The Diagnosis: Vibrio vulnificus Infection

At the initial presentation, the differential diagnosis included infectious processes such as bacterial or angioinvasive fungal infections or an inflammatory process such as pyoderma gangrenosum. Blood cultures were found to be positive for pansensitive Vibrio vulnificus. He initially was treated with piperacillin-tazobactam and received surgical debridement of the affected tissues. Pathologic interpretation of the wound tissues revealed a diagnosis of necrotizing softtissue infection and positive Candida albicans growth. He received topical bacitracin on discharge as well as a 7-day course of amoxicillin-clavulanate and fluconazole. He continued to receive debridement procedures and skin grafts, followed by topical mupirocin treatment and silver sulfadiazine. He was seen 6 weeks after discharge with healing wounds and healthy-appearing granulation tissue at the base.

Our patient’s presentation of retiform purpura with stellate necrosis was consistent with a wide range of serious pathologies ranging from medium-vessel vasculitis to thromboembolic phenomena and angioinvasive fungal infections.¹ Although Vibrio infection rarely is the first explanation that comes to mind when observing necrotic retiform purpura, the chronic nonhealing injury on the leg combined with the recent history of ocean swimming made V vulnificus stand out as a likely culprit. Although V vulnificus infection traditionally presents with cellulitis, edema, and hemorrhagic bulla,² necrosis also has been observed.³Vibrio vulnificus produces multiple virulence factors, and it is believed that these severe cutaneous symptoms are attributable to the production of a specific metalloprotease that enhances vascular permeability, thereby inducing hemorrhage within the vascular basement membrane zone.²

Vibrio vulnificus is an opportunistic bacterial pathogen associated with consumption of contaminated seafood or swimming in ocean waters with open wounds. Infections are rare, with only approximately 100 cases reported annually in the United States.4 However, V vulnificus infections have demonstrated increasing incidence in recent years, especially infections of pre-existing wounds.^4,5 Risk factors for their development include age over 40 years and underlying conditions including liver disease, diabetes mellitus, and immune dysfunction.⁴Vibrio vulnificus infections also demonstrate a strong male predilection, with almost 90% of infections occurring in males.⁴ Although the precise etiology of this sex discrepancy remains unknown, estrogen has been suggested to be a protective factor.⁶ Alternatively, behavioral differences also have been proposed as possible explanations for this discrepancy, with women less likely to consume seafood or go swimming. However, epidemiologic data reveal strong correlations between male sex and liver cirrhosis, a primary risk factor for V vulnificus infections, suggesting that male sex may simply be a confounding variable.⁷

Infections with V vulnificus are notable for their short incubation periods, with onset of symptoms occurring within 24 hours of exposure, making prompt diagnosis and treatment of high importance.⁸ Although rare, V vulnificus infections are associated with high mortality rates. From 1988 to 2010, nearly 600 deaths were reported secondary to V vulnificus infections.⁴ Wound infections carry a 17.6% fatality rate,⁴ while bloodborne V vulnificus infections exceed 50% fatality.⁸ Although sepsis secondary to V vulnificus usually is caused by ingestion of raw or undercooked shellfish, primarily oysters,⁴ our case highlights a rarer instance of both sepsis and localized infection stemming from ocean water exposure.

Vibrio vulnificus is an obligate halophile and therefore is found in marine environments rather than freshwater bodies. However, it rarely is isolated from bodies of water with salinities over 25 parts per thousand, such as the Mediterranean Sea; it usually is found in warmer waters, making it more common in the summer months from May to October.⁴ Given this proclivity for warmer environments, climate change has contributed to both a greater incidence and global distribution of V vulnificus. ^9,10

Treatment of V vulnificus infections centers on antibiotic treatment, with Vibrio species generally demonstrating susceptibility to most antibiotics of human significance.¹¹ However, some Vibrio isolates within the United States have demonstrated antibiotic resistance; 45% of a variety of clinical and environmental samples from South Carolina and Georgia demonstrated resistance to at least 3 antibiotic classes, and 17.3% resisted 8 or more classes of antibiotics.¹² These included medications such as doxycycline, tetracycline, aminoglycosides, and cephalosporins—agents that normally are prescribed for V vulnificus infections. Although tetracyclines have long been touted as the preferred treatment of V vulnificus infections, the spread of antibiotic resistance may require greater reliance on alternative regimens such as combinations of cephalosporins and doxycycline or a single fluoroquinolone.¹³ Although rare, Vibrio infections can have rapidly fatal consequences and should be given serious consideration when evaluating patients with relevant risk factors.

The differential diagnosis included angioinvasive mucormycosis, calciphylaxis, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. Mucormycosis is a fungal infection caused by Mucorales fungi that most commonly is seen in patients with diabetes mellitus, hematologic malignancies, neutropenia, and immunocompromise.¹⁴ Calciphylaxis is a condition involving microvascular occlusion due to diffuse calcium deposition in cutaneous blood vessels. It typically presents as violaceous retiform patches and plaques commonly seen on areas such as the thighs, buttocks, or abdomen and usually is associated with chronic renal failure, hemodialysis, and/or secondary hyperparathyroidism.¹⁵ Pyoderma gangrenosum is an inflammatory condition involving neutrophilic ulceration of the skin that typically presents as ulceration with a classically undermined border. It frequently is considered a diagnosis of exclusion and therefore requires that providers rule out other causes of ulceration prior to diagnosis.¹⁶ Stevens-Johnson syndrome/toxic epidermal necrolysis is a rare drug reaction involving mucosal erosions and cutaneous detachment.¹⁷ This diagnosis is less likely given that our patient lacked mucosal involvement and did not have any notable medication exposures prior to symptom onset.

The Diagnosis: Vibrio vulnificus Infection

At the initial presentation, the differential diagnosis included infectious processes such as bacterial or angioinvasive fungal infections or an inflammatory process such as pyoderma gangrenosum. Blood cultures were found to be positive for pansensitive Vibrio vulnificus. He initially was treated with piperacillin-tazobactam and received surgical debridement of the affected tissues. Pathologic interpretation of the wound tissues revealed a diagnosis of necrotizing softtissue infection and positive Candida albicans growth. He received topical bacitracin on discharge as well as a 7-day course of amoxicillin-clavulanate and fluconazole. He continued to receive debridement procedures and skin grafts, followed by topical mupirocin treatment and silver sulfadiazine. He was seen 6 weeks after discharge with healing wounds and healthy-appearing granulation tissue at the base.

Our patient’s presentation of retiform purpura with stellate necrosis was consistent with a wide range of serious pathologies ranging from medium-vessel vasculitis to thromboembolic phenomena and angioinvasive fungal infections.¹ Although Vibrio infection rarely is the first explanation that comes to mind when observing necrotic retiform purpura, the chronic nonhealing injury on the leg combined with the recent history of ocean swimming made V vulnificus stand out as a likely culprit. Although V vulnificus infection traditionally presents with cellulitis, edema, and hemorrhagic bulla,² necrosis also has been observed.³Vibrio vulnificus produces multiple virulence factors, and it is believed that these severe cutaneous symptoms are attributable to the production of a specific metalloprotease that enhances vascular permeability, thereby inducing hemorrhage within the vascular basement membrane zone.²

Vibrio vulnificus is an opportunistic bacterial pathogen associated with consumption of contaminated seafood or swimming in ocean waters with open wounds. Infections are rare, with only approximately 100 cases reported annually in the United States.4 However, V vulnificus infections have demonstrated increasing incidence in recent years, especially infections of pre-existing wounds.^4,5 Risk factors for their development include age over 40 years and underlying conditions including liver disease, diabetes mellitus, and immune dysfunction.⁴Vibrio vulnificus infections also demonstrate a strong male predilection, with almost 90% of infections occurring in males.⁴ Although the precise etiology of this sex discrepancy remains unknown, estrogen has been suggested to be a protective factor.⁶ Alternatively, behavioral differences also have been proposed as possible explanations for this discrepancy, with women less likely to consume seafood or go swimming. However, epidemiologic data reveal strong correlations between male sex and liver cirrhosis, a primary risk factor for V vulnificus infections, suggesting that male sex may simply be a confounding variable.⁷

Infections with V vulnificus are notable for their short incubation periods, with onset of symptoms occurring within 24 hours of exposure, making prompt diagnosis and treatment of high importance.⁸ Although rare, V vulnificus infections are associated with high mortality rates. From 1988 to 2010, nearly 600 deaths were reported secondary to V vulnificus infections.⁴ Wound infections carry a 17.6% fatality rate,⁴ while bloodborne V vulnificus infections exceed 50% fatality.⁸ Although sepsis secondary to V vulnificus usually is caused by ingestion of raw or undercooked shellfish, primarily oysters,⁴ our case highlights a rarer instance of both sepsis and localized infection stemming from ocean water exposure.

Vibrio vulnificus is an obligate halophile and therefore is found in marine environments rather than freshwater bodies. However, it rarely is isolated from bodies of water with salinities over 25 parts per thousand, such as the Mediterranean Sea; it usually is found in warmer waters, making it more common in the summer months from May to October.⁴ Given this proclivity for warmer environments, climate change has contributed to both a greater incidence and global distribution of V vulnificus. ^9,10

Treatment of V vulnificus infections centers on antibiotic treatment, with Vibrio species generally demonstrating susceptibility to most antibiotics of human significance.¹¹ However, some Vibrio isolates within the United States have demonstrated antibiotic resistance; 45% of a variety of clinical and environmental samples from South Carolina and Georgia demonstrated resistance to at least 3 antibiotic classes, and 17.3% resisted 8 or more classes of antibiotics.¹² These included medications such as doxycycline, tetracycline, aminoglycosides, and cephalosporins—agents that normally are prescribed for V vulnificus infections. Although tetracyclines have long been touted as the preferred treatment of V vulnificus infections, the spread of antibiotic resistance may require greater reliance on alternative regimens such as combinations of cephalosporins and doxycycline or a single fluoroquinolone.¹³ Although rare, Vibrio infections can have rapidly fatal consequences and should be given serious consideration when evaluating patients with relevant risk factors.

The differential diagnosis included angioinvasive mucormycosis, calciphylaxis, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. Mucormycosis is a fungal infection caused by Mucorales fungi that most commonly is seen in patients with diabetes mellitus, hematologic malignancies, neutropenia, and immunocompromise.¹⁴ Calciphylaxis is a condition involving microvascular occlusion due to diffuse calcium deposition in cutaneous blood vessels. It typically presents as violaceous retiform patches and plaques commonly seen on areas such as the thighs, buttocks, or abdomen and usually is associated with chronic renal failure, hemodialysis, and/or secondary hyperparathyroidism.¹⁵ Pyoderma gangrenosum is an inflammatory condition involving neutrophilic ulceration of the skin that typically presents as ulceration with a classically undermined border. It frequently is considered a diagnosis of exclusion and therefore requires that providers rule out other causes of ulceration prior to diagnosis.¹⁶ Stevens-Johnson syndrome/toxic epidermal necrolysis is a rare drug reaction involving mucosal erosions and cutaneous detachment.¹⁷ This diagnosis is less likely given that our patient lacked mucosal involvement and did not have any notable medication exposures prior to symptom onset.

The Diagnosis: Vibrio vulnificus Infection

At the initial presentation, the differential diagnosis included infectious processes such as bacterial or angioinvasive fungal infections or an inflammatory process such as pyoderma gangrenosum. Blood cultures were found to be positive for pansensitive Vibrio vulnificus. He initially was treated with piperacillin-tazobactam and received surgical debridement of the affected tissues. Pathologic interpretation of the wound tissues revealed a diagnosis of necrotizing softtissue infection and positive Candida albicans growth. He received topical bacitracin on discharge as well as a 7-day course of amoxicillin-clavulanate and fluconazole. He continued to receive debridement procedures and skin grafts, followed by topical mupirocin treatment and silver sulfadiazine. He was seen 6 weeks after discharge with healing wounds and healthy-appearing granulation tissue at the base.

Our patient’s presentation of retiform purpura with stellate necrosis was consistent with a wide range of serious pathologies ranging from medium-vessel vasculitis to thromboembolic phenomena and angioinvasive fungal infections.¹ Although Vibrio infection rarely is the first explanation that comes to mind when observing necrotic retiform purpura, the chronic nonhealing injury on the leg combined with the recent history of ocean swimming made V vulnificus stand out as a likely culprit. Although V vulnificus infection traditionally presents with cellulitis, edema, and hemorrhagic bulla,² necrosis also has been observed.³Vibrio vulnificus produces multiple virulence factors, and it is believed that these severe cutaneous symptoms are attributable to the production of a specific metalloprotease that enhances vascular permeability, thereby inducing hemorrhage within the vascular basement membrane zone.²

Vibrio vulnificus is an opportunistic bacterial pathogen associated with consumption of contaminated seafood or swimming in ocean waters with open wounds. Infections are rare, with only approximately 100 cases reported annually in the United States.4 However, V vulnificus infections have demonstrated increasing incidence in recent years, especially infections of pre-existing wounds.^4,5 Risk factors for their development include age over 40 years and underlying conditions including liver disease, diabetes mellitus, and immune dysfunction.⁴Vibrio vulnificus infections also demonstrate a strong male predilection, with almost 90% of infections occurring in males.⁴ Although the precise etiology of this sex discrepancy remains unknown, estrogen has been suggested to be a protective factor.⁶ Alternatively, behavioral differences also have been proposed as possible explanations for this discrepancy, with women less likely to consume seafood or go swimming. However, epidemiologic data reveal strong correlations between male sex and liver cirrhosis, a primary risk factor for V vulnificus infections, suggesting that male sex may simply be a confounding variable.⁷

Infections with V vulnificus are notable for their short incubation periods, with onset of symptoms occurring within 24 hours of exposure, making prompt diagnosis and treatment of high importance.⁸ Although rare, V vulnificus infections are associated with high mortality rates. From 1988 to 2010, nearly 600 deaths were reported secondary to V vulnificus infections.⁴ Wound infections carry a 17.6% fatality rate,⁴ while bloodborne V vulnificus infections exceed 50% fatality.⁸ Although sepsis secondary to V vulnificus usually is caused by ingestion of raw or undercooked shellfish, primarily oysters,⁴ our case highlights a rarer instance of both sepsis and localized infection stemming from ocean water exposure.

