distribution, how we can really crack down? Are there other approaches that we could implement that might be more tangible?

Dr. Christo: Yes. No. 1 would be to support law enforcement. No. 2 would be to create and make available more overdose prevention centers. The first was in New York City. If you look at the data on overdose prevention centers, in Canada, for example, they’ve seen a 35% reduction in overdose deaths. These are places where people who are using can go to get clean needles and clean syringes. This is where people basically oversee the use of the drug and intervene if necessary.

It seems sort of antithetical. It seems like, “Boy, why would you fund a center for people to use drugs?” The data from Canada and outside Canada are such that it can be very helpful. That would be one of my messages to lawmakers as well.
 

Vaccines to combat the synthetic opioid crisis

Dr. Glatter: Do you think that the legislators could approach some of these factories as a way to crack down, and have law enforcement be more aggressive? Is that another possible solution?

Dr. Christo: It is. Law enforcement needs to be supported by the government, by the Biden administration, so that we can prevent the influx of fentanyl and other drugs into the United States, and also to crack down on those in the United States who are manufacturing these drugs – synthetic fentanyl, first and foremost – because we’re seeing a lot of deaths related to synthetic fentanyl.

Also, we’re seeing — and this is pretty intriguing and interesting – the use of vaccines to help prevent overdose. The first human trial is underway right now for a vaccine against oxycodone. Not only that, but there are other vaccines that are in animal trials now against heroin, cocaine, or fentanyl. There’s hope there that we can use vaccines to also help reduce deaths related to overdose from fentanyl and other opioids.

Dr. Glatter: Do you think this would be given widely to the population or only to those at higher risk?

Dr. Christo: It would probably be targeting those who are at higher risk and have a history of drug abuse. I don’t think it would be something that would be given to the entire population, but it certainly could be effective, and we’re seeing encouraging results from the human trial right now.

Dr. Glatter: That’s very intriguing. That’s something that certainly could be quite helpful in the future.

One thing I did want to address is law enforcement and first responders who have been exposed to dust, or inhaled dust possibly, or had fentanyl on their skin. There has been lots of controversy. The recent literature has dispelled the controversy that people who had supposedly passed out and required Narcan after exposure to intact skin, or even compromised skin, had an overdose of fentanyl. Maybe you could speak to that and dispel that myth.

Dr. Christo: Yes, I’ve been asked this question a couple of times in the past. It’s not sufficient just to have contact with fentanyl on the skin to lead to an overdose. You really need to ingest it. That is, take it by mouth in the form of a pill, inhale it, or inject it intravenously. Skin contact is very unlikely going to lead to an overdose and death.

Dr. Glatter: I want to thank you for a very informative interview. Do you have one or two pearls you’d like to give our audience as a takeaway?

Dr. Christo: I would say two things. One is, don’t give up if you have chronic pain because there is hope. We have nonopioid treatments that can be effective. Two, don’t give up if you have a substance use disorder. Talk to your primary care doctor or talk to emergency room physicians if you’re in the emergency room. The Substance Abuse and Mental Health Services Administration is a good resource, too. SAMHSA has an 800 number for support and a website. Take the opportunity to use the resources that are available.

Dr. Glatter is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Hofstra University, Hempstead, N.Y. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.

Dr. Christo is an associate professor and a pain specialist in the department of anesthesiology and critical care medicine at Johns Hopkins University, Baltimore. He also serves as director of the multidisciplinary pain fellowship program at Johns Hopkins Hospital. Christo is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain, and hosts an award-winning, nationally syndicated SiriusXM radio talk show on overcoming pain, called Aches and Gains.

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

This discussion was recorded on Aug. 31, 2022. This transcript has been edited for clarity.

Robert Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have Dr. Paul Christo, a pain specialist in the Division of Pain Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and host of the national radio show Aches and Gains on SiriusXM Radio, joining us to discuss the ongoing and worsening fentanyl crisis in the U.S.

Welcome, Dr Christo.

Paul J. Christo, MD, MBA: Thanks so much for having me.

Dr. Glatter: I want to begin with a sobering statistic regarding overdoses. There were over 107,000 overdose deaths in the U.S. from 2020 to 2021, of which over two thirds involved the synthetic opiate fentanyl, based on recent data from the CDC.

Let’s start by having you explain how deadly fentanyl is in terms of its potency compared with morphine and heroin.

Dr. Christo: Fentanyl is considered a synthetic opioid. It’s not a naturally occurring opioid like morphine, for example, or codeine. We use this drug, fentanyl, often in the anesthesia well. We’ve used it for many years as an anesthetic for surgery very safely. In the chronic pain world, we’ve used it to help reduce chronic pain in the form of a patch.

What we’re seeing now, though, is something entirely different, which is the use of synthetic fentanyl as a mind- and mood-altering substance for those who don’t have pain, and essentially those who are buying this off the street. Fentanyl is about 80-100 times more potent than morphine, so you can put that in perspective in terms of its danger.

Dr. Glatter: Let me have you take us through an evolution of the opioid crisis from the 1990s, from long-acting opioid OxyContin, which was approved in 1995, to where we are now. There are different phases. If you could, educate our audience on how we got to where fentanyl is now the most common opiate involved in drug overdoses.

Dr. Christo: It really stems from the epidemic related to chronic pain. We have over 100 million people in the United States alone who suffer from chronic pain. Most chronic pain, sadly, is undertreated or untreated. In the ‘90s, in the quest to reduce chronic pain to a better extent, we saw more and more literature and studies related to the use of opioids for noncancer pain (e.g., for lower back pain).

There were many primary care doctors and pain specialists who started using opioids, probably for patients who didn’t really need it. I think it was done out of good conscience in the sense that they were trying to reduce pain. We have other methods of pain relief, but we needed more. At that time, in the ‘90s, we had a greater use of opioids to treat noncancer pain.

Then from that point, we transitioned to the use of heroin. Again, this isn’t among the chronic pain population, but it was the nonchronic pain population that starting using heroin. Today we see synthetic fentanyl.
 

Addressing the synthetic opioid crisis

Dr. Glatter: With fentanyl being the most common opiate we’re seeing, we’re having problems trying to save patients. We’re trying to use naloxone, but obviously in increasing amounts, and sometimes it’s not adequate and we have to intubate patients.

In terms of addressing this issue of supply, the fentanyl is coming from Mexico, China, and it’s manufactured here in the United States. How do we address this crisis? What are the steps that you would recommend we take?

Dr. Christo: I think that we need to better support law enforcement to crack down on those who are manufacturing fentanyl in the United States, and also to crack down on those who are transporting it from, say, Mexico – I think it’s primarily coming from Mexico – but from outside the United States to the United States. I feel like that’s important to do.

Two, we need to better educate those who are using these mind- and mood-altering substances. We’re seeing more and more that it’s the young-adult population, those between the ages of 13 and 25, who are starting to use these substances, and they’re very dangerous.

Dr. Glatter: Are these teens seeking out heroin and it happens to be laced with fentanyl, or are they actually seeking pure fentanyl? Are they trying to buy the colorful pills that we know about? What’s your experience in terms of the population you’re treating and what you could tell us?

Dr. Christo: I think it’s both. We’re seeing young adults who are interested in the use of fentanyl as a mind- and mood-altering substance. We’re also seeing young and older adults use other drugs, like cocaine and heroin, that are laced with fentanyl, and they don’t know it. That’s exponentially more dangerous.

Fentanyl test strips

Dr. Glatter: People are unaware that there is fentanyl in what they’re using, and it is certainly leading to overdoses and deaths. I think that parents really need to be aware of this.

Dr. Christo: Yes, for sure. I think we need better educational methods in the schools to educate that population that we’re talking about (between the ages of 13 and 25). Let them know the dangers, because I don’t think they’re aware of the danger, and how potent fentanyl is in terms of its lethality, and that you don’t need very much to take in a form of a pill or to inhale or to inject intravenously to kill yourself. That is key – education at that level – and to let those who are going to use these substances (specifically, synthetic fentanyl) know that they should consider the use of fentanyl test strips.

Fentanyl test strips would be primarily used for those who are thinking that they’re using heroin but there may be fentanyl in there, or methamphetamine and there may be fentanyl, and they don’t know. The test strip gives them that knowledge.

The other harm reduction strategies would be the use of naloxone, known as Narcan. That’s a lifesaver. You just have to spritz it into the nostril. You don’t do it yourself if you’re using the substance, but you’ve got others who can do it for you. No question, that’s a lifesaver. We need to make sure that there’s greater availability of that throughout the entire country, and we’re seeing some of that in certain states. In certain states, you don’t need a prescription to get naloxone from the pharmacy.

Dr. Glatter: I think it’s so important that it should be widely available. Certainly, the COVID-19 pandemic exacerbated the number of overdoses we saw. Are overdoses coming down or are we still at a level that’s close to 2020?

Dr. Christo: Unfortunately, we’re still seeing the same level, if not seeing it escalate. Certainly, the pandemic, because of the economic cost associated with the pandemic – loss of employment, underemployment – as well as the emotional stress of the pandemic led many people to use substances on the street in order to cope. They’re coping mechanisms, and we really haven’t seen it abate quite yet.

Dr. Glatter: Do you have a message for the lawmakers on Capitol Hill as to what we can do regarding the illegal manufacturing and distribution, how we can really crack down? Are there other approaches that we could implement that might be more tangible?

Dr. Christo: Yes. No. 1 would be to support law enforcement. No. 2 would be to create and make available more overdose prevention centers. The first was in New York City. If you look at the data on overdose prevention centers, in Canada, for example, they’ve seen a 35% reduction in overdose deaths. These are places where people who are using can go to get clean needles and clean syringes. This is where people basically oversee the use of the drug and intervene if necessary.

It seems sort of antithetical. It seems like, “Boy, why would you fund a center for people to use drugs?” The data from Canada and outside Canada are such that it can be very helpful. That would be one of my messages to lawmakers as well.
 

Vaccines to combat the synthetic opioid crisis

Dr. Glatter: Do you think that the legislators could approach some of these factories as a way to crack down, and have law enforcement be more aggressive? Is that another possible solution?

Dr. Christo: It is. Law enforcement needs to be supported by the government, by the Biden administration, so that we can prevent the influx of fentanyl and other drugs into the United States, and also to crack down on those in the United States who are manufacturing these drugs – synthetic fentanyl, first and foremost – because we’re seeing a lot of deaths related to synthetic fentanyl.

Also, we’re seeing — and this is pretty intriguing and interesting – the use of vaccines to help prevent overdose. The first human trial is underway right now for a vaccine against oxycodone. Not only that, but there are other vaccines that are in animal trials now against heroin, cocaine, or fentanyl. There’s hope there that we can use vaccines to also help reduce deaths related to overdose from fentanyl and other opioids.

Dr. Glatter: Do you think this would be given widely to the population or only to those at higher risk?

Dr. Christo: It would probably be targeting those who are at higher risk and have a history of drug abuse. I don’t think it would be something that would be given to the entire population, but it certainly could be effective, and we’re seeing encouraging results from the human trial right now.

Dr. Glatter: That’s very intriguing. That’s something that certainly could be quite helpful in the future.

One thing I did want to address is law enforcement and first responders who have been exposed to dust, or inhaled dust possibly, or had fentanyl on their skin. There has been lots of controversy. The recent literature has dispelled the controversy that people who had supposedly passed out and required Narcan after exposure to intact skin, or even compromised skin, had an overdose of fentanyl. Maybe you could speak to that and dispel that myth.

Dr. Christo: Yes, I’ve been asked this question a couple of times in the past. It’s not sufficient just to have contact with fentanyl on the skin to lead to an overdose. You really need to ingest it. That is, take it by mouth in the form of a pill, inhale it, or inject it intravenously. Skin contact is very unlikely going to lead to an overdose and death.

Dr. Glatter: I want to thank you for a very informative interview. Do you have one or two pearls you’d like to give our audience as a takeaway?

Dr. Christo: I would say two things. One is, don’t give up if you have chronic pain because there is hope. We have nonopioid treatments that can be effective. Two, don’t give up if you have a substance use disorder. Talk to your primary care doctor or talk to emergency room physicians if you’re in the emergency room. The Substance Abuse and Mental Health Services Administration is a good resource, too. SAMHSA has an 800 number for support and a website. Take the opportunity to use the resources that are available.

Dr. Glatter is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Hofstra University, Hempstead, N.Y. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.

Dr. Christo is an associate professor and a pain specialist in the department of anesthesiology and critical care medicine at Johns Hopkins University, Baltimore. He also serves as director of the multidisciplinary pain fellowship program at Johns Hopkins Hospital. Christo is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain, and hosts an award-winning, nationally syndicated SiriusXM radio talk show on overcoming pain, called Aches and Gains.

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

This discussion was recorded on Aug. 31, 2022. This transcript has been edited for clarity.

Robert Glatter, MD: Welcome. I’m Dr. Robert Glatter, medical advisor for Medscape Emergency Medicine. Today we have Dr. Paul Christo, a pain specialist in the Division of Pain Medicine at Johns Hopkins University School of Medicine in Baltimore, Maryland, and host of the national radio show Aches and Gains on SiriusXM Radio, joining us to discuss the ongoing and worsening fentanyl crisis in the U.S.

Welcome, Dr Christo.

Paul J. Christo, MD, MBA: Thanks so much for having me.

Dr. Glatter: I want to begin with a sobering statistic regarding overdoses. There were over 107,000 overdose deaths in the U.S. from 2020 to 2021, of which over two thirds involved the synthetic opiate fentanyl, based on recent data from the CDC.

Let’s start by having you explain how deadly fentanyl is in terms of its potency compared with morphine and heroin.

Dr. Christo: Fentanyl is considered a synthetic opioid. It’s not a naturally occurring opioid like morphine, for example, or codeine. We use this drug, fentanyl, often in the anesthesia well. We’ve used it for many years as an anesthetic for surgery very safely. In the chronic pain world, we’ve used it to help reduce chronic pain in the form of a patch.

What we’re seeing now, though, is something entirely different, which is the use of synthetic fentanyl as a mind- and mood-altering substance for those who don’t have pain, and essentially those who are buying this off the street. Fentanyl is about 80-100 times more potent than morphine, so you can put that in perspective in terms of its danger.

