User login
Study eyes sunscreens marketed to individuals with skin of color
, and more than 40% contain a UV blocker that may create a white cast.
Those are among the findings from a study by Michelle Xiong, a medical student at Brown University, Providence, R.I., and Erin M. Warshaw, MD, of the department of dermatology at Park Nicollet/Health Partners Health Services, Minneapolis, which was published online in the Journal of the American Academy of Dermatology.
“There is increasing awareness of the negative effects of ultraviolet (UV) light in individuals with skin of color (SOC), especially in regards to pigmentation disorders induced and/or exacerbated by UV exposure,” the authors wrote. “As a result, there has been a surge in sunscreens marketed to this population. We aimed to characterize cost, marketing claims, and potential allergenic ingredients in sunscreens marketed to individuals with SOC.”
Between December 2021 and October 2022, the researchers used the following search terms on Google: “sunscreen” plus “skin of 36 color,” “dark skin,” “brown skin,” “LatinX skin,” and/or “Black skin.” They extracted price, marketing claims, and ingredients from manufacturers’ websites and used 90 allergens contained in the American Contact Dermatitis Society 2020 Core series to identify potential allergens. Next, they combined cross-reactors/synonyms into allergen categories based on ACDS Contact Allergen Management Plan (CAMP) cross-reactor classification. If multiple ingredients in a sunscreen were represented by a single allergen category, it was counted only once. A similar approach was utilized for marketing categories.
A total of 12 sunscreens were included in the analysis: Absolute Joi, Black Girl Sunscreen, Black Girl Sunscreen Make It Matte, Bolden SPF Brightening Moisturizer, Eleven on the Defense Unrivaled Sun Serum, Kinlo Golden Rays Sunscreen, Live Tinted Hueguard 3-in-1 Mineral Sunscreen, Mele Dew The Most Sheer Moisturizer SPF30 Broad Spectrum Sunscreen, Mele No Shade Sunscreen Oil, Specific Beauty Active Radiance Day Moi, Unsun Mineral Sunscreen, and Urban Skin Rx Complexion Protection. Their average cost was $19.30 per ounce (range, $6.33-$50.00) and common marketing claims for these products were “no white cast” (91.7%), being free of an ingredient (83.3%), and “moisturizing” (75%).
Of the 12 sunscreens, 7 (58.3%) contained a chemical sunscreen agent, 5 (41.7%) contained a physical UV blocker, and all contained at least one allergen. The average number of allergens per product was 4.7, most commonly fragrance/botanicals (83.3%), tocopherol (83.3%), sodium benzoates/derivatives (58.3%), and sorbitan sesquiolate/derivatives (58.3%).
“Average cost of sunscreens marketed to individuals with SOC was $19.30/oz, much higher than the median price of $3.32/oz reported in a separate study of 65 popular sunscreens,” the study authors wrote. “As many of the sunscreens in our study were sold by smaller businesses, higher prices may be due to higher production costs or a perceived smaller market.”
The authors expressed surprise that five sunscreens marketed to individuals with SOC contained a physical UV blocker which may create a white cast. They contacted the manufacturers of these five sunscreens and confirmed that three used micronized formulations. “While ingested/inhaled nanoparticles of titanium dioxide may cause tissue effects, most studies of topical products show excellent safety,” they wrote.
They also noted that the average of 4.7 allergens per product observed in the analysis was similar to the average of 4.9 seen in a separate study of 52 popular sunscreens. “However, that study only included 34 allergens while this study evaluated 90 allergens,” the authors wrote. “Consumers and providers should be aware sunscreens marketed to individuals with SOC may cause allergic contact dermatitis,” they commented.
“It is interesting to see how costly these products are now compared to store bought and general commercially available sunscreens several years ago,” said Lawrence J. Green, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “However, to me that is not surprising as products marketed and targeted to specific populations are often priced at a premium. It wasn’t clear to me how many of these specialized online SOC sunscreens are tinted. I wish the authors had compared the cost of tinted sunscreens in general to nontinted sunscreens because tinted ones are more useful for SOC, because when rubbed in, they can readily match SOC and can also offer protection in the visible light spectrum.”
The authors reported having no financial disclosures; the study had no funding source. Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies.
, and more than 40% contain a UV blocker that may create a white cast.
Those are among the findings from a study by Michelle Xiong, a medical student at Brown University, Providence, R.I., and Erin M. Warshaw, MD, of the department of dermatology at Park Nicollet/Health Partners Health Services, Minneapolis, which was published online in the Journal of the American Academy of Dermatology.
“There is increasing awareness of the negative effects of ultraviolet (UV) light in individuals with skin of color (SOC), especially in regards to pigmentation disorders induced and/or exacerbated by UV exposure,” the authors wrote. “As a result, there has been a surge in sunscreens marketed to this population. We aimed to characterize cost, marketing claims, and potential allergenic ingredients in sunscreens marketed to individuals with SOC.”
Between December 2021 and October 2022, the researchers used the following search terms on Google: “sunscreen” plus “skin of 36 color,” “dark skin,” “brown skin,” “LatinX skin,” and/or “Black skin.” They extracted price, marketing claims, and ingredients from manufacturers’ websites and used 90 allergens contained in the American Contact Dermatitis Society 2020 Core series to identify potential allergens. Next, they combined cross-reactors/synonyms into allergen categories based on ACDS Contact Allergen Management Plan (CAMP) cross-reactor classification. If multiple ingredients in a sunscreen were represented by a single allergen category, it was counted only once. A similar approach was utilized for marketing categories.
A total of 12 sunscreens were included in the analysis: Absolute Joi, Black Girl Sunscreen, Black Girl Sunscreen Make It Matte, Bolden SPF Brightening Moisturizer, Eleven on the Defense Unrivaled Sun Serum, Kinlo Golden Rays Sunscreen, Live Tinted Hueguard 3-in-1 Mineral Sunscreen, Mele Dew The Most Sheer Moisturizer SPF30 Broad Spectrum Sunscreen, Mele No Shade Sunscreen Oil, Specific Beauty Active Radiance Day Moi, Unsun Mineral Sunscreen, and Urban Skin Rx Complexion Protection. Their average cost was $19.30 per ounce (range, $6.33-$50.00) and common marketing claims for these products were “no white cast” (91.7%), being free of an ingredient (83.3%), and “moisturizing” (75%).
Of the 12 sunscreens, 7 (58.3%) contained a chemical sunscreen agent, 5 (41.7%) contained a physical UV blocker, and all contained at least one allergen. The average number of allergens per product was 4.7, most commonly fragrance/botanicals (83.3%), tocopherol (83.3%), sodium benzoates/derivatives (58.3%), and sorbitan sesquiolate/derivatives (58.3%).
“Average cost of sunscreens marketed to individuals with SOC was $19.30/oz, much higher than the median price of $3.32/oz reported in a separate study of 65 popular sunscreens,” the study authors wrote. “As many of the sunscreens in our study were sold by smaller businesses, higher prices may be due to higher production costs or a perceived smaller market.”
The authors expressed surprise that five sunscreens marketed to individuals with SOC contained a physical UV blocker which may create a white cast. They contacted the manufacturers of these five sunscreens and confirmed that three used micronized formulations. “While ingested/inhaled nanoparticles of titanium dioxide may cause tissue effects, most studies of topical products show excellent safety,” they wrote.
They also noted that the average of 4.7 allergens per product observed in the analysis was similar to the average of 4.9 seen in a separate study of 52 popular sunscreens. “However, that study only included 34 allergens while this study evaluated 90 allergens,” the authors wrote. “Consumers and providers should be aware sunscreens marketed to individuals with SOC may cause allergic contact dermatitis,” they commented.
“It is interesting to see how costly these products are now compared to store bought and general commercially available sunscreens several years ago,” said Lawrence J. Green, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “However, to me that is not surprising as products marketed and targeted to specific populations are often priced at a premium. It wasn’t clear to me how many of these specialized online SOC sunscreens are tinted. I wish the authors had compared the cost of tinted sunscreens in general to nontinted sunscreens because tinted ones are more useful for SOC, because when rubbed in, they can readily match SOC and can also offer protection in the visible light spectrum.”
The authors reported having no financial disclosures; the study had no funding source. Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies.
, and more than 40% contain a UV blocker that may create a white cast.
Those are among the findings from a study by Michelle Xiong, a medical student at Brown University, Providence, R.I., and Erin M. Warshaw, MD, of the department of dermatology at Park Nicollet/Health Partners Health Services, Minneapolis, which was published online in the Journal of the American Academy of Dermatology.
“There is increasing awareness of the negative effects of ultraviolet (UV) light in individuals with skin of color (SOC), especially in regards to pigmentation disorders induced and/or exacerbated by UV exposure,” the authors wrote. “As a result, there has been a surge in sunscreens marketed to this population. We aimed to characterize cost, marketing claims, and potential allergenic ingredients in sunscreens marketed to individuals with SOC.”
Between December 2021 and October 2022, the researchers used the following search terms on Google: “sunscreen” plus “skin of 36 color,” “dark skin,” “brown skin,” “LatinX skin,” and/or “Black skin.” They extracted price, marketing claims, and ingredients from manufacturers’ websites and used 90 allergens contained in the American Contact Dermatitis Society 2020 Core series to identify potential allergens. Next, they combined cross-reactors/synonyms into allergen categories based on ACDS Contact Allergen Management Plan (CAMP) cross-reactor classification. If multiple ingredients in a sunscreen were represented by a single allergen category, it was counted only once. A similar approach was utilized for marketing categories.
A total of 12 sunscreens were included in the analysis: Absolute Joi, Black Girl Sunscreen, Black Girl Sunscreen Make It Matte, Bolden SPF Brightening Moisturizer, Eleven on the Defense Unrivaled Sun Serum, Kinlo Golden Rays Sunscreen, Live Tinted Hueguard 3-in-1 Mineral Sunscreen, Mele Dew The Most Sheer Moisturizer SPF30 Broad Spectrum Sunscreen, Mele No Shade Sunscreen Oil, Specific Beauty Active Radiance Day Moi, Unsun Mineral Sunscreen, and Urban Skin Rx Complexion Protection. Their average cost was $19.30 per ounce (range, $6.33-$50.00) and common marketing claims for these products were “no white cast” (91.7%), being free of an ingredient (83.3%), and “moisturizing” (75%).
Of the 12 sunscreens, 7 (58.3%) contained a chemical sunscreen agent, 5 (41.7%) contained a physical UV blocker, and all contained at least one allergen. The average number of allergens per product was 4.7, most commonly fragrance/botanicals (83.3%), tocopherol (83.3%), sodium benzoates/derivatives (58.3%), and sorbitan sesquiolate/derivatives (58.3%).
“Average cost of sunscreens marketed to individuals with SOC was $19.30/oz, much higher than the median price of $3.32/oz reported in a separate study of 65 popular sunscreens,” the study authors wrote. “As many of the sunscreens in our study were sold by smaller businesses, higher prices may be due to higher production costs or a perceived smaller market.”
The authors expressed surprise that five sunscreens marketed to individuals with SOC contained a physical UV blocker which may create a white cast. They contacted the manufacturers of these five sunscreens and confirmed that three used micronized formulations. “While ingested/inhaled nanoparticles of titanium dioxide may cause tissue effects, most studies of topical products show excellent safety,” they wrote.
They also noted that the average of 4.7 allergens per product observed in the analysis was similar to the average of 4.9 seen in a separate study of 52 popular sunscreens. “However, that study only included 34 allergens while this study evaluated 90 allergens,” the authors wrote. “Consumers and providers should be aware sunscreens marketed to individuals with SOC may cause allergic contact dermatitis,” they commented.
“It is interesting to see how costly these products are now compared to store bought and general commercially available sunscreens several years ago,” said Lawrence J. Green, clinical professor of dermatology at George Washington University, Washington, who was asked to comment on the study. “However, to me that is not surprising as products marketed and targeted to specific populations are often priced at a premium. It wasn’t clear to me how many of these specialized online SOC sunscreens are tinted. I wish the authors had compared the cost of tinted sunscreens in general to nontinted sunscreens because tinted ones are more useful for SOC, because when rubbed in, they can readily match SOC and can also offer protection in the visible light spectrum.”
The authors reported having no financial disclosures; the study had no funding source. Dr. Green disclosed that he is a speaker, consultant, or investigator for many pharmaceutical companies.
FROM THE JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
Telemedicine increases access to care and optimizes practice revenue
The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.
We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.1 Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.2 What value might gastroenterologists gain from the use of telehealth going forward? 3 For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
As GI demand outpaces supply, it’s time to consider alternative channels of care
The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.4 On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.5 Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.6 And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.7
Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.8 Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
The case for virtual GI care
Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.9
In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.10
Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,11 and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.12
Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
Financial implications
Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.
The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.13 With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.14
While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.
Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
Overcoming obstacles
Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.
In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).
Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
The ultimate aim: Better patient outcomes
Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.15 Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.
Change can be hard, but it will come
The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.
The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.
As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).
References
1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.
2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.
3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.
4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.
5. See id.
6. See id.
7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.
8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).
9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.
10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.
11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.
12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.
13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.
14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.
15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.
The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.
We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.1 Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.2 What value might gastroenterologists gain from the use of telehealth going forward? 3 For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
As GI demand outpaces supply, it’s time to consider alternative channels of care
The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.4 On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.5 Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.6 And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.7
Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.8 Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
The case for virtual GI care
Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.9
In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.10
Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,11 and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.12
Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
Financial implications
Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.
The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.13 With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.14
While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.
Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
Overcoming obstacles
Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.
In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).
Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
The ultimate aim: Better patient outcomes
Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.15 Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.
Change can be hard, but it will come
The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.
The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.
As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).
References
1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.
2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.
3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.
4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.
5. See id.
6. See id.
7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.
8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).
9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.
10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.
11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.
12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.
13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.
14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.
15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.
The first time I considered telehealth as a viable option for care delivery was in February 2020. I had just heard that one of my patients had been diagnosed with COVID-19 and admitted to Evergreen Health, a hospital our practice covered just outside of Seattle. The news was jarring. Suddenly, it became crystal clear that patient access to care and the economic survival of our business would require another approach. Seemingly overnight, we built a telehealth program and began seeing patients virtually from the comfort and safety of home.
We certainly weren’t alone. From January to March 2020, the Centers for Disease Control and Prevention showed a 154% increase in telehealth visits.1 Even as the postpandemic era settles in, the use of telehealth today is 38 times greater than the pre-COVID baseline, creating a market valued at $250 billion per year.2 What value might gastroenterologists gain from the use of telehealth going forward? 3 For today’s overburdened GI practices, telehealth can improve patient access to care, alleviate the clinician shortage with work-from-home options for practitioners, and present innovative methods of increasing revenue streams – all while improving quality of care.
As GI demand outpaces supply, it’s time to consider alternative channels of care
The prevalence of gastrointestinal illness, the size of the market, and the growing difficulty in gaining access to care makes it natural to consider whether virtual care may benefit patients and GI practices alike. Approximately 70 million Americans, or 1 in 5, live with chronic GI symptoms.4 On an annual basis, more than 50 million primary care visits and 15 million ER visits in the United States have a primary diagnostic code for GI disease.5 Annual expenditures to address GI conditions, valued at $136 billion, outpace those of other high-cost conditions such as heart disease or mental health.6 And with the recent addition of 21 million patients between 45 and 49 years of age who now require colon cancer screening, plus the expected postpandemic increase in GI illness, those numbers are likely to grow.7
Compounding matters is a shortage of clinicians. Between early physician retirements and a limited number of GI fellowships, gastroenterology was recently identified by a Merritt Hawkins survey as the “most in-demand” specialty.8 Patients are already waiting months, and even up to a year in some parts of the country, to see a gastroenterologist. GI physicians, likewise, are running ragged trying to keep up and are burning out in the process.
The case for virtual GI care
Until the pandemic, many of us would not have seriously considered a significant role for virtual care in GI. When necessity demanded it, however, we used this channel effectively with both patients and providers reporting high rates of satisfaction with telehealth for GI clinic visits.9
In a recent published study with a sizable cohort of GI patients across a wide spectrum of conditions, only 17% required a physical exam following a telehealth visit. Over 50% said they were very likely or likely to continue using telehealth in the future. Interestingly, it was not only a young or tech-savvy population that ranked telehealth highly. In fact, Net Promoter Scores (a proven measure of customer experience) were consistently high for employed patients aged 60 or younger.10
Recent research also has demonstrated that telehealth visits meet quality standards and do so efficiently. A Mayo Clinic study demonstrated that telehealth visits in GI were delivered with a similar level of quality based on diagnostic concordance,11 and a recent study by Tang et al. found that 98% of visits for routine GI issues were completed within 20 minutes.12
Finally, establishing a virtual channel allows a clinic to increase its staffing radius by using geographically dispersed GI providers, including appropriately licensed physicians or advanced practice providers who may reside in other states. The use of remote providers opens up the possibility for “time zone arbitrage” to allow for more flexible staffing that’s similar to urgent care with wraparound and weekend hours – all without adding office space or overhead.