Vibrio vulnificus is an obligate halophile and therefore is found in marine environments rather than freshwater bodies. However, it rarely is isolated from bodies of water with salinities over 25 parts per thousand, such as the Mediterranean Sea; it usually is found in warmer waters, making it more common in the summer months from May to October.⁴ Given this proclivity for warmer environments, climate change has contributed to both a greater incidence and global distribution of V vulnificus. ^9,10

Treatment of V vulnificus infections centers on antibiotic treatment, with Vibrio species generally demonstrating susceptibility to most antibiotics of human significance.¹¹ However, some Vibrio isolates within the United States have demonstrated antibiotic resistance; 45% of a variety of clinical and environmental samples from South Carolina and Georgia demonstrated resistance to at least 3 antibiotic classes, and 17.3% resisted 8 or more classes of antibiotics.¹² These included medications such as doxycycline, tetracycline, aminoglycosides, and cephalosporins—agents that normally are prescribed for V vulnificus infections. Although tetracyclines have long been touted as the preferred treatment of V vulnificus infections, the spread of antibiotic resistance may require greater reliance on alternative regimens such as combinations of cephalosporins and doxycycline or a single fluoroquinolone.¹³ Although rare, Vibrio infections can have rapidly fatal consequences and should be given serious consideration when evaluating patients with relevant risk factors.

The differential diagnosis included angioinvasive mucormycosis, calciphylaxis, pyoderma gangrenosum, and Stevens-Johnson syndrome/toxic epidermal necrolysis. Mucormycosis is a fungal infection caused by Mucorales fungi that most commonly is seen in patients with diabetes mellitus, hematologic malignancies, neutropenia, and immunocompromise.¹⁴ Calciphylaxis is a condition involving microvascular occlusion due to diffuse calcium deposition in cutaneous blood vessels. It typically presents as violaceous retiform patches and plaques commonly seen on areas such as the thighs, buttocks, or abdomen and usually is associated with chronic renal failure, hemodialysis, and/or secondary hyperparathyroidism.¹⁵ Pyoderma gangrenosum is an inflammatory condition involving neutrophilic ulceration of the skin that typically presents as ulceration with a classically undermined border. It frequently is considered a diagnosis of exclusion and therefore requires that providers rule out other causes of ulceration prior to diagnosis.¹⁶ Stevens-Johnson syndrome/toxic epidermal necrolysis is a rare drug reaction involving mucosal erosions and cutaneous detachment.¹⁷ This diagnosis is less likely given that our patient lacked mucosal involvement and did not have any notable medication exposures prior to symptom onset.

A federal jury found William R. Bauer, 84, of Port Clinton, Ohio, guilty of prescribing powerful controlled substances, including opioids, to patients without medical necessity and outside the usual course of medical practice.

Dr. Bauer, a neurologist with over 50 years of experience, was convicted of 76 counts of distribution of controlled substances and 25 counts of healthcare fraud. According to television station WTOL, a federal indictment from 2019 listed 270 charges against the physician.

Federal officials claim that through his practice in Bellevue, Ohio, Dr. Bauer repeatedly prescribed controlled substances, including oxycodone, fentanyl, morphine, and tramadol, outside the usual course of professional practice and without legitimate medical purpose. The charges focused on 14 of his patients, to whom he prescribed high doses of opioids and other controlled substances without medical necessity. He also prescribed dangerous drug combinations. He ignored patients’ signs of addiction and abuse, such as early requests for refills, claims that medications had been lost, and claims that family members were stealing pills.

Dr. Bauer was also convicted of healthcare fraud for regularly administering epidural injections and trigger-point injections without medical necessity. Because these injections failed to meet the procedural requirements, they were rendered ineffective and were fraudulently billed to insurers. Dr. Bauer’s illegal prescriptions resulted in insurers paying for these medically unnecessary controlled substances.

Evidence at trial indicated that between January 2007 and August 16, 2019, Dr. Bauer prescribed controlled substances outside the usual course of medical practice and for illegitimate medical purposes. Insurers paid for these medically unnecessary controlled substances as well.

He will be sentenced at a later date.
 

Lab pays $1.2 million to resolve allegations of false claims for drug testing

Bluewater Toxicology, LLC, a clinical laboratory in Mount Washington, Ky., has agreed to pay $1.2 million to resolve civil allegations that it violated the False Claims Act.

The U.S. Department of Justice alleged three issues relating to claims for urine drug testing services that Bluewater submitted to Medicare, Kentucky Medicaid, Indiana Medicaid, TRICARE, and CHAMPVA. First, Bluewater submitted claims in which it misrepresented the number of drug classes it tested. Bluewater claimed it conducted definitive urine drug tests of 22 or more drug classes. In truth, Bluewater tested for fewer than 22 drug classes and secured reimbursement for drug tests that it did not conduct.

Second, Bluewater submitted certain claims without sufficient documentation to support the physician’s intent to order the test that was billed. In this way Bluewater obtained further unwarranted reimbursements.

Finally, Bluewater billed Medicare for specimen validity testing, a quality control process used to analyze a urine specimen to ensure that it has not been diluted or adulterated. Since January 2014, Medicare’s guidance has stated that specimen validity testing should not be separately billed to Medicare, but Bluewater did so anyway.
 

Home care company owner pays $1 million in Medicare fraud restitution

Richard Wennerberg, 72, of Grantham, N.H., pleaded guilty and was sentenced to two counts of class B felony Medicaid fraud, according to the New Hampshire Department of Justice.

Mr. Wennerberg is the owner of Alternative Care @ Home, LLC, a company licensed to provide in-home personal care services to Medicaid beneficiaries. He also pleaded guilty to a third charge of Medicaid fraud, through which Alternative Care @ Home, LLC, will be excluded from future participation in federal healthcare programs.

According to New Hampshire officials, Mr. Wennerberg submitted claims for reimbursement for in-home, personal care services that were never provided. Wennerberg billed Medicaid up to the maximum hours allowed under certain clients’ service authorizations, knowing that his employees did not provide care for all of those hours. He would use the difference to reimburse some caregivers for mileage.

Mr. Wennerberg will serve 1 year in state prison and will pay $1 million in restitution.
 

North Carolina wins two “Operation Root Canal” settlements

North Carolina Attorney General Josh Stein announced two separate civil settlements with ProHealth Dental Inc and Henry W. Davis, Jr, DDS, as part of Operation Root Canal, an ongoing effort to find and stop healthcare fraud among dental practitioners. The settlements, totaling $75,000, resolve allegations of the submission of false claims to the North Carolina Medicaid program.

In Operation Root Canal, the state Medicaid investigations department reviews billing practices for a wide variety of dental services, including dental cleanings, use of nitrous oxide, repetitive restorations on the same tooth, palliative care, and upcoding of patient examinations. In total, the operation has netted more than $7 million for the state.

The recent settlement relates to a prior criminal plea the attorney general’s Medicaid Investigations Division obtained involving Mr. Christian Ekberg, of Maryland, who was sentenced to 18 months in prison for healthcare fraud and was ordered to pay $173,870.12 to the North Carolina Medicaid Fund in restitution. Ekberg was an officer and minority shareholder of ProHealth Dental, a company that entered into a practice management agreement with Henry W. Davis, Jr, DDS., a North Carolina dentist and Medicaid practitioner who provided dental services to patients living in skilled nursing facilities throughout North Carolina. ProHealth Dental would provide professional management services to Dr. Davis, including submitting Medicaid claims. The company submitted claims for dental services that Dr. Davis did not perform on Medicaid recipients.

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

A federal jury found William R. Bauer, 84, of Port Clinton, Ohio, guilty of prescribing powerful controlled substances, including opioids, to patients without medical necessity and outside the usual course of medical practice.

Dr. Bauer, a neurologist with over 50 years of experience, was convicted of 76 counts of distribution of controlled substances and 25 counts of healthcare fraud. According to television station WTOL, a federal indictment from 2019 listed 270 charges against the physician.

Federal officials claim that through his practice in Bellevue, Ohio, Dr. Bauer repeatedly prescribed controlled substances, including oxycodone, fentanyl, morphine, and tramadol, outside the usual course of professional practice and without legitimate medical purpose. The charges focused on 14 of his patients, to whom he prescribed high doses of opioids and other controlled substances without medical necessity. He also prescribed dangerous drug combinations. He ignored patients’ signs of addiction and abuse, such as early requests for refills, claims that medications had been lost, and claims that family members were stealing pills.

Dr. Bauer was also convicted of healthcare fraud for regularly administering epidural injections and trigger-point injections without medical necessity. Because these injections failed to meet the procedural requirements, they were rendered ineffective and were fraudulently billed to insurers. Dr. Bauer’s illegal prescriptions resulted in insurers paying for these medically unnecessary controlled substances.

Evidence at trial indicated that between January 2007 and August 16, 2019, Dr. Bauer prescribed controlled substances outside the usual course of medical practice and for illegitimate medical purposes. Insurers paid for these medically unnecessary controlled substances as well.

He will be sentenced at a later date.
 

Lab pays $1.2 million to resolve allegations of false claims for drug testing

Bluewater Toxicology, LLC, a clinical laboratory in Mount Washington, Ky., has agreed to pay $1.2 million to resolve civil allegations that it violated the False Claims Act.

The U.S. Department of Justice alleged three issues relating to claims for urine drug testing services that Bluewater submitted to Medicare, Kentucky Medicaid, Indiana Medicaid, TRICARE, and CHAMPVA. First, Bluewater submitted claims in which it misrepresented the number of drug classes it tested. Bluewater claimed it conducted definitive urine drug tests of 22 or more drug classes. In truth, Bluewater tested for fewer than 22 drug classes and secured reimbursement for drug tests that it did not conduct.

Second, Bluewater submitted certain claims without sufficient documentation to support the physician’s intent to order the test that was billed. In this way Bluewater obtained further unwarranted reimbursements.

Finally, Bluewater billed Medicare for specimen validity testing, a quality control process used to analyze a urine specimen to ensure that it has not been diluted or adulterated. Since January 2014, Medicare’s guidance has stated that specimen validity testing should not be separately billed to Medicare, but Bluewater did so anyway.
 

Home care company owner pays $1 million in Medicare fraud restitution

Richard Wennerberg, 72, of Grantham, N.H., pleaded guilty and was sentenced to two counts of class B felony Medicaid fraud, according to the New Hampshire Department of Justice.

Mr. Wennerberg is the owner of Alternative Care @ Home, LLC, a company licensed to provide in-home personal care services to Medicaid beneficiaries. He also pleaded guilty to a third charge of Medicaid fraud, through which Alternative Care @ Home, LLC, will be excluded from future participation in federal healthcare programs.

According to New Hampshire officials, Mr. Wennerberg submitted claims for reimbursement for in-home, personal care services that were never provided. Wennerberg billed Medicaid up to the maximum hours allowed under certain clients’ service authorizations, knowing that his employees did not provide care for all of those hours. He would use the difference to reimburse some caregivers for mileage.

Mr. Wennerberg will serve 1 year in state prison and will pay $1 million in restitution.
 

North Carolina wins two “Operation Root Canal” settlements

North Carolina Attorney General Josh Stein announced two separate civil settlements with ProHealth Dental Inc and Henry W. Davis, Jr, DDS, as part of Operation Root Canal, an ongoing effort to find and stop healthcare fraud among dental practitioners. The settlements, totaling $75,000, resolve allegations of the submission of false claims to the North Carolina Medicaid program.

In Operation Root Canal, the state Medicaid investigations department reviews billing practices for a wide variety of dental services, including dental cleanings, use of nitrous oxide, repetitive restorations on the same tooth, palliative care, and upcoding of patient examinations. In total, the operation has netted more than $7 million for the state.

The recent settlement relates to a prior criminal plea the attorney general’s Medicaid Investigations Division obtained involving Mr. Christian Ekberg, of Maryland, who was sentenced to 18 months in prison for healthcare fraud and was ordered to pay $173,870.12 to the North Carolina Medicaid Fund in restitution. Ekberg was an officer and minority shareholder of ProHealth Dental, a company that entered into a practice management agreement with Henry W. Davis, Jr, DDS., a North Carolina dentist and Medicaid practitioner who provided dental services to patients living in skilled nursing facilities throughout North Carolina. ProHealth Dental would provide professional management services to Dr. Davis, including submitting Medicaid claims. The company submitted claims for dental services that Dr. Davis did not perform on Medicaid recipients.