Dr. Glatter: Let me have you take us through an evolution of the opioid crisis from the 1990s, from long-acting opioid OxyContin, which was approved in 1995, to where we are now. There are different phases. If you could, educate our audience on how we got to where fentanyl is now the most common opiate involved in drug overdoses.

Dr. Christo: It really stems from the epidemic related to chronic pain. We have over 100 million people in the United States alone who suffer from chronic pain. Most chronic pain, sadly, is undertreated or untreated. In the ‘90s, in the quest to reduce chronic pain to a better extent, we saw more and more literature and studies related to the use of opioids for noncancer pain (e.g., for lower back pain).

There were many primary care doctors and pain specialists who started using opioids, probably for patients who didn’t really need it. I think it was done out of good conscience in the sense that they were trying to reduce pain. We have other methods of pain relief, but we needed more. At that time, in the ‘90s, we had a greater use of opioids to treat noncancer pain.

Then from that point, we transitioned to the use of heroin. Again, this isn’t among the chronic pain population, but it was the nonchronic pain population that starting using heroin. Today we see synthetic fentanyl.
 

Addressing the synthetic opioid crisis

Dr. Glatter: With fentanyl being the most common opiate we’re seeing, we’re having problems trying to save patients. We’re trying to use naloxone, but obviously in increasing amounts, and sometimes it’s not adequate and we have to intubate patients.

In terms of addressing this issue of supply, the fentanyl is coming from Mexico, China, and it’s manufactured here in the United States. How do we address this crisis? What are the steps that you would recommend we take?

Dr. Christo: I think that we need to better support law enforcement to crack down on those who are manufacturing fentanyl in the United States, and also to crack down on those who are transporting it from, say, Mexico – I think it’s primarily coming from Mexico – but from outside the United States to the United States. I feel like that’s important to do.

Two, we need to better educate those who are using these mind- and mood-altering substances. We’re seeing more and more that it’s the young-adult population, those between the ages of 13 and 25, who are starting to use these substances, and they’re very dangerous.

Dr. Glatter: Are these teens seeking out heroin and it happens to be laced with fentanyl, or are they actually seeking pure fentanyl? Are they trying to buy the colorful pills that we know about? What’s your experience in terms of the population you’re treating and what you could tell us?

Dr. Christo: I think it’s both. We’re seeing young adults who are interested in the use of fentanyl as a mind- and mood-altering substance. We’re also seeing young and older adults use other drugs, like cocaine and heroin, that are laced with fentanyl, and they don’t know it. That’s exponentially more dangerous.

Fentanyl test strips

Dr. Glatter: People are unaware that there is fentanyl in what they’re using, and it is certainly leading to overdoses and deaths. I think that parents really need to be aware of this.

Dr. Christo: Yes, for sure. I think we need better educational methods in the schools to educate that population that we’re talking about (between the ages of 13 and 25). Let them know the dangers, because I don’t think they’re aware of the danger, and how potent fentanyl is in terms of its lethality, and that you don’t need very much to take in a form of a pill or to inhale or to inject intravenously to kill yourself. That is key – education at that level – and to let those who are going to use these substances (specifically, synthetic fentanyl) know that they should consider the use of fentanyl test strips.

Fentanyl test strips would be primarily used for those who are thinking that they’re using heroin but there may be fentanyl in there, or methamphetamine and there may be fentanyl, and they don’t know. The test strip gives them that knowledge.

The other harm reduction strategies would be the use of naloxone, known as Narcan. That’s a lifesaver. You just have to spritz it into the nostril. You don’t do it yourself if you’re using the substance, but you’ve got others who can do it for you. No question, that’s a lifesaver. We need to make sure that there’s greater availability of that throughout the entire country, and we’re seeing some of that in certain states. In certain states, you don’t need a prescription to get naloxone from the pharmacy.

Dr. Glatter: I think it’s so important that it should be widely available. Certainly, the COVID-19 pandemic exacerbated the number of overdoses we saw. Are overdoses coming down or are we still at a level that’s close to 2020?

Dr. Christo: Unfortunately, we’re still seeing the same level, if not seeing it escalate. Certainly, the pandemic, because of the economic cost associated with the pandemic – loss of employment, underemployment – as well as the emotional stress of the pandemic led many people to use substances on the street in order to cope. They’re coping mechanisms, and we really haven’t seen it abate quite yet.

Dr. Glatter: Do you have a message for the lawmakers on Capitol Hill as to what we can do regarding the illegal manufacturing and distribution, how we can really crack down? Are there other approaches that we could implement that might be more tangible?

Dr. Christo: Yes. No. 1 would be to support law enforcement. No. 2 would be to create and make available more overdose prevention centers. The first was in New York City. If you look at the data on overdose prevention centers, in Canada, for example, they’ve seen a 35% reduction in overdose deaths. These are places where people who are using can go to get clean needles and clean syringes. This is where people basically oversee the use of the drug and intervene if necessary.

It seems sort of antithetical. It seems like, “Boy, why would you fund a center for people to use drugs?” The data from Canada and outside Canada are such that it can be very helpful. That would be one of my messages to lawmakers as well.
 

Vaccines to combat the synthetic opioid crisis

Dr. Glatter: Do you think that the legislators could approach some of these factories as a way to crack down, and have law enforcement be more aggressive? Is that another possible solution?

Dr. Christo: It is. Law enforcement needs to be supported by the government, by the Biden administration, so that we can prevent the influx of fentanyl and other drugs into the United States, and also to crack down on those in the United States who are manufacturing these drugs – synthetic fentanyl, first and foremost – because we’re seeing a lot of deaths related to synthetic fentanyl.

Also, we’re seeing — and this is pretty intriguing and interesting – the use of vaccines to help prevent overdose. The first human trial is underway right now for a vaccine against oxycodone. Not only that, but there are other vaccines that are in animal trials now against heroin, cocaine, or fentanyl. There’s hope there that we can use vaccines to also help reduce deaths related to overdose from fentanyl and other opioids.

Dr. Glatter: Do you think this would be given widely to the population or only to those at higher risk?

Dr. Christo: It would probably be targeting those who are at higher risk and have a history of drug abuse. I don’t think it would be something that would be given to the entire population, but it certainly could be effective, and we’re seeing encouraging results from the human trial right now.

Dr. Glatter: That’s very intriguing. That’s something that certainly could be quite helpful in the future.

One thing I did want to address is law enforcement and first responders who have been exposed to dust, or inhaled dust possibly, or had fentanyl on their skin. There has been lots of controversy. The recent literature has dispelled the controversy that people who had supposedly passed out and required Narcan after exposure to intact skin, or even compromised skin, had an overdose of fentanyl. Maybe you could speak to that and dispel that myth.

Dr. Christo: Yes, I’ve been asked this question a couple of times in the past. It’s not sufficient just to have contact with fentanyl on the skin to lead to an overdose. You really need to ingest it. That is, take it by mouth in the form of a pill, inhale it, or inject it intravenously. Skin contact is very unlikely going to lead to an overdose and death.

Dr. Glatter: I want to thank you for a very informative interview. Do you have one or two pearls you’d like to give our audience as a takeaway?

Dr. Christo: I would say two things. One is, don’t give up if you have chronic pain because there is hope. We have nonopioid treatments that can be effective. Two, don’t give up if you have a substance use disorder. Talk to your primary care doctor or talk to emergency room physicians if you’re in the emergency room. The Substance Abuse and Mental Health Services Administration is a good resource, too. SAMHSA has an 800 number for support and a website. Take the opportunity to use the resources that are available.

Dr. Glatter is assistant professor of emergency medicine at Lenox Hill Hospital in New York City and at Hofstra University, Hempstead, N.Y. He is an editorial advisor and hosts the Hot Topics in EM series on Medscape. He is also a medical contributor for Forbes.

Dr. Christo is an associate professor and a pain specialist in the department of anesthesiology and critical care medicine at Johns Hopkins University, Baltimore. He also serves as director of the multidisciplinary pain fellowship program at Johns Hopkins Hospital. Christo is the author of Aches and Gains, A Comprehensive Guide to Overcoming Your Pain, and hosts an award-winning, nationally syndicated SiriusXM radio talk show on overcoming pain, called Aches and Gains.

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

About 5% of traditional Medicare patients who had telehealth visits were seen virtually by out-of-state clinicians in the first half of 2021, according to a new study in JAMA Health Forum.

Since then, however, many states have restored restrictions that prevent physicians who are licensed in one state from having telehealth visits with patients unless they’re licensed in the state where the patients live.

RichLegg/Getty Images

This is not fair to many people who live in areas near state borders, the authors argued. For those patients, it is much more convenient to see their primary care physician in a virtual visit from home than to travel to the doctor’s office in another state. This convenience is enjoyed by most patients who reside elsewhere in their state because they’re seeing physicians who are licensed there.

Moreover, the paper said, patients who live in rural areas and in counties with relatively few physicians per capita would also benefit from relaxed telemedicine restrictions.

Using Medicare claims data, the researchers examined the characteristics of out-of-state (OOS) telemedicine visits for the 6 months from January to June 2021. They chose that period for two reasons: by then, health care had stabilized after the chaotic early phase of the pandemic, and in most states, the relaxation of licensing rules for OOS telehealth had not yet lapsed. Earlier periods of time were also used for certain types of comparisons.

Among fee-for-service Medicare beneficiaries, the number of OOS telemedicine visits peaked at 451,086 in April 2020 and slowly fell to 175,545 in June 2021, according to the study. The fraction of OOS telehealth visits among all virtual visits was 4.5% in April 2020 and increased to 5.6% by June 2021.
 

Staying close to home

Of all beneficiaries with a telemedicine visit in the study period, 33% lived within 15 miles of a state border. That cohort accounted for 57.2% of all OOS telemedicine visits.

The highest rates of OOS telehealth visits were seen in the District of Columbia (38.5%), Wyoming (25.6%), and North Dakota (21.1%). California (1%), Texas (2%), and Massachusetts (2.1%) had the lowest rates.

Though intuitive in retrospect, the correlation of OOS telemedicine use with proximity to state borders was one of the study’s most important findings, lead author Ateev Mehrotra, MD, a professor at Harvard Medical School, Boston, said in an interview. “It makes sense,” he said. “If you’re in D.C. and you need a cardiologist, you don’t think: ‘I’ll stay in D.C.’ No, Maryland is right there, so you might use a Maryland cardiologist. Now you’re out of state, even though that office might be only half a mile away from you.”

Similar dynamics, he noted, are seen in many metropolitan areas that border on other states, such as Cincinnati; Philadelphia; and Portland, Ore.

This finding lines up with another result of the study: The majority of patients who had OOS telemedicine visits had previously seen in person the doctor who conducted the virtual visit.

Across all OOS telemedicine visits in the first half of 2021, the researchers observed a prior in-person visit between March 2019 and the date of the virtual visit with the same patient and the same clinician in 62.8% of those visits. Across all in-state telehealth visits, 75.8% of them were made by patients who had seen the same clinician in person since March 2019. This preponderance of virtual visits to clinicians whom the patients had already seen in person reflects the fact that, during the pandemic, most physicians began conducting telehealth visits with their own patients, Dr. Mehrotra said.

It also lays to rest the concern that some states have had about allowing OOS telemedicine visits to physicians not licensed in those states, he added. “They think that all these docs from far away are going to start taking care of patients they don’t even know. But our study shows that isn’t the case. Most of the time, doctors are seeing a patient who’s switching over from in-person visits to out-of-state telemedicine.”
 

More specialty care sought

The dominant conditions that patients presented with were the same in OOS telemedicine and within-state virtual visits. However, the use of OOS telemedicine was higher for some types of specialized care.

For example, the rate of OOS telemedicine use, compared with all telemedicine use, was highest for cancer care (9.8%). Drilling down to more specific conditions, the top three in OOS telemedicine visits were assessment of organ transplant (13%); male reproductive cancers, such as prostate cancer (11.3%); and graft-related issues (10.2%).

The specialty trend was also evident in the types of OOS clinicians from whom Medicare patients sought virtual care. The rates of OOS telemedicine use as a percentage of all telemedicine use in particular specialties were highest for uncommon specialties, such as hematology/oncology, rheumatology, urology, medical oncology, and orthopedic surgery (8.5%). There was less use of OOS telemedicine as a percentage of all telemedicine among more common medical specialties (6.4%), mental health specialties (4.4%), and primary care (4.4%).

Despite its relatively low showing in this category, however, behavioral health was the leading condition treated in both within-state and OOS telemedicine visits, accounting for 30.7% and 25.8%, respectively, of those encounters.

States backslide on OOS telehealth

Since the end of the study period, over half of the states have restored some or all of the restrictions on OOS telemedicine that they had lifted during the pandemic.

According to Dr. Mehrotra, 22 states have some kind of regulation in place to allow an OOS clinician to conduct telehealth visits without being licensed in the state. This varies all the way from complete reciprocity with other states’ licenses to “emergency” telemedicine licenses. The other 28 states and Washington, D.C., require an OOS telemedicine practitioner to get a state license.

Various proposals have been floated to ameliorate this situation, the JAMA paper noted. These proposals include an expansion of the Interstate Medical Licensure Compact that the Federation of State Medical Boards organized in 2014. Since the pact became effective in 2014, at least 35 states and the District of Columbia have joined it. Those states have made it simpler for physicians to gain licensure in states other than their original state of licensure. However, Mehrotra said, it’s still not easy, and not many physicians have taken advantage of it.

One new wrinkle has emerged in this policy debate as a result of the Supreme Court decision overturning Roe v. Wade, he noted. Because people are using OOS telemedicine visits to get prescriptions to abort their fetuses, “that has changed the enthusiasm level for it among many states,” he said.

Dr. Mehrotra reported personal fees from the Pew Charitable Trust, Sanofi Pasteur, and Black Opal Ventures outside the submitted work. One coauthor reported receiving grants from Patient-Centered Outcomes Research, National Institute on Aging, Roundtrip, Independence Blue Cross; personal fees or salary from RAND Corporation from Verily Life Sciences; and that the American Telemedicine Association covered a conference fee. No other disclosures were reported.

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

About 5% of traditional Medicare patients who had telehealth visits were seen virtually by out-of-state clinicians in the first half of 2021, according to a new study in JAMA Health Forum.

Since then, however, many states have restored restrictions that prevent physicians who are licensed in one state from having telehealth visits with patients unless they’re licensed in the state where the patients live.