Financial implications
Given the long tail of demand in GI, increasing capacity will increase revenue. Telehealth increases capacity by allowing for the efficient use of resources and expanding the reach of practices in engaging potential providers.
The majority of telehealth visits are reimbursable. Since 1995, 40 states and the District of Columbia have enacted mandatory telehealth coverage laws, and 20 states require that telehealth visits be paid on par with in-person visits.13 With the pandemic Medicare waivers, parity was extended through government programs and is expected by many insiders to continue in some form going forward. By an overwhelming bipartisan majority, the House of Representatives recently passed the Advancing Telehealth Beyond COVID-19 Act, which would extend most temporary telemedicine policies through 2024. This legislation would affect only Medicare reimbursement, but changes in Medicare policy often influence the policies of commercial payers.14
While reimbursement for clinic visits is important, the larger financial implication for extending clinics virtually is in the endoscopy suite. Most revenue (70%-80%) in community GI practices is generated from endoscopic services and related ancillary streams. For an endoscopist, spending time in the clinic is effectively a loss leader. Adding capacity with a virtual clinic and geographically dispersed providers can open up GI physicians to spend more time in the endoscopy suite, thereby generating additional revenue.
Given the rapid consolidation of the GI space, income repair post private equity transaction is top of mind for both established physicians and young physicians entering the labor market. Having a virtual ancillary differentiates practices and may prove useful for recruitment. Increasing access by using remote providers during evenings and weekends may “unclog the pipes,” improve the patient and provider experience, and increase revenue.
Overcoming obstacles
Creating a telehealth platform – particularly one that crosses state lines – requires an understanding of a complex and evolving regulatory environment. Licensing is one example. When telehealth is used, it is considered to be rendered at the location of the patient. A provider typically has to be licensed in the state where the patient is located at the time of the clinical encounter. So, if providers cross jurisdictional boundaries to provide care, multiple state licenses may be required.
In addition, medical malpractice and cyber insurance for telemedicine providers are niche products. And as with the use of any technology, risks of a data breach or other unauthorized disclosure of protected health information make it vital to ensure data are fully encrypted, networks are secure, and all safeguards are followed according to the Health Information and Portability and Accountability Act (HIPAA).
Perhaps most challenging are payers, both commercial and governmental. The location of a distant site provider can affect network participation for some but not all payers. Understanding payer reimbursement policies is time-intensive, and building relationships within these organizations is crucial in today’s rapidly changing environment.
The ultimate aim: Better patient outcomes
Of course, the main goal is to take care of patients well and in a timely fashion. Better access will lead to an improved patient experience and a greater emphasis on the important cognitive aspects of GI care. Moreover, efficient use of physician time will also improve clinician satisfaction while increasing revenue and downstream value. Most importantly, increased access via a virtual channel may positively impact patient outcomes. For instance, data show that distance from an endoscopy center is negatively associated with the stage of colon cancer diagnosis.15 Providing a virtual channel to reach these distant patients will likely increase the opportunity for high-impact procedures like colonoscopy.
Change can be hard, but it will come
The old saying is that change comes slowly, then all at once. Access is a chronic pain point for GI practices that has now reached a critical level.
The GI market is enormous and rapidly evolving; it will continue to attract disruptive interest and several early-stage digital first GI companies have entered the ecosystem. There is a risk for disintermediation as well as opportunities for collaboration. The next few years will be interesting.
As we transition to a postpandemic environment, telehealth can continue to improve patient access and present new revenue streams for GI practices – all while improving quality of care. Seeing around the corner likely means expanding the reach of your clinic and offering multiple channels of care. There is likely a significant opportunity for those who choose to adapt.
Dr. Arjal is cofounder, chief medical officer, and president of Telebelly Health and is a board-certified gastroenterologist who previously served as vice president of Puget Sound Gastroenterology and a vice president of clinical affairs for GastroHealth. He currently serves on the American Gastroenterological Association (AGA) Practice Management and Economics Committee. He has no conflicts. He is on LinkedIn and Twitter (@RussArjalMD).
References
1. Koonin LM et al. Trends in the use of telehealth during the emergence of the COVID-19 pandemic – United States, January-March 2020. MMWR Morb Mortal Wkly Rep. 2020. Oct 30;69(43):1595-9.
2. “Telehealth: A quarter-trillion-dollar post-COVID-19 reality?” McKinsey & Company, July 9, 2021.
3. The telehealth era is just beginning, Robert Pearl and Brian Wayling, Harvard Business Review, May-June, 2022.
4. Peery et al. Burden and cost of gastrointestinal, liver, and pancreatic diseases in the United States: Update 2018. Gastroenterology. 2019. Jan;156(1):254-72.
5. See id.
6. See id.
7. Sieh, K. Post-COVID-19 functional gastrointestinal disorders: Prepare for a GI aftershock. J Gastroenterol Hepatol. 2022 March;37(3):413-4.
8. Newitt, P. Gastroenterology’s biggest threats. Becker’s, GI & Endoscopy, 2021 Oct 8, and Physician Compensation Report, 2022. Physicians Thrive (projecting a shortage of over 1,600 Gastroenterologists by 2025).
9. Dobrusin et al. Gastroenterologists and patients report high satisfaction rates with Telehealth services during the novel coronavirus 2019 pandemic. Clin Gastroenterol Hepatol. 2020;8(11):2393-7.
10. Dobrusin et al. Patients with gastrointestinal conditions consider telehealth equivalent to in-person care. Gastroenterology. 2022 Oct 4. doi: 10.1053/j.gastro.2022.09.035.
11. Demaerschalk et al. Assessment of clinician diagnostic concordance with video telemedicine in the integrated multispecialty practice at Mayo Clinic during the beginning of COVID-19 pandemic from March to June, 2020. JAMA Netw Open. 2022 Sep;5(9):e2229958.
12. Tang et al. A model for the pandemic and beyond: Telemedicine for all gastroenterology referrals reduces unnecessary clinic visits. J Telemed Telecare. 2022 Sep 28(8):577-82.
13. Dills A. Policy brief: Telehealth payment parity laws at the state level. Mercatus Center, George Mason University.
14. H.R.4040 – Advancing Telehealth Beyond COVID-19 Act of 2021. Congress.gov.
15. Brand et al. Association of distance, region, and insurance with advanced colon cancer at initial diagnosis. JAMA Netw Open. 2022 Sep 1;5(9):e2229954.
How a cheap liver drug may be the key to preventing COVID
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.
One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.
You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.
I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But
How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.
All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.
That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?
The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.
As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.
Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?
They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.
So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies
Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.
Of course, mice aren’t humans either. So the researchers didn’t stop there.
To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.
They didn’t stop there.
Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.
Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.
Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.
But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.
For Medscape, I’m Perry Wilson.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.
A version of this video transcript first appeared on Medscape.com.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.
One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.
You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.
I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But
How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.
All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.
That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?
The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.
As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.
Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?
They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.
So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies
Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.
Of course, mice aren’t humans either. So the researchers didn’t stop there.
To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.
They didn’t stop there.
Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.
Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.
Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.
But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.
For Medscape, I’m Perry Wilson.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.
A version of this video transcript first appeared on Medscape.com.
Welcome to Impact Factor, your weekly dose of commentary on a new medical study. I’m Dr F. Perry Wilson of the Yale School of Medicine.
As soon as the pandemic started, the search was on for a medication that could stave off infection, or at least the worst consequences of infection.
One that would be cheap to make, safe, easy to distribute, and, ideally, was already available. The search had a quest-like quality, like something from a fairy tale. Society, poisoned by COVID, would find the antidote out there, somewhere, if we looked hard enough.
You know the story. There were some pretty dramatic failures: hydroxychloroquine, ivermectin. There were some successes, like dexamethasone.
I’m not here today to tell you that the antidote has been found – no, it takes large randomized trials to figure that out. But
How do you make a case that an existing drug – UDCA, in this case – might be useful to prevent or treat COVID? In contrast to prior basic-science studies, like the original ivermectin study, which essentially took a bunch of cells and virus in a tube filled with varying concentrations of the antiparasitic agent, the authors of this paper appearing in Nature give us multiple, complementary lines of evidence. Let me walk you through it.
All good science starts with a biologically plausible hypothesis. In this case, the authors recognized that SARS-CoV-2, in all its variants, requires the presence of the ACE2 receptor on the surface of cells to bind.
That is the doorway to infection. Vaccines and antibodies block the key to this door, the spike protein and its receptor binding domain. But what if you could get rid of the doors altogether?
The authors first showed that ACE2 expression is controlled by a certain transcription factor known as the farnesoid X receptor, or FXR. Reducing the binding of FXR should therefore reduce ACE2 expression.
As luck would have it, UDCA – Actigall – reduces the levels of FXR and thus the expression of ACE2 in cells.
Okay. So we have a drug that can reduce ACE2, and we know that ACE2 is necessary for the virus to infect cells. Would UDCA prevent viral infection?
They started with test tubes, showing that cells were less likely to be infected by SARS-CoV-2 in the presence of UDCA at concentrations similar to what humans achieve in their blood after standard dosing. The red staining here is spike protein; you can see that it is markedly lower in the cells exposed to UDCA.
So far, so good. But test tubes aren’t people. So they moved up to mice and Syrian golden hamsters. These cute fellows are quite susceptible to human COVID and have been a model organism in countless studies
Mice and hamsters treated with UDCA in the presence of littermates with COVID infections were less likely to become infected themselves compared with mice not so treated. They also showed that mice and hamsters treated with UDCA had lower levels of ACE2 in their nasal passages.
Of course, mice aren’t humans either. So the researchers didn’t stop there.
To determine the effects of UDCA on human tissue, they utilized perfused human lungs that had been declined for transplantation. The lungs were perfused with a special fluid to keep them viable, and were mechanically ventilated. One lung was exposed to UDCA and the other served as a control. The authors were able to show that ACE2 levels went down in the exposed lung. And, importantly, when samples of tissue from both lungs were exposed to SARS-CoV-2, the lung tissue exposed to UDCA had lower levels of viral infection.
They didn’t stop there.
Eight human volunteers were recruited to take UDCA for 5 days. ACE2 levels in the nasal passages went down over the course of treatment. They confirmed those results from a proteomics dataset with several hundred people who had received UDCA for clinical reasons. Treated individuals had lower ACE2 levels.
Finally, they looked at the epidemiologic effect. They examined a dataset that contained information on over 1,000 patients with liver disease who had contracted COVID-19, 31 of whom had been receiving UDCA. Even after adjustment for baseline differences, those receiving UDCA were less likely to be hospitalized, require an ICU, or die.
Okay, we’ll stop there. Reading this study, all I could think was, Yes! This is how you generate evidence that you have a drug that might work – step by careful step.
But let’s be careful as well. Does this study show that taking Actigall will prevent COVID? Of course not. It doesn’t show that it will treat COVID either. But I bring it up because the rigor of this study stands in contrast to those that generated huge enthusiasm earlier in the pandemic only to let us down in randomized trials. If there has been a drug out there this whole time which will prevent or treat COVID, this is how we’ll find it. The next step? Test it in a randomized trial.
For Medscape, I’m Perry Wilson.
F. Perry Wilson, MD, MSCE, is an associate professor of medicine and director of Yale’s Clinical and Translational Research Accelerator. He disclosed no relevant financial relationships.
A version of this video transcript first appeared on Medscape.com.
Pooled safety data analysis of tralokinumab reported
The most , according to a review published in the British Journal of Dermatology.
These findings underscore the mechanistic elegance of interleukin (IL)-13 inhibition and highlight potential advantages of flexible dosing, according to the study’s lead author, Eric Simpson, MD, MCR. Overall, the pooled analysis of safety data from five phase 2 and 3 trials shows that “blockade of a single cytokine provides excellent short- and long-term safety, which is useful for a severe chronic disease,” said Dr. Simpson, professor of dermatology at Oregon Health & Science University in Portland.
Most patients with AD require years of treatment. “So for clinicians to confidently report to patients the low rates of serious adverse events (AEs) and lack of immune suppression side-effect profile is very encouraging for both the provider and patient,” Dr. Simpson said, noting there were no new signals or concerning short-term AEs.
Tralokinumab (Adbry), an IL-13 antagonist administered subcutaneously, was approved by the Food and Drug Administration for treatment of moderate to severe AD in adults in December 2021.
Minor differences vs. placebo
In the pooled analysis involving 1,605 patients treated for 16 weeks with tralokinumab and 680 who received placebo, frequency of any AE was 65.7% and 67.2%, respectively. Severe AEs occurred in 4.6% and 6.3% of patients, respectively.
The most common AE overall was AD, which occurred less often in tralokinumab-treated patients (15.4%) than those on placebo (26.2%). Other common AEs that occurred more frequently with tralokinumab included viral upper respiratory tract infections (15.7% vs. 12.2%), upper respiratory tract infections (URTI, 5.6% vs. 4.8%), conjunctivitis (5.4% vs. 1.9%), and injection-site reactions (3.5% vs. 0.3%).
AEs that occurred less often with tralokinumab than placebo included skin infections (3.7% vs. 9.2%, respectively) and infected dermatitis (1.6% vs. 6.4%).
Regarding safety areas of special interest, eye disorders classified as conjunctivitis, keratoconjunctivitis, or keratitis occurred more commonly with tralokinumab (7.9%) than placebo (3.4%). Most eye disorders were mild or moderate and resolved during the study. During maintenance treatment up to 52 weeks, AE rates mirrored those in the initial treatment period and did not increase with treatment duration.
In fact, Dr. Simpson said, the low rate of AEs that are known to accompany type 2 blockade, such as conjunctivitis, do not increase but rather appear to drop with longer-term use. The fact that skin infections were reduced vs. placebo and decreased over time suggests that long-term IL-13 blockade with tralokinumab positively impacts skin infections, a well-known comorbidity in uncontrolled AD, he added.
Raj Chovatiya, MD, PhD, who was asked to comment on the study, said, “These findings provide additional data supporting the safety and tolerability of tralokinumab and support my personal real-world experience with tralokinumab as a safe and effective biologic therapy for patients with moderate to severe AD.”
Dr. Chovatiya is assistant professor, director of the Center for Eczema and Itch, and medical director of clinical trials at Northwestern University in Chicago.
Four-week dosing
Consistent with ECZTRA 3, the rates of URTIs and conjunctivitis were lower with maintenance dosing 300 mg every 4 weeks, consideration of which is approved for responders weighing less than 220 pounds, vs. 300 mg every 2 weeks. Specifically, 6.7% of patients on every 4-week dosing schedule experienced URTIs, vs. 9.4% on the every 2-week dosing schedule and 7% of those on the every 2-week dosing schedule plus optional topical corticosteroids. Corresponding figures for conjunctivitis were 3%, 5%, and 5.6%, respectively.
“Four-week dosing is a possibility in your patients with a good clinical response at 16 weeks,” Dr. Simpson said. Advantages include improved convenience for patients, he added, and this analysis shows that dosing every 4 weeks may improve tolerability, with a lower rate of conjunctivitis.
Although it is difficult to directly compare review data to other studies, said Dr. Chovatiya, findings also suggest that tralokinumab may be associated with reduced infections and conjunctivitis compared with other advanced AD therapies. Head-to-head trials and real-world studies are needed to better understand comparative safety, he added.
Some patients will lose a degree of response with the 4-week dosing schedule, Dr. Simpson said. In ECZTRA 1 and 2, 55.9% of patients who achieved investigator global assessment (IGA) scores of 0 or 1 after 16 weeks of dosing every 2 weeks maintained this response level through week 52, vs. 42.4% of responders who switched from dosing every 2 weeks to every 4 weeks after week 16. But according to data that Dr. Simpson recently presented, 95% of patients switched to monthly dosing who relapsed and returned to dosing every 2 weeks regained their original response level within approximately 4 weeks.
In his personal practice, Dr. Simpson has prescribed tralokinumab for patients with AD for up to a year. However, he and fellow investigators have been following much larger populations for more than 2 years and are planning additional publications. “Safety data will continue to accrue” said Dr. Simpson, “but I don’t expect any surprises.”
The clinical trials were sponsored by MedImmune (phase 2b) and LEO Pharma ( ECZTRA phase 3 trials), which also sponsored the review. Dr. Simpson reports grants and personal fees from numerous pharmaceutical companies. Dr. Chovatiya has been an advisory board member, consultant, investigator, and speaker for numerous pharmaceutical companies including LEO Pharma.
A version of this article first appeared on Medscape.com.
The most , according to a review published in the British Journal of Dermatology.
These findings underscore the mechanistic elegance of interleukin (IL)-13 inhibition and highlight potential advantages of flexible dosing, according to the study’s lead author, Eric Simpson, MD, MCR. Overall, the pooled analysis of safety data from five phase 2 and 3 trials shows that “blockade of a single cytokine provides excellent short- and long-term safety, which is useful for a severe chronic disease,” said Dr. Simpson, professor of dermatology at Oregon Health & Science University in Portland.