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

A federal jury found William R. Bauer, 84, of Port Clinton, Ohio, guilty of prescribing powerful controlled substances, including opioids, to patients without medical necessity and outside the usual course of medical practice.

Dr. Bauer, a neurologist with over 50 years of experience, was convicted of 76 counts of distribution of controlled substances and 25 counts of healthcare fraud. According to television station WTOL, a federal indictment from 2019 listed 270 charges against the physician.

Federal officials claim that through his practice in Bellevue, Ohio, Dr. Bauer repeatedly prescribed controlled substances, including oxycodone, fentanyl, morphine, and tramadol, outside the usual course of professional practice and without legitimate medical purpose. The charges focused on 14 of his patients, to whom he prescribed high doses of opioids and other controlled substances without medical necessity. He also prescribed dangerous drug combinations. He ignored patients’ signs of addiction and abuse, such as early requests for refills, claims that medications had been lost, and claims that family members were stealing pills.

Dr. Bauer was also convicted of healthcare fraud for regularly administering epidural injections and trigger-point injections without medical necessity. Because these injections failed to meet the procedural requirements, they were rendered ineffective and were fraudulently billed to insurers. Dr. Bauer’s illegal prescriptions resulted in insurers paying for these medically unnecessary controlled substances.

Evidence at trial indicated that between January 2007 and August 16, 2019, Dr. Bauer prescribed controlled substances outside the usual course of medical practice and for illegitimate medical purposes. Insurers paid for these medically unnecessary controlled substances as well.

He will be sentenced at a later date.
 

Lab pays $1.2 million to resolve allegations of false claims for drug testing

Bluewater Toxicology, LLC, a clinical laboratory in Mount Washington, Ky., has agreed to pay $1.2 million to resolve civil allegations that it violated the False Claims Act.

The U.S. Department of Justice alleged three issues relating to claims for urine drug testing services that Bluewater submitted to Medicare, Kentucky Medicaid, Indiana Medicaid, TRICARE, and CHAMPVA. First, Bluewater submitted claims in which it misrepresented the number of drug classes it tested. Bluewater claimed it conducted definitive urine drug tests of 22 or more drug classes. In truth, Bluewater tested for fewer than 22 drug classes and secured reimbursement for drug tests that it did not conduct.

Second, Bluewater submitted certain claims without sufficient documentation to support the physician’s intent to order the test that was billed. In this way Bluewater obtained further unwarranted reimbursements.

Finally, Bluewater billed Medicare for specimen validity testing, a quality control process used to analyze a urine specimen to ensure that it has not been diluted or adulterated. Since January 2014, Medicare’s guidance has stated that specimen validity testing should not be separately billed to Medicare, but Bluewater did so anyway.
 

Home care company owner pays $1 million in Medicare fraud restitution

Richard Wennerberg, 72, of Grantham, N.H., pleaded guilty and was sentenced to two counts of class B felony Medicaid fraud, according to the New Hampshire Department of Justice.

Mr. Wennerberg is the owner of Alternative Care @ Home, LLC, a company licensed to provide in-home personal care services to Medicaid beneficiaries. He also pleaded guilty to a third charge of Medicaid fraud, through which Alternative Care @ Home, LLC, will be excluded from future participation in federal healthcare programs.

According to New Hampshire officials, Mr. Wennerberg submitted claims for reimbursement for in-home, personal care services that were never provided. Wennerberg billed Medicaid up to the maximum hours allowed under certain clients’ service authorizations, knowing that his employees did not provide care for all of those hours. He would use the difference to reimburse some caregivers for mileage.

Mr. Wennerberg will serve 1 year in state prison and will pay $1 million in restitution.
 

North Carolina wins two “Operation Root Canal” settlements

North Carolina Attorney General Josh Stein announced two separate civil settlements with ProHealth Dental Inc and Henry W. Davis, Jr, DDS, as part of Operation Root Canal, an ongoing effort to find and stop healthcare fraud among dental practitioners. The settlements, totaling $75,000, resolve allegations of the submission of false claims to the North Carolina Medicaid program.

In Operation Root Canal, the state Medicaid investigations department reviews billing practices for a wide variety of dental services, including dental cleanings, use of nitrous oxide, repetitive restorations on the same tooth, palliative care, and upcoding of patient examinations. In total, the operation has netted more than $7 million for the state.

The recent settlement relates to a prior criminal plea the attorney general’s Medicaid Investigations Division obtained involving Mr. Christian Ekberg, of Maryland, who was sentenced to 18 months in prison for healthcare fraud and was ordered to pay $173,870.12 to the North Carolina Medicaid Fund in restitution. Ekberg was an officer and minority shareholder of ProHealth Dental, a company that entered into a practice management agreement with Henry W. Davis, Jr, DDS., a North Carolina dentist and Medicaid practitioner who provided dental services to patients living in skilled nursing facilities throughout North Carolina. ProHealth Dental would provide professional management services to Dr. Davis, including submitting Medicaid claims. The company submitted claims for dental services that Dr. Davis did not perform on Medicaid recipients.

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

Use of a transdermal blonanserin patch significantly improved extrapyramidal symptoms (EPS), compared with oral blonanserin tablets in patients with schizophrenia, according to results of an open-label study of 155 adults.

Blonanserin, a second-generation antipsychotic, has been shown to reduce extrapyramidal symptoms when used to treat schizophrenia, but the impact of switching to a patch on extrapyramidal symptoms and on the use of antiparkinson drugs has not been well studied, Kazutaka Ohi, MD, of Gifu University Graduate School of Medicine, Seki, Japan, and colleagues wrote. Advantages of the patch include the ability to provide stable blood concentrations and the ability to be concealed under clothing to avoid patients’ embarrassment at taking oral medications.

In a study published in Progress in Neuropsychopharmacology & Biological Psychiatry, the researchers identified 155 adults aged 18 years and older diagnosed with schizophrenia who were treated at 37 medical institutions in Japan between February 2015 and May 2017.

The first cohort of 97 patients received blonanserin tablets (8-16 mg/day) for 6 weeks, followed by blonanserin transdermal patches (40-80 mg/day) once daily for 1 year. The second cohort of 58 patients received continuous blonanserin patch therapy. Extrapyramidal symptoms were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS); individual scores ranged from a 0 for normal to a 4 for severe.

Overall, DIEPSS scores decreased significantly in both cohorts after switching from blonanserin tablets or powders to transdermal patches. The average DIEPSS change from baseline at 3, 6, and 12 months was –0.44, –0.07, and –0.14, respectively, in cohort 1, and –0.16, –0.74, and –0.81, respectively, in cohort 2.

The researchers also assessed the impact of transition to transdermal patches on the use of antiparkinsonism drugs using the biperiden equivalents of total antiparkinsonian drugs (BPD-eq) measure. At baseline, about 22% of patients used concomitant antiparkinsonism drugs, compared with 25.8% at 1 year after starting patch treatment. The dose of antiparkinson drugs was not significantly decreased after switching to transdermal patches, in part because of psychiatrists’ prescribing behaviors, Dr. Ohi and colleagues noted.

As a secondary outcome, the researchers examined psychotic symptoms and found that Positive and Negative Syndrome Scale (PANSS) negative symptom scores decreased significantly in patients in cohort 1 who switched from tablets or powders to patches. Changes in scores from baseline to 3, 6, and 12 months were –0.7, –1.0, and –1.3, respectively. Positive PANSS scores did not change significantly in cohort 1. In cohort 2, both positive and negative PANSS scores decreased significantly over 12 months after switching from blonanserin tablets/powders to patches. The mean changes in scores from baseline to 3, 6, and 12 months were –1.6, –2.3, and –2.4, respectively, for PANSS positive symptom scores, and –1.4, –2.7, and –2.8, respectively, for negative symptom scores.

A total of 41.2% of cohort 1 patients and 44.8% of cohort 2 patients discontinued patch treatments by 1 year. Four patients discontinued the patch because of EPS during the treatment period in cohort 1; no patients in cohort 2 discontinued because of EPS.

The study findings were limited by several factors, including the open-label design and lack of controls; also, the study did not examine crossover changes in patients who switched from tablets or powders to patches, the researchers noted.

However, the results indicate that direct switching from blonanserin tablets or powders to transdermal patches reduced EPS and psychotic symptoms in schizophrenia and may be more acceptable to patients, compared with oral medications, as well as more effective, they concluded.

The study received no outside funding, and Dr. Ohi and colleagues had no disclosures.

Use of a transdermal blonanserin patch significantly improved extrapyramidal symptoms (EPS), compared with oral blonanserin tablets in patients with schizophrenia, according to results of an open-label study of 155 adults.

Blonanserin, a second-generation antipsychotic, has been shown to reduce extrapyramidal symptoms when used to treat schizophrenia, but the impact of switching to a patch on extrapyramidal symptoms and on the use of antiparkinson drugs has not been well studied, Kazutaka Ohi, MD, of Gifu University Graduate School of Medicine, Seki, Japan, and colleagues wrote. Advantages of the patch include the ability to provide stable blood concentrations and the ability to be concealed under clothing to avoid patients’ embarrassment at taking oral medications.

In a study published in Progress in Neuropsychopharmacology & Biological Psychiatry, the researchers identified 155 adults aged 18 years and older diagnosed with schizophrenia who were treated at 37 medical institutions in Japan between February 2015 and May 2017.

The first cohort of 97 patients received blonanserin tablets (8-16 mg/day) for 6 weeks, followed by blonanserin transdermal patches (40-80 mg/day) once daily for 1 year. The second cohort of 58 patients received continuous blonanserin patch therapy. Extrapyramidal symptoms were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS); individual scores ranged from a 0 for normal to a 4 for severe.

Overall, DIEPSS scores decreased significantly in both cohorts after switching from blonanserin tablets or powders to transdermal patches. The average DIEPSS change from baseline at 3, 6, and 12 months was –0.44, –0.07, and –0.14, respectively, in cohort 1, and –0.16, –0.74, and –0.81, respectively, in cohort 2.

The researchers also assessed the impact of transition to transdermal patches on the use of antiparkinsonism drugs using the biperiden equivalents of total antiparkinsonian drugs (BPD-eq) measure. At baseline, about 22% of patients used concomitant antiparkinsonism drugs, compared with 25.8% at 1 year after starting patch treatment. The dose of antiparkinson drugs was not significantly decreased after switching to transdermal patches, in part because of psychiatrists’ prescribing behaviors, Dr. Ohi and colleagues noted.

As a secondary outcome, the researchers examined psychotic symptoms and found that Positive and Negative Syndrome Scale (PANSS) negative symptom scores decreased significantly in patients in cohort 1 who switched from tablets or powders to patches. Changes in scores from baseline to 3, 6, and 12 months were –0.7, –1.0, and –1.3, respectively. Positive PANSS scores did not change significantly in cohort 1. In cohort 2, both positive and negative PANSS scores decreased significantly over 12 months after switching from blonanserin tablets/powders to patches. The mean changes in scores from baseline to 3, 6, and 12 months were –1.6, –2.3, and –2.4, respectively, for PANSS positive symptom scores, and –1.4, –2.7, and –2.8, respectively, for negative symptom scores.

A total of 41.2% of cohort 1 patients and 44.8% of cohort 2 patients discontinued patch treatments by 1 year. Four patients discontinued the patch because of EPS during the treatment period in cohort 1; no patients in cohort 2 discontinued because of EPS.

The study findings were limited by several factors, including the open-label design and lack of controls; also, the study did not examine crossover changes in patients who switched from tablets or powders to patches, the researchers noted.

However, the results indicate that direct switching from blonanserin tablets or powders to transdermal patches reduced EPS and psychotic symptoms in schizophrenia and may be more acceptable to patients, compared with oral medications, as well as more effective, they concluded.

The study received no outside funding, and Dr. Ohi and colleagues had no disclosures.

Use of a transdermal blonanserin patch significantly improved extrapyramidal symptoms (EPS), compared with oral blonanserin tablets in patients with schizophrenia, according to results of an open-label study of 155 adults.

Blonanserin, a second-generation antipsychotic, has been shown to reduce extrapyramidal symptoms when used to treat schizophrenia, but the impact of switching to a patch on extrapyramidal symptoms and on the use of antiparkinson drugs has not been well studied, Kazutaka Ohi, MD, of Gifu University Graduate School of Medicine, Seki, Japan, and colleagues wrote. Advantages of the patch include the ability to provide stable blood concentrations and the ability to be concealed under clothing to avoid patients’ embarrassment at taking oral medications.

In a study published in Progress in Neuropsychopharmacology & Biological Psychiatry, the researchers identified 155 adults aged 18 years and older diagnosed with schizophrenia who were treated at 37 medical institutions in Japan between February 2015 and May 2017.

The first cohort of 97 patients received blonanserin tablets (8-16 mg/day) for 6 weeks, followed by blonanserin transdermal patches (40-80 mg/day) once daily for 1 year. The second cohort of 58 patients received continuous blonanserin patch therapy. Extrapyramidal symptoms were assessed using the Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS); individual scores ranged from a 0 for normal to a 4 for severe.