RichLegg/Getty Images

This is not fair to many people who live in areas near state borders, the authors argued. For those patients, it is much more convenient to see their primary care physician in a virtual visit from home than to travel to the doctor’s office in another state. This convenience is enjoyed by most patients who reside elsewhere in their state because they’re seeing physicians who are licensed there.

Moreover, the paper said, patients who live in rural areas and in counties with relatively few physicians per capita would also benefit from relaxed telemedicine restrictions.

Using Medicare claims data, the researchers examined the characteristics of out-of-state (OOS) telemedicine visits for the 6 months from January to June 2021. They chose that period for two reasons: by then, health care had stabilized after the chaotic early phase of the pandemic, and in most states, the relaxation of licensing rules for OOS telehealth had not yet lapsed. Earlier periods of time were also used for certain types of comparisons.

Among fee-for-service Medicare beneficiaries, the number of OOS telemedicine visits peaked at 451,086 in April 2020 and slowly fell to 175,545 in June 2021, according to the study. The fraction of OOS telehealth visits among all virtual visits was 4.5% in April 2020 and increased to 5.6% by June 2021.
 

Staying close to home

Of all beneficiaries with a telemedicine visit in the study period, 33% lived within 15 miles of a state border. That cohort accounted for 57.2% of all OOS telemedicine visits.

The highest rates of OOS telehealth visits were seen in the District of Columbia (38.5%), Wyoming (25.6%), and North Dakota (21.1%). California (1%), Texas (2%), and Massachusetts (2.1%) had the lowest rates.

Though intuitive in retrospect, the correlation of OOS telemedicine use with proximity to state borders was one of the study’s most important findings, lead author Ateev Mehrotra, MD, a professor at Harvard Medical School, Boston, said in an interview. “It makes sense,” he said. “If you’re in D.C. and you need a cardiologist, you don’t think: ‘I’ll stay in D.C.’ No, Maryland is right there, so you might use a Maryland cardiologist. Now you’re out of state, even though that office might be only half a mile away from you.”

Similar dynamics, he noted, are seen in many metropolitan areas that border on other states, such as Cincinnati; Philadelphia; and Portland, Ore.

This finding lines up with another result of the study: The majority of patients who had OOS telemedicine visits had previously seen in person the doctor who conducted the virtual visit.

Across all OOS telemedicine visits in the first half of 2021, the researchers observed a prior in-person visit between March 2019 and the date of the virtual visit with the same patient and the same clinician in 62.8% of those visits. Across all in-state telehealth visits, 75.8% of them were made by patients who had seen the same clinician in person since March 2019. This preponderance of virtual visits to clinicians whom the patients had already seen in person reflects the fact that, during the pandemic, most physicians began conducting telehealth visits with their own patients, Dr. Mehrotra said.

It also lays to rest the concern that some states have had about allowing OOS telemedicine visits to physicians not licensed in those states, he added. “They think that all these docs from far away are going to start taking care of patients they don’t even know. But our study shows that isn’t the case. Most of the time, doctors are seeing a patient who’s switching over from in-person visits to out-of-state telemedicine.”
 

More specialty care sought

The dominant conditions that patients presented with were the same in OOS telemedicine and within-state virtual visits. However, the use of OOS telemedicine was higher for some types of specialized care.

For example, the rate of OOS telemedicine use, compared with all telemedicine use, was highest for cancer care (9.8%). Drilling down to more specific conditions, the top three in OOS telemedicine visits were assessment of organ transplant (13%); male reproductive cancers, such as prostate cancer (11.3%); and graft-related issues (10.2%).

The specialty trend was also evident in the types of OOS clinicians from whom Medicare patients sought virtual care. The rates of OOS telemedicine use as a percentage of all telemedicine use in particular specialties were highest for uncommon specialties, such as hematology/oncology, rheumatology, urology, medical oncology, and orthopedic surgery (8.5%). There was less use of OOS telemedicine as a percentage of all telemedicine among more common medical specialties (6.4%), mental health specialties (4.4%), and primary care (4.4%).

Despite its relatively low showing in this category, however, behavioral health was the leading condition treated in both within-state and OOS telemedicine visits, accounting for 30.7% and 25.8%, respectively, of those encounters.

States backslide on OOS telehealth

Since the end of the study period, over half of the states have restored some or all of the restrictions on OOS telemedicine that they had lifted during the pandemic.

According to Dr. Mehrotra, 22 states have some kind of regulation in place to allow an OOS clinician to conduct telehealth visits without being licensed in the state. This varies all the way from complete reciprocity with other states’ licenses to “emergency” telemedicine licenses. The other 28 states and Washington, D.C., require an OOS telemedicine practitioner to get a state license.

Various proposals have been floated to ameliorate this situation, the JAMA paper noted. These proposals include an expansion of the Interstate Medical Licensure Compact that the Federation of State Medical Boards organized in 2014. Since the pact became effective in 2014, at least 35 states and the District of Columbia have joined it. Those states have made it simpler for physicians to gain licensure in states other than their original state of licensure. However, Mehrotra said, it’s still not easy, and not many physicians have taken advantage of it.

One new wrinkle has emerged in this policy debate as a result of the Supreme Court decision overturning Roe v. Wade, he noted. Because people are using OOS telemedicine visits to get prescriptions to abort their fetuses, “that has changed the enthusiasm level for it among many states,” he said.

Dr. Mehrotra reported personal fees from the Pew Charitable Trust, Sanofi Pasteur, and Black Opal Ventures outside the submitted work. One coauthor reported receiving grants from Patient-Centered Outcomes Research, National Institute on Aging, Roundtrip, Independence Blue Cross; personal fees or salary from RAND Corporation from Verily Life Sciences; and that the American Telemedicine Association covered a conference fee. No other disclosures were reported.

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

About 5% of traditional Medicare patients who had telehealth visits were seen virtually by out-of-state clinicians in the first half of 2021, according to a new study in JAMA Health Forum.

Since then, however, many states have restored restrictions that prevent physicians who are licensed in one state from having telehealth visits with patients unless they’re licensed in the state where the patients live.

RichLegg/Getty Images

This is not fair to many people who live in areas near state borders, the authors argued. For those patients, it is much more convenient to see their primary care physician in a virtual visit from home than to travel to the doctor’s office in another state. This convenience is enjoyed by most patients who reside elsewhere in their state because they’re seeing physicians who are licensed there.

Moreover, the paper said, patients who live in rural areas and in counties with relatively few physicians per capita would also benefit from relaxed telemedicine restrictions.

Using Medicare claims data, the researchers examined the characteristics of out-of-state (OOS) telemedicine visits for the 6 months from January to June 2021. They chose that period for two reasons: by then, health care had stabilized after the chaotic early phase of the pandemic, and in most states, the relaxation of licensing rules for OOS telehealth had not yet lapsed. Earlier periods of time were also used for certain types of comparisons.

Among fee-for-service Medicare beneficiaries, the number of OOS telemedicine visits peaked at 451,086 in April 2020 and slowly fell to 175,545 in June 2021, according to the study. The fraction of OOS telehealth visits among all virtual visits was 4.5% in April 2020 and increased to 5.6% by June 2021.
 

Staying close to home

Of all beneficiaries with a telemedicine visit in the study period, 33% lived within 15 miles of a state border. That cohort accounted for 57.2% of all OOS telemedicine visits.

The highest rates of OOS telehealth visits were seen in the District of Columbia (38.5%), Wyoming (25.6%), and North Dakota (21.1%). California (1%), Texas (2%), and Massachusetts (2.1%) had the lowest rates.

Though intuitive in retrospect, the correlation of OOS telemedicine use with proximity to state borders was one of the study’s most important findings, lead author Ateev Mehrotra, MD, a professor at Harvard Medical School, Boston, said in an interview. “It makes sense,” he said. “If you’re in D.C. and you need a cardiologist, you don’t think: ‘I’ll stay in D.C.’ No, Maryland is right there, so you might use a Maryland cardiologist. Now you’re out of state, even though that office might be only half a mile away from you.”

Similar dynamics, he noted, are seen in many metropolitan areas that border on other states, such as Cincinnati; Philadelphia; and Portland, Ore.

This finding lines up with another result of the study: The majority of patients who had OOS telemedicine visits had previously seen in person the doctor who conducted the virtual visit.

Across all OOS telemedicine visits in the first half of 2021, the researchers observed a prior in-person visit between March 2019 and the date of the virtual visit with the same patient and the same clinician in 62.8% of those visits. Across all in-state telehealth visits, 75.8% of them were made by patients who had seen the same clinician in person since March 2019. This preponderance of virtual visits to clinicians whom the patients had already seen in person reflects the fact that, during the pandemic, most physicians began conducting telehealth visits with their own patients, Dr. Mehrotra said.

It also lays to rest the concern that some states have had about allowing OOS telemedicine visits to physicians not licensed in those states, he added. “They think that all these docs from far away are going to start taking care of patients they don’t even know. But our study shows that isn’t the case. Most of the time, doctors are seeing a patient who’s switching over from in-person visits to out-of-state telemedicine.”
 

More specialty care sought

The dominant conditions that patients presented with were the same in OOS telemedicine and within-state virtual visits. However, the use of OOS telemedicine was higher for some types of specialized care.

For example, the rate of OOS telemedicine use, compared with all telemedicine use, was highest for cancer care (9.8%). Drilling down to more specific conditions, the top three in OOS telemedicine visits were assessment of organ transplant (13%); male reproductive cancers, such as prostate cancer (11.3%); and graft-related issues (10.2%).

The specialty trend was also evident in the types of OOS clinicians from whom Medicare patients sought virtual care. The rates of OOS telemedicine use as a percentage of all telemedicine use in particular specialties were highest for uncommon specialties, such as hematology/oncology, rheumatology, urology, medical oncology, and orthopedic surgery (8.5%). There was less use of OOS telemedicine as a percentage of all telemedicine among more common medical specialties (6.4%), mental health specialties (4.4%), and primary care (4.4%).

Despite its relatively low showing in this category, however, behavioral health was the leading condition treated in both within-state and OOS telemedicine visits, accounting for 30.7% and 25.8%, respectively, of those encounters.

States backslide on OOS telehealth

Since the end of the study period, over half of the states have restored some or all of the restrictions on OOS telemedicine that they had lifted during the pandemic.

According to Dr. Mehrotra, 22 states have some kind of regulation in place to allow an OOS clinician to conduct telehealth visits without being licensed in the state. This varies all the way from complete reciprocity with other states’ licenses to “emergency” telemedicine licenses. The other 28 states and Washington, D.C., require an OOS telemedicine practitioner to get a state license.

Various proposals have been floated to ameliorate this situation, the JAMA paper noted. These proposals include an expansion of the Interstate Medical Licensure Compact that the Federation of State Medical Boards organized in 2014. Since the pact became effective in 2014, at least 35 states and the District of Columbia have joined it. Those states have made it simpler for physicians to gain licensure in states other than their original state of licensure. However, Mehrotra said, it’s still not easy, and not many physicians have taken advantage of it.

One new wrinkle has emerged in this policy debate as a result of the Supreme Court decision overturning Roe v. Wade, he noted. Because people are using OOS telemedicine visits to get prescriptions to abort their fetuses, “that has changed the enthusiasm level for it among many states,” he said.

Dr. Mehrotra reported personal fees from the Pew Charitable Trust, Sanofi Pasteur, and Black Opal Ventures outside the submitted work. One coauthor reported receiving grants from Patient-Centered Outcomes Research, National Institute on Aging, Roundtrip, Independence Blue Cross; personal fees or salary from RAND Corporation from Verily Life Sciences; and that the American Telemedicine Association covered a conference fee. No other disclosures were reported.

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

Uptake of the approved extended-interval dosing regimen for pembrolizumab has been poor, according to a review of Veterans Health Administration data.

In April 2020, the Food and Drug Administration approved extended dosing for standalone pembrolizumab – 400 mg every 6 weeks instead of the standard dosing of 200 mg every 3 weeks. The shift came, in part, to reduce patient health care encounters during the early days of the COVID-19 pandemic, but also because fewer infusions save patients time and out-of-pocket costs and reduce the burden on the health care system.

The FDA deemed this move safe after pharmacologic studies and a small melanoma study found that responses and adverse events were equivalent in comparison with standard dosing.

Given the benefits, one would expect “brisk adoption” of extended-interval dosing, Garth Strohbehn, MD, an oncologist at the VA Medical Center in Ann Arbor, Mich., and colleagues wrote in a recent report in JAMA Oncology.

However, when the team reviewed data on 835 veterans from the Veterans Health Administration who began taking single-agent pembrolizumab between April 1, 2020, and July 1, 2021, only about one-third received extended-interval dosing.

Between April and January 2021, use of extended-interval dosing rose steadily to about 35% of patients but then hovered in that range through August 2021.

Among the patients, age, sex, Charlson comorbidity index, and pembrolizumab indications were well balanced between the standard-dosing and the extended-interval dosing groups.

Notably, Dr. Strohbehn and colleagues also found no difference in time-to-treatment discontinuation between patients receiving extended dosing in comparison with patients receiving standard dosing, which is “a real-world measure of clinical effectiveness,” the team said.

And there was no difference in immune-related side effects between the two regimens, as assessed by incident levothyroxine and prednisone prescriptions.

The real-world near equivalence of extended and standard dosing intervals that was demonstrated in the study is “reassuring” and helps make the case for considering it “as a best practice” for single-agent pembrolizumab, the investigators wrote.

Dr. Strohbehn remained somewhat puzzled by the low uptake of the extended-dosing option.

“I was frankly surprised by the small number of patients who received the extended-interval regimen,” Dr. Strohbehn said in an interview.

“Admittedly, there are patients who would prefer to receive standard-interval therapy, and that preference should of course be accommodated whenever possible, but in my experience, those numbers are small,” at least in the VA system, he noted.

In addition, the authors noted, there is no direct financial incentive for more frequent dosing in the VA system.

It’s possible that low uptake could stem from clinicians’ doubts about switching to an extended-interval dose, given that the FDA’s approval was based largely on a study of 44 patients with melanoma in a single-arm trial.

If that is indeed the case, the new findings – which represent the first health system–level, real-world comparative effectiveness data for standard vs. extended-interval pembrolizumab – should help address these concerns, the team said.