Most patients with AD require years of treatment. “So for clinicians to confidently report to patients the low rates of serious adverse events (AEs) and lack of immune suppression side-effect profile is very encouraging for both the provider and patient,” Dr. Simpson said, noting there were no new signals or concerning short-term AEs.
Tralokinumab (Adbry), an IL-13 antagonist administered subcutaneously, was approved by the Food and Drug Administration for treatment of moderate to severe AD in adults in December 2021.
Minor differences vs. placebo
In the pooled analysis involving 1,605 patients treated for 16 weeks with tralokinumab and 680 who received placebo, frequency of any AE was 65.7% and 67.2%, respectively. Severe AEs occurred in 4.6% and 6.3% of patients, respectively.
The most common AE overall was AD, which occurred less often in tralokinumab-treated patients (15.4%) than those on placebo (26.2%). Other common AEs that occurred more frequently with tralokinumab included viral upper respiratory tract infections (15.7% vs. 12.2%), upper respiratory tract infections (URTI, 5.6% vs. 4.8%), conjunctivitis (5.4% vs. 1.9%), and injection-site reactions (3.5% vs. 0.3%).
AEs that occurred less often with tralokinumab than placebo included skin infections (3.7% vs. 9.2%, respectively) and infected dermatitis (1.6% vs. 6.4%).
Regarding safety areas of special interest, eye disorders classified as conjunctivitis, keratoconjunctivitis, or keratitis occurred more commonly with tralokinumab (7.9%) than placebo (3.4%). Most eye disorders were mild or moderate and resolved during the study. During maintenance treatment up to 52 weeks, AE rates mirrored those in the initial treatment period and did not increase with treatment duration.
In fact, Dr. Simpson said, the low rate of AEs that are known to accompany type 2 blockade, such as conjunctivitis, do not increase but rather appear to drop with longer-term use. The fact that skin infections were reduced vs. placebo and decreased over time suggests that long-term IL-13 blockade with tralokinumab positively impacts skin infections, a well-known comorbidity in uncontrolled AD, he added.
Raj Chovatiya, MD, PhD, who was asked to comment on the study, said, “These findings provide additional data supporting the safety and tolerability of tralokinumab and support my personal real-world experience with tralokinumab as a safe and effective biologic therapy for patients with moderate to severe AD.”
Dr. Chovatiya is assistant professor, director of the Center for Eczema and Itch, and medical director of clinical trials at Northwestern University in Chicago.
Four-week dosing
Consistent with ECZTRA 3, the rates of URTIs and conjunctivitis were lower with maintenance dosing 300 mg every 4 weeks, consideration of which is approved for responders weighing less than 220 pounds, vs. 300 mg every 2 weeks. Specifically, 6.7% of patients on every 4-week dosing schedule experienced URTIs, vs. 9.4% on the every 2-week dosing schedule and 7% of those on the every 2-week dosing schedule plus optional topical corticosteroids. Corresponding figures for conjunctivitis were 3%, 5%, and 5.6%, respectively.
“Four-week dosing is a possibility in your patients with a good clinical response at 16 weeks,” Dr. Simpson said. Advantages include improved convenience for patients, he added, and this analysis shows that dosing every 4 weeks may improve tolerability, with a lower rate of conjunctivitis.
Although it is difficult to directly compare review data to other studies, said Dr. Chovatiya, findings also suggest that tralokinumab may be associated with reduced infections and conjunctivitis compared with other advanced AD therapies. Head-to-head trials and real-world studies are needed to better understand comparative safety, he added.
Some patients will lose a degree of response with the 4-week dosing schedule, Dr. Simpson said. In ECZTRA 1 and 2, 55.9% of patients who achieved investigator global assessment (IGA) scores of 0 or 1 after 16 weeks of dosing every 2 weeks maintained this response level through week 52, vs. 42.4% of responders who switched from dosing every 2 weeks to every 4 weeks after week 16. But according to data that Dr. Simpson recently presented, 95% of patients switched to monthly dosing who relapsed and returned to dosing every 2 weeks regained their original response level within approximately 4 weeks.
In his personal practice, Dr. Simpson has prescribed tralokinumab for patients with AD for up to a year. However, he and fellow investigators have been following much larger populations for more than 2 years and are planning additional publications. “Safety data will continue to accrue” said Dr. Simpson, “but I don’t expect any surprises.”
The clinical trials were sponsored by MedImmune (phase 2b) and LEO Pharma ( ECZTRA phase 3 trials), which also sponsored the review. Dr. Simpson reports grants and personal fees from numerous pharmaceutical companies. Dr. Chovatiya has been an advisory board member, consultant, investigator, and speaker for numerous pharmaceutical companies including LEO Pharma.
A version of this article first appeared on Medscape.com.
The most , according to a review published in the British Journal of Dermatology.
These findings underscore the mechanistic elegance of interleukin (IL)-13 inhibition and highlight potential advantages of flexible dosing, according to the study’s lead author, Eric Simpson, MD, MCR. Overall, the pooled analysis of safety data from five phase 2 and 3 trials shows that “blockade of a single cytokine provides excellent short- and long-term safety, which is useful for a severe chronic disease,” said Dr. Simpson, professor of dermatology at Oregon Health & Science University in Portland.
Most patients with AD require years of treatment. “So for clinicians to confidently report to patients the low rates of serious adverse events (AEs) and lack of immune suppression side-effect profile is very encouraging for both the provider and patient,” Dr. Simpson said, noting there were no new signals or concerning short-term AEs.
Tralokinumab (Adbry), an IL-13 antagonist administered subcutaneously, was approved by the Food and Drug Administration for treatment of moderate to severe AD in adults in December 2021.
Minor differences vs. placebo
In the pooled analysis involving 1,605 patients treated for 16 weeks with tralokinumab and 680 who received placebo, frequency of any AE was 65.7% and 67.2%, respectively. Severe AEs occurred in 4.6% and 6.3% of patients, respectively.
The most common AE overall was AD, which occurred less often in tralokinumab-treated patients (15.4%) than those on placebo (26.2%). Other common AEs that occurred more frequently with tralokinumab included viral upper respiratory tract infections (15.7% vs. 12.2%), upper respiratory tract infections (URTI, 5.6% vs. 4.8%), conjunctivitis (5.4% vs. 1.9%), and injection-site reactions (3.5% vs. 0.3%).
AEs that occurred less often with tralokinumab than placebo included skin infections (3.7% vs. 9.2%, respectively) and infected dermatitis (1.6% vs. 6.4%).
Regarding safety areas of special interest, eye disorders classified as conjunctivitis, keratoconjunctivitis, or keratitis occurred more commonly with tralokinumab (7.9%) than placebo (3.4%). Most eye disorders were mild or moderate and resolved during the study. During maintenance treatment up to 52 weeks, AE rates mirrored those in the initial treatment period and did not increase with treatment duration.
In fact, Dr. Simpson said, the low rate of AEs that are known to accompany type 2 blockade, such as conjunctivitis, do not increase but rather appear to drop with longer-term use. The fact that skin infections were reduced vs. placebo and decreased over time suggests that long-term IL-13 blockade with tralokinumab positively impacts skin infections, a well-known comorbidity in uncontrolled AD, he added.
Raj Chovatiya, MD, PhD, who was asked to comment on the study, said, “These findings provide additional data supporting the safety and tolerability of tralokinumab and support my personal real-world experience with tralokinumab as a safe and effective biologic therapy for patients with moderate to severe AD.”
Dr. Chovatiya is assistant professor, director of the Center for Eczema and Itch, and medical director of clinical trials at Northwestern University in Chicago.
Four-week dosing
Consistent with ECZTRA 3, the rates of URTIs and conjunctivitis were lower with maintenance dosing 300 mg every 4 weeks, consideration of which is approved for responders weighing less than 220 pounds, vs. 300 mg every 2 weeks. Specifically, 6.7% of patients on every 4-week dosing schedule experienced URTIs, vs. 9.4% on the every 2-week dosing schedule and 7% of those on the every 2-week dosing schedule plus optional topical corticosteroids. Corresponding figures for conjunctivitis were 3%, 5%, and 5.6%, respectively.
“Four-week dosing is a possibility in your patients with a good clinical response at 16 weeks,” Dr. Simpson said. Advantages include improved convenience for patients, he added, and this analysis shows that dosing every 4 weeks may improve tolerability, with a lower rate of conjunctivitis.
Although it is difficult to directly compare review data to other studies, said Dr. Chovatiya, findings also suggest that tralokinumab may be associated with reduced infections and conjunctivitis compared with other advanced AD therapies. Head-to-head trials and real-world studies are needed to better understand comparative safety, he added.
Some patients will lose a degree of response with the 4-week dosing schedule, Dr. Simpson said. In ECZTRA 1 and 2, 55.9% of patients who achieved investigator global assessment (IGA) scores of 0 or 1 after 16 weeks of dosing every 2 weeks maintained this response level through week 52, vs. 42.4% of responders who switched from dosing every 2 weeks to every 4 weeks after week 16. But according to data that Dr. Simpson recently presented, 95% of patients switched to monthly dosing who relapsed and returned to dosing every 2 weeks regained their original response level within approximately 4 weeks.
In his personal practice, Dr. Simpson has prescribed tralokinumab for patients with AD for up to a year. However, he and fellow investigators have been following much larger populations for more than 2 years and are planning additional publications. “Safety data will continue to accrue” said Dr. Simpson, “but I don’t expect any surprises.”
The clinical trials were sponsored by MedImmune (phase 2b) and LEO Pharma ( ECZTRA phase 3 trials), which also sponsored the review. Dr. Simpson reports grants and personal fees from numerous pharmaceutical companies. Dr. Chovatiya has been an advisory board member, consultant, investigator, and speaker for numerous pharmaceutical companies including LEO Pharma.
A version of this article first appeared on Medscape.com.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Know the right resuscitation for right-sided heart failure
Amado Alejandro Baez, MD, said in a presentation at the 2022 scientific assembly of the American College of Emergency Physicians.
The patient arrived on day 20 after a radical cystoprostatectomy. He had driven 4 hours from another city for a urology follow-up visit. On arrival, he developed respiratory distress symptoms and presented to the emergency department, said Dr. Baez, professor of emergency medicine and epidemiology at the Medical College of Georgia/Augusta University and triple-board certified in EMS, emergency medicine, and critical care.
The patient developed a massive pulmonary embolism with acute cor pulmonale (right-sided heart failure). An electrocardiogram showed an S1Q3T3, demonstrating the distinctive nature of right ventricular failure, said Dr. Baez.
Research has demonstrated the differences in physiology between the right and left ventricles, he said.
Dr. Baez highlighted some of the features of right ventricle (RV) failure and how to manage it. Notably, the RV is thinner and less resilient. “RV failure patients may fall off the Starling curve,” in contrast to patients with isolated left ventricle (LV) failure.
RV pressure overload is associated with a range of conditions, such as pericardial disease, pulmonary embolism, acute respiratory distress syndrome, and pulmonary arterial hypertension. When combined with RV overload, patients may develop intracardiac shunting or coronary heart disease, Dr. Baez said. Decreased contractility associated with RV failure can result from sepsis, right ventricular myocardial infarction, myocarditis, and arrhythmia.
Dr. Baez cited the 2018 scientific statement from the American Heart Association on the evaluation and management of right-sided heart failure. The authors of the statement noted that the complicated geometry of the right heart makes functional assessment a challenge. They wrote that various hemodynamic and biochemical markers can help guide clinical assessment and therapeutic decision-making.
Increased RV afterload drives multiple factors that can ultimately lead to cardiogenic shock and death, said Dr. Baez. These factors include decreased RV oxygen delivery, decreased RV coronary perfusion, decreased systemic blood pressure, and low carbon monoxide levels. RV afterload also leads to decreased RV contractility, an increase in RV oxygen demand, and tension in the RV wall, and it may contribute to tricuspid valve insufficiency, neurohormonal activation, and RV ischemia.
Treatment strategies involve improving symptoms and stopping disease progression, said Baez. In its scientific statement, the AHA recommends steps for assessing RV and LV function so as to identify RV failure as soon as possible, he said. After excluding pericardial disease, the AHA advises diagnosis and treatment of etiology-specific causes, such as right ventricular MI, pulmonary embolism, and sepsis. For arrhythmias, it recommends maintaining sinus rhythm when possible and considering a pacemaker to maintain atrioventricular synchrony and to avoid excessive bradycardia.
In its statement, the AHA also recommends optimizing preload with right arterial pressure/central venous pressure of 8-12 mm Hg, said Dr. Baez. Preload optimization combined with afterload reduction and improved contractility are hallmarks of care for patients with RV failure.
Avoiding systemic hypotension can prevent sequelae, such as myocardial ischemia and further hypotension, he said.
Optimization of fluid status is another key to managing RV failure, said Dr. Baez. Right heart coronary perfusion pressure can be protected by maintaining mean arterial pressure, and consideration should be given to reducing the RV afterload. Other strategies include inotropic medications and rhythm stabilization.
In general, for RV failure patients, “correct hypoxia, hypercarbia, and acidosis and avoid intubation when possible,” he said. Extracorporeal membrane oxygenation (ECMO) may be an option, depending on how many mechanical ventilator settings need to be adjusted.
In a study by Dr. Baez and colleagues published in Critical Care Medicine, the authors presented a Bayesian probability model for plasma lactate and severity of illness in cases of acute pulmonary embolism. “This Bayesian model demonstrated that the combination of shock index and lactate yield superior diagnostic gains than those compare to the sPESI and lactate,” Dr. Baez said.
The care model needs to be specific to the etiology, he added. Volume management in congested pulmonary hypertension involves a “squeeze and diurese” strategy.
According to the Internet Book of Critical Care, for patients with mean arterial pressure (MAP) of 60 mm Hg, central venous pressure (CVP) of 25 mm Hg, renal perfusion pressure of 25 mm Hg, and no urine output, a vasopressor should be added to treatment, Dr. Baez said. In cases in which the MAP 75 mm Hg, the CVP is 25 mm Hg, the renal perfusion pressure is 50 mm Hg, and the patient has good urine output, vasopressors should be continued and fluid should be removed through use of a diuretic. For patients with a MAP of 75 mm Hg, a CVP of 12 mm Hg, and renal perfusion pressure of 63 mm Hg who have good urine output, the diuretic and the vasopressor should be discontinued.
Dr. Baez also reviewed several clinical studies of the utility of acute mechanical circulatory support systems for RV failure.
In two small studies involving a heart pump and a right ventricular assistive device, the 30-day survival rate was approximately 72%-73%. A study of 179 patients involving ECMO showed an in-hospital mortality rate of 38.6%, he said.
Overall, “prompt diagnosis, hemodynamic support, and initiation of specific treatment” are the foundations of managing RV failure, he concluded.
Dr. Baez disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Amado Alejandro Baez, MD, said in a presentation at the 2022 scientific assembly of the American College of Emergency Physicians.
The patient arrived on day 20 after a radical cystoprostatectomy. He had driven 4 hours from another city for a urology follow-up visit. On arrival, he developed respiratory distress symptoms and presented to the emergency department, said Dr. Baez, professor of emergency medicine and epidemiology at the Medical College of Georgia/Augusta University and triple-board certified in EMS, emergency medicine, and critical care.
The patient developed a massive pulmonary embolism with acute cor pulmonale (right-sided heart failure). An electrocardiogram showed an S1Q3T3, demonstrating the distinctive nature of right ventricular failure, said Dr. Baez.
Research has demonstrated the differences in physiology between the right and left ventricles, he said.
Dr. Baez highlighted some of the features of right ventricle (RV) failure and how to manage it. Notably, the RV is thinner and less resilient. “RV failure patients may fall off the Starling curve,” in contrast to patients with isolated left ventricle (LV) failure.
RV pressure overload is associated with a range of conditions, such as pericardial disease, pulmonary embolism, acute respiratory distress syndrome, and pulmonary arterial hypertension. When combined with RV overload, patients may develop intracardiac shunting or coronary heart disease, Dr. Baez said. Decreased contractility associated with RV failure can result from sepsis, right ventricular myocardial infarction, myocarditis, and arrhythmia.
Dr. Baez cited the 2018 scientific statement from the American Heart Association on the evaluation and management of right-sided heart failure. The authors of the statement noted that the complicated geometry of the right heart makes functional assessment a challenge. They wrote that various hemodynamic and biochemical markers can help guide clinical assessment and therapeutic decision-making.
Increased RV afterload drives multiple factors that can ultimately lead to cardiogenic shock and death, said Dr. Baez. These factors include decreased RV oxygen delivery, decreased RV coronary perfusion, decreased systemic blood pressure, and low carbon monoxide levels. RV afterload also leads to decreased RV contractility, an increase in RV oxygen demand, and tension in the RV wall, and it may contribute to tricuspid valve insufficiency, neurohormonal activation, and RV ischemia.