Overall, DIEPSS scores decreased significantly in both cohorts after switching from blonanserin tablets or powders to transdermal patches. The average DIEPSS change from baseline at 3, 6, and 12 months was –0.44, –0.07, and –0.14, respectively, in cohort 1, and –0.16, –0.74, and –0.81, respectively, in cohort 2.

The researchers also assessed the impact of transition to transdermal patches on the use of antiparkinsonism drugs using the biperiden equivalents of total antiparkinsonian drugs (BPD-eq) measure. At baseline, about 22% of patients used concomitant antiparkinsonism drugs, compared with 25.8% at 1 year after starting patch treatment. The dose of antiparkinson drugs was not significantly decreased after switching to transdermal patches, in part because of psychiatrists’ prescribing behaviors, Dr. Ohi and colleagues noted.

As a secondary outcome, the researchers examined psychotic symptoms and found that Positive and Negative Syndrome Scale (PANSS) negative symptom scores decreased significantly in patients in cohort 1 who switched from tablets or powders to patches. Changes in scores from baseline to 3, 6, and 12 months were –0.7, –1.0, and –1.3, respectively. Positive PANSS scores did not change significantly in cohort 1. In cohort 2, both positive and negative PANSS scores decreased significantly over 12 months after switching from blonanserin tablets/powders to patches. The mean changes in scores from baseline to 3, 6, and 12 months were –1.6, –2.3, and –2.4, respectively, for PANSS positive symptom scores, and –1.4, –2.7, and –2.8, respectively, for negative symptom scores.

A total of 41.2% of cohort 1 patients and 44.8% of cohort 2 patients discontinued patch treatments by 1 year. Four patients discontinued the patch because of EPS during the treatment period in cohort 1; no patients in cohort 2 discontinued because of EPS.

The study findings were limited by several factors, including the open-label design and lack of controls; also, the study did not examine crossover changes in patients who switched from tablets or powders to patches, the researchers noted.

However, the results indicate that direct switching from blonanserin tablets or powders to transdermal patches reduced EPS and psychotic symptoms in schizophrenia and may be more acceptable to patients, compared with oral medications, as well as more effective, they concluded.

The study received no outside funding, and Dr. Ohi and colleagues had no disclosures.

To the Editor:

Bullous pemphigoid (BP) is an autoimmune bullous dermatosis characterized by tense subepidermal blisters. It primarily affects older individuals who typically report pruritus in the affected area. Subepidermal blisters are caused by a humoral and cellular autoimmune attack directed against 2 BP antigens—BP180 and BP230—which are 2 critical components of the hemidesmosome whose primary function is to anchor the epidermis to the underlying dermis. Although tense bullae typically prompt immediate consideration of BP in the differential diagnosis, early disease often is characterized by urticarial plaques that require a high degree of suspicion to make the appropriate diagnosis. Locus minoris resistentiae is a term used to describe the phenomenon of skin disease occurring at the point of least resistance.¹

A 79-year-old woman with type 2 diabetes mellitus, peptic ulcer disease, and hypertension was referred to the dermatology clinic due to concern for allergic contact dermatitis limited to the area of and adjacent to a well-healed surgical wound. History and examination revealed that the patient had sustained a left femoral neck fracture 10 months prior to presentation that required closed reduction and surgical pinning. The surgical site healed well postoperatively; however, 7 months after surgery, she began to develop edema and erythema within and immediately adjacent to the surgical scar. She subsequently developed areas of superficial erosion within the erythema and was evaluated by her surgeon who was concerned for suture granuloma. Superficial wound debridement of the area was performed without improvement. Approximately 9 months after surgery, the patient developed bullae along the old surgical site, which raised concern for an allergic reaction to the implanted screws. Orthopedics elected to remove the hardware but also sent intraoperative tissue for pathologic examination, which revealed subepidermal bullae containing eosinophils and neutrophils, most consistent with a bullous drug eruption. During the ensuing weeks after hardware removal, the plaque spread along the old surgical wound, and several bullous lesions began to appear. The patient’s primary care physician became concerned for allergic contact dermatitis, possibly to the surgical scrub employed during hardware removal. He prescribed triamcinolone ointment 0.1% and referred the patient to dermatology.

Upon presentation to dermatology, the patient noted stinging pain and intense pruritus of the affected area. Examination revealed a pink edematous plaque distributed along a well-healed surgical wound (Figure). Numerous fluid-filled tense bullae were superimposed on this plaque as well as areas of superficial erosion with serum crust. An expanded examination revealed similar smaller lesions on the upper arms, inner thighs, and lateral breasts. A 4-mm punch biopsy of lesional and perilesional skin was sent for hematoxylin and eosin staining and direct immunofluorescence, which demonstrated a subepidermal bullous dermatosis with a predominance of neutrophilic inflammation as well as a band of linear IgG deposition at the dermal-epidermal junction. The patient was diagnosed with BP exhibiting a locus minoris resistentiae phenomenon within the surgical site. She was started on prednisone 1 mg/kg daily and doxycycline 100 mg twice daily and demonstrated rapid improvement.

Although the tense bullae seen in well-developed BP are fairly characteristic, the prodromal phase of this disease can present with urticarial plaques that are nonspecific. This progression is well described, but our case demonstrates the difficulty of considering BP when a patient presents with an urticarial plaque. As lesions progress to the bullous phase, they may be inappropriately diagnosed as allergic contact dermatitis, an error that may lead to unnecessary interventions (eg, removal of an implicated prosthesis). This case is a reminder that not all cutaneous eruptions in and around postsurgical scars are allergic in nature.

This case also depicts BP appearing in the locus minoris resistentiae, a well-healed surgical wound in our patient. Although many diseases have been shown to exhibit this type of isomorphic response, this phenomenon may pose diagnostic and management conundrums. Locus minoris resistentiae has been reported in many different diseases, both cutaneous and otherwise, but there likely are distinct disease- and case-specific mechanisms via which this occurs. Local phenomena reported to trigger BP include contact dermatitis, vaccination, radiation therapy, phototherapy, infection, and surgery.² We suspect that the mechanism of locus minoris resistentiae in our patient was disruption of the architecture of the dermal-epidermal basement membrane zone due to surgical trauma. Disruption of this architecture may have resulted in exposure of previously occult antigens, recognition by T cells, T-cell stimulation of autoantibody production by B cells, binding of autoantibodies to BP180, complement deposition, recruitment of inflammatory cells, release of proteinases, and degradation of BP180 and extracellular matrix proteins.²

To the Editor:

Bullous pemphigoid (BP) is an autoimmune bullous dermatosis characterized by tense subepidermal blisters. It primarily affects older individuals who typically report pruritus in the affected area. Subepidermal blisters are caused by a humoral and cellular autoimmune attack directed against 2 BP antigens—BP180 and BP230—which are 2 critical components of the hemidesmosome whose primary function is to anchor the epidermis to the underlying dermis. Although tense bullae typically prompt immediate consideration of BP in the differential diagnosis, early disease often is characterized by urticarial plaques that require a high degree of suspicion to make the appropriate diagnosis. Locus minoris resistentiae is a term used to describe the phenomenon of skin disease occurring at the point of least resistance.¹

A 79-year-old woman with type 2 diabetes mellitus, peptic ulcer disease, and hypertension was referred to the dermatology clinic due to concern for allergic contact dermatitis limited to the area of and adjacent to a well-healed surgical wound. History and examination revealed that the patient had sustained a left femoral neck fracture 10 months prior to presentation that required closed reduction and surgical pinning. The surgical site healed well postoperatively; however, 7 months after surgery, she began to develop edema and erythema within and immediately adjacent to the surgical scar. She subsequently developed areas of superficial erosion within the erythema and was evaluated by her surgeon who was concerned for suture granuloma. Superficial wound debridement of the area was performed without improvement. Approximately 9 months after surgery, the patient developed bullae along the old surgical site, which raised concern for an allergic reaction to the implanted screws. Orthopedics elected to remove the hardware but also sent intraoperative tissue for pathologic examination, which revealed subepidermal bullae containing eosinophils and neutrophils, most consistent with a bullous drug eruption. During the ensuing weeks after hardware removal, the plaque spread along the old surgical wound, and several bullous lesions began to appear. The patient’s primary care physician became concerned for allergic contact dermatitis, possibly to the surgical scrub employed during hardware removal. He prescribed triamcinolone ointment 0.1% and referred the patient to dermatology.

Upon presentation to dermatology, the patient noted stinging pain and intense pruritus of the affected area. Examination revealed a pink edematous plaque distributed along a well-healed surgical wound (Figure). Numerous fluid-filled tense bullae were superimposed on this plaque as well as areas of superficial erosion with serum crust. An expanded examination revealed similar smaller lesions on the upper arms, inner thighs, and lateral breasts. A 4-mm punch biopsy of lesional and perilesional skin was sent for hematoxylin and eosin staining and direct immunofluorescence, which demonstrated a subepidermal bullous dermatosis with a predominance of neutrophilic inflammation as well as a band of linear IgG deposition at the dermal-epidermal junction. The patient was diagnosed with BP exhibiting a locus minoris resistentiae phenomenon within the surgical site. She was started on prednisone 1 mg/kg daily and doxycycline 100 mg twice daily and demonstrated rapid improvement.

Although the tense bullae seen in well-developed BP are fairly characteristic, the prodromal phase of this disease can present with urticarial plaques that are nonspecific. This progression is well described, but our case demonstrates the difficulty of considering BP when a patient presents with an urticarial plaque. As lesions progress to the bullous phase, they may be inappropriately diagnosed as allergic contact dermatitis, an error that may lead to unnecessary interventions (eg, removal of an implicated prosthesis). This case is a reminder that not all cutaneous eruptions in and around postsurgical scars are allergic in nature.

This case also depicts BP appearing in the locus minoris resistentiae, a well-healed surgical wound in our patient. Although many diseases have been shown to exhibit this type of isomorphic response, this phenomenon may pose diagnostic and management conundrums. Locus minoris resistentiae has been reported in many different diseases, both cutaneous and otherwise, but there likely are distinct disease- and case-specific mechanisms via which this occurs. Local phenomena reported to trigger BP include contact dermatitis, vaccination, radiation therapy, phototherapy, infection, and surgery.² We suspect that the mechanism of locus minoris resistentiae in our patient was disruption of the architecture of the dermal-epidermal basement membrane zone due to surgical trauma. Disruption of this architecture may have resulted in exposure of previously occult antigens, recognition by T cells, T-cell stimulation of autoantibody production by B cells, binding of autoantibodies to BP180, complement deposition, recruitment of inflammatory cells, release of proteinases, and degradation of BP180 and extracellular matrix proteins.²

To the Editor:

Bullous pemphigoid (BP) is an autoimmune bullous dermatosis characterized by tense subepidermal blisters. It primarily affects older individuals who typically report pruritus in the affected area. Subepidermal blisters are caused by a humoral and cellular autoimmune attack directed against 2 BP antigens—BP180 and BP230—which are 2 critical components of the hemidesmosome whose primary function is to anchor the epidermis to the underlying dermis. Although tense bullae typically prompt immediate consideration of BP in the differential diagnosis, early disease often is characterized by urticarial plaques that require a high degree of suspicion to make the appropriate diagnosis. Locus minoris resistentiae is a term used to describe the phenomenon of skin disease occurring at the point of least resistance.¹

A 79-year-old woman with type 2 diabetes mellitus, peptic ulcer disease, and hypertension was referred to the dermatology clinic due to concern for allergic contact dermatitis limited to the area of and adjacent to a well-healed surgical wound. History and examination revealed that the patient had sustained a left femoral neck fracture 10 months prior to presentation that required closed reduction and surgical pinning. The surgical site healed well postoperatively; however, 7 months after surgery, she began to develop edema and erythema within and immediately adjacent to the surgical scar. She subsequently developed areas of superficial erosion within the erythema and was evaluated by her surgeon who was concerned for suture granuloma. Superficial wound debridement of the area was performed without improvement. Approximately 9 months after surgery, the patient developed bullae along the old surgical site, which raised concern for an allergic reaction to the implanted screws. Orthopedics elected to remove the hardware but also sent intraoperative tissue for pathologic examination, which revealed subepidermal bullae containing eosinophils and neutrophils, most consistent with a bullous drug eruption. During the ensuing weeks after hardware removal, the plaque spread along the old surgical wound, and several bullous lesions began to appear. The patient’s primary care physician became concerned for allergic contact dermatitis, possibly to the surgical scrub employed during hardware removal. He prescribed triamcinolone ointment 0.1% and referred the patient to dermatology.

Upon presentation to dermatology, the patient noted stinging pain and intense pruritus of the affected area. Examination revealed a pink edematous plaque distributed along a well-healed surgical wound (Figure). Numerous fluid-filled tense bullae were superimposed on this plaque as well as areas of superficial erosion with serum crust. An expanded examination revealed similar smaller lesions on the upper arms, inner thighs, and lateral breasts. A 4-mm punch biopsy of lesional and perilesional skin was sent for hematoxylin and eosin staining and direct immunofluorescence, which demonstrated a subepidermal bullous dermatosis with a predominance of neutrophilic inflammation as well as a band of linear IgG deposition at the dermal-epidermal junction. The patient was diagnosed with BP exhibiting a locus minoris resistentiae phenomenon within the surgical site. She was started on prednisone 1 mg/kg daily and doxycycline 100 mg twice daily and demonstrated rapid improvement.