“This observational dataset lends further credence to [the dosing] regimens being clinically equivalent,” said Zachery Reichert, MD, PhD, a urologic oncologist at the University of Michigan, Ann Arbor, who was not involved in the study.

To address the issue, Dr. Strohbehn and his team suggested “clinical guideline promotion to overcome some of the barriers to the adoption of extended-interval pembrolizumab.”

Dr. Riechert suggested further validation of equivalent outcomes for the two regimens, more advocacy to encourage patients to ask about the 6-week option, as well as incentives from insurers to adopt it.

Dr. Strohbehn added that the situation highlights a broader issue in oncology, namely that many drugs “end up on the market with dosing regimens that haven’t necessarily been optimized.”

Across the world, investigators are conducting clinical trials “to identify the minimum dosages, frequencies, and durations patients need in order to achieve their best outcome,” Dr. Strohbehn said. In oncology, much of this effort is being led by Project Optimus, from the FDA’s Oncology Center of Excellence, he said.

The study was funded by the VA National Oncology Program. Dr. Reichert and Dr. Strohbehn have disclosed no relevant financial relationships. One investigator has received grants from Novartis, Bristol-Myers Squibb, Regeneron, and Genentech.

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

Uptake of the approved extended-interval dosing regimen for pembrolizumab has been poor, according to a review of Veterans Health Administration data.

In April 2020, the Food and Drug Administration approved extended dosing for standalone pembrolizumab – 400 mg every 6 weeks instead of the standard dosing of 200 mg every 3 weeks. The shift came, in part, to reduce patient health care encounters during the early days of the COVID-19 pandemic, but also because fewer infusions save patients time and out-of-pocket costs and reduce the burden on the health care system.

The FDA deemed this move safe after pharmacologic studies and a small melanoma study found that responses and adverse events were equivalent in comparison with standard dosing.

Given the benefits, one would expect “brisk adoption” of extended-interval dosing, Garth Strohbehn, MD, an oncologist at the VA Medical Center in Ann Arbor, Mich., and colleagues wrote in a recent report in JAMA Oncology.

However, when the team reviewed data on 835 veterans from the Veterans Health Administration who began taking single-agent pembrolizumab between April 1, 2020, and July 1, 2021, only about one-third received extended-interval dosing.

Between April and January 2021, use of extended-interval dosing rose steadily to about 35% of patients but then hovered in that range through August 2021.

Among the patients, age, sex, Charlson comorbidity index, and pembrolizumab indications were well balanced between the standard-dosing and the extended-interval dosing groups.

Notably, Dr. Strohbehn and colleagues also found no difference in time-to-treatment discontinuation between patients receiving extended dosing in comparison with patients receiving standard dosing, which is “a real-world measure of clinical effectiveness,” the team said.

And there was no difference in immune-related side effects between the two regimens, as assessed by incident levothyroxine and prednisone prescriptions.

The real-world near equivalence of extended and standard dosing intervals that was demonstrated in the study is “reassuring” and helps make the case for considering it “as a best practice” for single-agent pembrolizumab, the investigators wrote.

Dr. Strohbehn remained somewhat puzzled by the low uptake of the extended-dosing option.

“I was frankly surprised by the small number of patients who received the extended-interval regimen,” Dr. Strohbehn said in an interview.

“Admittedly, there are patients who would prefer to receive standard-interval therapy, and that preference should of course be accommodated whenever possible, but in my experience, those numbers are small,” at least in the VA system, he noted.

In addition, the authors noted, there is no direct financial incentive for more frequent dosing in the VA system.

It’s possible that low uptake could stem from clinicians’ doubts about switching to an extended-interval dose, given that the FDA’s approval was based largely on a study of 44 patients with melanoma in a single-arm trial.

If that is indeed the case, the new findings – which represent the first health system–level, real-world comparative effectiveness data for standard vs. extended-interval pembrolizumab – should help address these concerns, the team said.

“This observational dataset lends further credence to [the dosing] regimens being clinically equivalent,” said Zachery Reichert, MD, PhD, a urologic oncologist at the University of Michigan, Ann Arbor, who was not involved in the study.

To address the issue, Dr. Strohbehn and his team suggested “clinical guideline promotion to overcome some of the barriers to the adoption of extended-interval pembrolizumab.”

Dr. Riechert suggested further validation of equivalent outcomes for the two regimens, more advocacy to encourage patients to ask about the 6-week option, as well as incentives from insurers to adopt it.

Dr. Strohbehn added that the situation highlights a broader issue in oncology, namely that many drugs “end up on the market with dosing regimens that haven’t necessarily been optimized.”

Across the world, investigators are conducting clinical trials “to identify the minimum dosages, frequencies, and durations patients need in order to achieve their best outcome,” Dr. Strohbehn said. In oncology, much of this effort is being led by Project Optimus, from the FDA’s Oncology Center of Excellence, he said.

The study was funded by the VA National Oncology Program. Dr. Reichert and Dr. Strohbehn have disclosed no relevant financial relationships. One investigator has received grants from Novartis, Bristol-Myers Squibb, Regeneron, and Genentech.

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

Uptake of the approved extended-interval dosing regimen for pembrolizumab has been poor, according to a review of Veterans Health Administration data.

In April 2020, the Food and Drug Administration approved extended dosing for standalone pembrolizumab – 400 mg every 6 weeks instead of the standard dosing of 200 mg every 3 weeks. The shift came, in part, to reduce patient health care encounters during the early days of the COVID-19 pandemic, but also because fewer infusions save patients time and out-of-pocket costs and reduce the burden on the health care system.

The FDA deemed this move safe after pharmacologic studies and a small melanoma study found that responses and adverse events were equivalent in comparison with standard dosing.

Given the benefits, one would expect “brisk adoption” of extended-interval dosing, Garth Strohbehn, MD, an oncologist at the VA Medical Center in Ann Arbor, Mich., and colleagues wrote in a recent report in JAMA Oncology.

However, when the team reviewed data on 835 veterans from the Veterans Health Administration who began taking single-agent pembrolizumab between April 1, 2020, and July 1, 2021, only about one-third received extended-interval dosing.

Between April and January 2021, use of extended-interval dosing rose steadily to about 35% of patients but then hovered in that range through August 2021.

Among the patients, age, sex, Charlson comorbidity index, and pembrolizumab indications were well balanced between the standard-dosing and the extended-interval dosing groups.

Notably, Dr. Strohbehn and colleagues also found no difference in time-to-treatment discontinuation between patients receiving extended dosing in comparison with patients receiving standard dosing, which is “a real-world measure of clinical effectiveness,” the team said.

And there was no difference in immune-related side effects between the two regimens, as assessed by incident levothyroxine and prednisone prescriptions.

The real-world near equivalence of extended and standard dosing intervals that was demonstrated in the study is “reassuring” and helps make the case for considering it “as a best practice” for single-agent pembrolizumab, the investigators wrote.

Dr. Strohbehn remained somewhat puzzled by the low uptake of the extended-dosing option.

“I was frankly surprised by the small number of patients who received the extended-interval regimen,” Dr. Strohbehn said in an interview.

“Admittedly, there are patients who would prefer to receive standard-interval therapy, and that preference should of course be accommodated whenever possible, but in my experience, those numbers are small,” at least in the VA system, he noted.

In addition, the authors noted, there is no direct financial incentive for more frequent dosing in the VA system.

It’s possible that low uptake could stem from clinicians’ doubts about switching to an extended-interval dose, given that the FDA’s approval was based largely on a study of 44 patients with melanoma in a single-arm trial.

If that is indeed the case, the new findings – which represent the first health system–level, real-world comparative effectiveness data for standard vs. extended-interval pembrolizumab – should help address these concerns, the team said.

“This observational dataset lends further credence to [the dosing] regimens being clinically equivalent,” said Zachery Reichert, MD, PhD, a urologic oncologist at the University of Michigan, Ann Arbor, who was not involved in the study.

To address the issue, Dr. Strohbehn and his team suggested “clinical guideline promotion to overcome some of the barriers to the adoption of extended-interval pembrolizumab.”

Dr. Riechert suggested further validation of equivalent outcomes for the two regimens, more advocacy to encourage patients to ask about the 6-week option, as well as incentives from insurers to adopt it.

Dr. Strohbehn added that the situation highlights a broader issue in oncology, namely that many drugs “end up on the market with dosing regimens that haven’t necessarily been optimized.”

Across the world, investigators are conducting clinical trials “to identify the minimum dosages, frequencies, and durations patients need in order to achieve their best outcome,” Dr. Strohbehn said. In oncology, much of this effort is being led by Project Optimus, from the FDA’s Oncology Center of Excellence, he said.

The study was funded by the VA National Oncology Program. Dr. Reichert and Dr. Strohbehn have disclosed no relevant financial relationships. One investigator has received grants from Novartis, Bristol-Myers Squibb, Regeneron, and Genentech.

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

A scoop shave biopsy at the lower edge of the lesion revealed that this was a well-differentiated squamous cell carcinoma.

Squamous cell carcinoma is the second most common cancer in the United States and the most common skin cancer in Black people.¹ A patient’s age and their accumulated UV radiation from sun exposure or artificial tanning is a major contributing factor. Lesions may manifest as precancers characterized as rough pink or brown papules with a sandpaper-like texture on sun-exposed skin. These lesions may clear spontaneously or develop into invasive disease, as occurred in this case.

Surgical treatment is often curative. Fusiform excision and Mohs micrographic surgery are 2 common options. More advanced squamous cell carcinomas that are large or found to have poorly differentiated cells or large perineural invasion carry a risk of metastasis.

In elderly patients, optimal treatment isn’t always straightforward.¹ Nonsurgical options include radiation and intralesional chemotherapy. These nonsurgical choices may seem less aggressive, but total inconvenience, wound care, and discomfort can be equal to or worse than a single session of curative surgery.

This patient’s lesion was excised with a 5-mm margin. The patient tolerated an in-office procedure lasting about 45 minutes but would have struggled with a longer session with Mohs microsurgery. The postoperative period required limiting full use of his left hand for about 2 weeks.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A scoop shave biopsy at the lower edge of the lesion revealed that this was a well-differentiated squamous cell carcinoma.

Squamous cell carcinoma is the second most common cancer in the United States and the most common skin cancer in Black people.¹ A patient’s age and their accumulated UV radiation from sun exposure or artificial tanning is a major contributing factor. Lesions may manifest as precancers characterized as rough pink or brown papules with a sandpaper-like texture on sun-exposed skin. These lesions may clear spontaneously or develop into invasive disease, as occurred in this case.

Surgical treatment is often curative. Fusiform excision and Mohs micrographic surgery are 2 common options. More advanced squamous cell carcinomas that are large or found to have poorly differentiated cells or large perineural invasion carry a risk of metastasis.

In elderly patients, optimal treatment isn’t always straightforward.¹ Nonsurgical options include radiation and intralesional chemotherapy. These nonsurgical choices may seem less aggressive, but total inconvenience, wound care, and discomfort can be equal to or worse than a single session of curative surgery.

This patient’s lesion was excised with a 5-mm margin. The patient tolerated an in-office procedure lasting about 45 minutes but would have struggled with a longer session with Mohs microsurgery. The postoperative period required limiting full use of his left hand for about 2 weeks.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

A scoop shave biopsy at the lower edge of the lesion revealed that this was a well-differentiated squamous cell carcinoma.

Squamous cell carcinoma is the second most common cancer in the United States and the most common skin cancer in Black people.¹ A patient’s age and their accumulated UV radiation from sun exposure or artificial tanning is a major contributing factor. Lesions may manifest as precancers characterized as rough pink or brown papules with a sandpaper-like texture on sun-exposed skin. These lesions may clear spontaneously or develop into invasive disease, as occurred in this case.

Surgical treatment is often curative. Fusiform excision and Mohs micrographic surgery are 2 common options. More advanced squamous cell carcinomas that are large or found to have poorly differentiated cells or large perineural invasion carry a risk of metastasis.

In elderly patients, optimal treatment isn’t always straightforward.¹ Nonsurgical options include radiation and intralesional chemotherapy. These nonsurgical choices may seem less aggressive, but total inconvenience, wound care, and discomfort can be equal to or worse than a single session of curative surgery.

This patient’s lesion was excised with a 5-mm margin. The patient tolerated an in-office procedure lasting about 45 minutes but would have struggled with a longer session with Mohs microsurgery. The postoperative period required limiting full use of his left hand for about 2 weeks.

‌

Photos and text for Photo Rounds Friday courtesy of Jonathan Karnes, MD (copyright retained). Dr. Karnes is the medical director of MDFMR Dermatology Services, Augusta, ME.

Every year, the Centers for Disease Control and Prevention (CDC) conducts a national survey to provide an estimate of vaccination rates among adolescents ages 13 to 17 years. The results for 2021, published recently, illustrate the progress that we’ve made and the areas in which improvement is still needed; notably, human papillomavirus (HPV) vaccine is an example of both.¹

First, what’s recommended? The CDC recommends the following vaccines at age 11 to 12 years: tetanus, diphtheria, and acellular pertussis vaccine (Tdap); HPV vaccine series (2 doses if the first dose is received prior to age 15 years; 3 doses if the first dose is received at age 15 years or older); and quadrivalent meningococcal conjugate vaccine (MenACWY). A second (booster) dose of MenACWY is recommended at age 16 years. Adolescents should also receive an annual influenza vaccine and a COVID-19 vaccine series.²

For adolescents not fully vaccinated in childhood, catch-up vaccination is recommended for hepatitis A (HepA); hepatitis B (HepB); measles, mumps, and rubella (MMR); and varicella (VAR).²

How are we doing? In 2021, 89.6% of adolescents had received ≥ 1 Tdap dose and 89.0% had received ≥ 1 MenACWY dose; both these rates remained stable from the year before. For HPV vaccine, 76.9% had received ≥ 1 dose (an increase of 1.8 percentage points from 2020); 61.7% were HPV vaccine “up to date” (an increase of 3.1 percentage points). The teen HPV vaccination rate has increased slowly but progressively since the first recommendation for routine HPV vaccination was made for females in 2006 and for males in 2011.¹

Among those age 17 years, coverage with ≥ 2 MenACWY doses was 60.0% (an increase of 5.6 percentage points from 2020). Coverage was 85% for ≥ 2 HepA doses (an increase of 2.9 percentage points from 2020) and remained stable at > 90% for each of the following: ≥ 2 doses of MMR, ≥ 3 doses of HepB, and both VAR doses.¹

Keeping the momentum. As a country, we continue to make progress at increasing vaccination rates among US adolescents—but there is still plenty of room for improvement. Family physicians should check vaccine status at each clinical encounter and encourage parents and caregivers to schedule future wellness and vaccine visits for these young patients. This may be especially important among adolescents who were due for and missed a vaccination during the COVID-19 pandemic.