Treatment strategies involve improving symptoms and stopping disease progression, said Baez. In its scientific statement, the AHA recommends steps for assessing RV and LV function so as to identify RV failure as soon as possible, he said. After excluding pericardial disease, the AHA advises diagnosis and treatment of etiology-specific causes, such as right ventricular MI, pulmonary embolism, and sepsis. For arrhythmias, it recommends maintaining sinus rhythm when possible and considering a pacemaker to maintain atrioventricular synchrony and to avoid excessive bradycardia.
In its statement, the AHA also recommends optimizing preload with right arterial pressure/central venous pressure of 8-12 mm Hg, said Dr. Baez. Preload optimization combined with afterload reduction and improved contractility are hallmarks of care for patients with RV failure.
Avoiding systemic hypotension can prevent sequelae, such as myocardial ischemia and further hypotension, he said.
Optimization of fluid status is another key to managing RV failure, said Dr. Baez. Right heart coronary perfusion pressure can be protected by maintaining mean arterial pressure, and consideration should be given to reducing the RV afterload. Other strategies include inotropic medications and rhythm stabilization.
In general, for RV failure patients, “correct hypoxia, hypercarbia, and acidosis and avoid intubation when possible,” he said. Extracorporeal membrane oxygenation (ECMO) may be an option, depending on how many mechanical ventilator settings need to be adjusted.
In a study by Dr. Baez and colleagues published in Critical Care Medicine, the authors presented a Bayesian probability model for plasma lactate and severity of illness in cases of acute pulmonary embolism. “This Bayesian model demonstrated that the combination of shock index and lactate yield superior diagnostic gains than those compare to the sPESI and lactate,” Dr. Baez said.
The care model needs to be specific to the etiology, he added. Volume management in congested pulmonary hypertension involves a “squeeze and diurese” strategy.
According to the Internet Book of Critical Care, for patients with mean arterial pressure (MAP) of 60 mm Hg, central venous pressure (CVP) of 25 mm Hg, renal perfusion pressure of 25 mm Hg, and no urine output, a vasopressor should be added to treatment, Dr. Baez said. In cases in which the MAP 75 mm Hg, the CVP is 25 mm Hg, the renal perfusion pressure is 50 mm Hg, and the patient has good urine output, vasopressors should be continued and fluid should be removed through use of a diuretic. For patients with a MAP of 75 mm Hg, a CVP of 12 mm Hg, and renal perfusion pressure of 63 mm Hg who have good urine output, the diuretic and the vasopressor should be discontinued.
Dr. Baez also reviewed several clinical studies of the utility of acute mechanical circulatory support systems for RV failure.
In two small studies involving a heart pump and a right ventricular assistive device, the 30-day survival rate was approximately 72%-73%. A study of 179 patients involving ECMO showed an in-hospital mortality rate of 38.6%, he said.
Overall, “prompt diagnosis, hemodynamic support, and initiation of specific treatment” are the foundations of managing RV failure, he concluded.
Dr. Baez disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Amado Alejandro Baez, MD, said in a presentation at the 2022 scientific assembly of the American College of Emergency Physicians.
The patient arrived on day 20 after a radical cystoprostatectomy. He had driven 4 hours from another city for a urology follow-up visit. On arrival, he developed respiratory distress symptoms and presented to the emergency department, said Dr. Baez, professor of emergency medicine and epidemiology at the Medical College of Georgia/Augusta University and triple-board certified in EMS, emergency medicine, and critical care.
The patient developed a massive pulmonary embolism with acute cor pulmonale (right-sided heart failure). An electrocardiogram showed an S1Q3T3, demonstrating the distinctive nature of right ventricular failure, said Dr. Baez.
Research has demonstrated the differences in physiology between the right and left ventricles, he said.
Dr. Baez highlighted some of the features of right ventricle (RV) failure and how to manage it. Notably, the RV is thinner and less resilient. “RV failure patients may fall off the Starling curve,” in contrast to patients with isolated left ventricle (LV) failure.
RV pressure overload is associated with a range of conditions, such as pericardial disease, pulmonary embolism, acute respiratory distress syndrome, and pulmonary arterial hypertension. When combined with RV overload, patients may develop intracardiac shunting or coronary heart disease, Dr. Baez said. Decreased contractility associated with RV failure can result from sepsis, right ventricular myocardial infarction, myocarditis, and arrhythmia.
Dr. Baez cited the 2018 scientific statement from the American Heart Association on the evaluation and management of right-sided heart failure. The authors of the statement noted that the complicated geometry of the right heart makes functional assessment a challenge. They wrote that various hemodynamic and biochemical markers can help guide clinical assessment and therapeutic decision-making.
Increased RV afterload drives multiple factors that can ultimately lead to cardiogenic shock and death, said Dr. Baez. These factors include decreased RV oxygen delivery, decreased RV coronary perfusion, decreased systemic blood pressure, and low carbon monoxide levels. RV afterload also leads to decreased RV contractility, an increase in RV oxygen demand, and tension in the RV wall, and it may contribute to tricuspid valve insufficiency, neurohormonal activation, and RV ischemia.
Treatment strategies involve improving symptoms and stopping disease progression, said Baez. In its scientific statement, the AHA recommends steps for assessing RV and LV function so as to identify RV failure as soon as possible, he said. After excluding pericardial disease, the AHA advises diagnosis and treatment of etiology-specific causes, such as right ventricular MI, pulmonary embolism, and sepsis. For arrhythmias, it recommends maintaining sinus rhythm when possible and considering a pacemaker to maintain atrioventricular synchrony and to avoid excessive bradycardia.
In its statement, the AHA also recommends optimizing preload with right arterial pressure/central venous pressure of 8-12 mm Hg, said Dr. Baez. Preload optimization combined with afterload reduction and improved contractility are hallmarks of care for patients with RV failure.
Avoiding systemic hypotension can prevent sequelae, such as myocardial ischemia and further hypotension, he said.
Optimization of fluid status is another key to managing RV failure, said Dr. Baez. Right heart coronary perfusion pressure can be protected by maintaining mean arterial pressure, and consideration should be given to reducing the RV afterload. Other strategies include inotropic medications and rhythm stabilization.
In general, for RV failure patients, “correct hypoxia, hypercarbia, and acidosis and avoid intubation when possible,” he said. Extracorporeal membrane oxygenation (ECMO) may be an option, depending on how many mechanical ventilator settings need to be adjusted.
In a study by Dr. Baez and colleagues published in Critical Care Medicine, the authors presented a Bayesian probability model for plasma lactate and severity of illness in cases of acute pulmonary embolism. “This Bayesian model demonstrated that the combination of shock index and lactate yield superior diagnostic gains than those compare to the sPESI and lactate,” Dr. Baez said.
The care model needs to be specific to the etiology, he added. Volume management in congested pulmonary hypertension involves a “squeeze and diurese” strategy.
According to the Internet Book of Critical Care, for patients with mean arterial pressure (MAP) of 60 mm Hg, central venous pressure (CVP) of 25 mm Hg, renal perfusion pressure of 25 mm Hg, and no urine output, a vasopressor should be added to treatment, Dr. Baez said. In cases in which the MAP 75 mm Hg, the CVP is 25 mm Hg, the renal perfusion pressure is 50 mm Hg, and the patient has good urine output, vasopressors should be continued and fluid should be removed through use of a diuretic. For patients with a MAP of 75 mm Hg, a CVP of 12 mm Hg, and renal perfusion pressure of 63 mm Hg who have good urine output, the diuretic and the vasopressor should be discontinued.
Dr. Baez also reviewed several clinical studies of the utility of acute mechanical circulatory support systems for RV failure.
In two small studies involving a heart pump and a right ventricular assistive device, the 30-day survival rate was approximately 72%-73%. A study of 179 patients involving ECMO showed an in-hospital mortality rate of 38.6%, he said.
Overall, “prompt diagnosis, hemodynamic support, and initiation of specific treatment” are the foundations of managing RV failure, he concluded.
Dr. Baez disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACEP 2022
Does dopamine dysregulation cause schizophrenia?
Investigators identified a mechanism on the dopamine receptor, known as the autoreceptor, which regulates how much dopamine is released from the presynaptic neuron. Impairment of this autoreceptor leads to poorly controlled dopamine release and excessive dopamine flow.
The researchers found decreased expression of this autoreceptor accounts for the genetic evidence of schizophrenia risk, and, using a suite of statistical routines, they showed that this relationship is probably causative.
“Our research confirms the scientific hypothesis that too much dopamine plays a likely causative role in psychosis and precisely how this is based on genetic factors,” study investigator Daniel Weinberger, MD, director and CEO of the Lieber Institute for Brain Development, Baltimore, told this news organization.
“Drugs that treat psychosis symptoms by simply blocking dopamine receptors have harsh side effects. ... Theoretically, scientists could now develop therapies that target these malfunctioning autoreceptors to treat this devastating condition with fewer side effects,” he said.
The study was published online in Nature Neuroscience.
‘Privileged spot’
“Large international genetic studies known as genomewide association studies have identified hundreds of regions of the human genome housing potential risk genes for schizophrenia,” Dr. Weinberger said.
“However, these regions are still poorly resolved in terms of specific genes, and treatments and diagnostic techniques are far from what they should be.” Moreover, “treatments for schizophrenia address the symptoms of psychosis but not the cause,” he said.
“For more than 70 years, neuroscientists have suspected that dopamine plays a key role in schizophrenia, but what kind of role, exactly, has remained a mystery,” Dr. Weinberger noted. “It occupied a privileged spot in the principal hypothesis about schizophrenia for over 60 years – the so-called ‘dopamine hypothesis.’ ”
Antipsychotic drugs that reduce dopamine “are the principal medical treatments but they cause serious side effects, including an inability to experience pleasure and joy – a sad reality for patients and their families,” he continued.
The current study “set out to understand how dopamine acts in schizophrenia” using “analysis of the genetic and transcriptional landscape” of the postmortem caudate nucleus from 443 donors (245 neurotypical, 154 with schizophrenia, and 44 with bipolar disorder).
Brain samples were from individuals of diverse ancestry (210 were of African ancestry and 2,233 were of European ancestry).
New treatment target?
The researchers performed an analysis of transancestry expression quantitative trait loci, genetic variants that explain variations in gene expression levels, which express in the caudate, annotating “hundreds of caudate-specific cis-eQTLs.”
Then they integrated this analysis with gene expression that emerged from the latest genomewide association study and transcriptome-wide association study, identifying hundreds of genes that “showed a potential causal association with schizophrenia risk in the caudate nucleus,” including a specific isoform of the dopamine D2 receptor, which is upregulated in the caudate nucleus of those with schizophrenia.
“If autoreceptors don’t function properly the flow of dopamine in the brain is poorly controlled and too much dopamine flows for too long,” said Dr. Weinberger.
In particular, they observed “extensive differential gene expression” for schizophrenia in 2,701 genes in those with schizophrenia, compared with those without: glial cell–derived neurotrophic factor antisense RNA was a top-up gene and tyrosine hydroxylase, which is a rate-limiting enzyme in dopamine synthesis, was a down-regulated gene. Dopamine receptors DRD2 and DRD3 were differentially expressed.
Having done this, they looked at the effects of antipsychotic medications that target D2 regions on gene expression in the caudate by testing for differences between individuals with schizophrenia who were taking antipsychotics at the time of death, those not taking antipsychotics at the time of death (n = 104 and 49, respectively), and neurotypical individuals (n = 239).
There were 2,692 differentially expressed genes between individuals taking antipsychotics versus neurotypical individuals (false discovery rate < 0.05). By contrast, there were only 665 differentially expressed genes (FDR < .05) between those not taking antipsychotics and neurotypical individuals.
“We found that antipsychotic medication has an extensive influence on caudate gene expression,” the investigators noted.
They then developed a new approach to “infer gene networks from expression data.” This method is based on deep neural networks, obtaining a “low-dimensional representation of each gene’s expression across individuals.” The representation is then used to build a “gene neighborhood graph and assign genes to modules.”
This method identified “several modules enriched for genes associated with schizophrenia risk.” The expression representations captured in this approach placed genes in “biologically meaningful neighborhoods, which can provide insight into potential interactions if these genes are targeted for therapeutic intervention,” the authors summarized.
“Now that our new research has identified the specific mechanism by which dopamine plays a causative role in schizophrenia, we hope we have opened the door for more targeted drugs or diagnostic tests that could make life better for patients and their families,” Dr. Weinberger said.
No causal link?
Commenting on the study, Rifaat El-Mallakh, MD, director of the mood disorders research program, department of psychiatry and behavioral sciences, University of Louisville (Ky.), called it an “excellent study performed by an excellent research group” that “fills an important lacuna in our research database.”
However, Dr. El-Mallakh, who was not involved in the research, disagreed that the findings show causality. “The data that can be gleaned from this study is limited and the design has significant limitations. As with all genetic studies, this is an association study. It tells us nothing about the cause-effect relationship between the genes and the illness.
“We do not know why genes are associated with the illness. Genetic overrepresentation can have multiple causes, and more so when the data is a convenience sample. As noted by the authors, much of what they observed was probably related to medication effect. I don’t think this study specifically tells us anything clinically,” he added.
The study was supported by the LIBD, the BrainSeq Consortium, an National Institutes of Health fellowship to two of the authors, and a NARSAD Young Investigator Grant from the Brain & Behavior Research Foundation to one of the authors. Dr. Weinberger has reported no relevant financial relationships. Dr. El-Mallakh declared no specific financial relationships relevant to the study but has reported being a speaker for several companies that manufacture antipsychotics.
A version of this article first appeared on Medscape.com.
Investigators identified a mechanism on the dopamine receptor, known as the autoreceptor, which regulates how much dopamine is released from the presynaptic neuron. Impairment of this autoreceptor leads to poorly controlled dopamine release and excessive dopamine flow.
The researchers found decreased expression of this autoreceptor accounts for the genetic evidence of schizophrenia risk, and, using a suite of statistical routines, they showed that this relationship is probably causative.
“Our research confirms the scientific hypothesis that too much dopamine plays a likely causative role in psychosis and precisely how this is based on genetic factors,” study investigator Daniel Weinberger, MD, director and CEO of the Lieber Institute for Brain Development, Baltimore, told this news organization.
“Drugs that treat psychosis symptoms by simply blocking dopamine receptors have harsh side effects. ... Theoretically, scientists could now develop therapies that target these malfunctioning autoreceptors to treat this devastating condition with fewer side effects,” he said.
The study was published online in Nature Neuroscience.
‘Privileged spot’
“Large international genetic studies known as genomewide association studies have identified hundreds of regions of the human genome housing potential risk genes for schizophrenia,” Dr. Weinberger said.
“However, these regions are still poorly resolved in terms of specific genes, and treatments and diagnostic techniques are far from what they should be.” Moreover, “treatments for schizophrenia address the symptoms of psychosis but not the cause,” he said.
“For more than 70 years, neuroscientists have suspected that dopamine plays a key role in schizophrenia, but what kind of role, exactly, has remained a mystery,” Dr. Weinberger noted. “It occupied a privileged spot in the principal hypothesis about schizophrenia for over 60 years – the so-called ‘dopamine hypothesis.’ ”
Antipsychotic drugs that reduce dopamine “are the principal medical treatments but they cause serious side effects, including an inability to experience pleasure and joy – a sad reality for patients and their families,” he continued.
The current study “set out to understand how dopamine acts in schizophrenia” using “analysis of the genetic and transcriptional landscape” of the postmortem caudate nucleus from 443 donors (245 neurotypical, 154 with schizophrenia, and 44 with bipolar disorder).
Brain samples were from individuals of diverse ancestry (210 were of African ancestry and 2,233 were of European ancestry).
New treatment target?
The researchers performed an analysis of transancestry expression quantitative trait loci, genetic variants that explain variations in gene expression levels, which express in the caudate, annotating “hundreds of caudate-specific cis-eQTLs.”
Then they integrated this analysis with gene expression that emerged from the latest genomewide association study and transcriptome-wide association study, identifying hundreds of genes that “showed a potential causal association with schizophrenia risk in the caudate nucleus,” including a specific isoform of the dopamine D2 receptor, which is upregulated in the caudate nucleus of those with schizophrenia.
“If autoreceptors don’t function properly the flow of dopamine in the brain is poorly controlled and too much dopamine flows for too long,” said Dr. Weinberger.
In particular, they observed “extensive differential gene expression” for schizophrenia in 2,701 genes in those with schizophrenia, compared with those without: glial cell–derived neurotrophic factor antisense RNA was a top-up gene and tyrosine hydroxylase, which is a rate-limiting enzyme in dopamine synthesis, was a down-regulated gene. Dopamine receptors DRD2 and DRD3 were differentially expressed.
Having done this, they looked at the effects of antipsychotic medications that target D2 regions on gene expression in the caudate by testing for differences between individuals with schizophrenia who were taking antipsychotics at the time of death, those not taking antipsychotics at the time of death (n = 104 and 49, respectively), and neurotypical individuals (n = 239).