Although the tense bullae seen in well-developed BP are fairly characteristic, the prodromal phase of this disease can present with urticarial plaques that are nonspecific. This progression is well described, but our case demonstrates the difficulty of considering BP when a patient presents with an urticarial plaque. As lesions progress to the bullous phase, they may be inappropriately diagnosed as allergic contact dermatitis, an error that may lead to unnecessary interventions (eg, removal of an implicated prosthesis). This case is a reminder that not all cutaneous eruptions in and around postsurgical scars are allergic in nature.

This case also depicts BP appearing in the locus minoris resistentiae, a well-healed surgical wound in our patient. Although many diseases have been shown to exhibit this type of isomorphic response, this phenomenon may pose diagnostic and management conundrums. Locus minoris resistentiae has been reported in many different diseases, both cutaneous and otherwise, but there likely are distinct disease- and case-specific mechanisms via which this occurs. Local phenomena reported to trigger BP include contact dermatitis, vaccination, radiation therapy, phototherapy, infection, and surgery.² We suspect that the mechanism of locus minoris resistentiae in our patient was disruption of the architecture of the dermal-epidermal basement membrane zone due to surgical trauma. Disruption of this architecture may have resulted in exposure of previously occult antigens, recognition by T cells, T-cell stimulation of autoantibody production by B cells, binding of autoantibodies to BP180, complement deposition, recruitment of inflammatory cells, release of proteinases, and degradation of BP180 and extracellular matrix proteins.²

Roughly 5% of adults with type 2 diabetes achieve remission of their disease, often unbeknownst to the patient and without aggressive weight-loss interventions, according to a new analysis of data from more than 160,000 people in a national diabetes registry in Scotland.

“One of our key new findings is that a reasonably large proportion of people [with type 2 diabetes] were able to achieve remission in routine care, without undergoing bariatric surgery and prior to the introduction of very-low-calorie interventions in routine care,” said Mireille Captieux, MBChB, lead author of the report, in an interview.

The findings “support previous reports that weight loss is associated with type 2 diabetes remission,” said Dr. Captieux, a diabetes researcher at the University of Edinburgh (Scotland).

In her analysis, two of the strongest correlates of remission related to weight loss.

First, a history of bariatric surgery, which included a scant 488 people (0.3% of the study cohort), was associated with a 13-fold increase in the rate of remission, compared with those who did not undergo bariatric surgery. Second, weight loss of 15 kg (33 lb) or more at the time of remission detection in 2019, in comparison with their weight at initial diabetes diagnosis, was linked with a greater than fourfold increase in the rate of remission, compared with those who did not have this amount of weight loss.

But “even losing a small amount of weight increased the chances of remission,” highlights Dr. Captieux. “This finding offers a counterbalance to the pessimistic assumption that almost all people find it very difficult to lose weight.”
 

Hopeful message, but which people achieve diabetes remission?

“What’s encouraging here is that you have people who probably did not do anything radical, and yet they went into remission. The next step is to find out who these people are and what they did to go into remission,” commented Julia Lawton, PhD, a professor of health and social science at the University of Edinburgh whose research focuses on how patients with diabetes manage their disorder.

“If we can understand who the patients are who can achieve remission without taking extreme measures, it could help people in the health professions get beyond their presumptions about who is, or is not, a good candidate for achieving diabetes remission,” said Dr. Lawton, who was not involved with the study.

The message from this study is “very hopeful,” Dr. Lawton said in an interview. “How can we make this opportunity [for diabetes remission] available to more people? What can we learn from these patients that we could then apply to other patients?”

Dr. Captieux agrees. Given her findings, an important next step is to find out more about the population in remission to better understand “their perspectives on the challenges and benefits of supporting weight loss.

“Obesity is a complex issue, and therefore weight loss interventions that target individual actions and behaviors are much more likely to be effective if they are accompanied by multiple interventions at different levels,” Dr. Captieux said.

In addition, “more evidence is needed to assess the sustainability of diabetes remission and the effect of different durations of remission for a clinically relevant definition.”
 

Duration, definition of diabetes remission

Dr. Captieux noted that the new international consensus definition of type 2 diabetes remission – which specifies a minimum 3-month duration of glycemic control to qualify as remission – means that people with diabetes “may frequently oscillate” between remission and active disease.

This makes it important to better define the effect of duration of diabetes remission regarding various diabetes complications.

Another issue raised by the new findings is the importance of distinguishing people who lose weight because of a healthier diet and increased activity from those who lose weight because of chronic illness or frailty that’s followed by long-term adverse outcomes.

If these two populations are not distinguished in an observational cohort study – such as the one run by Dr. Captieux and her associates – then the people with chronic illness might appear to have worse outcomes following diabetes remission.

Dr. Captieux and her coauthors used data collected in the Scottish Care Information–Diabetes registry, which includes almost all people diagnosed with diabetes in Scotland. They focused on people with diabetes who had first been diagnosed with diabetes during 2004-2018, who were at least 30 years old at the time of their initial diagnosis, and who had received care in the national health system during 2019.

This yielded a study cohort of 162,316 people, of whom 7,710 (4.8%) were identified by the researchers as being in remission in 2019.

Patients in remission were defined as those whose hemoglobin A1c level was less than 6.5% at their index reading in 2019 and whose A1c level could be documented as being lower than 6.5% for at least 1 year prior to the 2019 measurement.

In a primary logistic regression analysis, the authors identified five variables that were significantly linked with remission: age of at least 65 years (the association was even stronger for age older than 75 years), a lower A1c level at the time of initial diabetes diagnosis, weight loss, prior bariatric surgery, and no prior treatment with a glucose-lowering therapy.

The strongest association was with having had no prior treatment with a glucose-lowering therapy in 2019. People who met this criterion were nearly 15 times more likely to be in remission in 2019, compared with those who had received at least one of these agents.

The study received no commercial funding. Dr. Captieux and Dr. Lawton have disclosed no relevant financial relationships.

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

Roughly 5% of adults with type 2 diabetes achieve remission of their disease, often unbeknownst to the patient and without aggressive weight-loss interventions, according to a new analysis of data from more than 160,000 people in a national diabetes registry in Scotland.

“One of our key new findings is that a reasonably large proportion of people [with type 2 diabetes] were able to achieve remission in routine care, without undergoing bariatric surgery and prior to the introduction of very-low-calorie interventions in routine care,” said Mireille Captieux, MBChB, lead author of the report, in an interview.

The findings “support previous reports that weight loss is associated with type 2 diabetes remission,” said Dr. Captieux, a diabetes researcher at the University of Edinburgh (Scotland).

In her analysis, two of the strongest correlates of remission related to weight loss.

First, a history of bariatric surgery, which included a scant 488 people (0.3% of the study cohort), was associated with a 13-fold increase in the rate of remission, compared with those who did not undergo bariatric surgery. Second, weight loss of 15 kg (33 lb) or more at the time of remission detection in 2019, in comparison with their weight at initial diabetes diagnosis, was linked with a greater than fourfold increase in the rate of remission, compared with those who did not have this amount of weight loss.

But “even losing a small amount of weight increased the chances of remission,” highlights Dr. Captieux. “This finding offers a counterbalance to the pessimistic assumption that almost all people find it very difficult to lose weight.”
 

Hopeful message, but which people achieve diabetes remission?

“What’s encouraging here is that you have people who probably did not do anything radical, and yet they went into remission. The next step is to find out who these people are and what they did to go into remission,” commented Julia Lawton, PhD, a professor of health and social science at the University of Edinburgh whose research focuses on how patients with diabetes manage their disorder.

“If we can understand who the patients are who can achieve remission without taking extreme measures, it could help people in the health professions get beyond their presumptions about who is, or is not, a good candidate for achieving diabetes remission,” said Dr. Lawton, who was not involved with the study.

The message from this study is “very hopeful,” Dr. Lawton said in an interview. “How can we make this opportunity [for diabetes remission] available to more people? What can we learn from these patients that we could then apply to other patients?”

Dr. Captieux agrees. Given her findings, an important next step is to find out more about the population in remission to better understand “their perspectives on the challenges and benefits of supporting weight loss.

“Obesity is a complex issue, and therefore weight loss interventions that target individual actions and behaviors are much more likely to be effective if they are accompanied by multiple interventions at different levels,” Dr. Captieux said.

In addition, “more evidence is needed to assess the sustainability of diabetes remission and the effect of different durations of remission for a clinically relevant definition.”
 

Duration, definition of diabetes remission

Dr. Captieux noted that the new international consensus definition of type 2 diabetes remission – which specifies a minimum 3-month duration of glycemic control to qualify as remission – means that people with diabetes “may frequently oscillate” between remission and active disease.

This makes it important to better define the effect of duration of diabetes remission regarding various diabetes complications.

Another issue raised by the new findings is the importance of distinguishing people who lose weight because of a healthier diet and increased activity from those who lose weight because of chronic illness or frailty that’s followed by long-term adverse outcomes.

If these two populations are not distinguished in an observational cohort study – such as the one run by Dr. Captieux and her associates – then the people with chronic illness might appear to have worse outcomes following diabetes remission.

Dr. Captieux and her coauthors used data collected in the Scottish Care Information–Diabetes registry, which includes almost all people diagnosed with diabetes in Scotland. They focused on people with diabetes who had first been diagnosed with diabetes during 2004-2018, who were at least 30 years old at the time of their initial diagnosis, and who had received care in the national health system during 2019.

This yielded a study cohort of 162,316 people, of whom 7,710 (4.8%) were identified by the researchers as being in remission in 2019.

Patients in remission were defined as those whose hemoglobin A1c level was less than 6.5% at their index reading in 2019 and whose A1c level could be documented as being lower than 6.5% for at least 1 year prior to the 2019 measurement.

In a primary logistic regression analysis, the authors identified five variables that were significantly linked with remission: age of at least 65 years (the association was even stronger for age older than 75 years), a lower A1c level at the time of initial diabetes diagnosis, weight loss, prior bariatric surgery, and no prior treatment with a glucose-lowering therapy.

The strongest association was with having had no prior treatment with a glucose-lowering therapy in 2019. People who met this criterion were nearly 15 times more likely to be in remission in 2019, compared with those who had received at least one of these agents.

The study received no commercial funding. Dr. Captieux and Dr. Lawton have disclosed no relevant financial relationships.

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

Roughly 5% of adults with type 2 diabetes achieve remission of their disease, often unbeknownst to the patient and without aggressive weight-loss interventions, according to a new analysis of data from more than 160,000 people in a national diabetes registry in Scotland.

“One of our key new findings is that a reasonably large proportion of people [with type 2 diabetes] were able to achieve remission in routine care, without undergoing bariatric surgery and prior to the introduction of very-low-calorie interventions in routine care,” said Mireille Captieux, MBChB, lead author of the report, in an interview.

The findings “support previous reports that weight loss is associated with type 2 diabetes remission,” said Dr. Captieux, a diabetes researcher at the University of Edinburgh (Scotland).

In her analysis, two of the strongest correlates of remission related to weight loss.

First, a history of bariatric surgery, which included a scant 488 people (0.3% of the study cohort), was associated with a 13-fold increase in the rate of remission, compared with those who did not undergo bariatric surgery. Second, weight loss of 15 kg (33 lb) or more at the time of remission detection in 2019, in comparison with their weight at initial diabetes diagnosis, was linked with a greater than fourfold increase in the rate of remission, compared with those who did not have this amount of weight loss.

But “even losing a small amount of weight increased the chances of remission,” highlights Dr. Captieux. “This finding offers a counterbalance to the pessimistic assumption that almost all people find it very difficult to lose weight.”
 

Hopeful message, but which people achieve diabetes remission?

“What’s encouraging here is that you have people who probably did not do anything radical, and yet they went into remission. The next step is to find out who these people are and what they did to go into remission,” commented Julia Lawton, PhD, a professor of health and social science at the University of Edinburgh whose research focuses on how patients with diabetes manage their disorder.

“If we can understand who the patients are who can achieve remission without taking extreme measures, it could help people in the health professions get beyond their presumptions about who is, or is not, a good candidate for achieving diabetes remission,” said Dr. Lawton, who was not involved with the study.

The message from this study is “very hopeful,” Dr. Lawton said in an interview. “How can we make this opportunity [for diabetes remission] available to more people? What can we learn from these patients that we could then apply to other patients?”

Dr. Captieux agrees. Given her findings, an important next step is to find out more about the population in remission to better understand “their perspectives on the challenges and benefits of supporting weight loss.

“Obesity is a complex issue, and therefore weight loss interventions that target individual actions and behaviors are much more likely to be effective if they are accompanied by multiple interventions at different levels,” Dr. Captieux said.

In addition, “more evidence is needed to assess the sustainability of diabetes remission and the effect of different durations of remission for a clinically relevant definition.”
 