Every year, the Centers for Disease Control and Prevention (CDC) conducts a national survey to provide an estimate of vaccination rates among adolescents ages 13 to 17 years. The results for 2021, published recently, illustrate the progress that we’ve made and the areas in which improvement is still needed; notably, human papillomavirus (HPV) vaccine is an example of both.¹

First, what’s recommended? The CDC recommends the following vaccines at age 11 to 12 years: tetanus, diphtheria, and acellular pertussis vaccine (Tdap); HPV vaccine series (2 doses if the first dose is received prior to age 15 years; 3 doses if the first dose is received at age 15 years or older); and quadrivalent meningococcal conjugate vaccine (MenACWY). A second (booster) dose of MenACWY is recommended at age 16 years. Adolescents should also receive an annual influenza vaccine and a COVID-19 vaccine series.²

For adolescents not fully vaccinated in childhood, catch-up vaccination is recommended for hepatitis A (HepA); hepatitis B (HepB); measles, mumps, and rubella (MMR); and varicella (VAR).²

How are we doing? In 2021, 89.6% of adolescents had received ≥ 1 Tdap dose and 89.0% had received ≥ 1 MenACWY dose; both these rates remained stable from the year before. For HPV vaccine, 76.9% had received ≥ 1 dose (an increase of 1.8 percentage points from 2020); 61.7% were HPV vaccine “up to date” (an increase of 3.1 percentage points). The teen HPV vaccination rate has increased slowly but progressively since the first recommendation for routine HPV vaccination was made for females in 2006 and for males in 2011.¹

Among those age 17 years, coverage with ≥ 2 MenACWY doses was 60.0% (an increase of 5.6 percentage points from 2020). Coverage was 85% for ≥ 2 HepA doses (an increase of 2.9 percentage points from 2020) and remained stable at > 90% for each of the following: ≥ 2 doses of MMR, ≥ 3 doses of HepB, and both VAR doses.¹

Keeping the momentum. As a country, we continue to make progress at increasing vaccination rates among US adolescents—but there is still plenty of room for improvement. Family physicians should check vaccine status at each clinical encounter and encourage parents and caregivers to schedule future wellness and vaccine visits for these young patients. This may be especially important among adolescents who were due for and missed a vaccination during the COVID-19 pandemic.

Every year, the Centers for Disease Control and Prevention (CDC) conducts a national survey to provide an estimate of vaccination rates among adolescents ages 13 to 17 years. The results for 2021, published recently, illustrate the progress that we’ve made and the areas in which improvement is still needed; notably, human papillomavirus (HPV) vaccine is an example of both.¹

First, what’s recommended? The CDC recommends the following vaccines at age 11 to 12 years: tetanus, diphtheria, and acellular pertussis vaccine (Tdap); HPV vaccine series (2 doses if the first dose is received prior to age 15 years; 3 doses if the first dose is received at age 15 years or older); and quadrivalent meningococcal conjugate vaccine (MenACWY). A second (booster) dose of MenACWY is recommended at age 16 years. Adolescents should also receive an annual influenza vaccine and a COVID-19 vaccine series.²

For adolescents not fully vaccinated in childhood, catch-up vaccination is recommended for hepatitis A (HepA); hepatitis B (HepB); measles, mumps, and rubella (MMR); and varicella (VAR).²

How are we doing? In 2021, 89.6% of adolescents had received ≥ 1 Tdap dose and 89.0% had received ≥ 1 MenACWY dose; both these rates remained stable from the year before. For HPV vaccine, 76.9% had received ≥ 1 dose (an increase of 1.8 percentage points from 2020); 61.7% were HPV vaccine “up to date” (an increase of 3.1 percentage points). The teen HPV vaccination rate has increased slowly but progressively since the first recommendation for routine HPV vaccination was made for females in 2006 and for males in 2011.¹

Among those age 17 years, coverage with ≥ 2 MenACWY doses was 60.0% (an increase of 5.6 percentage points from 2020). Coverage was 85% for ≥ 2 HepA doses (an increase of 2.9 percentage points from 2020) and remained stable at > 90% for each of the following: ≥ 2 doses of MMR, ≥ 3 doses of HepB, and both VAR doses.¹

Keeping the momentum. As a country, we continue to make progress at increasing vaccination rates among US adolescents—but there is still plenty of room for improvement. Family physicians should check vaccine status at each clinical encounter and encourage parents and caregivers to schedule future wellness and vaccine visits for these young patients. This may be especially important among adolescents who were due for and missed a vaccination during the COVID-19 pandemic.

LONDON – A little over a decade ago, Four Seasons Health Care was among the largest long-term care home companies in Britain, operating 500 sites with 20,000 residents and more than 60 specialist centers. Domestic and global private equity investors had supercharged the company’s growth, betting that the rising needs of aging Britons would yield big returns.

Within weeks, the Four Seasons brand may be finished.

Christie & Co., a commercial real estate broker, splashed a summer sale across its website that signaled the demise: The last 111 Four Seasons facilities in England, Scotland, and Jersey were on the market. Already sold were its 29 homes in Northern Ireland.

Four Seasons collapsed after years of private equity investors rolling in one after another to buy its business, sell its real estate, and at times wrest multimillion-dollar profits through complex debt schemes – until the last big equity fund, Terra Firma, which in 2012 paid about $1.3 billion for the company, was caught short.

In a country where government health care is a right, the Four Seasons story exemplifies the high-stakes rise – and, ultimately, fall – of private equity investment in health and social services. Hanging over society’s most vulnerable patients, these heavily leveraged deals failed to account for the cost of their care. Private equity firms are known for making a profit on quick-turnaround investments.

“People often say: ‘Why have American investors, as well as professional investors here and in other countries, poured so much into this sector?’ I think they were dazzled by the potential of the demographics,” said Nick Hood, an analyst at Opus Restructuring & Insolvency in London, which advises care homes – the British equivalent of U.S. nursing homes or assisted living facilities. They “saw the baby boomers aging and thought there would be infinite demands.”

What they missed, Mr. Hood said, “was that about half of all the residents in U.K. homes are funded by the government in one way or another. They aren’t private pay – and they’ve got no money.”
 

Residents as ‘revenue streams’

As in the United States, long-term care homes in Britain serve a mixed market of public- and private-pay residents, and those whose balance sheets rest heavily on government payments are stressed even in better economic times. Andrew Dobbie, a community officer for Unison, a union that represents care home workers, said private equity investors often see homes like Four Seasons as having “two revenue streams, the properties themselves and the residents,” with efficiencies to exploit.

But investors don’t always understand what caregivers do, he said, or that older residents require more time than spreadsheets have calculated. “That’s a problem when you are looking at operating care homes,” Mr. Dobbie said. “Care workers need to have soft skills to work with a vulnerable group of people. It’s not the same skills as stocking shelves in a supermarket.”

A recent study, funded in part by Unison and conducted by University of Surrey researchers, found big changes in the quality of care after private equity investments. More than a dozen staff members, who weren’t identified by name or facility, said companies were “cutting corners” to curb costs because their priority was profit. Staffers said “these changes meant residents sometimes went without the appropriate care, timely medication or sufficient sanitary supplies.”

In August, the House of Commons received a sobering account: The number of adults 65 and older who will need care is speedily rising, estimated to go from 3.5 million in 2018 to 5.2 million in 2038. Yet workers at care homes are among the lowest paid in health care.

“The covid-19 pandemic shone a light on the adult social care sector,” according to the parliamentary report, which noted that “many frustrated and burnt out care workers left” for better-paying jobs. The report’s advice in a year of soaring inflation and energy costs? The government should add “at least £7 billion a year” – more than $8 billion – or risk deterioration of care.

Britain’s care homes are separate from the much-lauded National Health Service, funded by the government. Care homes rely on support from local authorities, akin to counties in the United States. But they have seen a sharp drop in funding from the British government, which cut a third of its payments in the past decade. When the pandemic hit, the differences were apparent: Care home workers were not afforded masks, gloves, or gowns to shield them from the deadly virus.

Years ago, care homes were largely run by families or local entities. In the 1990s, the government promoted privatization, triggering investments and consolidations. Today, private equity firms own three of the country’s five biggest care home providers.

Chris Thomas, a research fellow at the Institute for Public Policy Research, said investors benefited from scant financial oversight. “The accounting practices are horrendously complicated and meant to be complicated,” he said. Local authorities try “to regulate more, but they don’t have the expertise.”
 

The financial shuffle

At Four Seasons, the speed of change was dizzying. From 2004 to 2017, big money came and went, with revenue at times threaded through multiple offshore vehicles. Among the groups that owned Four Seasons, in part or in its entirety: British private equity firm Alchemy Partners; Allianz Capital Partners, a German private equity firm; Three Delta, an investment fund backed by Qatar; the American hedge fund Monarch Alternative Capital; and Terra Firma, the British private equity group that wallowed in debt demands. H/2 Capital Partners, a hedge fund in Connecticut, was Four Seasons’ main creditor and took over. By 2019, Four Seasons was managed by insolvency experts.

Pressed on whether Four Seasons would exist in any form after the current sale of its property and businesses, MHP Communications, representing the company, said in an email: “It is too early in the process to speculate about the future of the brand.”

Vivek Kotecha, an accountant who has examined the Four Seasons financial shuffle and coauthored the Unison report, said private equity investment – in homes for older residents and, increasingly, in facilities for troubled children – is now part of the financial mainstream. The consulting firm McKinsey in 2022estimated that private markets manage nearly $10 trillion in assets, making them a dominant force in global markets.

“What you find in America with private equity is much the same here,” said Mr. Kotecha, the founder of Trinava Consulting in London. “They are often the same firms, doing the same things.” What was remarkable about Four Seasons was the enormous liability from high-yield bonds that underpinned the deal – one equaling $514 million at 8.75% interest and another for $277 million at 12.75% interest.

Guy Hands, the high-flying British founder of Terra Firma, bought Four Seasons in 2012, soon after losing an epic court battle with Citigroup over the purchase price of the music company EMI Group. Terra Firma acquired the care homes and then a gardening business with more than 100 stores. Neither proved easy, or good, bets. Hands, a Londoner who moved offshore to Guernsey, declined through a representative to discuss Four Seasons.

Mr. Kotecha, however, helped the BBC try to make sense of Four Seasons’ holdings by tracking financial filings. It was “the most complicated spreadsheet I’ve ever seen,” Mr. Kotecha said. “I think there were more subsidiaries involved in Four Seasons’ care homes than there were with General Motors in Europe.”

As Britain’s small homes were swept up in consolidations, some financial practices were dubious. At times, businesses sold the buildings as lease-back deals – not a problem at first – that, after multiple purchases, left operators paying rent with heavy interest that sapped operating budgets. By 2020, some care homes were estimated to be spending as much as 16% of their bed fees on debt payments, according to parliamentary testimony this year.

How could that happen? In part, for-profit providers – backed by private-equity groups and other corporations – had subsidiaries of their parent companies act as lender, setting the rates.

Britain’s elder care was unrecognizable within a generation. By 2022, private-equity companies alone accounted for 55,000 beds, or about 12.6% of the total for-profit care beds for older people in the United Kingdom, according to LaingBuisson, a health care consultancy. LaingBuisson calculated that the average residential care home fee as of February 2022 was about $44,700 a year; the average nursing home fee was $62,275 a year.

From 1980 to 2018, the number of residential care beds provided by local authorities fell 88% – from 141,719 to 17,100, according to the nonprofit Centre for Health and the Public Interest. Independent operators – nonprofits and for-profits – moved in, it said, controlling 243,000 beds by 2018. Nursing homes saw a similar shift: Private providers accounted for 194,100 beds in 2018, compared with 25,500 decades earlier.
 

Beyond government control

British lawmakers in the winter of 2021-2022 tried – and failed – to bolster financial reporting rules for care homes, including banning the use of government funds to pay off debt.

“I don’t have a problem with offshore companies that make profits if they offer good services. I don’t have a problem with private equity and hedge funds who deliver good returns to their shareholders,” Ros Altmann, a Conservative Party member in the House of Lords and a pension expert, said in a February debate. “I do have a problem if those companies are taking advantage of some of the most vulnerable people in our society without oversight, without controls.”

She cited Four Seasons as an example of how regulators “have no control over the financial models that are used.” Ms. Altmann warned that economic headwinds could worsen matters: “We now have very heavily debt-laden [homes] in an environment where interest rates are heading upward.”

In August, the Bank of England raised borrowing rates. It now forecasts double-digit inflation – as much as 11% – through 2023.

And that leaves care home owner Robert Kilgour pensive about whether government grasps the risks and possibilities that the sector is facing. “It’s a struggle, and it’s becoming more of a struggle,” he said. A global energy crisis is the latest unexpected emergency. Mr. Kilgour said he recently signed electricity contracts, for April 2023, at rates that will rise by 200%. That means an extra $2,400 a day in utility costs for his homes.

Mr. Kilgour founded Four Seasons, opening its first home, in Fife, Scotland, in 1989. His ambition for its growth was modest: “Ten by 2000.” That changed in 1999 when Alchemy swooped in to expand nationally. Mr. Kilgour had left Four Seasons by 2004, turning to other ventures.

Still, he saw opportunity in elder care and opened Renaissance Care, which now operates 16 homes with 750 beds in Scotland. “I missed it,” he said in an interview in London. “It’s people and it’s property, and I like that.”

“People asked me if I had any regrets about selling to private equity. Well, no, the people I dealt with were very fair, very straight. There were no shenanigans,” Mr. Kilgour said, noting that Alchemy made money but invested as well.

Mr. Kilgour said the pandemic motivated him to improve his business. He is spending millions on new LED lighting and boilers, as well as training staffers on digital record-keeping, all to winnow costs. He increased hourly wages by 5%, but employees have suggested other ways to retain staff: shorter shifts and workdays that fit school schedules or allow them to care for their own older relatives.