There were 2,692 differentially expressed genes between individuals taking antipsychotics versus neurotypical individuals (false discovery rate < 0.05). By contrast, there were only 665 differentially expressed genes (FDR < .05) between those not taking antipsychotics and neurotypical individuals.
“We found that antipsychotic medication has an extensive influence on caudate gene expression,” the investigators noted.
They then developed a new approach to “infer gene networks from expression data.” This method is based on deep neural networks, obtaining a “low-dimensional representation of each gene’s expression across individuals.” The representation is then used to build a “gene neighborhood graph and assign genes to modules.”
This method identified “several modules enriched for genes associated with schizophrenia risk.” The expression representations captured in this approach placed genes in “biologically meaningful neighborhoods, which can provide insight into potential interactions if these genes are targeted for therapeutic intervention,” the authors summarized.
“Now that our new research has identified the specific mechanism by which dopamine plays a causative role in schizophrenia, we hope we have opened the door for more targeted drugs or diagnostic tests that could make life better for patients and their families,” Dr. Weinberger said.
No causal link?
Commenting on the study, Rifaat El-Mallakh, MD, director of the mood disorders research program, department of psychiatry and behavioral sciences, University of Louisville (Ky.), called it an “excellent study performed by an excellent research group” that “fills an important lacuna in our research database.”
However, Dr. El-Mallakh, who was not involved in the research, disagreed that the findings show causality. “The data that can be gleaned from this study is limited and the design has significant limitations. As with all genetic studies, this is an association study. It tells us nothing about the cause-effect relationship between the genes and the illness.
“We do not know why genes are associated with the illness. Genetic overrepresentation can have multiple causes, and more so when the data is a convenience sample. As noted by the authors, much of what they observed was probably related to medication effect. I don’t think this study specifically tells us anything clinically,” he added.
The study was supported by the LIBD, the BrainSeq Consortium, an National Institutes of Health fellowship to two of the authors, and a NARSAD Young Investigator Grant from the Brain & Behavior Research Foundation to one of the authors. Dr. Weinberger has reported no relevant financial relationships. Dr. El-Mallakh declared no specific financial relationships relevant to the study but has reported being a speaker for several companies that manufacture antipsychotics.
A version of this article first appeared on Medscape.com.
Investigators identified a mechanism on the dopamine receptor, known as the autoreceptor, which regulates how much dopamine is released from the presynaptic neuron. Impairment of this autoreceptor leads to poorly controlled dopamine release and excessive dopamine flow.
The researchers found decreased expression of this autoreceptor accounts for the genetic evidence of schizophrenia risk, and, using a suite of statistical routines, they showed that this relationship is probably causative.
“Our research confirms the scientific hypothesis that too much dopamine plays a likely causative role in psychosis and precisely how this is based on genetic factors,” study investigator Daniel Weinberger, MD, director and CEO of the Lieber Institute for Brain Development, Baltimore, told this news organization.
“Drugs that treat psychosis symptoms by simply blocking dopamine receptors have harsh side effects. ... Theoretically, scientists could now develop therapies that target these malfunctioning autoreceptors to treat this devastating condition with fewer side effects,” he said.
The study was published online in Nature Neuroscience.
‘Privileged spot’
“Large international genetic studies known as genomewide association studies have identified hundreds of regions of the human genome housing potential risk genes for schizophrenia,” Dr. Weinberger said.
“However, these regions are still poorly resolved in terms of specific genes, and treatments and diagnostic techniques are far from what they should be.” Moreover, “treatments for schizophrenia address the symptoms of psychosis but not the cause,” he said.
“For more than 70 years, neuroscientists have suspected that dopamine plays a key role in schizophrenia, but what kind of role, exactly, has remained a mystery,” Dr. Weinberger noted. “It occupied a privileged spot in the principal hypothesis about schizophrenia for over 60 years – the so-called ‘dopamine hypothesis.’ ”
Antipsychotic drugs that reduce dopamine “are the principal medical treatments but they cause serious side effects, including an inability to experience pleasure and joy – a sad reality for patients and their families,” he continued.
The current study “set out to understand how dopamine acts in schizophrenia” using “analysis of the genetic and transcriptional landscape” of the postmortem caudate nucleus from 443 donors (245 neurotypical, 154 with schizophrenia, and 44 with bipolar disorder).
Brain samples were from individuals of diverse ancestry (210 were of African ancestry and 2,233 were of European ancestry).
New treatment target?
The researchers performed an analysis of transancestry expression quantitative trait loci, genetic variants that explain variations in gene expression levels, which express in the caudate, annotating “hundreds of caudate-specific cis-eQTLs.”
Then they integrated this analysis with gene expression that emerged from the latest genomewide association study and transcriptome-wide association study, identifying hundreds of genes that “showed a potential causal association with schizophrenia risk in the caudate nucleus,” including a specific isoform of the dopamine D2 receptor, which is upregulated in the caudate nucleus of those with schizophrenia.
“If autoreceptors don’t function properly the flow of dopamine in the brain is poorly controlled and too much dopamine flows for too long,” said Dr. Weinberger.
In particular, they observed “extensive differential gene expression” for schizophrenia in 2,701 genes in those with schizophrenia, compared with those without: glial cell–derived neurotrophic factor antisense RNA was a top-up gene and tyrosine hydroxylase, which is a rate-limiting enzyme in dopamine synthesis, was a down-regulated gene. Dopamine receptors DRD2 and DRD3 were differentially expressed.
Having done this, they looked at the effects of antipsychotic medications that target D2 regions on gene expression in the caudate by testing for differences between individuals with schizophrenia who were taking antipsychotics at the time of death, those not taking antipsychotics at the time of death (n = 104 and 49, respectively), and neurotypical individuals (n = 239).
There were 2,692 differentially expressed genes between individuals taking antipsychotics versus neurotypical individuals (false discovery rate < 0.05). By contrast, there were only 665 differentially expressed genes (FDR < .05) between those not taking antipsychotics and neurotypical individuals.
“We found that antipsychotic medication has an extensive influence on caudate gene expression,” the investigators noted.
They then developed a new approach to “infer gene networks from expression data.” This method is based on deep neural networks, obtaining a “low-dimensional representation of each gene’s expression across individuals.” The representation is then used to build a “gene neighborhood graph and assign genes to modules.”
This method identified “several modules enriched for genes associated with schizophrenia risk.” The expression representations captured in this approach placed genes in “biologically meaningful neighborhoods, which can provide insight into potential interactions if these genes are targeted for therapeutic intervention,” the authors summarized.
“Now that our new research has identified the specific mechanism by which dopamine plays a causative role in schizophrenia, we hope we have opened the door for more targeted drugs or diagnostic tests that could make life better for patients and their families,” Dr. Weinberger said.
No causal link?
Commenting on the study, Rifaat El-Mallakh, MD, director of the mood disorders research program, department of psychiatry and behavioral sciences, University of Louisville (Ky.), called it an “excellent study performed by an excellent research group” that “fills an important lacuna in our research database.”
However, Dr. El-Mallakh, who was not involved in the research, disagreed that the findings show causality. “The data that can be gleaned from this study is limited and the design has significant limitations. As with all genetic studies, this is an association study. It tells us nothing about the cause-effect relationship between the genes and the illness.
“We do not know why genes are associated with the illness. Genetic overrepresentation can have multiple causes, and more so when the data is a convenience sample. As noted by the authors, much of what they observed was probably related to medication effect. I don’t think this study specifically tells us anything clinically,” he added.
The study was supported by the LIBD, the BrainSeq Consortium, an National Institutes of Health fellowship to two of the authors, and a NARSAD Young Investigator Grant from the Brain & Behavior Research Foundation to one of the authors. Dr. Weinberger has reported no relevant financial relationships. Dr. El-Mallakh declared no specific financial relationships relevant to the study but has reported being a speaker for several companies that manufacture antipsychotics.
A version of this article first appeared on Medscape.com.
FROM NATURE NEUROSCIENCE
Current alopecia areata options include old and new therapies
LAS VEGAS – in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
“Some patients don’t have alopecia, but they have been managed for it,” he said. “Whenever there is an ounce of doubt, take a biopsy,” he advised.
Assessing disease severity in patients with alopecia areata (AA) is especially important as new therapies become available, said Dr. King, associate professor of dermatology at Yale University, New Haven, Conn. The Severity of Alopecia Tool (SALT) Score has been available since 2004, and remains a useful tool to estimate percent hair loss. The SALT Score divides the scalp into four sections: 18% each for the right and left sides, 40% for the top of the head, and 24% for the back of the head, said Dr. King. However, the SALT Score can be enhanced or modified based on a holistic approach to disease severity that categorizes alopecia as mild (scalp hair loss of 20% or less), moderate (scalp hair loss of 21 to 49%), or severe (scalp hair loss of 50% or more).
For example, if a patient’s hair loss based on SALT Score is mild or moderate, increase the severity by 1 level (from mild to moderate, or moderate to severe) if any of the following conditions apply: Noticeable eyebrow or eyelash involvement, inadequate treatment response after 6 months, diffuse positive hair pull test consistent with rapid progression of AA, or a negative impact on psychosocial functioning because of AA, he said.
Treatment advances
Understanding of the pathogenesis of AA has been slow to evolve, Dr. King noted. “We haven’t been able to shake this concept that people are causing the disease by being depressed,” as noted in the literature from the 1950s.
In 2014, breakthrough research changed the game by identifying the roles of interferon gamma and interleukin 15, Dr. King said. Since then, more research has been conducted on Janus kinase (JAK) inhibitors for AA. Dr. King was a coinvestigator on a 2014 case report in which a patient with psoriasis and alopecia universalis experienced regrowth of most of his body hair after 8 months of daily oral tofacitinib, a JAK inhibitor.
However, despite the dramatic results in some patients, “tofacitinib doesn’t always work,” said Dr. King. In his experience, patients for whom tofacitinib didn’t work were those with complete or nearly complete scalp hair loss for more than 10 years.
Approval of baricitinib
Dr. King’s recent work supported the approval in June 2022 of oral baricitinib, a JAK inhibitor, for AA. He reviewed data from his late-breaker abstract presented at the annual meeting of the American Academy of Dermatology in March 2022, where he reported that almost 40% of adults with AA treated with 4 mg of baricitinib daily had significant hair regrowth over 52 weeks.
Two other oral JAK inhibitors in the pipeline for AA are deuruxolitinib and ritlecitinib, which significantly increased the proportion of patients achieving SALT scores of 20 or less, compared with patients on placebo in early clinical trials. Data on both were presented at the annual meeting of the European Academy of Dermatology and Venereology.
So far, topical JAK inhibitors have not shown success in hair regrowth for AA patients, said Dr. King. Phase 2 studies of both ruxolitinib 1.5% cream and delgocitinib ointment were ineffective for AA.
Emerging role for oral minoxidil
Oral minoxidil has had a recent resurgence as an adjunct therapy to the new JAK inhibitors. A study published in 1987 found that, with oral minoxidil monotherapy, a cosmetic response was seen in 18% of patients with AA, Dr. King said.
In a study published in the Journal of the American Academy of Dermatology, Dr. King and colleagues noted that dose escalation is sometimes needed for effective treatment of AA with tofacitinib. They examined the effect of adding oral minoxidil to tofacitinib in patients with severe AA as a way to increase efficacy without increasing tofacitinib dosage. They reviewed data from 12 patients ages 18-51 years who were prescribed 5 mg of tofacitinib twice daily, plus 2.5 mg oral minoxidil daily for women and 2.5 mg of minoxidil twice daily for men; women received a lower dose to minimize the side effect of hypertrichosis.
After 6 months, 67% (eight patients) achieved at least 75% hair regrowth; of those eight patients, seven (58% of the total) had hair regrowth on a twice-daily dose of 5 mg tofacitinib with no need for dose escalation, Dr. King said.
More research is needed, but oral minoxidil may be a useful adjunct treatment for some patients with AA, he added.
During a question and answer session, Dr. King was asked to elaborate on the mechanism of minoxidil in combination with JAK inhibitors. “The truth is that I just don’t know” why the combination works for some patients. However, the majority of patients who succeed with this combination regrow hair by 4 months. “There is something special about that combination.”
Dr. King disclosed serving as a consultant or adviser for AbbVie, AltruBio, Almirall, AnaptysBio, Arena Pharmaceuticals, Bioniz, Bristol Myers Squibb, Concert Pharmaceuticals, Horizon, Incyte, Leo Pharma, Eli Lilly, Otsuka, Pfizer, Regeneron, Sanofi Genzyme, Twi Biotechnology, Viela Bio, and Visterra; serving as a speaker or as a member of the speakers bureau for Incyte, Pfizer, Regeneron, Sanofi Genzyme; and receiving research funding from Concert Pharmaceuticals, Eli Lilly, and Pfizer.
MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
“Some patients don’t have alopecia, but they have been managed for it,” he said. “Whenever there is an ounce of doubt, take a biopsy,” he advised.
Assessing disease severity in patients with alopecia areata (AA) is especially important as new therapies become available, said Dr. King, associate professor of dermatology at Yale University, New Haven, Conn. The Severity of Alopecia Tool (SALT) Score has been available since 2004, and remains a useful tool to estimate percent hair loss. The SALT Score divides the scalp into four sections: 18% each for the right and left sides, 40% for the top of the head, and 24% for the back of the head, said Dr. King. However, the SALT Score can be enhanced or modified based on a holistic approach to disease severity that categorizes alopecia as mild (scalp hair loss of 20% or less), moderate (scalp hair loss of 21 to 49%), or severe (scalp hair loss of 50% or more).
For example, if a patient’s hair loss based on SALT Score is mild or moderate, increase the severity by 1 level (from mild to moderate, or moderate to severe) if any of the following conditions apply: Noticeable eyebrow or eyelash involvement, inadequate treatment response after 6 months, diffuse positive hair pull test consistent with rapid progression of AA, or a negative impact on psychosocial functioning because of AA, he said.
Treatment advances
Understanding of the pathogenesis of AA has been slow to evolve, Dr. King noted. “We haven’t been able to shake this concept that people are causing the disease by being depressed,” as noted in the literature from the 1950s.
In 2014, breakthrough research changed the game by identifying the roles of interferon gamma and interleukin 15, Dr. King said. Since then, more research has been conducted on Janus kinase (JAK) inhibitors for AA. Dr. King was a coinvestigator on a 2014 case report in which a patient with psoriasis and alopecia universalis experienced regrowth of most of his body hair after 8 months of daily oral tofacitinib, a JAK inhibitor.
However, despite the dramatic results in some patients, “tofacitinib doesn’t always work,” said Dr. King. In his experience, patients for whom tofacitinib didn’t work were those with complete or nearly complete scalp hair loss for more than 10 years.
Approval of baricitinib
Dr. King’s recent work supported the approval in June 2022 of oral baricitinib, a JAK inhibitor, for AA. He reviewed data from his late-breaker abstract presented at the annual meeting of the American Academy of Dermatology in March 2022, where he reported that almost 40% of adults with AA treated with 4 mg of baricitinib daily had significant hair regrowth over 52 weeks.
Two other oral JAK inhibitors in the pipeline for AA are deuruxolitinib and ritlecitinib, which significantly increased the proportion of patients achieving SALT scores of 20 or less, compared with patients on placebo in early clinical trials. Data on both were presented at the annual meeting of the European Academy of Dermatology and Venereology.
So far, topical JAK inhibitors have not shown success in hair regrowth for AA patients, said Dr. King. Phase 2 studies of both ruxolitinib 1.5% cream and delgocitinib ointment were ineffective for AA.
Emerging role for oral minoxidil
Oral minoxidil has had a recent resurgence as an adjunct therapy to the new JAK inhibitors. A study published in 1987 found that, with oral minoxidil monotherapy, a cosmetic response was seen in 18% of patients with AA, Dr. King said.
In a study published in the Journal of the American Academy of Dermatology, Dr. King and colleagues noted that dose escalation is sometimes needed for effective treatment of AA with tofacitinib. They examined the effect of adding oral minoxidil to tofacitinib in patients with severe AA as a way to increase efficacy without increasing tofacitinib dosage. They reviewed data from 12 patients ages 18-51 years who were prescribed 5 mg of tofacitinib twice daily, plus 2.5 mg oral minoxidil daily for women and 2.5 mg of minoxidil twice daily for men; women received a lower dose to minimize the side effect of hypertrichosis.
After 6 months, 67% (eight patients) achieved at least 75% hair regrowth; of those eight patients, seven (58% of the total) had hair regrowth on a twice-daily dose of 5 mg tofacitinib with no need for dose escalation, Dr. King said.
More research is needed, but oral minoxidil may be a useful adjunct treatment for some patients with AA, he added.
During a question and answer session, Dr. King was asked to elaborate on the mechanism of minoxidil in combination with JAK inhibitors. “The truth is that I just don’t know” why the combination works for some patients. However, the majority of patients who succeed with this combination regrow hair by 4 months. “There is something special about that combination.”