Duration, definition of diabetes remission

Dr. Captieux noted that the new international consensus definition of type 2 diabetes remission – which specifies a minimum 3-month duration of glycemic control to qualify as remission – means that people with diabetes “may frequently oscillate” between remission and active disease.

This makes it important to better define the effect of duration of diabetes remission regarding various diabetes complications.

Another issue raised by the new findings is the importance of distinguishing people who lose weight because of a healthier diet and increased activity from those who lose weight because of chronic illness or frailty that’s followed by long-term adverse outcomes.

If these two populations are not distinguished in an observational cohort study – such as the one run by Dr. Captieux and her associates – then the people with chronic illness might appear to have worse outcomes following diabetes remission.

Dr. Captieux and her coauthors used data collected in the Scottish Care Information–Diabetes registry, which includes almost all people diagnosed with diabetes in Scotland. They focused on people with diabetes who had first been diagnosed with diabetes during 2004-2018, who were at least 30 years old at the time of their initial diagnosis, and who had received care in the national health system during 2019.

This yielded a study cohort of 162,316 people, of whom 7,710 (4.8%) were identified by the researchers as being in remission in 2019.

Patients in remission were defined as those whose hemoglobin A1c level was less than 6.5% at their index reading in 2019 and whose A1c level could be documented as being lower than 6.5% for at least 1 year prior to the 2019 measurement.

In a primary logistic regression analysis, the authors identified five variables that were significantly linked with remission: age of at least 65 years (the association was even stronger for age older than 75 years), a lower A1c level at the time of initial diabetes diagnosis, weight loss, prior bariatric surgery, and no prior treatment with a glucose-lowering therapy.

The strongest association was with having had no prior treatment with a glucose-lowering therapy in 2019. People who met this criterion were nearly 15 times more likely to be in remission in 2019, compared with those who had received at least one of these agents.

The study received no commercial funding. Dr. Captieux and Dr. Lawton have disclosed no relevant financial relationships.

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

Patients with giant cell arteritis (GCA) remained in remission longer when they took secukinumab (Cosentyx) during a 6-month–long taper of glucocorticoids, a monoclonal antibody drug that inhibits interleukin-17A, compared with placebo, according to phase 2 trial results presented at the virtual annual meeting of the American College of Rheumatology.

The mainstay of GCA treatment is glucocorticoids, although IL-6 inhibition with tocilizumab (Actemra) has recently become another option, Jens Thiel, MD, vice director of the Clinic for Rheumatology and Clinical Immunology at University Hospital Freiburg (Germany), told attendees.

“Secukinumab has shown significant improvements in the signs and symptoms of IL-17A-driven medical conditions such as psoriasis and psoriatic arthritis, and it has a very favorable long-term safety profile,” Dr. Thiel said. “There is experimental and preclinical data that points toward the role of IL-17A in the pathogenesis of giant cell arteritis, and therefore IL-17A inhibition, blocking vascular inflammation, is potentially a new therapeutic target for GCA.”

Christopher R. Palma, MD, ScM, assistant professor in the division of allergy, immunology, and rheumatology at the University of Rochester (N.Y.), said in an interview that the trial’s preliminary findings were exciting because they suggest that IL-17A is likely to be an effective strategy for treating GCA. ”This aligns with known pathophysiology of GCA, where IL-17A is an important part of pathology of disease,” Dr. Palma said.

In the randomized, controlled, double-blind trial, researchers enrolled 52 patients, all at least 50 years old, who had never taken a biologic for GCA. Most of the participants (80.8%) had new-onset GCA, diagnosed within the previous 6 weeks, and 19.2% had relapsing GCA. The participants received either 300 mg of secukinumab or placebo every week for 5 weeks, and then every 4 weeks for 48 total weeks. At baseline, all participants also began a 26-week taper of prednisolone from a dose of 25-60 mg/day at baseline to 0 at week 27. The primary endpoint was the proportion of participants in sustained remission through week 28.

Among the 27 participants taking secukinumab and the 25 taking placebo, 37 completed the study treatment (71%). At week 28, those still in remission included 70.1% of participants taking secukinumab and 20.3% of those taking placebo (odds ratio [OR], 9.3). Through week 52, the proportion of participants in remission included 59.3% of the secukinumab group and 8% of the placebo group.

Determination of flare was based on signs and symptoms along with a C-reactive protein level of more than 10 mg/L or an increased erythrocyte sedimentation rate. Dr. Thiel did not provide more details on these parameters or on how flares were determined, but reported that participants taking secukinumab did not reach a median time to first flare, compared to a median 197 days in the placebo group.

All the participants taking secukinumab and 96% of those taking placebo experienced treatment-emergent adverse events, with serious adverse events occurring in 22.2% of those taking secukinumab and 44% of those taking placebo. Two patients in each group discontinued the treatment because of adverse events, and one participant in each group died from causes determined to be unrelated to the treatment.

The trial’s effect size was large, but Dr. Palma noted that the study’s generalizability is limited by prednisolone tapering in the placebo arm because that’s not reflective of most clinical practice for treatment of GCA.

“We would be unlikely to mimic this trial design as we know rates of disease flare and recurrence are high without long-term therapy of some kind,” Dr. Palma said. ”The real challenge will be in assessing relative benefit and risk among many possible therapies and how IL-17A–directed therapies fit in. Obviously, a head-to-head trial design would help answer many of these questions.”

Dr. Palma said it’s too early to recommend widespread off-label use of secukinumab for GCA, but he would encourage his patients with GCA to consider participating in a phase 3 trial of the drug.

Novartis, which markets secukinumab, funded the research. Dr. Thiel has received speaking and/or advising fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis, and research grants from Bristol-Myers Squibb and Novartis. His coauthors had disclosures for a wide range of pharmaceutical companies. Dr. Palma has received research funding from AbbVie, Incyte, and Regeneron.

Patients with giant cell arteritis (GCA) remained in remission longer when they took secukinumab (Cosentyx) during a 6-month–long taper of glucocorticoids, a monoclonal antibody drug that inhibits interleukin-17A, compared with placebo, according to phase 2 trial results presented at the virtual annual meeting of the American College of Rheumatology.

The mainstay of GCA treatment is glucocorticoids, although IL-6 inhibition with tocilizumab (Actemra) has recently become another option, Jens Thiel, MD, vice director of the Clinic for Rheumatology and Clinical Immunology at University Hospital Freiburg (Germany), told attendees.

“Secukinumab has shown significant improvements in the signs and symptoms of IL-17A-driven medical conditions such as psoriasis and psoriatic arthritis, and it has a very favorable long-term safety profile,” Dr. Thiel said. “There is experimental and preclinical data that points toward the role of IL-17A in the pathogenesis of giant cell arteritis, and therefore IL-17A inhibition, blocking vascular inflammation, is potentially a new therapeutic target for GCA.”

Christopher R. Palma, MD, ScM, assistant professor in the division of allergy, immunology, and rheumatology at the University of Rochester (N.Y.), said in an interview that the trial’s preliminary findings were exciting because they suggest that IL-17A is likely to be an effective strategy for treating GCA. ”This aligns with known pathophysiology of GCA, where IL-17A is an important part of pathology of disease,” Dr. Palma said.

In the randomized, controlled, double-blind trial, researchers enrolled 52 patients, all at least 50 years old, who had never taken a biologic for GCA. Most of the participants (80.8%) had new-onset GCA, diagnosed within the previous 6 weeks, and 19.2% had relapsing GCA. The participants received either 300 mg of secukinumab or placebo every week for 5 weeks, and then every 4 weeks for 48 total weeks. At baseline, all participants also began a 26-week taper of prednisolone from a dose of 25-60 mg/day at baseline to 0 at week 27. The primary endpoint was the proportion of participants in sustained remission through week 28.

Among the 27 participants taking secukinumab and the 25 taking placebo, 37 completed the study treatment (71%). At week 28, those still in remission included 70.1% of participants taking secukinumab and 20.3% of those taking placebo (odds ratio [OR], 9.3). Through week 52, the proportion of participants in remission included 59.3% of the secukinumab group and 8% of the placebo group.

Determination of flare was based on signs and symptoms along with a C-reactive protein level of more than 10 mg/L or an increased erythrocyte sedimentation rate. Dr. Thiel did not provide more details on these parameters or on how flares were determined, but reported that participants taking secukinumab did not reach a median time to first flare, compared to a median 197 days in the placebo group.

All the participants taking secukinumab and 96% of those taking placebo experienced treatment-emergent adverse events, with serious adverse events occurring in 22.2% of those taking secukinumab and 44% of those taking placebo. Two patients in each group discontinued the treatment because of adverse events, and one participant in each group died from causes determined to be unrelated to the treatment.

The trial’s effect size was large, but Dr. Palma noted that the study’s generalizability is limited by prednisolone tapering in the placebo arm because that’s not reflective of most clinical practice for treatment of GCA.

“We would be unlikely to mimic this trial design as we know rates of disease flare and recurrence are high without long-term therapy of some kind,” Dr. Palma said. ”The real challenge will be in assessing relative benefit and risk among many possible therapies and how IL-17A–directed therapies fit in. Obviously, a head-to-head trial design would help answer many of these questions.”

Dr. Palma said it’s too early to recommend widespread off-label use of secukinumab for GCA, but he would encourage his patients with GCA to consider participating in a phase 3 trial of the drug.

Novartis, which markets secukinumab, funded the research. Dr. Thiel has received speaking and/or advising fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis, and research grants from Bristol-Myers Squibb and Novartis. His coauthors had disclosures for a wide range of pharmaceutical companies. Dr. Palma has received research funding from AbbVie, Incyte, and Regeneron.

Patients with giant cell arteritis (GCA) remained in remission longer when they took secukinumab (Cosentyx) during a 6-month–long taper of glucocorticoids, a monoclonal antibody drug that inhibits interleukin-17A, compared with placebo, according to phase 2 trial results presented at the virtual annual meeting of the American College of Rheumatology.

The mainstay of GCA treatment is glucocorticoids, although IL-6 inhibition with tocilizumab (Actemra) has recently become another option, Jens Thiel, MD, vice director of the Clinic for Rheumatology and Clinical Immunology at University Hospital Freiburg (Germany), told attendees.

“Secukinumab has shown significant improvements in the signs and symptoms of IL-17A-driven medical conditions such as psoriasis and psoriatic arthritis, and it has a very favorable long-term safety profile,” Dr. Thiel said. “There is experimental and preclinical data that points toward the role of IL-17A in the pathogenesis of giant cell arteritis, and therefore IL-17A inhibition, blocking vascular inflammation, is potentially a new therapeutic target for GCA.”

Christopher R. Palma, MD, ScM, assistant professor in the division of allergy, immunology, and rheumatology at the University of Rochester (N.Y.), said in an interview that the trial’s preliminary findings were exciting because they suggest that IL-17A is likely to be an effective strategy for treating GCA. ”This aligns with known pathophysiology of GCA, where IL-17A is an important part of pathology of disease,” Dr. Palma said.

In the randomized, controlled, double-blind trial, researchers enrolled 52 patients, all at least 50 years old, who had never taken a biologic for GCA. Most of the participants (80.8%) had new-onset GCA, diagnosed within the previous 6 weeks, and 19.2% had relapsing GCA. The participants received either 300 mg of secukinumab or placebo every week for 5 weeks, and then every 4 weeks for 48 total weeks. At baseline, all participants also began a 26-week taper of prednisolone from a dose of 25-60 mg/day at baseline to 0 at week 27. The primary endpoint was the proportion of participants in sustained remission through week 28.

Among the 27 participants taking secukinumab and the 25 taking placebo, 37 completed the study treatment (71%). At week 28, those still in remission included 70.1% of participants taking secukinumab and 20.3% of those taking placebo (odds ratio [OR], 9.3). Through week 52, the proportion of participants in remission included 59.3% of the secukinumab group and 8% of the placebo group.

Determination of flare was based on signs and symptoms along with a C-reactive protein level of more than 10 mg/L or an increased erythrocyte sedimentation rate. Dr. Thiel did not provide more details on these parameters or on how flares were determined, but reported that participants taking secukinumab did not reach a median time to first flare, compared to a median 197 days in the placebo group.

All the participants taking secukinumab and 96% of those taking placebo experienced treatment-emergent adverse events, with serious adverse events occurring in 22.2% of those taking secukinumab and 44% of those taking placebo. Two patients in each group discontinued the treatment because of adverse events, and one participant in each group died from causes determined to be unrelated to the treatment.

The trial’s effect size was large, but Dr. Palma noted that the study’s generalizability is limited by prednisolone tapering in the placebo arm because that’s not reflective of most clinical practice for treatment of GCA.

“We would be unlikely to mimic this trial design as we know rates of disease flare and recurrence are high without long-term therapy of some kind,” Dr. Palma said. ”The real challenge will be in assessing relative benefit and risk among many possible therapies and how IL-17A–directed therapies fit in. Obviously, a head-to-head trial design would help answer many of these questions.”

Dr. Palma said it’s too early to recommend widespread off-label use of secukinumab for GCA, but he would encourage his patients with GCA to consider participating in a phase 3 trial of the drug.