Debates over whether the government should move back into elder care make little sense to Mr. Kilgour. Britain has had private care for decades, and he doesn’t see that changing. Instead, operators need help balancing private and publicly funded beds “so you have a blended rate for care and some certainty in the business.”

Consolidations are slowing, he said, which might be part of a long-overdue reckoning. “The idea of 200, 300, 400 care homes – that big is good and big is best – those days are gone,” Mr. Kilgour said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

LONDON – A little over a decade ago, Four Seasons Health Care was among the largest long-term care home companies in Britain, operating 500 sites with 20,000 residents and more than 60 specialist centers. Domestic and global private equity investors had supercharged the company’s growth, betting that the rising needs of aging Britons would yield big returns.

Within weeks, the Four Seasons brand may be finished.

Christie & Co., a commercial real estate broker, splashed a summer sale across its website that signaled the demise: The last 111 Four Seasons facilities in England, Scotland, and Jersey were on the market. Already sold were its 29 homes in Northern Ireland.

Four Seasons collapsed after years of private equity investors rolling in one after another to buy its business, sell its real estate, and at times wrest multimillion-dollar profits through complex debt schemes – until the last big equity fund, Terra Firma, which in 2012 paid about $1.3 billion for the company, was caught short.

In a country where government health care is a right, the Four Seasons story exemplifies the high-stakes rise – and, ultimately, fall – of private equity investment in health and social services. Hanging over society’s most vulnerable patients, these heavily leveraged deals failed to account for the cost of their care. Private equity firms are known for making a profit on quick-turnaround investments.

“People often say: ‘Why have American investors, as well as professional investors here and in other countries, poured so much into this sector?’ I think they were dazzled by the potential of the demographics,” said Nick Hood, an analyst at Opus Restructuring & Insolvency in London, which advises care homes – the British equivalent of U.S. nursing homes or assisted living facilities. They “saw the baby boomers aging and thought there would be infinite demands.”

What they missed, Mr. Hood said, “was that about half of all the residents in U.K. homes are funded by the government in one way or another. They aren’t private pay – and they’ve got no money.”
 

Residents as ‘revenue streams’

As in the United States, long-term care homes in Britain serve a mixed market of public- and private-pay residents, and those whose balance sheets rest heavily on government payments are stressed even in better economic times. Andrew Dobbie, a community officer for Unison, a union that represents care home workers, said private equity investors often see homes like Four Seasons as having “two revenue streams, the properties themselves and the residents,” with efficiencies to exploit.

But investors don’t always understand what caregivers do, he said, or that older residents require more time than spreadsheets have calculated. “That’s a problem when you are looking at operating care homes,” Mr. Dobbie said. “Care workers need to have soft skills to work with a vulnerable group of people. It’s not the same skills as stocking shelves in a supermarket.”

A recent study, funded in part by Unison and conducted by University of Surrey researchers, found big changes in the quality of care after private equity investments. More than a dozen staff members, who weren’t identified by name or facility, said companies were “cutting corners” to curb costs because their priority was profit. Staffers said “these changes meant residents sometimes went without the appropriate care, timely medication or sufficient sanitary supplies.”

In August, the House of Commons received a sobering account: The number of adults 65 and older who will need care is speedily rising, estimated to go from 3.5 million in 2018 to 5.2 million in 2038. Yet workers at care homes are among the lowest paid in health care.

“The covid-19 pandemic shone a light on the adult social care sector,” according to the parliamentary report, which noted that “many frustrated and burnt out care workers left” for better-paying jobs. The report’s advice in a year of soaring inflation and energy costs? The government should add “at least £7 billion a year” – more than $8 billion – or risk deterioration of care.

Britain’s care homes are separate from the much-lauded National Health Service, funded by the government. Care homes rely on support from local authorities, akin to counties in the United States. But they have seen a sharp drop in funding from the British government, which cut a third of its payments in the past decade. When the pandemic hit, the differences were apparent: Care home workers were not afforded masks, gloves, or gowns to shield them from the deadly virus.

Years ago, care homes were largely run by families or local entities. In the 1990s, the government promoted privatization, triggering investments and consolidations. Today, private equity firms own three of the country’s five biggest care home providers.

Chris Thomas, a research fellow at the Institute for Public Policy Research, said investors benefited from scant financial oversight. “The accounting practices are horrendously complicated and meant to be complicated,” he said. Local authorities try “to regulate more, but they don’t have the expertise.”
 

The financial shuffle

At Four Seasons, the speed of change was dizzying. From 2004 to 2017, big money came and went, with revenue at times threaded through multiple offshore vehicles. Among the groups that owned Four Seasons, in part or in its entirety: British private equity firm Alchemy Partners; Allianz Capital Partners, a German private equity firm; Three Delta, an investment fund backed by Qatar; the American hedge fund Monarch Alternative Capital; and Terra Firma, the British private equity group that wallowed in debt demands. H/2 Capital Partners, a hedge fund in Connecticut, was Four Seasons’ main creditor and took over. By 2019, Four Seasons was managed by insolvency experts.

Pressed on whether Four Seasons would exist in any form after the current sale of its property and businesses, MHP Communications, representing the company, said in an email: “It is too early in the process to speculate about the future of the brand.”

Vivek Kotecha, an accountant who has examined the Four Seasons financial shuffle and coauthored the Unison report, said private equity investment – in homes for older residents and, increasingly, in facilities for troubled children – is now part of the financial mainstream. The consulting firm McKinsey in 2022estimated that private markets manage nearly $10 trillion in assets, making them a dominant force in global markets.

“What you find in America with private equity is much the same here,” said Mr. Kotecha, the founder of Trinava Consulting in London. “They are often the same firms, doing the same things.” What was remarkable about Four Seasons was the enormous liability from high-yield bonds that underpinned the deal – one equaling $514 million at 8.75% interest and another for $277 million at 12.75% interest.

Guy Hands, the high-flying British founder of Terra Firma, bought Four Seasons in 2012, soon after losing an epic court battle with Citigroup over the purchase price of the music company EMI Group. Terra Firma acquired the care homes and then a gardening business with more than 100 stores. Neither proved easy, or good, bets. Hands, a Londoner who moved offshore to Guernsey, declined through a representative to discuss Four Seasons.

Mr. Kotecha, however, helped the BBC try to make sense of Four Seasons’ holdings by tracking financial filings. It was “the most complicated spreadsheet I’ve ever seen,” Mr. Kotecha said. “I think there were more subsidiaries involved in Four Seasons’ care homes than there were with General Motors in Europe.”

As Britain’s small homes were swept up in consolidations, some financial practices were dubious. At times, businesses sold the buildings as lease-back deals – not a problem at first – that, after multiple purchases, left operators paying rent with heavy interest that sapped operating budgets. By 2020, some care homes were estimated to be spending as much as 16% of their bed fees on debt payments, according to parliamentary testimony this year.

How could that happen? In part, for-profit providers – backed by private-equity groups and other corporations – had subsidiaries of their parent companies act as lender, setting the rates.

Britain’s elder care was unrecognizable within a generation. By 2022, private-equity companies alone accounted for 55,000 beds, or about 12.6% of the total for-profit care beds for older people in the United Kingdom, according to LaingBuisson, a health care consultancy. LaingBuisson calculated that the average residential care home fee as of February 2022 was about $44,700 a year; the average nursing home fee was $62,275 a year.

From 1980 to 2018, the number of residential care beds provided by local authorities fell 88% – from 141,719 to 17,100, according to the nonprofit Centre for Health and the Public Interest. Independent operators – nonprofits and for-profits – moved in, it said, controlling 243,000 beds by 2018. Nursing homes saw a similar shift: Private providers accounted for 194,100 beds in 2018, compared with 25,500 decades earlier.
 

Beyond government control

British lawmakers in the winter of 2021-2022 tried – and failed – to bolster financial reporting rules for care homes, including banning the use of government funds to pay off debt.

“I don’t have a problem with offshore companies that make profits if they offer good services. I don’t have a problem with private equity and hedge funds who deliver good returns to their shareholders,” Ros Altmann, a Conservative Party member in the House of Lords and a pension expert, said in a February debate. “I do have a problem if those companies are taking advantage of some of the most vulnerable people in our society without oversight, without controls.”

She cited Four Seasons as an example of how regulators “have no control over the financial models that are used.” Ms. Altmann warned that economic headwinds could worsen matters: “We now have very heavily debt-laden [homes] in an environment where interest rates are heading upward.”

In August, the Bank of England raised borrowing rates. It now forecasts double-digit inflation – as much as 11% – through 2023.

And that leaves care home owner Robert Kilgour pensive about whether government grasps the risks and possibilities that the sector is facing. “It’s a struggle, and it’s becoming more of a struggle,” he said. A global energy crisis is the latest unexpected emergency. Mr. Kilgour said he recently signed electricity contracts, for April 2023, at rates that will rise by 200%. That means an extra $2,400 a day in utility costs for his homes.

Mr. Kilgour founded Four Seasons, opening its first home, in Fife, Scotland, in 1989. His ambition for its growth was modest: “Ten by 2000.” That changed in 1999 when Alchemy swooped in to expand nationally. Mr. Kilgour had left Four Seasons by 2004, turning to other ventures.

Still, he saw opportunity in elder care and opened Renaissance Care, which now operates 16 homes with 750 beds in Scotland. “I missed it,” he said in an interview in London. “It’s people and it’s property, and I like that.”

“People asked me if I had any regrets about selling to private equity. Well, no, the people I dealt with were very fair, very straight. There were no shenanigans,” Mr. Kilgour said, noting that Alchemy made money but invested as well.

Mr. Kilgour said the pandemic motivated him to improve his business. He is spending millions on new LED lighting and boilers, as well as training staffers on digital record-keeping, all to winnow costs. He increased hourly wages by 5%, but employees have suggested other ways to retain staff: shorter shifts and workdays that fit school schedules or allow them to care for their own older relatives.

Debates over whether the government should move back into elder care make little sense to Mr. Kilgour. Britain has had private care for decades, and he doesn’t see that changing. Instead, operators need help balancing private and publicly funded beds “so you have a blended rate for care and some certainty in the business.”

Consolidations are slowing, he said, which might be part of a long-overdue reckoning. “The idea of 200, 300, 400 care homes – that big is good and big is best – those days are gone,” Mr. Kilgour said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

LONDON – A little over a decade ago, Four Seasons Health Care was among the largest long-term care home companies in Britain, operating 500 sites with 20,000 residents and more than 60 specialist centers. Domestic and global private equity investors had supercharged the company’s growth, betting that the rising needs of aging Britons would yield big returns.

Within weeks, the Four Seasons brand may be finished.

Christie & Co., a commercial real estate broker, splashed a summer sale across its website that signaled the demise: The last 111 Four Seasons facilities in England, Scotland, and Jersey were on the market. Already sold were its 29 homes in Northern Ireland.

Four Seasons collapsed after years of private equity investors rolling in one after another to buy its business, sell its real estate, and at times wrest multimillion-dollar profits through complex debt schemes – until the last big equity fund, Terra Firma, which in 2012 paid about $1.3 billion for the company, was caught short.

In a country where government health care is a right, the Four Seasons story exemplifies the high-stakes rise – and, ultimately, fall – of private equity investment in health and social services. Hanging over society’s most vulnerable patients, these heavily leveraged deals failed to account for the cost of their care. Private equity firms are known for making a profit on quick-turnaround investments.

“People often say: ‘Why have American investors, as well as professional investors here and in other countries, poured so much into this sector?’ I think they were dazzled by the potential of the demographics,” said Nick Hood, an analyst at Opus Restructuring & Insolvency in London, which advises care homes – the British equivalent of U.S. nursing homes or assisted living facilities. They “saw the baby boomers aging and thought there would be infinite demands.”

What they missed, Mr. Hood said, “was that about half of all the residents in U.K. homes are funded by the government in one way or another. They aren’t private pay – and they’ve got no money.”
 

Residents as ‘revenue streams’

As in the United States, long-term care homes in Britain serve a mixed market of public- and private-pay residents, and those whose balance sheets rest heavily on government payments are stressed even in better economic times. Andrew Dobbie, a community officer for Unison, a union that represents care home workers, said private equity investors often see homes like Four Seasons as having “two revenue streams, the properties themselves and the residents,” with efficiencies to exploit.

But investors don’t always understand what caregivers do, he said, or that older residents require more time than spreadsheets have calculated. “That’s a problem when you are looking at operating care homes,” Mr. Dobbie said. “Care workers need to have soft skills to work with a vulnerable group of people. It’s not the same skills as stocking shelves in a supermarket.”

A recent study, funded in part by Unison and conducted by University of Surrey researchers, found big changes in the quality of care after private equity investments. More than a dozen staff members, who weren’t identified by name or facility, said companies were “cutting corners” to curb costs because their priority was profit. Staffers said “these changes meant residents sometimes went without the appropriate care, timely medication or sufficient sanitary supplies.”

In August, the House of Commons received a sobering account: The number of adults 65 and older who will need care is speedily rising, estimated to go from 3.5 million in 2018 to 5.2 million in 2038. Yet workers at care homes are among the lowest paid in health care.

“The covid-19 pandemic shone a light on the adult social care sector,” according to the parliamentary report, which noted that “many frustrated and burnt out care workers left” for better-paying jobs. The report’s advice in a year of soaring inflation and energy costs? The government should add “at least £7 billion a year” – more than $8 billion – or risk deterioration of care.

Britain’s care homes are separate from the much-lauded National Health Service, funded by the government. Care homes rely on support from local authorities, akin to counties in the United States. But they have seen a sharp drop in funding from the British government, which cut a third of its payments in the past decade. When the pandemic hit, the differences were apparent: Care home workers were not afforded masks, gloves, or gowns to shield them from the deadly virus.

Years ago, care homes were largely run by families or local entities. In the 1990s, the government promoted privatization, triggering investments and consolidations. Today, private equity firms own three of the country’s five biggest care home providers.

Chris Thomas, a research fellow at the Institute for Public Policy Research, said investors benefited from scant financial oversight. “The accounting practices are horrendously complicated and meant to be complicated,” he said. Local authorities try “to regulate more, but they don’t have the expertise.”
 