Dr. King disclosed serving as a consultant or adviser for AbbVie, AltruBio, Almirall, AnaptysBio, Arena Pharmaceuticals, Bioniz, Bristol Myers Squibb, Concert Pharmaceuticals, Horizon, Incyte, Leo Pharma, Eli Lilly, Otsuka, Pfizer, Regeneron, Sanofi Genzyme, Twi Biotechnology, Viela Bio, and Visterra; serving as a speaker or as a member of the speakers bureau for Incyte, Pfizer, Regeneron, Sanofi Genzyme; and receiving research funding from Concert Pharmaceuticals, Eli Lilly, and Pfizer.
MedscapeLive and this news organization are owned by the same parent company.
LAS VEGAS – in a presentation at MedscapeLive’s annual Las Vegas Dermatology Seminar.
“Some patients don’t have alopecia, but they have been managed for it,” he said. “Whenever there is an ounce of doubt, take a biopsy,” he advised.
Assessing disease severity in patients with alopecia areata (AA) is especially important as new therapies become available, said Dr. King, associate professor of dermatology at Yale University, New Haven, Conn. The Severity of Alopecia Tool (SALT) Score has been available since 2004, and remains a useful tool to estimate percent hair loss. The SALT Score divides the scalp into four sections: 18% each for the right and left sides, 40% for the top of the head, and 24% for the back of the head, said Dr. King. However, the SALT Score can be enhanced or modified based on a holistic approach to disease severity that categorizes alopecia as mild (scalp hair loss of 20% or less), moderate (scalp hair loss of 21 to 49%), or severe (scalp hair loss of 50% or more).
For example, if a patient’s hair loss based on SALT Score is mild or moderate, increase the severity by 1 level (from mild to moderate, or moderate to severe) if any of the following conditions apply: Noticeable eyebrow or eyelash involvement, inadequate treatment response after 6 months, diffuse positive hair pull test consistent with rapid progression of AA, or a negative impact on psychosocial functioning because of AA, he said.
Treatment advances
Understanding of the pathogenesis of AA has been slow to evolve, Dr. King noted. “We haven’t been able to shake this concept that people are causing the disease by being depressed,” as noted in the literature from the 1950s.
In 2014, breakthrough research changed the game by identifying the roles of interferon gamma and interleukin 15, Dr. King said. Since then, more research has been conducted on Janus kinase (JAK) inhibitors for AA. Dr. King was a coinvestigator on a 2014 case report in which a patient with psoriasis and alopecia universalis experienced regrowth of most of his body hair after 8 months of daily oral tofacitinib, a JAK inhibitor.
However, despite the dramatic results in some patients, “tofacitinib doesn’t always work,” said Dr. King. In his experience, patients for whom tofacitinib didn’t work were those with complete or nearly complete scalp hair loss for more than 10 years.
Approval of baricitinib
Dr. King’s recent work supported the approval in June 2022 of oral baricitinib, a JAK inhibitor, for AA. He reviewed data from his late-breaker abstract presented at the annual meeting of the American Academy of Dermatology in March 2022, where he reported that almost 40% of adults with AA treated with 4 mg of baricitinib daily had significant hair regrowth over 52 weeks.
Two other oral JAK inhibitors in the pipeline for AA are deuruxolitinib and ritlecitinib, which significantly increased the proportion of patients achieving SALT scores of 20 or less, compared with patients on placebo in early clinical trials. Data on both were presented at the annual meeting of the European Academy of Dermatology and Venereology.
So far, topical JAK inhibitors have not shown success in hair regrowth for AA patients, said Dr. King. Phase 2 studies of both ruxolitinib 1.5% cream and delgocitinib ointment were ineffective for AA.
Emerging role for oral minoxidil
Oral minoxidil has had a recent resurgence as an adjunct therapy to the new JAK inhibitors. A study published in 1987 found that, with oral minoxidil monotherapy, a cosmetic response was seen in 18% of patients with AA, Dr. King said.
In a study published in the Journal of the American Academy of Dermatology, Dr. King and colleagues noted that dose escalation is sometimes needed for effective treatment of AA with tofacitinib. They examined the effect of adding oral minoxidil to tofacitinib in patients with severe AA as a way to increase efficacy without increasing tofacitinib dosage. They reviewed data from 12 patients ages 18-51 years who were prescribed 5 mg of tofacitinib twice daily, plus 2.5 mg oral minoxidil daily for women and 2.5 mg of minoxidil twice daily for men; women received a lower dose to minimize the side effect of hypertrichosis.
After 6 months, 67% (eight patients) achieved at least 75% hair regrowth; of those eight patients, seven (58% of the total) had hair regrowth on a twice-daily dose of 5 mg tofacitinib with no need for dose escalation, Dr. King said.
More research is needed, but oral minoxidil may be a useful adjunct treatment for some patients with AA, he added.
During a question and answer session, Dr. King was asked to elaborate on the mechanism of minoxidil in combination with JAK inhibitors. “The truth is that I just don’t know” why the combination works for some patients. However, the majority of patients who succeed with this combination regrow hair by 4 months. “There is something special about that combination.”
Dr. King disclosed serving as a consultant or adviser for AbbVie, AltruBio, Almirall, AnaptysBio, Arena Pharmaceuticals, Bioniz, Bristol Myers Squibb, Concert Pharmaceuticals, Horizon, Incyte, Leo Pharma, Eli Lilly, Otsuka, Pfizer, Regeneron, Sanofi Genzyme, Twi Biotechnology, Viela Bio, and Visterra; serving as a speaker or as a member of the speakers bureau for Incyte, Pfizer, Regeneron, Sanofi Genzyme; and receiving research funding from Concert Pharmaceuticals, Eli Lilly, and Pfizer.
MedscapeLive and this news organization are owned by the same parent company.
AT INNOVATIONS IN DERMATOLOGY
Paxlovid has been free so far. Next year, sticker shock awaits
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID.
And that means fewer people will get the potentially lifesaving treatments, experts said.
“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.
In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.
But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”
Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.
Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.
Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.
“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.
In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.
Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.
People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.
About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.
States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.
“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.
People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.
Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.
And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.
One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.
HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.
Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.
HHS did not make officials available for an interview or answer written questions about the commercialization plans.
The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.
Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.
“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”
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.
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID.
And that means fewer people will get the potentially lifesaving treatments, experts said.
“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.
In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.
But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”
Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.
Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.
Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.
“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.
In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.
Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.
People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.
About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.
States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.
“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.
People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.
Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.
And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.
One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.
HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.
Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.
HHS did not make officials available for an interview or answer written questions about the commercialization plans.
The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.
Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.
“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”
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.
Nearly 6 million Americans have taken Paxlovid for free, courtesy of the federal government. The Pfizer pill has helped prevent many people infected with COVID-19 from being hospitalized or dying, and it may even reduce the risk of developing long COVID.
And that means fewer people will get the potentially lifesaving treatments, experts said.
“I think the numbers will go way down,” said Jill Rosenthal, director of public health policy at the Center for American Progress, a left-leaning think tank. A bill for several hundred dollars or more would lead many people to decide the medication isn’t worth the price, she said.
In response to the unprecedented public health crisis caused by COVID, the federal government spent billions of dollars on developing new vaccines and treatments, to swift success: Less than a year after the pandemic was declared, medical workers got their first vaccines. But as many people have refused the shots and stopped wearing masks, the virus still rages and mutates. In 2022 alone, 250,000 Americans have died from COVID, more than from strokes or diabetes.
But soon the Department of Health & Human Services will stop supplying COVID treatments, and pharmacies will purchase and bill for them the same way they do for antibiotic pills or asthma inhalers. Paxlovid is expected to hit the private market in mid-2023, according to HHS plans shared in an October meeting with state health officials and clinicians. Merck’s Lagevrio, a less-effective COVID treatment pill, and AstraZeneca’s Evusheld, a preventive therapy for the immunocompromised, are on track to be commercialized sooner, sometime in the winter.
The U.S. government has so far purchased 20 million courses of Paxlovid, priced at about $530 each, a discount for buying in bulk that Pfizer CEO Albert Bourla called “really very attractive” to the federal government in a July earnings call. The drug will cost far more on the private market, although in a statement to Kaiser Health News, Pfizer declined to share the planned price. The government will also stop paying for the company’s COVID vaccine next year – those shots will quadruple in price, from the discount rate the government pays of $30 to about $120.
Mr. Bourla told investors in November that he expects the move will make Paxlovid and its COVID vaccine “a multibillion-dollars franchise.”
Nearly 9 in 10 people dying from the virus now are 65 or older. Yet federal law restricts Medicare Part D – the prescription drug program that covers nearly 50 million seniors – from covering the COVID treatment pills. The medications are meant for those most at risk of serious illness, including seniors.
Paxlovid and the other treatments are currently available under an emergency use authorization from the FDA, a fast-track review used in extraordinary situations. Although Pfizer applied for full approval in June, the process can take anywhere from several months to years. And Medicare Part D can’t cover any medications without that full stamp of approval.
Paying out-of-pocket would be “a substantial barrier” for seniors on Medicare – the very people who would benefit most from the drug, wrote federal health experts.
“From a public health perspective, and even from a health care capacity and cost perspective, it would just defy reason to not continue to make these drugs readily available,” said Dr. Larry Madoff, medical director of Massachusetts’s Bureau of Infectious Disease and Laboratory Sciences. He’s hopeful that the federal health agency will find a way to set aside unused doses for seniors and people without insurance.
In mid-November, the White House requested that Congress approve an additional $2.5 billion for COVID therapeutics and vaccines to make sure people can afford the medications when they’re no longer free. But there’s little hope it will be approved – the Senate voted that same day to end the public health emergency and denied similar requests in recent months.
Many Americans have already faced hurdles just getting a prescription for COVID treatment. Although the federal government doesn’t track who’s gotten the drug, a Centers for Disease Control and Prevention study using data from 30 medical centers found that Black and Hispanic patients with COVID were much less likely to receive Paxlovid than White patients. (Hispanic people can be of any race or combination of races.) And when the government is no longer picking up the tab, experts predict that these gaps by race, income, and geography will widen.
People in Northeastern states used the drug far more often than those in the rest of the country, according to a KHN analysis of Paxlovid use in September and October. But it wasn’t because people in the region were getting sick from COVID at much higher rates – instead, many of those states offered better access to health care to begin with and created special programs to get Paxlovid to their residents.
About 10 mostly Democratic states and several large counties in the Northeast and elsewhere created free “test-to-treat” programs that allow their residents to get an immediate doctor visit and prescription for treatment after testing positive for COVID. In Massachusetts, more than 20,000 residents have used the state’s video and phone hotline, which is available 7 days a week in 13 languages. Massachusetts, which has the highest insurance rate in the country and relatively low travel times to pharmacies, had the second-highest Paxlovid usage rate among states this fall.
States with higher COVID death rates, like Florida and Kentucky, where residents must travel farther for health care and are more likely to be uninsured, used the drug less often. Without no-cost test-to-treat options, residents have struggled to get prescriptions even though the drug itself is still free.
“If you look at access to medications for people who are uninsured, I think that there’s no question that will widen those disparities,” Ms. Rosenthal said.
People who get insurance through their jobs could face high copays at the register, too, just as they do for insulin and other expensive or brand-name drugs.
Most private insurance companies will end up covering COVID therapeutics to some extent, said Sabrina Corlette, a research professor at Georgetown University’s Center on Health Insurance Reforms. After all, the pills are cheaper than a hospital stay. But for most people who get insurance through their jobs, there are “really no rules at all,” she said. Some insurers could take months to add the drugs to their plans or decide not to pay for them.
And the additional cost means many people will go without the medication. “We know from lots of research that when people face cost sharing for these drugs that they need to take, they will often forgo or cut back,” Ms. Corlette said.
One group doesn’t need to worry about sticker shock. Medicaid, the public insurance program for low-income adults and children, will cover the treatments in full until at least early 2024.
HHS officials could set aside any leftover taxpayer-funded medication for people who can’t afford to pay the full cost, but they haven’t shared any concrete plans to do so. The government purchased 20 million courses of Paxlovid and 3 million of Lagevrio. Fewer than a third have been used, and usage has fallen in recent months, according to KHN’s analysis of the data from HHS.
Sixty percent of the government’s supply of Evusheld is also still available, although the COVID prevention therapy is less effective against new strains of the virus. The health department in one state, New Mexico, has recommended against using it.
HHS did not make officials available for an interview or answer written questions about the commercialization plans.
The government created a potential workaround when they moved bebtelovimab, another COVID treatment, to the private market this summer. It now retails for $2,100 per patient. The agency set aside the remaining 60,000 government-purchased doses that hospitals could use to treat uninsured patients in a convoluted dose-replacement process. But it’s hard to tell how well that setup would work for Paxlovid: Bebtelovimab was already much less popular, and the FDA halted its use on Nov. 30 because it’s less effective against current strains of the virus.
Federal officials and insurance companies would have good reason to make sure patients can continue to afford COVID drugs: They’re far cheaper than if patients land in the emergency room.
“The medications are so worthwhile,” said Dr. Madoff, the Massachusetts health official. “They’re not expensive in the grand scheme of health care costs.”
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.
Mind the geriatrician gap
These should be the best of times for geriatric medicine.
The baby boom has become a senior surge, bringing in a rapidly growing pool of aging patients for geriatricians to treat. According to the U.S. Census Bureau, more than 56 million adults aged 65 and older live in the United States. They account for about 17% of the nation’s population. That number is expected to hit 73 million by 2030 and 86 million by 2050.
The American Geriatrics Society estimates that 30% of older people require the attention of geriatricians. These clinicians excel in managing complex cases – patients with multiple comorbidities, such as coronary artery disease, dementia, and osteoporosis, who are taking a half dozen, and often more, medications.
. In the 2010s, geriatricians called for “25,000 [such specialists] by 2025.” As of 2021, 7123 certified geriatricians were practicing in the United States, according to the American Board of Medical Specialties.
The Health Resources and Services Administration, a federal agency that addresses medical workforce shortages, estimates that there will be 6,230 geriatricians by 2025, or approximately 1 for every 3,000 older adults requiring geriatric care. HRSA projects a shortage of 27,000 geriatricians by 2025.
The specialty has faced an uphill battle to attract fellows. This year, only 43% of the nation’s 177 geriatrics fellowship slots were filled, according to November’s National Resident Match Program report. Family medicine–based geriatrics achieved only a 32% fill rate, while internal medicine–based programs saw a rate of 45%.
“Our numbers are shrinking so we need another approach to make sure older adults get the care they need and deserve,” said G. Michael Harper, MD, president of the 6,000-member AGS.
But Dr. Harper, who practices at the University of California, San Francisco, and the San Francisco VA Medical Center, added a positive note: “We may be struggling to increase the number of board-certified geriatricians, but the field itself has made a lot of progress in terms of improving clinical care through advancements in science and in the ways we deliver care.”
Dr. Harper cited the Hospital Elder Life Program, a hospital model developed at the Harvard-affiliated Marcus Institute for Aging Research, which uses an interprofessional team and trained volunteers to prevent delirium and functional decline. HELP has been adopted by more than 200 hospitals worldwide and has been successful at returning older adults to their homes or previous living situations with maintained or improved ability to function, he said.
Mark Supiano, MD, professor and chief of geriatrics at the University of Utah, Salt Lake City, said the specialty has been in shortage mode since ABMS recognized it in 1988. He was in the initial cohort of fellowship-trained geriatricians, sitting for the first certifying exam in geriatrics offered that year.
“Back then, the demographic imperative of the aging of our society was on the horizon. We’re living it now. I knew enough to recognize it was coming and saw an opportunity,” Dr. Supiano said in an interview. “There was so much then that we didn’t know about how to understand aging or how to care for older adults that there really was such a knowledge gap.”
Dr. Supiano is an associate editor of Hazzard’s Geriatric Medicine and Gerontology (McGraw-Hill Education), which has more than doubled in pages and word count during his career.
Unfavorable finances
Katherine Thompson, MD, director of the geriatrics fellowship program at the University of Chicago and codirector of UChicago’s Successful Aging and Frailty Evaluation Clinic, said money is a major reason for the struggle. “I think probably the biggest driver is financial,” she said. “A lot of people are graduating medical school with really astronomical amounts of medical school loans.”
Geriatricians, like other doctors, carry a large debt – $200,000, on average, not counting undergraduate debt, according to the Association of American Medical Colleges.
But the typical geriatrician earns less than an internist or family medicine doctor who doesn’t undergo the additional year of training, Dr. Thompson said. “There’s not a lot of financial motivation to do this fellowship,” she said.
The jobs website Zippia reports that geriatricians earned roughly $165,000 per year on average in 2022. The average annual incomes in 2022 were $191,000 for pediatricians, $215,000 for family physicians, and $223,000 for internists, according to the site.
In other words, Dr. Harper said, “geriatrics is one of the few professions where you can actually do additional training and make less money.”