Novartis, which markets secukinumab, funded the research. Dr. Thiel has received speaking and/or advising fees from AbbVie, Bristol-Myers Squibb, GlaxoSmithKline, and Novartis, and research grants from Bristol-Myers Squibb and Novartis. His coauthors had disclosures for a wide range of pharmaceutical companies. Dr. Palma has received research funding from AbbVie, Incyte, and Regeneron.

Health experts are warning the United States could be headed for another COVID-19 surge just as we enter the holiday season, following a massive new wave of infections in Europe – a troubling pattern seen throughout the pandemic.

Eighteen months into the global health crisis that has killed 5.1 million people worldwide including more than 767,000 Americans, Europe has become the epicenter of the global health crisis once again.

And some infectious disease specialists say the United States may be next.

“It’s déjà vu, yet again,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute. In a new analysis published in The Guardian, the professor of molecular medicine argues that it’s “wishful thinking” for U.S. authorities to believe the nation is “immune” to what’s happening in Europe.

Dr. Topol is also editor-in-chief of Medscape, MDedge’s sister site for medical professionals.

Three times over the past 18 months coronavirus surges in the United States followed similar spikes in Europe, where COVID-19 deaths grew by 10% this month.

Dr. Topol argues another wave may be in store for the states, as European countries implement new lockdowns. COVID-19 spikes are hitting some regions of the continent hard, including areas with high vaccination rates and strict control measures.

Eastern Europe and Russia, where vaccination rates are low, have experienced the worst of it. But even western countries, such as Germany, Austria and the United Kingdom, are reporting some of the highest daily infection figures in the world today.

Countries are responding in increasingly drastic ways.

In Russia, President Vladimir Putin ordered tens of thousands of workers to stay home earlier this month.

In the Dutch city of Utrecht, traditional Christmas celebrations have been canceled as the country is headed for a partial lockdown.

Austria announced a 20-day lockdown beginning Nov. 22 and on Nov. 19 leaders there announced that all 9 million residents will be required to be vaccinated by February. Leaders there are telling unvaccinated individuals to stay at home and out of restaurants, cafes, and other shops in hard-hit regions of the country.

And in Germany, where daily new-infection rates now stand at 50,000, officials have introduced stricter mask mandates and made proof of vaccination or past infection mandatory for entry to many venues. Berlin is also eyeing proposals to shut down the city’s traditional Christmas markets while authorities in Cologne have already called off holiday celebrations, after the ceremonial head of festivities tested positive for COVID-19. Bavaria canceled its popular Christmas markets and will order lockdowns in particularly vulnerable districts, while unvaccinated people will face serious restrictions on where they can go.

Former FDA Commissioner Scott Gottlieb, MD, says what’s happening across the European continent is troubling.

But he also believes it’s possible the United States may be better prepared to head off a similar surge this time around, with increased testing, vaccination and new therapies such as monoclonal antibodies, and antiviral therapeutics.

“Germany’s challenges are [a] caution to [the] world, the COVID pandemic isn’t over globally, won’t be for long time,” he says. “But [the] U.S. is further along than many other countries, in part because we already suffered more spread, in part because we’re making progress on vaccines, therapeutics, testing.”

Other experts agree the United States may not be as vulnerable to another wave of COVID-19 in coming weeks but have stopped short of suggesting we’re out of the woods.

“I don’t think that what we’re seeing in Europe necessarily means that we’re in for a huge surge of serious illness and death the way that we saw last year here in the states,” says David Dowdy, MD, PhD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and a general internist with Baltimore Medical Services.

“But I think anyone who says that they can predict the course of the pandemic for the next few months or few years has been proven wrong in the past and will probably be proven wrong in the future,” Dr. Dowdy says. “None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness.”
 

Looking back, and forward

What’s happening in Europe today mirrors past COVID-19 spikes that presaged big upticks in cases, hospitalizations, and deaths in the United States.

When the pandemic first hit Europe in March 2020, then-President Donald Trump downplayed the threat of the virus despite the warnings of his own advisors and independent public health experts who said COVID-19 could have dire impacts without an aggressive federal action plan.

By late spring the United States had become the epicenter of the pandemic, when case totals eclipsed those of other countries and New York City became a hot zone, according to data compiled by the Johns Hopkins Coronavirus Resource Center. Over the summer, spread of the disease slowed in New York, after tough control measures were instituted, but steadily increased in other states.

Then, later in the year, the Alpha variant of the virus took hold in the United Kingdom and the United States was again unprepared. By winter, the number of cases accelerated in every state in a major second surge that kept millions of Americans from traveling and gathering for the winter holidays.

With the rollout of COVID vaccines last December, cases in the United States – and in many parts of the world – began to fall. Some experts even suggested we’d turned a corner on the pandemic.

But then, last spring and summer, the Delta variant popped up in India and spread to the United Kingdom in a third major wave of COVID. Once again, the United States was unprepared, with 4 in 10 Americans refusing the vaccine and even some vaccinated individuals succumbing to breakthrough Delta infections.

The resulting Delta surge swept the country, preventing many businesses and schools from fully reopening and stressing hospitals in some areas of the country – particularly southern states – with new influxes of COVID-19 patients.

Now, Europe is facing another rise in COVID, with about 350 cases per 100,000 people and many countries hitting new record highs.
 

What’s driving the European resurgence?

So, what’s behind the new COVID-19 wave in Europe and what might it mean for the United States?

Shaun Truelove, PhD, an infectious disease epidemiologist and faculty member of the Johns Hopkins School of Public Health, says experts are examining several likely factors:

Waning immunity from the vaccines. Data from Johns Hopkins shows infections rising in nations with lower vaccination rates.

The impact of the Delta variant, which is three times more transmissible than the original virus and can even sicken some vaccinated individuals.

The spread of COVID-19 among teens and children; the easing of precautions (such as masking and social distancing); differences in the types of vaccines used in European nations and the United States.

“These are all possibilities,” says Dr. Truelove. “There are so many factors and so it’s difficult to pinpoint exactly what’s driving it and what effect each of those things might be having.”

As a result, it’s difficult to predict and prepare for what might lie ahead for the United States, he says.

“There’s a ton of uncertainty and we’re trying to understand what’s going to happen here over the next 6 months,” he says.

Even so, Dr. Truelove adds that what’s happening overseas might not be “super predictive” of a new wave of COVID in the United States.

For one thing, he says, the Pfizer and Moderna vaccines, the two mRNA vaccines used predominantly in the United States, are far more effective – 94-95% – than the Oxford/AstraZeneca COVID shot (63%) widely administered across Europe.

Secondly, European countries have imposed much stronger and stricter control measures throughout the pandemic than the United States. That might actually be driving the new surges because fewer unvaccinated people have been exposed to the virus, which means they have lower “natural immunity” from prior COVID infection.

Dr. Truelove explains: “Stronger and stricter control measures … have the consequence of leaving a lot more susceptible individuals in the population, [because] the stronger the controls, the fewer people get infected. And so, you have more individuals remaining in the population who are more susceptible and at risk of getting infected in the future.”

By contrast, he notes, a “large chunk” of the United States has not put strict lockdowns in place.

“So, what we’ve seen over the past couple months with the Delta wave is that in a lot of those states with lower vaccination coverage and lower controls this virus has really burned through a lot of the susceptible population. As a result, we’re seeing the curves coming down and what really looks like a lot of the built-up immunity in these states, especially southern states.”

But whether these differences will be enough for the United States to dodge another COVID-19 bullet this winter is uncertain.

“I don’t want to say that the [Europe] surge is NOT a predictor of what might come in the U.S., because I think that it very well could be,” Dr. Truelove says. “And so, people need to be aware of that, and be cautious and be sure get their vaccines and everything else.

“But I’m hopeful that because of some of the differences that maybe we’ll have a little bit of a different situation.”
 

The takeaway: How best to prepare?

Dr. Dowdy agrees that Europe’s current troubles might not necessarily mean a major new winter surge in the United States.

But he also points out that cases are beginning to head up again in New England, the Midwest, and other regions of the country that are just experiencing the first chill of winter.

“After reaching a low point about 3 weeks ago, cases due to COVID-19 have started to rise again in the United States,” he says. “Cases were falling consistently until mid-October, but over the last 3 weeks, cases have started to rise again in most states.

“Cases in Eastern and Central Europe have more than doubled during that time, meaning that the possibility of a winter surge here is very real.”

Even so, Dr. Dowdy believes the rising rates of vaccination could limit the number of Americans who will be hospitalized with severe disease or die this winter.

Still, he warns against being too optimistic, as Americans travel and get together for the winter holidays.

None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness, Dr. Dowdy says.”

The upshot?

“People need to realize that it’s not quite over,” Dr. Truelove says. “We still have a substantial amount of infection in our country. We’re still above 200 cases per million [and] 500,000 incident cases per week or so. That’s a lot of death and a lot of hospitalizations. So, we still have to be concerned and do our best to reduce transmission … by wearing masks, getting vaccinated, getting a booster shot, and getting your children vaccinated.”

Johns Hopkins social and behavioral scientist Rupali Limaye, PhD, MPH, adds that while COVID vaccines have been a “game changer” in the pandemic, more than a third of Americans have yet to receive one.

“That’s really what we need to be messaging around -- that people can still get COVID, there can still be breakthrough infections,” says Dr. Limaye, a health communications scholar. “But the great news is if you have been vaccinated, you are very much less likely, I think it’s 12 times, to be hospitalized or have severe COVID compared to those that are un-vaccinated.”

Dr. Topol agrees, adding: “Now is the time for the U.S. to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates ...

“Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute.”

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

Health experts are warning the United States could be headed for another COVID-19 surge just as we enter the holiday season, following a massive new wave of infections in Europe – a troubling pattern seen throughout the pandemic.

Eighteen months into the global health crisis that has killed 5.1 million people worldwide including more than 767,000 Americans, Europe has become the epicenter of the global health crisis once again.

And some infectious disease specialists say the United States may be next.

“It’s déjà vu, yet again,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute. In a new analysis published in The Guardian, the professor of molecular medicine argues that it’s “wishful thinking” for U.S. authorities to believe the nation is “immune” to what’s happening in Europe.

Dr. Topol is also editor-in-chief of Medscape, MDedge’s sister site for medical professionals.

Three times over the past 18 months coronavirus surges in the United States followed similar spikes in Europe, where COVID-19 deaths grew by 10% this month.

Dr. Topol argues another wave may be in store for the states, as European countries implement new lockdowns. COVID-19 spikes are hitting some regions of the continent hard, including areas with high vaccination rates and strict control measures.

Eastern Europe and Russia, where vaccination rates are low, have experienced the worst of it. But even western countries, such as Germany, Austria and the United Kingdom, are reporting some of the highest daily infection figures in the world today.

Countries are responding in increasingly drastic ways.

In Russia, President Vladimir Putin ordered tens of thousands of workers to stay home earlier this month.

In the Dutch city of Utrecht, traditional Christmas celebrations have been canceled as the country is headed for a partial lockdown.

Austria announced a 20-day lockdown beginning Nov. 22 and on Nov. 19 leaders there announced that all 9 million residents will be required to be vaccinated by February. Leaders there are telling unvaccinated individuals to stay at home and out of restaurants, cafes, and other shops in hard-hit regions of the country.

And in Germany, where daily new-infection rates now stand at 50,000, officials have introduced stricter mask mandates and made proof of vaccination or past infection mandatory for entry to many venues. Berlin is also eyeing proposals to shut down the city’s traditional Christmas markets while authorities in Cologne have already called off holiday celebrations, after the ceremonial head of festivities tested positive for COVID-19. Bavaria canceled its popular Christmas markets and will order lockdowns in particularly vulnerable districts, while unvaccinated people will face serious restrictions on where they can go.

Former FDA Commissioner Scott Gottlieb, MD, says what’s happening across the European continent is troubling.

But he also believes it’s possible the United States may be better prepared to head off a similar surge this time around, with increased testing, vaccination and new therapies such as monoclonal antibodies, and antiviral therapeutics.

“Germany’s challenges are [a] caution to [the] world, the COVID pandemic isn’t over globally, won’t be for long time,” he says. “But [the] U.S. is further along than many other countries, in part because we already suffered more spread, in part because we’re making progress on vaccines, therapeutics, testing.”

Other experts agree the United States may not be as vulnerable to another wave of COVID-19 in coming weeks but have stopped short of suggesting we’re out of the woods.

“I don’t think that what we’re seeing in Europe necessarily means that we’re in for a huge surge of serious illness and death the way that we saw last year here in the states,” says David Dowdy, MD, PhD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and a general internist with Baltimore Medical Services.

“But I think anyone who says that they can predict the course of the pandemic for the next few months or few years has been proven wrong in the past and will probably be proven wrong in the future,” Dr. Dowdy says. “None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness.”
 

Looking back, and forward

What’s happening in Europe today mirrors past COVID-19 spikes that presaged big upticks in cases, hospitalizations, and deaths in the United States.

When the pandemic first hit Europe in March 2020, then-President Donald Trump downplayed the threat of the virus despite the warnings of his own advisors and independent public health experts who said COVID-19 could have dire impacts without an aggressive federal action plan.

By late spring the United States had become the epicenter of the pandemic, when case totals eclipsed those of other countries and New York City became a hot zone, according to data compiled by the Johns Hopkins Coronavirus Resource Center. Over the summer, spread of the disease slowed in New York, after tough control measures were instituted, but steadily increased in other states.