The financial shuffle

At Four Seasons, the speed of change was dizzying. From 2004 to 2017, big money came and went, with revenue at times threaded through multiple offshore vehicles. Among the groups that owned Four Seasons, in part or in its entirety: British private equity firm Alchemy Partners; Allianz Capital Partners, a German private equity firm; Three Delta, an investment fund backed by Qatar; the American hedge fund Monarch Alternative Capital; and Terra Firma, the British private equity group that wallowed in debt demands. H/2 Capital Partners, a hedge fund in Connecticut, was Four Seasons’ main creditor and took over. By 2019, Four Seasons was managed by insolvency experts.

Pressed on whether Four Seasons would exist in any form after the current sale of its property and businesses, MHP Communications, representing the company, said in an email: “It is too early in the process to speculate about the future of the brand.”

Vivek Kotecha, an accountant who has examined the Four Seasons financial shuffle and coauthored the Unison report, said private equity investment – in homes for older residents and, increasingly, in facilities for troubled children – is now part of the financial mainstream. The consulting firm McKinsey in 2022estimated that private markets manage nearly $10 trillion in assets, making them a dominant force in global markets.

“What you find in America with private equity is much the same here,” said Mr. Kotecha, the founder of Trinava Consulting in London. “They are often the same firms, doing the same things.” What was remarkable about Four Seasons was the enormous liability from high-yield bonds that underpinned the deal – one equaling $514 million at 8.75% interest and another for $277 million at 12.75% interest.

Guy Hands, the high-flying British founder of Terra Firma, bought Four Seasons in 2012, soon after losing an epic court battle with Citigroup over the purchase price of the music company EMI Group. Terra Firma acquired the care homes and then a gardening business with more than 100 stores. Neither proved easy, or good, bets. Hands, a Londoner who moved offshore to Guernsey, declined through a representative to discuss Four Seasons.

Mr. Kotecha, however, helped the BBC try to make sense of Four Seasons’ holdings by tracking financial filings. It was “the most complicated spreadsheet I’ve ever seen,” Mr. Kotecha said. “I think there were more subsidiaries involved in Four Seasons’ care homes than there were with General Motors in Europe.”

As Britain’s small homes were swept up in consolidations, some financial practices were dubious. At times, businesses sold the buildings as lease-back deals – not a problem at first – that, after multiple purchases, left operators paying rent with heavy interest that sapped operating budgets. By 2020, some care homes were estimated to be spending as much as 16% of their bed fees on debt payments, according to parliamentary testimony this year.

How could that happen? In part, for-profit providers – backed by private-equity groups and other corporations – had subsidiaries of their parent companies act as lender, setting the rates.

Britain’s elder care was unrecognizable within a generation. By 2022, private-equity companies alone accounted for 55,000 beds, or about 12.6% of the total for-profit care beds for older people in the United Kingdom, according to LaingBuisson, a health care consultancy. LaingBuisson calculated that the average residential care home fee as of February 2022 was about $44,700 a year; the average nursing home fee was $62,275 a year.

From 1980 to 2018, the number of residential care beds provided by local authorities fell 88% – from 141,719 to 17,100, according to the nonprofit Centre for Health and the Public Interest. Independent operators – nonprofits and for-profits – moved in, it said, controlling 243,000 beds by 2018. Nursing homes saw a similar shift: Private providers accounted for 194,100 beds in 2018, compared with 25,500 decades earlier.
 

Beyond government control

British lawmakers in the winter of 2021-2022 tried – and failed – to bolster financial reporting rules for care homes, including banning the use of government funds to pay off debt.

“I don’t have a problem with offshore companies that make profits if they offer good services. I don’t have a problem with private equity and hedge funds who deliver good returns to their shareholders,” Ros Altmann, a Conservative Party member in the House of Lords and a pension expert, said in a February debate. “I do have a problem if those companies are taking advantage of some of the most vulnerable people in our society without oversight, without controls.”

She cited Four Seasons as an example of how regulators “have no control over the financial models that are used.” Ms. Altmann warned that economic headwinds could worsen matters: “We now have very heavily debt-laden [homes] in an environment where interest rates are heading upward.”

In August, the Bank of England raised borrowing rates. It now forecasts double-digit inflation – as much as 11% – through 2023.

And that leaves care home owner Robert Kilgour pensive about whether government grasps the risks and possibilities that the sector is facing. “It’s a struggle, and it’s becoming more of a struggle,” he said. A global energy crisis is the latest unexpected emergency. Mr. Kilgour said he recently signed electricity contracts, for April 2023, at rates that will rise by 200%. That means an extra $2,400 a day in utility costs for his homes.

Mr. Kilgour founded Four Seasons, opening its first home, in Fife, Scotland, in 1989. His ambition for its growth was modest: “Ten by 2000.” That changed in 1999 when Alchemy swooped in to expand nationally. Mr. Kilgour had left Four Seasons by 2004, turning to other ventures.

Still, he saw opportunity in elder care and opened Renaissance Care, which now operates 16 homes with 750 beds in Scotland. “I missed it,” he said in an interview in London. “It’s people and it’s property, and I like that.”

“People asked me if I had any regrets about selling to private equity. Well, no, the people I dealt with were very fair, very straight. There were no shenanigans,” Mr. Kilgour said, noting that Alchemy made money but invested as well.

Mr. Kilgour said the pandemic motivated him to improve his business. He is spending millions on new LED lighting and boilers, as well as training staffers on digital record-keeping, all to winnow costs. He increased hourly wages by 5%, but employees have suggested other ways to retain staff: shorter shifts and workdays that fit school schedules or allow them to care for their own older relatives.

Debates over whether the government should move back into elder care make little sense to Mr. Kilgour. Britain has had private care for decades, and he doesn’t see that changing. Instead, operators need help balancing private and publicly funded beds “so you have a blended rate for care and some certainty in the business.”

Consolidations are slowing, he said, which might be part of a long-overdue reckoning. “The idea of 200, 300, 400 care homes – that big is good and big is best – those days are gone,” Mr. Kilgour said.

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Spironolactone, a potassium-sparing diuretic typically used to treat heart failure and hypertension, shows promise in treating alcohol use disorder (AUD), new research suggests.

Researchers at the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Yale University, New Haven, Conn., investigated the impact of spironolactone on AUD.

Initially, they studied rodents and found that spironolactone reduced binge drinking in mice and reduced self-administration of alcohol in rats without adversely affecting food or water intake or causing motor or coordination problems.

They also analyzed electronic health records of patients drawn from the United States Veterans Affairs health care system to explore potential changes in alcohol use after spironolactone treatment was initiated for other conditions and found a significant link between spironolactone treatment and reduction in self-reported alcohol consumption, with the largest effects observed among those who reported hazardous/heavy episodic alcohol use prior to starting spironolactone treatment.

“Combining findings across three species and different types of research studies, and then seeing similarities in these data, gives us confidence that we are onto something potentially important scientifically and clinically,” senior coauthor Lorenzo Leggio, MD, PhD, senior investigator in the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, a joint NIDA and NIAAA laboratory, said in a news release.

The study was published online in Molecular Psychiatry.
 

There is a “critical need to increase the armamentarium of pharmacotherapies to treat individuals with AUD,” the authors note, adding that neuroendocrine systems involved in alcohol craving and drinking “offer promising pharmacologic targets in this regard.”

“Both our team and others have observed that patients with AUD often present with changes in peripheral hormones, including aldosterone, which plays a key role in regulating blood pressure and electrolytes,” Dr. Leggio said in an interview.

Spironolactone is a nonselective mineralocorticoid receptor (MT) antagonist. In studies in animal models, investigators said they found “an inverse correlation between alcohol drinking and the expression of the MR in the amygdala, a key brain region in the development and maintenance of AUD and addiction in general.”

Taken together, this led them to hypothesize that blocking the MR, which is the mechanism of action of spironolactone, “could be a novel pharmacotherapeutic approach for AUD,” he said.

Previous research by the same group of researchers suggested spironolactone “may be a potential new medication to treat patients with AUD.” The present study expanded on those findings and consisted of a three-part investigation.

In the current study, the investigators tested different dosages of spironolactone on binge-like alcohol consumption in male and female mice and assessed food and water intake, blood alcohol levels, motor coordination, and spontaneous locomotion.

They then tested the effects of different dosages of spironolactone injections on operant alcohol self-administration in alcohol-dependent and nondependent male and female rats, also testing blood alcohol levels and motor coordination.

Finally, they analyzed health records of veterans to examine the association between at least 60 continuous days of spironolactone treatment and self-reported alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]).

Each of the spironolactone-exposed patients was matched using propensity scores with up to five unexposed patients who had reported alcohol consumption in the 2 years prior to the index date.

The final analysis included a matched cohort of 10,726 spironolactone-exposed individuals who were matched to 34,461 unexposed individuals.
 

New targets

Spironolactone reduced alcohol intake in mice drinking a sweetened alcohol solution; a 2-way ANOVA revealed a main effect of dose (F 4,52 = 9.09; P < .0001) and sex, with female mice drinking more alcohol, compared to male mice (F 1,13 = 6.05; P = .02).

Post hoc comparisons showed that spironolactone at doses of 50, 100, and 200 mg/kg significantly reduced alcohol intake (P values = .007, .002, and .0001, respectively).

In mice drinking an unsweetened alcohol solution, the 2-way repeated measures ANOVA similarly found a main effect of dose (F 4,52 = 5.77; P = .0006), but not of sex (F 1,13 = 1.41; P = .25).

Spironolactone had no effect on the mice’s intake of a sweet solution without alcohol and had no impact on the consumption of food and water or on locomotion and coordination.

In rats, a 2-way ANOVA revealed a significant spironolactone effect of dose (F 3,66 = 43.95; P < .001), with a post hoc test indicating that spironolactone at 25, 50, and 75 mg/kg reduced alcohol self-administration in alcohol-dependent and nondependent rats (all P values = .0001).

In humans, among the exposed individuals in the matched cohort, 25%, 57%, and 18% received daily doses of spironolactone of less than 25 mg/day, 25-49 mg/day, and 50 mg/day or higher, respectively, with a median follow-up time of 542 (interquartile range, 337-730) days.

The AUDIT-C scores decreased during the study period in both treatment groups, with a larger decrease in average AUDIT-C scores among the exposed vs. unexposed individuals.

“These are very exciting times because, thanks to the progress in the addiction biomedical research field, we are increasing our understanding of the mechanisms how some people develop AUD; hence we can use this knowledge to identify new targets.” The current study “is an example of these ongoing efforts,” said Dr. Leggio.

“It is important to note that [these results] are important but preliminary.” At this juncture, “it would be too premature to think about prescribing spironolactone to treat AUD,” he added.

 

Exciting findings

Commenting on the study, Joyce Besheer, PhD, professor, department of psychiatry and Bowles Center for Alcohol Studies, University of North Carolina at Chapel Hill, called the study an “elegant demonstration of translational science.”

“While clinical trials will be needed to determine whether this medication is effective at reducing drinking in patients with AUD, these findings are exciting as they suggest that spironolactone may be a promising compound and new treatment options for AUD are much needed,” said Dr. Besheer, who was not involved with the current study.

Dr. Leggio agreed. “We now need prospective, placebo-controlled studies to assess the potential safety and efficacy of spironolactone in people with AUD,” he said.

This work was supported by the National Institutes of Health and the NIAAA. Dr. Leggio, study coauthors, and Dr. Besheer declare no relevant financial relationships.

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

Spironolactone, a potassium-sparing diuretic typically used to treat heart failure and hypertension, shows promise in treating alcohol use disorder (AUD), new research suggests.

Researchers at the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Yale University, New Haven, Conn., investigated the impact of spironolactone on AUD.

Initially, they studied rodents and found that spironolactone reduced binge drinking in mice and reduced self-administration of alcohol in rats without adversely affecting food or water intake or causing motor or coordination problems.

They also analyzed electronic health records of patients drawn from the United States Veterans Affairs health care system to explore potential changes in alcohol use after spironolactone treatment was initiated for other conditions and found a significant link between spironolactone treatment and reduction in self-reported alcohol consumption, with the largest effects observed among those who reported hazardous/heavy episodic alcohol use prior to starting spironolactone treatment.

“Combining findings across three species and different types of research studies, and then seeing similarities in these data, gives us confidence that we are onto something potentially important scientifically and clinically,” senior coauthor Lorenzo Leggio, MD, PhD, senior investigator in the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, a joint NIDA and NIAAA laboratory, said in a news release.

The study was published online in Molecular Psychiatry.
 

There is a “critical need to increase the armamentarium of pharmacotherapies to treat individuals with AUD,” the authors note, adding that neuroendocrine systems involved in alcohol craving and drinking “offer promising pharmacologic targets in this regard.”

“Both our team and others have observed that patients with AUD often present with changes in peripheral hormones, including aldosterone, which plays a key role in regulating blood pressure and electrolytes,” Dr. Leggio said in an interview.

Spironolactone is a nonselective mineralocorticoid receptor (MT) antagonist. In studies in animal models, investigators said they found “an inverse correlation between alcohol drinking and the expression of the MR in the amygdala, a key brain region in the development and maintenance of AUD and addiction in general.”

Taken together, this led them to hypothesize that blocking the MR, which is the mechanism of action of spironolactone, “could be a novel pharmacotherapeutic approach for AUD,” he said.

Previous research by the same group of researchers suggested spironolactone “may be a potential new medication to treat patients with AUD.” The present study expanded on those findings and consisted of a three-part investigation.

In the current study, the investigators tested different dosages of spironolactone on binge-like alcohol consumption in male and female mice and assessed food and water intake, blood alcohol levels, motor coordination, and spontaneous locomotion.

They then tested the effects of different dosages of spironolactone injections on operant alcohol self-administration in alcohol-dependent and nondependent male and female rats, also testing blood alcohol levels and motor coordination.

Finally, they analyzed health records of veterans to examine the association between at least 60 continuous days of spironolactone treatment and self-reported alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]).

Each of the spironolactone-exposed patients was matched using propensity scores with up to five unexposed patients who had reported alcohol consumption in the 2 years prior to the index date.

The final analysis included a matched cohort of 10,726 spironolactone-exposed individuals who were matched to 34,461 unexposed individuals.
 

New targets

Spironolactone reduced alcohol intake in mice drinking a sweetened alcohol solution; a 2-way ANOVA revealed a main effect of dose (F 4,52 = 9.09; P < .0001) and sex, with female mice drinking more alcohol, compared to male mice (F 1,13 = 6.05; P = .02).