The reason for the pay issue is simple: Geriatricians treat patients covered by Medicare, whose reimbursement schedules lag behind those of commercial insurers. The Kaiser Family Foundation reported in 2020 that private insurance paid 143% of Medicare rates on average for physician services.
Dr. Harper said overall compensation for geriatricians has “not gained a lot of traction,” but they can earn comfortable livings.
Still, representation of the specialty on the American Medical Association’s Relative Value Scale Update Committee has led to approval by the Centers for Medicare & Medicaid Services of billing codes that pay geriatricians “for what they do. Examples include chronic care management, advance care planning, and dementia evaluation,” he said.
But the geriatrician gap goes beyond money.
Ageism, too, may play a role in residents not choosing geriatrics.
“Our culture is ageist. It definitely focuses on youth and looks at aging as being loss rather than just a change in what works well and what doesn’t work well,” said Mary Tinetti, MD, a geriatrician and researcher at Yale University, New Haven, Conn. “Ageism happens among physicians, just because they’re part of the broader society.”
Time for a new goal?
Dr. Tinetti said she’s optimistic that new ideas about geriatricians teaching other primary care clinicians about the tenets of geriatric medicine, which offer a wholistic approach to comorbidities, such as diabetes, atrial fibrillation, dementia, hypertension, hyperlipidemia, and polypharmacy problems faced by this population, especially those 85 and older.
She has called on her profession to abandon the goal of increasing the numbers of board-certified geriatricians – whom she refers to as big “G” geriatricians. She instead wants to develop a “small, elite workforce” that discovers and tests geriatrics principles through research, teaches these principles to all healthcare professions and to the public, and disseminates and implements the policies.
“We need a cadre of geriatricians who train all other clinicians in the care of older adults,” Dr. Tinetti said. “The goal is not more geriatricians but rather the preparation of all clinicians in the care of older adults.”
Dr. Thompson said geriatricians are teaching primary care specialists, nurses, social workers, and other health care providers the principles of age-friendly care. AGS has for the past 20 years led a program called the Geriatrics for Specialists Initiative to increase geriatrics knowledge and expertise of surgical and medical specialists.
Some specialties have taken the cue and have added geriatrics-related hyphens through additional training: geriatric-emergency, geriatric-general surgery, geriatric-hospitalists, and more.
HRSA runs programs to encourage physicians to train as geriatricians and geriatrics faculty, and it encourages the geriatrics interdisciplinary team approach.
Richard Olague, director of public affairs for HRSA, said his agency has invested over $160 million over the past 4 years in the education and training of geriatricians and other health care professionals who care for the elderly through its Geriatrics Workforce Enhancement Program and Geriatrics Academic Career Awards Program. In the academic year 2020-2021, the two programs trained 109 geriatricians; 456 other geriatric/gerontology providers and students; 44,450 other healthcare workforce professionals and students; and served 17,666 patients and 5,409 caregivers.
Dr. Harper, like his fellow geriatricians, tells young doctors that geriatrics is a fulfilling specialty.
“I get to care for the whole person and sometimes their families, too, and in the process form rich and meaningful relationships. And while I’m rarely in the position to cure, I always have the ability to care,” he said. “Sometimes that can mean being an advocate trying to make sure my patients receive the care they need, and other times it might mean protecting them from burdensome care that is unlikely to lead to any meaningful benefit. There is great reward in all of that.”
Dr. Supiano said geriatric patients are being helped by the Age-Friendly Health System initiative of the John A. Hartford Foundation and the Institute for Healthcare Improvement in partnership with the American Hospital Association and the Catholic Health Association of the United States. This is sort of a seal of approval for facilities committed to age-friendly care.
“When you go to your hospital, if they don’t have this age-friendly health system banner on the front door ... you either ask why that is not there, or you vote with your feet and go to another health system that is age friendly,” he said. “Geriatricians are eternal optimists.”
A version of this article first appeared on Medscape.com.
These should be the best of times for geriatric medicine.
The baby boom has become a senior surge, bringing in a rapidly growing pool of aging patients for geriatricians to treat. According to the U.S. Census Bureau, more than 56 million adults aged 65 and older live in the United States. They account for about 17% of the nation’s population. That number is expected to hit 73 million by 2030 and 86 million by 2050.
The American Geriatrics Society estimates that 30% of older people require the attention of geriatricians. These clinicians excel in managing complex cases – patients with multiple comorbidities, such as coronary artery disease, dementia, and osteoporosis, who are taking a half dozen, and often more, medications.
. In the 2010s, geriatricians called for “25,000 [such specialists] by 2025.” As of 2021, 7123 certified geriatricians were practicing in the United States, according to the American Board of Medical Specialties.
The Health Resources and Services Administration, a federal agency that addresses medical workforce shortages, estimates that there will be 6,230 geriatricians by 2025, or approximately 1 for every 3,000 older adults requiring geriatric care. HRSA projects a shortage of 27,000 geriatricians by 2025.
The specialty has faced an uphill battle to attract fellows. This year, only 43% of the nation’s 177 geriatrics fellowship slots were filled, according to November’s National Resident Match Program report. Family medicine–based geriatrics achieved only a 32% fill rate, while internal medicine–based programs saw a rate of 45%.
“Our numbers are shrinking so we need another approach to make sure older adults get the care they need and deserve,” said G. Michael Harper, MD, president of the 6,000-member AGS.
But Dr. Harper, who practices at the University of California, San Francisco, and the San Francisco VA Medical Center, added a positive note: “We may be struggling to increase the number of board-certified geriatricians, but the field itself has made a lot of progress in terms of improving clinical care through advancements in science and in the ways we deliver care.”
Dr. Harper cited the Hospital Elder Life Program, a hospital model developed at the Harvard-affiliated Marcus Institute for Aging Research, which uses an interprofessional team and trained volunteers to prevent delirium and functional decline. HELP has been adopted by more than 200 hospitals worldwide and has been successful at returning older adults to their homes or previous living situations with maintained or improved ability to function, he said.
Mark Supiano, MD, professor and chief of geriatrics at the University of Utah, Salt Lake City, said the specialty has been in shortage mode since ABMS recognized it in 1988. He was in the initial cohort of fellowship-trained geriatricians, sitting for the first certifying exam in geriatrics offered that year.
“Back then, the demographic imperative of the aging of our society was on the horizon. We’re living it now. I knew enough to recognize it was coming and saw an opportunity,” Dr. Supiano said in an interview. “There was so much then that we didn’t know about how to understand aging or how to care for older adults that there really was such a knowledge gap.”
Dr. Supiano is an associate editor of Hazzard’s Geriatric Medicine and Gerontology (McGraw-Hill Education), which has more than doubled in pages and word count during his career.
Unfavorable finances
Katherine Thompson, MD, director of the geriatrics fellowship program at the University of Chicago and codirector of UChicago’s Successful Aging and Frailty Evaluation Clinic, said money is a major reason for the struggle. “I think probably the biggest driver is financial,” she said. “A lot of people are graduating medical school with really astronomical amounts of medical school loans.”
Geriatricians, like other doctors, carry a large debt – $200,000, on average, not counting undergraduate debt, according to the Association of American Medical Colleges.
But the typical geriatrician earns less than an internist or family medicine doctor who doesn’t undergo the additional year of training, Dr. Thompson said. “There’s not a lot of financial motivation to do this fellowship,” she said.
The jobs website Zippia reports that geriatricians earned roughly $165,000 per year on average in 2022. The average annual incomes in 2022 were $191,000 for pediatricians, $215,000 for family physicians, and $223,000 for internists, according to the site.
In other words, Dr. Harper said, “geriatrics is one of the few professions where you can actually do additional training and make less money.”
The reason for the pay issue is simple: Geriatricians treat patients covered by Medicare, whose reimbursement schedules lag behind those of commercial insurers. The Kaiser Family Foundation reported in 2020 that private insurance paid 143% of Medicare rates on average for physician services.
Dr. Harper said overall compensation for geriatricians has “not gained a lot of traction,” but they can earn comfortable livings.
Still, representation of the specialty on the American Medical Association’s Relative Value Scale Update Committee has led to approval by the Centers for Medicare & Medicaid Services of billing codes that pay geriatricians “for what they do. Examples include chronic care management, advance care planning, and dementia evaluation,” he said.
But the geriatrician gap goes beyond money.
Ageism, too, may play a role in residents not choosing geriatrics.
“Our culture is ageist. It definitely focuses on youth and looks at aging as being loss rather than just a change in what works well and what doesn’t work well,” said Mary Tinetti, MD, a geriatrician and researcher at Yale University, New Haven, Conn. “Ageism happens among physicians, just because they’re part of the broader society.”
Time for a new goal?
Dr. Tinetti said she’s optimistic that new ideas about geriatricians teaching other primary care clinicians about the tenets of geriatric medicine, which offer a wholistic approach to comorbidities, such as diabetes, atrial fibrillation, dementia, hypertension, hyperlipidemia, and polypharmacy problems faced by this population, especially those 85 and older.
She has called on her profession to abandon the goal of increasing the numbers of board-certified geriatricians – whom she refers to as big “G” geriatricians. She instead wants to develop a “small, elite workforce” that discovers and tests geriatrics principles through research, teaches these principles to all healthcare professions and to the public, and disseminates and implements the policies.
“We need a cadre of geriatricians who train all other clinicians in the care of older adults,” Dr. Tinetti said. “The goal is not more geriatricians but rather the preparation of all clinicians in the care of older adults.”
Dr. Thompson said geriatricians are teaching primary care specialists, nurses, social workers, and other health care providers the principles of age-friendly care. AGS has for the past 20 years led a program called the Geriatrics for Specialists Initiative to increase geriatrics knowledge and expertise of surgical and medical specialists.
Some specialties have taken the cue and have added geriatrics-related hyphens through additional training: geriatric-emergency, geriatric-general surgery, geriatric-hospitalists, and more.
HRSA runs programs to encourage physicians to train as geriatricians and geriatrics faculty, and it encourages the geriatrics interdisciplinary team approach.
Richard Olague, director of public affairs for HRSA, said his agency has invested over $160 million over the past 4 years in the education and training of geriatricians and other health care professionals who care for the elderly through its Geriatrics Workforce Enhancement Program and Geriatrics Academic Career Awards Program. In the academic year 2020-2021, the two programs trained 109 geriatricians; 456 other geriatric/gerontology providers and students; 44,450 other healthcare workforce professionals and students; and served 17,666 patients and 5,409 caregivers.
Dr. Harper, like his fellow geriatricians, tells young doctors that geriatrics is a fulfilling specialty.
“I get to care for the whole person and sometimes their families, too, and in the process form rich and meaningful relationships. And while I’m rarely in the position to cure, I always have the ability to care,” he said. “Sometimes that can mean being an advocate trying to make sure my patients receive the care they need, and other times it might mean protecting them from burdensome care that is unlikely to lead to any meaningful benefit. There is great reward in all of that.”
Dr. Supiano said geriatric patients are being helped by the Age-Friendly Health System initiative of the John A. Hartford Foundation and the Institute for Healthcare Improvement in partnership with the American Hospital Association and the Catholic Health Association of the United States. This is sort of a seal of approval for facilities committed to age-friendly care.
“When you go to your hospital, if they don’t have this age-friendly health system banner on the front door ... you either ask why that is not there, or you vote with your feet and go to another health system that is age friendly,” he said. “Geriatricians are eternal optimists.”
A version of this article first appeared on Medscape.com.
These should be the best of times for geriatric medicine.
The baby boom has become a senior surge, bringing in a rapidly growing pool of aging patients for geriatricians to treat. According to the U.S. Census Bureau, more than 56 million adults aged 65 and older live in the United States. They account for about 17% of the nation’s population. That number is expected to hit 73 million by 2030 and 86 million by 2050.
The American Geriatrics Society estimates that 30% of older people require the attention of geriatricians. These clinicians excel in managing complex cases – patients with multiple comorbidities, such as coronary artery disease, dementia, and osteoporosis, who are taking a half dozen, and often more, medications.
. In the 2010s, geriatricians called for “25,000 [such specialists] by 2025.” As of 2021, 7123 certified geriatricians were practicing in the United States, according to the American Board of Medical Specialties.
The Health Resources and Services Administration, a federal agency that addresses medical workforce shortages, estimates that there will be 6,230 geriatricians by 2025, or approximately 1 for every 3,000 older adults requiring geriatric care. HRSA projects a shortage of 27,000 geriatricians by 2025.
The specialty has faced an uphill battle to attract fellows. This year, only 43% of the nation’s 177 geriatrics fellowship slots were filled, according to November’s National Resident Match Program report. Family medicine–based geriatrics achieved only a 32% fill rate, while internal medicine–based programs saw a rate of 45%.
“Our numbers are shrinking so we need another approach to make sure older adults get the care they need and deserve,” said G. Michael Harper, MD, president of the 6,000-member AGS.
But Dr. Harper, who practices at the University of California, San Francisco, and the San Francisco VA Medical Center, added a positive note: “We may be struggling to increase the number of board-certified geriatricians, but the field itself has made a lot of progress in terms of improving clinical care through advancements in science and in the ways we deliver care.”
Dr. Harper cited the Hospital Elder Life Program, a hospital model developed at the Harvard-affiliated Marcus Institute for Aging Research, which uses an interprofessional team and trained volunteers to prevent delirium and functional decline. HELP has been adopted by more than 200 hospitals worldwide and has been successful at returning older adults to their homes or previous living situations with maintained or improved ability to function, he said.
Mark Supiano, MD, professor and chief of geriatrics at the University of Utah, Salt Lake City, said the specialty has been in shortage mode since ABMS recognized it in 1988. He was in the initial cohort of fellowship-trained geriatricians, sitting for the first certifying exam in geriatrics offered that year.
“Back then, the demographic imperative of the aging of our society was on the horizon. We’re living it now. I knew enough to recognize it was coming and saw an opportunity,” Dr. Supiano said in an interview. “There was so much then that we didn’t know about how to understand aging or how to care for older adults that there really was such a knowledge gap.”
Dr. Supiano is an associate editor of Hazzard’s Geriatric Medicine and Gerontology (McGraw-Hill Education), which has more than doubled in pages and word count during his career.
Unfavorable finances
Katherine Thompson, MD, director of the geriatrics fellowship program at the University of Chicago and codirector of UChicago’s Successful Aging and Frailty Evaluation Clinic, said money is a major reason for the struggle. “I think probably the biggest driver is financial,” she said. “A lot of people are graduating medical school with really astronomical amounts of medical school loans.”
Geriatricians, like other doctors, carry a large debt – $200,000, on average, not counting undergraduate debt, according to the Association of American Medical Colleges.
But the typical geriatrician earns less than an internist or family medicine doctor who doesn’t undergo the additional year of training, Dr. Thompson said. “There’s not a lot of financial motivation to do this fellowship,” she said.
The jobs website Zippia reports that geriatricians earned roughly $165,000 per year on average in 2022. The average annual incomes in 2022 were $191,000 for pediatricians, $215,000 for family physicians, and $223,000 for internists, according to the site.
In other words, Dr. Harper said, “geriatrics is one of the few professions where you can actually do additional training and make less money.”
The reason for the pay issue is simple: Geriatricians treat patients covered by Medicare, whose reimbursement schedules lag behind those of commercial insurers. The Kaiser Family Foundation reported in 2020 that private insurance paid 143% of Medicare rates on average for physician services.
Dr. Harper said overall compensation for geriatricians has “not gained a lot of traction,” but they can earn comfortable livings.
Still, representation of the specialty on the American Medical Association’s Relative Value Scale Update Committee has led to approval by the Centers for Medicare & Medicaid Services of billing codes that pay geriatricians “for what they do. Examples include chronic care management, advance care planning, and dementia evaluation,” he said.
But the geriatrician gap goes beyond money.
Ageism, too, may play a role in residents not choosing geriatrics.
“Our culture is ageist. It definitely focuses on youth and looks at aging as being loss rather than just a change in what works well and what doesn’t work well,” said Mary Tinetti, MD, a geriatrician and researcher at Yale University, New Haven, Conn. “Ageism happens among physicians, just because they’re part of the broader society.”
Time for a new goal?
Dr. Tinetti said she’s optimistic that new ideas about geriatricians teaching other primary care clinicians about the tenets of geriatric medicine, which offer a wholistic approach to comorbidities, such as diabetes, atrial fibrillation, dementia, hypertension, hyperlipidemia, and polypharmacy problems faced by this population, especially those 85 and older.
She has called on her profession to abandon the goal of increasing the numbers of board-certified geriatricians – whom she refers to as big “G” geriatricians. She instead wants to develop a “small, elite workforce” that discovers and tests geriatrics principles through research, teaches these principles to all healthcare professions and to the public, and disseminates and implements the policies.
“We need a cadre of geriatricians who train all other clinicians in the care of older adults,” Dr. Tinetti said. “The goal is not more geriatricians but rather the preparation of all clinicians in the care of older adults.”
Dr. Thompson said geriatricians are teaching primary care specialists, nurses, social workers, and other health care providers the principles of age-friendly care. AGS has for the past 20 years led a program called the Geriatrics for Specialists Initiative to increase geriatrics knowledge and expertise of surgical and medical specialists.
Some specialties have taken the cue and have added geriatrics-related hyphens through additional training: geriatric-emergency, geriatric-general surgery, geriatric-hospitalists, and more.
HRSA runs programs to encourage physicians to train as geriatricians and geriatrics faculty, and it encourages the geriatrics interdisciplinary team approach.
Richard Olague, director of public affairs for HRSA, said his agency has invested over $160 million over the past 4 years in the education and training of geriatricians and other health care professionals who care for the elderly through its Geriatrics Workforce Enhancement Program and Geriatrics Academic Career Awards Program. In the academic year 2020-2021, the two programs trained 109 geriatricians; 456 other geriatric/gerontology providers and students; 44,450 other healthcare workforce professionals and students; and served 17,666 patients and 5,409 caregivers.
Dr. Harper, like his fellow geriatricians, tells young doctors that geriatrics is a fulfilling specialty.
“I get to care for the whole person and sometimes their families, too, and in the process form rich and meaningful relationships. And while I’m rarely in the position to cure, I always have the ability to care,” he said. “Sometimes that can mean being an advocate trying to make sure my patients receive the care they need, and other times it might mean protecting them from burdensome care that is unlikely to lead to any meaningful benefit. There is great reward in all of that.”
Dr. Supiano said geriatric patients are being helped by the Age-Friendly Health System initiative of the John A. Hartford Foundation and the Institute for Healthcare Improvement in partnership with the American Hospital Association and the Catholic Health Association of the United States. This is sort of a seal of approval for facilities committed to age-friendly care.
“When you go to your hospital, if they don’t have this age-friendly health system banner on the front door ... you either ask why that is not there, or you vote with your feet and go to another health system that is age friendly,” he said. “Geriatricians are eternal optimists.”
A version of this article first appeared on Medscape.com.
Nurses questions answered: Could you face repercussions for your actions?
Nurses are the most trusted profession for one reason. They care.
Nurses are passionate about patient interactions, quality, and giving optimal support, often to the detriment of self-care. Many do not hesitate to voice concerns in an atmosphere that produces anxiety, whether it be regarding supplies, documentation, or staffing. As a result,
In October, three nurses at Ascension Saint Joseph in Joliet, Ill., were escorted off the premises of a hospital emergency room when they began an understaffed shift. They were removed from work by hospital security and then suspended for 1 week. It was a decision that was incomprehensible, because the emergency room faced an overwhelming influx of patients – 46 that evening alone – and only four nurses instead of the more than 10 approved staffing were on duty. Why were they suspended?
Hospital officials have been quiet in responding to their alarmed community as well as in answering the Illinois Nurses Association, who criticized the hospital’s response. It has been suggested that the nurses had been intensely vocal about staffing for several weeks and the hospital might have wanted to silence their voices.
In my opinion, this could be considered a professional repercussion of the post-pandemic work environment. Though the nurses were reinstated after the week expired, nursing organizations believed that the actions of their employer were too harsh.
There was a similar response by employers after a string of large strikes of California nurses earlier this year. For example, a walkout by nurses at Stanford Health Care and Lucile Packard Children’s Hospital resulted in the hospitals withholding wages during the strike period and stating they might withhold health coverage from striking workers.
“Our sincere hope is that an agreement can be reached promptly so that nurses don’t lose additional pay, don’t risk losing the subsidy for employer-paid health benefits, and can return to patient care,” the hospital newsletter StanfordPackardVoice.com reported before the strike began in April. “Nurses who choose to go out on strike will not paid for missed shifts and cannot use PTO, ESL, or Education Hours.”
Nurse: Could a similar repercussion be in my work future?
Nurses may take to picket lines or contact administrators (for example, Human Resources) for multiple reasons, but the most common issues are related to staffing, scheduling, mandatory overtime, or equipment required to do their job: safety or lifting equipment and broken or missing tools for monitoring patients. The lack of hospital security services to assist with violent or threatening patients has also become a concern.
Goodman: The inability to provide safe care is a common fear of all nurses, one that was exacerbated by health care workers leaving during the pandemic, primarily from nursing homes. Although overall safety has improved, that may not be the case in smaller, rural institutions. Staffing for all shifts may also be erratic as the country faces an uphill winter battle with influenza, respiratory syncytial virus, and newer COVID variants.
Report to your supervisor: First, be familiar with your institution’s policy regarding chain of command. Know where to take a complaint when staffing seems unsafe. Contact your immediate supervisor as soon as the situation has been assessed. They might be able to shift resources to your area or find coverage to help. In addition, keep accurate notes related to your actions.
I covered a night shift where I was directly responsible for the care of 13 subacute medical-surgical patients (new admissions and postoperative patients). Patients kept arriving with no regard for the load that was present. One of the patients was completely unhappy with her pain regimen and kept calling for assistance, as is often the case.
While I was doing my best to assess arrivals, another nurse contacted a supervisor. The next thing that happened was an on-site visit by hospital administrators (unusual!) who asked to see my assignment sheet. I had been hesitant to share the list, fearing recrimination from intermediate leadership (this was not my home unit). But it led to an immediate change in staffing. The ordeal ended amicably, but not all do. Thereafter, no nurse was expected to care for more than eight patients on the night shift.
Notify proper authorities: Nurses may believe contacting the Occupational Safety and Health Administration (OSHA) might be helpful; however, OSHA may not have jurisdiction over the hospital, as the Saint Joseph nurses discovered. Working without safety equipment or with reduced supplies (for example, automatic blood pressure cuffs, oxygen saturation monitors, isolation gear) may appear to be a federal complaint, but it depends where the nurse is employed. The hospital in Joliet was covered by the Illinois Department of Public Health.
Federal law entitles you to work in a safe place. Contacting OSHA for direction should not lead to recrimination for nurses. Although OSHA has been overwhelmed with complaints since the onset of the pandemic, their website directs nurses. For example, a whistleblower complaint can be filed up to 30 days after an incident of worker retaliation.
If you are a member of a nursing union, follow union guidelines related to your actions. Thousands of nurses went on strike in the past 2 years. Most remained employed and returned to work with negotiations complete. As far as the nurses in Massachusetts, the state does not have mandatory staffing ratios – most do not – which complicated contract negotiations. At this time, California is the only state that has mandatory nurse-patient ratios written into law.
It is also important to know state law and to be cognizant of nursing organizations within your geographic area. Staying connected means staying informed and having nursing resources.
Respond rationally: An additional reminder for nurses is not to react to a tense situation impulsively. Leaving an assignment unfinished or walking off the job is never a good idea. (A scheduled strike organized by union leaders is different). Leaving work is viewed by institutions as job abandonment and can be grounds for dismissal. Most states are currently “at will” employers, meaning hospitals can terminate nurses without due process.
Above all, know that nurses worry about providing safe practice and avoiding recrimination. Only one of these should be in your future.
Ms. Goodman has no disclosures.
A version of this article first appeared on Medscape.com.
Nurses are the most trusted profession for one reason. They care.
Nurses are passionate about patient interactions, quality, and giving optimal support, often to the detriment of self-care. Many do not hesitate to voice concerns in an atmosphere that produces anxiety, whether it be regarding supplies, documentation, or staffing. As a result,
In October, three nurses at Ascension Saint Joseph in Joliet, Ill., were escorted off the premises of a hospital emergency room when they began an understaffed shift. They were removed from work by hospital security and then suspended for 1 week. It was a decision that was incomprehensible, because the emergency room faced an overwhelming influx of patients – 46 that evening alone – and only four nurses instead of the more than 10 approved staffing were on duty. Why were they suspended?
Hospital officials have been quiet in responding to their alarmed community as well as in answering the Illinois Nurses Association, who criticized the hospital’s response. It has been suggested that the nurses had been intensely vocal about staffing for several weeks and the hospital might have wanted to silence their voices.
In my opinion, this could be considered a professional repercussion of the post-pandemic work environment. Though the nurses were reinstated after the week expired, nursing organizations believed that the actions of their employer were too harsh.
There was a similar response by employers after a string of large strikes of California nurses earlier this year. For example, a walkout by nurses at Stanford Health Care and Lucile Packard Children’s Hospital resulted in the hospitals withholding wages during the strike period and stating they might withhold health coverage from striking workers.
“Our sincere hope is that an agreement can be reached promptly so that nurses don’t lose additional pay, don’t risk losing the subsidy for employer-paid health benefits, and can return to patient care,” the hospital newsletter StanfordPackardVoice.com reported before the strike began in April. “Nurses who choose to go out on strike will not paid for missed shifts and cannot use PTO, ESL, or Education Hours.”
Nurse: Could a similar repercussion be in my work future?
Nurses may take to picket lines or contact administrators (for example, Human Resources) for multiple reasons, but the most common issues are related to staffing, scheduling, mandatory overtime, or equipment required to do their job: safety or lifting equipment and broken or missing tools for monitoring patients. The lack of hospital security services to assist with violent or threatening patients has also become a concern.
Goodman: The inability to provide safe care is a common fear of all nurses, one that was exacerbated by health care workers leaving during the pandemic, primarily from nursing homes. Although overall safety has improved, that may not be the case in smaller, rural institutions. Staffing for all shifts may also be erratic as the country faces an uphill winter battle with influenza, respiratory syncytial virus, and newer COVID variants.
Report to your supervisor: First, be familiar with your institution’s policy regarding chain of command. Know where to take a complaint when staffing seems unsafe. Contact your immediate supervisor as soon as the situation has been assessed. They might be able to shift resources to your area or find coverage to help. In addition, keep accurate notes related to your actions.
I covered a night shift where I was directly responsible for the care of 13 subacute medical-surgical patients (new admissions and postoperative patients). Patients kept arriving with no regard for the load that was present. One of the patients was completely unhappy with her pain regimen and kept calling for assistance, as is often the case.
While I was doing my best to assess arrivals, another nurse contacted a supervisor. The next thing that happened was an on-site visit by hospital administrators (unusual!) who asked to see my assignment sheet. I had been hesitant to share the list, fearing recrimination from intermediate leadership (this was not my home unit). But it led to an immediate change in staffing. The ordeal ended amicably, but not all do. Thereafter, no nurse was expected to care for more than eight patients on the night shift.
Notify proper authorities: Nurses may believe contacting the Occupational Safety and Health Administration (OSHA) might be helpful; however, OSHA may not have jurisdiction over the hospital, as the Saint Joseph nurses discovered. Working without safety equipment or with reduced supplies (for example, automatic blood pressure cuffs, oxygen saturation monitors, isolation gear) may appear to be a federal complaint, but it depends where the nurse is employed. The hospital in Joliet was covered by the Illinois Department of Public Health.
Federal law entitles you to work in a safe place. Contacting OSHA for direction should not lead to recrimination for nurses. Although OSHA has been overwhelmed with complaints since the onset of the pandemic, their website directs nurses. For example, a whistleblower complaint can be filed up to 30 days after an incident of worker retaliation.
If you are a member of a nursing union, follow union guidelines related to your actions. Thousands of nurses went on strike in the past 2 years. Most remained employed and returned to work with negotiations complete. As far as the nurses in Massachusetts, the state does not have mandatory staffing ratios – most do not – which complicated contract negotiations. At this time, California is the only state that has mandatory nurse-patient ratios written into law.
It is also important to know state law and to be cognizant of nursing organizations within your geographic area. Staying connected means staying informed and having nursing resources.
Respond rationally: An additional reminder for nurses is not to react to a tense situation impulsively. Leaving an assignment unfinished or walking off the job is never a good idea. (A scheduled strike organized by union leaders is different). Leaving work is viewed by institutions as job abandonment and can be grounds for dismissal. Most states are currently “at will” employers, meaning hospitals can terminate nurses without due process.
Above all, know that nurses worry about providing safe practice and avoiding recrimination. Only one of these should be in your future.
Ms. Goodman has no disclosures.
A version of this article first appeared on Medscape.com.
Nurses are the most trusted profession for one reason. They care.
Nurses are passionate about patient interactions, quality, and giving optimal support, often to the detriment of self-care. Many do not hesitate to voice concerns in an atmosphere that produces anxiety, whether it be regarding supplies, documentation, or staffing. As a result,
In October, three nurses at Ascension Saint Joseph in Joliet, Ill., were escorted off the premises of a hospital emergency room when they began an understaffed shift. They were removed from work by hospital security and then suspended for 1 week. It was a decision that was incomprehensible, because the emergency room faced an overwhelming influx of patients – 46 that evening alone – and only four nurses instead of the more than 10 approved staffing were on duty. Why were they suspended?
Hospital officials have been quiet in responding to their alarmed community as well as in answering the Illinois Nurses Association, who criticized the hospital’s response. It has been suggested that the nurses had been intensely vocal about staffing for several weeks and the hospital might have wanted to silence their voices.
In my opinion, this could be considered a professional repercussion of the post-pandemic work environment. Though the nurses were reinstated after the week expired, nursing organizations believed that the actions of their employer were too harsh.
There was a similar response by employers after a string of large strikes of California nurses earlier this year. For example, a walkout by nurses at Stanford Health Care and Lucile Packard Children’s Hospital resulted in the hospitals withholding wages during the strike period and stating they might withhold health coverage from striking workers.
“Our sincere hope is that an agreement can be reached promptly so that nurses don’t lose additional pay, don’t risk losing the subsidy for employer-paid health benefits, and can return to patient care,” the hospital newsletter StanfordPackardVoice.com reported before the strike began in April. “Nurses who choose to go out on strike will not paid for missed shifts and cannot use PTO, ESL, or Education Hours.”
Nurse: Could a similar repercussion be in my work future?
Nurses may take to picket lines or contact administrators (for example, Human Resources) for multiple reasons, but the most common issues are related to staffing, scheduling, mandatory overtime, or equipment required to do their job: safety or lifting equipment and broken or missing tools for monitoring patients. The lack of hospital security services to assist with violent or threatening patients has also become a concern.
Goodman: The inability to provide safe care is a common fear of all nurses, one that was exacerbated by health care workers leaving during the pandemic, primarily from nursing homes. Although overall safety has improved, that may not be the case in smaller, rural institutions. Staffing for all shifts may also be erratic as the country faces an uphill winter battle with influenza, respiratory syncytial virus, and newer COVID variants.
Report to your supervisor: First, be familiar with your institution’s policy regarding chain of command. Know where to take a complaint when staffing seems unsafe. Contact your immediate supervisor as soon as the situation has been assessed. They might be able to shift resources to your area or find coverage to help. In addition, keep accurate notes related to your actions.
I covered a night shift where I was directly responsible for the care of 13 subacute medical-surgical patients (new admissions and postoperative patients). Patients kept arriving with no regard for the load that was present. One of the patients was completely unhappy with her pain regimen and kept calling for assistance, as is often the case.
While I was doing my best to assess arrivals, another nurse contacted a supervisor. The next thing that happened was an on-site visit by hospital administrators (unusual!) who asked to see my assignment sheet. I had been hesitant to share the list, fearing recrimination from intermediate leadership (this was not my home unit). But it led to an immediate change in staffing. The ordeal ended amicably, but not all do. Thereafter, no nurse was expected to care for more than eight patients on the night shift.
Notify proper authorities: Nurses may believe contacting the Occupational Safety and Health Administration (OSHA) might be helpful; however, OSHA may not have jurisdiction over the hospital, as the Saint Joseph nurses discovered. Working without safety equipment or with reduced supplies (for example, automatic blood pressure cuffs, oxygen saturation monitors, isolation gear) may appear to be a federal complaint, but it depends where the nurse is employed. The hospital in Joliet was covered by the Illinois Department of Public Health.
Federal law entitles you to work in a safe place. Contacting OSHA for direction should not lead to recrimination for nurses. Although OSHA has been overwhelmed with complaints since the onset of the pandemic, their website directs nurses. For example, a whistleblower complaint can be filed up to 30 days after an incident of worker retaliation.
If you are a member of a nursing union, follow union guidelines related to your actions. Thousands of nurses went on strike in the past 2 years. Most remained employed and returned to work with negotiations complete. As far as the nurses in Massachusetts, the state does not have mandatory staffing ratios – most do not – which complicated contract negotiations. At this time, California is the only state that has mandatory nurse-patient ratios written into law.
It is also important to know state law and to be cognizant of nursing organizations within your geographic area. Staying connected means staying informed and having nursing resources.
Respond rationally: An additional reminder for nurses is not to react to a tense situation impulsively. Leaving an assignment unfinished or walking off the job is never a good idea. (A scheduled strike organized by union leaders is different). Leaving work is viewed by institutions as job abandonment and can be grounds for dismissal. Most states are currently “at will” employers, meaning hospitals can terminate nurses without due process.
Above all, know that nurses worry about providing safe practice and avoiding recrimination. Only one of these should be in your future.
Ms. Goodman has no disclosures.
A version of this article first appeared on Medscape.com.