Post hoc comparisons showed that spironolactone at doses of 50, 100, and 200 mg/kg significantly reduced alcohol intake (P values = .007, .002, and .0001, respectively).

In mice drinking an unsweetened alcohol solution, the 2-way repeated measures ANOVA similarly found a main effect of dose (F 4,52 = 5.77; P = .0006), but not of sex (F 1,13 = 1.41; P = .25).

Spironolactone had no effect on the mice’s intake of a sweet solution without alcohol and had no impact on the consumption of food and water or on locomotion and coordination.

In rats, a 2-way ANOVA revealed a significant spironolactone effect of dose (F 3,66 = 43.95; P < .001), with a post hoc test indicating that spironolactone at 25, 50, and 75 mg/kg reduced alcohol self-administration in alcohol-dependent and nondependent rats (all P values = .0001).

In humans, among the exposed individuals in the matched cohort, 25%, 57%, and 18% received daily doses of spironolactone of less than 25 mg/day, 25-49 mg/day, and 50 mg/day or higher, respectively, with a median follow-up time of 542 (interquartile range, 337-730) days.

The AUDIT-C scores decreased during the study period in both treatment groups, with a larger decrease in average AUDIT-C scores among the exposed vs. unexposed individuals.

“These are very exciting times because, thanks to the progress in the addiction biomedical research field, we are increasing our understanding of the mechanisms how some people develop AUD; hence we can use this knowledge to identify new targets.” The current study “is an example of these ongoing efforts,” said Dr. Leggio.

“It is important to note that [these results] are important but preliminary.” At this juncture, “it would be too premature to think about prescribing spironolactone to treat AUD,” he added.

 

Exciting findings

Commenting on the study, Joyce Besheer, PhD, professor, department of psychiatry and Bowles Center for Alcohol Studies, University of North Carolina at Chapel Hill, called the study an “elegant demonstration of translational science.”

“While clinical trials will be needed to determine whether this medication is effective at reducing drinking in patients with AUD, these findings are exciting as they suggest that spironolactone may be a promising compound and new treatment options for AUD are much needed,” said Dr. Besheer, who was not involved with the current study.

Dr. Leggio agreed. “We now need prospective, placebo-controlled studies to assess the potential safety and efficacy of spironolactone in people with AUD,” he said.

This work was supported by the National Institutes of Health and the NIAAA. Dr. Leggio, study coauthors, and Dr. Besheer declare no relevant financial relationships.

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

Spironolactone, a potassium-sparing diuretic typically used to treat heart failure and hypertension, shows promise in treating alcohol use disorder (AUD), new research suggests.

Researchers at the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism, and Yale University, New Haven, Conn., investigated the impact of spironolactone on AUD.

Initially, they studied rodents and found that spironolactone reduced binge drinking in mice and reduced self-administration of alcohol in rats without adversely affecting food or water intake or causing motor or coordination problems.

They also analyzed electronic health records of patients drawn from the United States Veterans Affairs health care system to explore potential changes in alcohol use after spironolactone treatment was initiated for other conditions and found a significant link between spironolactone treatment and reduction in self-reported alcohol consumption, with the largest effects observed among those who reported hazardous/heavy episodic alcohol use prior to starting spironolactone treatment.

“Combining findings across three species and different types of research studies, and then seeing similarities in these data, gives us confidence that we are onto something potentially important scientifically and clinically,” senior coauthor Lorenzo Leggio, MD, PhD, senior investigator in the Clinical Psychoneuroendocrinology and Neuropsychopharmacology Section, a joint NIDA and NIAAA laboratory, said in a news release.

The study was published online in Molecular Psychiatry.
 

There is a “critical need to increase the armamentarium of pharmacotherapies to treat individuals with AUD,” the authors note, adding that neuroendocrine systems involved in alcohol craving and drinking “offer promising pharmacologic targets in this regard.”

“Both our team and others have observed that patients with AUD often present with changes in peripheral hormones, including aldosterone, which plays a key role in regulating blood pressure and electrolytes,” Dr. Leggio said in an interview.

Spironolactone is a nonselective mineralocorticoid receptor (MT) antagonist. In studies in animal models, investigators said they found “an inverse correlation between alcohol drinking and the expression of the MR in the amygdala, a key brain region in the development and maintenance of AUD and addiction in general.”

Taken together, this led them to hypothesize that blocking the MR, which is the mechanism of action of spironolactone, “could be a novel pharmacotherapeutic approach for AUD,” he said.

Previous research by the same group of researchers suggested spironolactone “may be a potential new medication to treat patients with AUD.” The present study expanded on those findings and consisted of a three-part investigation.

In the current study, the investigators tested different dosages of spironolactone on binge-like alcohol consumption in male and female mice and assessed food and water intake, blood alcohol levels, motor coordination, and spontaneous locomotion.

They then tested the effects of different dosages of spironolactone injections on operant alcohol self-administration in alcohol-dependent and nondependent male and female rats, also testing blood alcohol levels and motor coordination.

Finally, they analyzed health records of veterans to examine the association between at least 60 continuous days of spironolactone treatment and self-reported alcohol consumption (measured by the Alcohol Use Disorders Identification Test-Consumption [AUDIT-C]).

Each of the spironolactone-exposed patients was matched using propensity scores with up to five unexposed patients who had reported alcohol consumption in the 2 years prior to the index date.

The final analysis included a matched cohort of 10,726 spironolactone-exposed individuals who were matched to 34,461 unexposed individuals.
 

New targets

Spironolactone reduced alcohol intake in mice drinking a sweetened alcohol solution; a 2-way ANOVA revealed a main effect of dose (F 4,52 = 9.09; P < .0001) and sex, with female mice drinking more alcohol, compared to male mice (F 1,13 = 6.05; P = .02).

Post hoc comparisons showed that spironolactone at doses of 50, 100, and 200 mg/kg significantly reduced alcohol intake (P values = .007, .002, and .0001, respectively).

In mice drinking an unsweetened alcohol solution, the 2-way repeated measures ANOVA similarly found a main effect of dose (F 4,52 = 5.77; P = .0006), but not of sex (F 1,13 = 1.41; P = .25).

Spironolactone had no effect on the mice’s intake of a sweet solution without alcohol and had no impact on the consumption of food and water or on locomotion and coordination.

In rats, a 2-way ANOVA revealed a significant spironolactone effect of dose (F 3,66 = 43.95; P < .001), with a post hoc test indicating that spironolactone at 25, 50, and 75 mg/kg reduced alcohol self-administration in alcohol-dependent and nondependent rats (all P values = .0001).

In humans, among the exposed individuals in the matched cohort, 25%, 57%, and 18% received daily doses of spironolactone of less than 25 mg/day, 25-49 mg/day, and 50 mg/day or higher, respectively, with a median follow-up time of 542 (interquartile range, 337-730) days.

The AUDIT-C scores decreased during the study period in both treatment groups, with a larger decrease in average AUDIT-C scores among the exposed vs. unexposed individuals.

“These are very exciting times because, thanks to the progress in the addiction biomedical research field, we are increasing our understanding of the mechanisms how some people develop AUD; hence we can use this knowledge to identify new targets.” The current study “is an example of these ongoing efforts,” said Dr. Leggio.

“It is important to note that [these results] are important but preliminary.” At this juncture, “it would be too premature to think about prescribing spironolactone to treat AUD,” he added.

 

Exciting findings

Commenting on the study, Joyce Besheer, PhD, professor, department of psychiatry and Bowles Center for Alcohol Studies, University of North Carolina at Chapel Hill, called the study an “elegant demonstration of translational science.”

“While clinical trials will be needed to determine whether this medication is effective at reducing drinking in patients with AUD, these findings are exciting as they suggest that spironolactone may be a promising compound and new treatment options for AUD are much needed,” said Dr. Besheer, who was not involved with the current study.

Dr. Leggio agreed. “We now need prospective, placebo-controlled studies to assess the potential safety and efficacy of spironolactone in people with AUD,” he said.

This work was supported by the National Institutes of Health and the NIAAA. Dr. Leggio, study coauthors, and Dr. Besheer declare no relevant financial relationships.

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

Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.

Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.

Visual_Intermezzo/iStock/Getty Images Plus

“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.

“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.

“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.

“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.

The study was published online in the European Journal of Preventive Cardiology.

 

Clear cardiovascular benefits

A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.

During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.

Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).

Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.

Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).

Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.

Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).

“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.

Plausible mechanisms

There are a number of proposed mechanisms to explain the benefits of coffee on CVD.

“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.

Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.

“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.

“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.

“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
 

Direction of relationship unclear

Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”

However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.

Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.

“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.

The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.

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

Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.

Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.

Visual_Intermezzo/iStock/Getty Images Plus

“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.

“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.

“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.

“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.

The study was published online in the European Journal of Preventive Cardiology.

 

Clear cardiovascular benefits

A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.

During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.

Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).

Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.

Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).

Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.

Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).

“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.

Plausible mechanisms

There are a number of proposed mechanisms to explain the benefits of coffee on CVD.

“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.

Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.

“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.

“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.

“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
 

Direction of relationship unclear

Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”

However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.

Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.

“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.

The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.

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

Drinking two to three daily cups of – ground, instant, or decaffeinated – is associated with significant reductions in new cardiovascular disease (CVD) and mortality risk, compared with avoiding coffee, a new analysis of the prospective UK Biobank suggests.

Ground and instant coffee, but not decaffeinated coffee, also was associated with reduced risk of new-onset arrhythmia, including atrial fibrillation.

Visual_Intermezzo/iStock/Getty Images Plus

“Our study is the first to look at differences in coffee subtypes to tease out important differences which may explain some of the mechanisms through which coffee works,” Peter M. Kistler, MD, of the Alfred Hospital and Baker Heart and Diabetes Institute, Melbourne, Australia, told this news organization.

“Daily coffee intake should not be discouraged by physicians but rather considered part of a healthy diet,” Dr. Kistler said.

“This study supports that coffee is safe and even potentially beneficial, which is consistent with most of the prior evidence,” Carl “Chip” Lavie, MD, who wasn’t involved in the study, told this news organization.

“We do not prescribe coffee to patients, but for the majority who like coffee, they can be encouraged it is fine to take a few cups daily,” said Dr. Lavie, with the Ochsner Heart and Vascular Institute in New Orleans.

The study was published online in the European Journal of Preventive Cardiology.

 

Clear cardiovascular benefits

A total of 449,563 UK Biobank participants (median age 58 years; 55% women), who were free of arrhythmias or other CVD at baseline, reported in questionnaires their level of daily coffee intake and preferred type of coffee.

During more than 12.5 years of follow-up, 27,809 participants (6.2%) died.

Drinking one to five cups per day of ground or instant coffee (but not decaffeinated coffee) was associated with a significant reduction in incident arrhythmia. The lowest risk was with four to five cups per day for ground coffee (hazard ratio [HR] 0.83; 95% confidence interval [CI], 0.76-0.91; P < .0001) and two to three cups per day for instant coffee (HR, 0.88; 95% CI, 0.85-0.92; P < .0001).

Habitual coffee drinking of up to five cups perday was also associated with significant reductions in the risk of incident CVD, when compared with nondrinkers.

Significant reductions in the risk of incident coronary heart disease (CHD) were associated with habitual coffee intake of up to five cups per day, with the lowest risk for CHD observed in those who consumed two to three cups per day (HR 0.89; 95% CI, 0.86-0.91; P < .0001).

Coffee consumption at all levels was linked to significant reduction in the risk of congestive cardiac failure (CCF) and ischemic stroke. The lowest risks were observed in those who consumed two to three cups per day, with HR, 0.83 (95% CI, 0.79-0.87; P < .0001) for CCF and HR, 0.84 (95% CI, 0.78-0.90; P < .0001) for ischemic stroke.

Death from any cause was significantly reduced for all coffee subtypes, with the greatest risk reduction seen with two to three cups per day for decaffeinated (HR, 0.86; 95% CI, 0.81-0.91; P < .0001); ground (HR, 0.73; 95% CI, 0.69-0.78; P < .0001); and instant coffee (HR, 0.89; 95% CI, 0.86-0.93; P < .0001).

“Coffee consumption is associated with cardiovascular benefits and should not empirically be discontinued in those with underlying heart rhythm disorders or cardiovascular disease,” Dr. Kistler told this news organization.

Plausible mechanisms

There are a number of proposed mechanisms to explain the benefits of coffee on CVD.

“Caffeine has antiarrhythmic properties through adenosine A1 and A2A receptor inhibition, hence the difference in effects of decaf vs. full-strength coffee on heart rhythm disorders,” Dr. Kistler explained.

Coffee has vasodilatory effects and coffee also contains antioxidant polyphenols, which reduce oxidative stress and modulate metabolism.

“The explanation for improved survival with habitual coffee consumption remains unclear,” Dr. Kistler said.

“Putative mechanisms include improved endothelial function, circulating antioxidants, improved insulin sensitivity, and reduced inflammation. Another potential mechanism includes the beneficial effects of coffee on metabolic syndrome,” he said.

“Caffeine has a role in weight loss through inhibition of gut fatty acid absorption and increase in basal metabolic rate. Furthermore, coffee has been associated with a significantly lower incidence of type 2 diabetes mellitus,” Dr. Kistler added.
 

Direction of relationship unclear

Charlotte Mills, PhD, University of Reading, England, said this study “adds to the body of evidence from observational trials associating moderate coffee consumption with cardioprotection, which looks promising.”

However, with the observational design, it’s unclear “which direction the relationship goes – for example, does coffee make you healthy or do inherently healthier people consume coffee? Randomized controlled trials are needed to fully understand the relationship between coffee and health before recommendations can be made,” Dr. Mills told the UK nonprofit Science Media Centre.

Annette Creedon, PhD, nutrition scientist with the British Nutrition Foundation, said it’s possible that respondents over- or underestimated the amount of coffee that they were consuming at the start of the study when they self-reported their intake.

“It is therefore difficult to determine whether the outcomes can be directly associated with the behaviors in coffee consumption reported at the start of the study,” she told the Science Media Centre.

The study had no funding. Dr. Kistler has received funding from Abbott Medical for consultancy and speaking engagements and fellowship support from Biosense Webster. Dr. Lavie has no relevant disclosures. Dr. Mills has worked in collaboration with Nestle on research relating to coffee and health funded by UKRI. Dr. Creedon has reported no relevant financial relationships.

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