Then, later in the year, the Alpha variant of the virus took hold in the United Kingdom and the United States was again unprepared. By winter, the number of cases accelerated in every state in a major second surge that kept millions of Americans from traveling and gathering for the winter holidays.

With the rollout of COVID vaccines last December, cases in the United States – and in many parts of the world – began to fall. Some experts even suggested we’d turned a corner on the pandemic.

But then, last spring and summer, the Delta variant popped up in India and spread to the United Kingdom in a third major wave of COVID. Once again, the United States was unprepared, with 4 in 10 Americans refusing the vaccine and even some vaccinated individuals succumbing to breakthrough Delta infections.

The resulting Delta surge swept the country, preventing many businesses and schools from fully reopening and stressing hospitals in some areas of the country – particularly southern states – with new influxes of COVID-19 patients.

Now, Europe is facing another rise in COVID, with about 350 cases per 100,000 people and many countries hitting new record highs.
 

What’s driving the European resurgence?

So, what’s behind the new COVID-19 wave in Europe and what might it mean for the United States?

Shaun Truelove, PhD, an infectious disease epidemiologist and faculty member of the Johns Hopkins School of Public Health, says experts are examining several likely factors:

Waning immunity from the vaccines. Data from Johns Hopkins shows infections rising in nations with lower vaccination rates.

The impact of the Delta variant, which is three times more transmissible than the original virus and can even sicken some vaccinated individuals.

The spread of COVID-19 among teens and children; the easing of precautions (such as masking and social distancing); differences in the types of vaccines used in European nations and the United States.

“These are all possibilities,” says Dr. Truelove. “There are so many factors and so it’s difficult to pinpoint exactly what’s driving it and what effect each of those things might be having.”

As a result, it’s difficult to predict and prepare for what might lie ahead for the United States, he says.

“There’s a ton of uncertainty and we’re trying to understand what’s going to happen here over the next 6 months,” he says.

Even so, Dr. Truelove adds that what’s happening overseas might not be “super predictive” of a new wave of COVID in the United States.

For one thing, he says, the Pfizer and Moderna vaccines, the two mRNA vaccines used predominantly in the United States, are far more effective – 94-95% – than the Oxford/AstraZeneca COVID shot (63%) widely administered across Europe.

Secondly, European countries have imposed much stronger and stricter control measures throughout the pandemic than the United States. That might actually be driving the new surges because fewer unvaccinated people have been exposed to the virus, which means they have lower “natural immunity” from prior COVID infection.

Dr. Truelove explains: “Stronger and stricter control measures … have the consequence of leaving a lot more susceptible individuals in the population, [because] the stronger the controls, the fewer people get infected. And so, you have more individuals remaining in the population who are more susceptible and at risk of getting infected in the future.”

By contrast, he notes, a “large chunk” of the United States has not put strict lockdowns in place.

“So, what we’ve seen over the past couple months with the Delta wave is that in a lot of those states with lower vaccination coverage and lower controls this virus has really burned through a lot of the susceptible population. As a result, we’re seeing the curves coming down and what really looks like a lot of the built-up immunity in these states, especially southern states.”

But whether these differences will be enough for the United States to dodge another COVID-19 bullet this winter is uncertain.

“I don’t want to say that the [Europe] surge is NOT a predictor of what might come in the U.S., because I think that it very well could be,” Dr. Truelove says. “And so, people need to be aware of that, and be cautious and be sure get their vaccines and everything else.

“But I’m hopeful that because of some of the differences that maybe we’ll have a little bit of a different situation.”
 

The takeaway: How best to prepare?

Dr. Dowdy agrees that Europe’s current troubles might not necessarily mean a major new winter surge in the United States.

But he also points out that cases are beginning to head up again in New England, the Midwest, and other regions of the country that are just experiencing the first chill of winter.

“After reaching a low point about 3 weeks ago, cases due to COVID-19 have started to rise again in the United States,” he says. “Cases were falling consistently until mid-October, but over the last 3 weeks, cases have started to rise again in most states.

“Cases in Eastern and Central Europe have more than doubled during that time, meaning that the possibility of a winter surge here is very real.”

Even so, Dr. Dowdy believes the rising rates of vaccination could limit the number of Americans who will be hospitalized with severe disease or die this winter.

Still, he warns against being too optimistic, as Americans travel and get together for the winter holidays.

None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness, Dr. Dowdy says.”

The upshot?

“People need to realize that it’s not quite over,” Dr. Truelove says. “We still have a substantial amount of infection in our country. We’re still above 200 cases per million [and] 500,000 incident cases per week or so. That’s a lot of death and a lot of hospitalizations. So, we still have to be concerned and do our best to reduce transmission … by wearing masks, getting vaccinated, getting a booster shot, and getting your children vaccinated.”

Johns Hopkins social and behavioral scientist Rupali Limaye, PhD, MPH, adds that while COVID vaccines have been a “game changer” in the pandemic, more than a third of Americans have yet to receive one.

“That’s really what we need to be messaging around -- that people can still get COVID, there can still be breakthrough infections,” says Dr. Limaye, a health communications scholar. “But the great news is if you have been vaccinated, you are very much less likely, I think it’s 12 times, to be hospitalized or have severe COVID compared to those that are un-vaccinated.”

Dr. Topol agrees, adding: “Now is the time for the U.S. to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates ...

“Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute.”

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

Health experts are warning the United States could be headed for another COVID-19 surge just as we enter the holiday season, following a massive new wave of infections in Europe – a troubling pattern seen throughout the pandemic.

Eighteen months into the global health crisis that has killed 5.1 million people worldwide including more than 767,000 Americans, Europe has become the epicenter of the global health crisis once again.

And some infectious disease specialists say the United States may be next.

“It’s déjà vu, yet again,” says Eric Topol, M.D., founder and director of the Scripps Research Translational Institute. In a new analysis published in The Guardian, the professor of molecular medicine argues that it’s “wishful thinking” for U.S. authorities to believe the nation is “immune” to what’s happening in Europe.

Dr. Topol is also editor-in-chief of Medscape, MDedge’s sister site for medical professionals.

Three times over the past 18 months coronavirus surges in the United States followed similar spikes in Europe, where COVID-19 deaths grew by 10% this month.

Dr. Topol argues another wave may be in store for the states, as European countries implement new lockdowns. COVID-19 spikes are hitting some regions of the continent hard, including areas with high vaccination rates and strict control measures.

Eastern Europe and Russia, where vaccination rates are low, have experienced the worst of it. But even western countries, such as Germany, Austria and the United Kingdom, are reporting some of the highest daily infection figures in the world today.

Countries are responding in increasingly drastic ways.

In Russia, President Vladimir Putin ordered tens of thousands of workers to stay home earlier this month.

In the Dutch city of Utrecht, traditional Christmas celebrations have been canceled as the country is headed for a partial lockdown.

Austria announced a 20-day lockdown beginning Nov. 22 and on Nov. 19 leaders there announced that all 9 million residents will be required to be vaccinated by February. Leaders there are telling unvaccinated individuals to stay at home and out of restaurants, cafes, and other shops in hard-hit regions of the country.

And in Germany, where daily new-infection rates now stand at 50,000, officials have introduced stricter mask mandates and made proof of vaccination or past infection mandatory for entry to many venues. Berlin is also eyeing proposals to shut down the city’s traditional Christmas markets while authorities in Cologne have already called off holiday celebrations, after the ceremonial head of festivities tested positive for COVID-19. Bavaria canceled its popular Christmas markets and will order lockdowns in particularly vulnerable districts, while unvaccinated people will face serious restrictions on where they can go.

Former FDA Commissioner Scott Gottlieb, MD, says what’s happening across the European continent is troubling.

But he also believes it’s possible the United States may be better prepared to head off a similar surge this time around, with increased testing, vaccination and new therapies such as monoclonal antibodies, and antiviral therapeutics.

“Germany’s challenges are [a] caution to [the] world, the COVID pandemic isn’t over globally, won’t be for long time,” he says. “But [the] U.S. is further along than many other countries, in part because we already suffered more spread, in part because we’re making progress on vaccines, therapeutics, testing.”

Other experts agree the United States may not be as vulnerable to another wave of COVID-19 in coming weeks but have stopped short of suggesting we’re out of the woods.

“I don’t think that what we’re seeing in Europe necessarily means that we’re in for a huge surge of serious illness and death the way that we saw last year here in the states,” says David Dowdy, MD, PhD, an associate professor of epidemiology at the Johns Hopkins Bloomberg School of Public Health and a general internist with Baltimore Medical Services.

“But I think anyone who says that they can predict the course of the pandemic for the next few months or few years has been proven wrong in the past and will probably be proven wrong in the future,” Dr. Dowdy says. “None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness.”
 

Looking back, and forward

What’s happening in Europe today mirrors past COVID-19 spikes that presaged big upticks in cases, hospitalizations, and deaths in the United States.

When the pandemic first hit Europe in March 2020, then-President Donald Trump downplayed the threat of the virus despite the warnings of his own advisors and independent public health experts who said COVID-19 could have dire impacts without an aggressive federal action plan.

By late spring the United States had become the epicenter of the pandemic, when case totals eclipsed those of other countries and New York City became a hot zone, according to data compiled by the Johns Hopkins Coronavirus Resource Center. Over the summer, spread of the disease slowed in New York, after tough control measures were instituted, but steadily increased in other states.

Then, later in the year, the Alpha variant of the virus took hold in the United Kingdom and the United States was again unprepared. By winter, the number of cases accelerated in every state in a major second surge that kept millions of Americans from traveling and gathering for the winter holidays.

With the rollout of COVID vaccines last December, cases in the United States – and in many parts of the world – began to fall. Some experts even suggested we’d turned a corner on the pandemic.

But then, last spring and summer, the Delta variant popped up in India and spread to the United Kingdom in a third major wave of COVID. Once again, the United States was unprepared, with 4 in 10 Americans refusing the vaccine and even some vaccinated individuals succumbing to breakthrough Delta infections.

The resulting Delta surge swept the country, preventing many businesses and schools from fully reopening and stressing hospitals in some areas of the country – particularly southern states – with new influxes of COVID-19 patients.

Now, Europe is facing another rise in COVID, with about 350 cases per 100,000 people and many countries hitting new record highs.
 

What’s driving the European resurgence?

So, what’s behind the new COVID-19 wave in Europe and what might it mean for the United States?

Shaun Truelove, PhD, an infectious disease epidemiologist and faculty member of the Johns Hopkins School of Public Health, says experts are examining several likely factors:

Waning immunity from the vaccines. Data from Johns Hopkins shows infections rising in nations with lower vaccination rates.

The impact of the Delta variant, which is three times more transmissible than the original virus and can even sicken some vaccinated individuals.

The spread of COVID-19 among teens and children; the easing of precautions (such as masking and social distancing); differences in the types of vaccines used in European nations and the United States.

“These are all possibilities,” says Dr. Truelove. “There are so many factors and so it’s difficult to pinpoint exactly what’s driving it and what effect each of those things might be having.”

As a result, it’s difficult to predict and prepare for what might lie ahead for the United States, he says.

“There’s a ton of uncertainty and we’re trying to understand what’s going to happen here over the next 6 months,” he says.

Even so, Dr. Truelove adds that what’s happening overseas might not be “super predictive” of a new wave of COVID in the United States.

For one thing, he says, the Pfizer and Moderna vaccines, the two mRNA vaccines used predominantly in the United States, are far more effective – 94-95% – than the Oxford/AstraZeneca COVID shot (63%) widely administered across Europe.

Secondly, European countries have imposed much stronger and stricter control measures throughout the pandemic than the United States. That might actually be driving the new surges because fewer unvaccinated people have been exposed to the virus, which means they have lower “natural immunity” from prior COVID infection.

Dr. Truelove explains: “Stronger and stricter control measures … have the consequence of leaving a lot more susceptible individuals in the population, [because] the stronger the controls, the fewer people get infected. And so, you have more individuals remaining in the population who are more susceptible and at risk of getting infected in the future.”

By contrast, he notes, a “large chunk” of the United States has not put strict lockdowns in place.

“So, what we’ve seen over the past couple months with the Delta wave is that in a lot of those states with lower vaccination coverage and lower controls this virus has really burned through a lot of the susceptible population. As a result, we’re seeing the curves coming down and what really looks like a lot of the built-up immunity in these states, especially southern states.”

But whether these differences will be enough for the United States to dodge another COVID-19 bullet this winter is uncertain.

“I don’t want to say that the [Europe] surge is NOT a predictor of what might come in the U.S., because I think that it very well could be,” Dr. Truelove says. “And so, people need to be aware of that, and be cautious and be sure get their vaccines and everything else.

“But I’m hopeful that because of some of the differences that maybe we’ll have a little bit of a different situation.”
 

The takeaway: How best to prepare?

Dr. Dowdy agrees that Europe’s current troubles might not necessarily mean a major new winter surge in the United States.

But he also points out that cases are beginning to head up again in New England, the Midwest, and other regions of the country that are just experiencing the first chill of winter.

“After reaching a low point about 3 weeks ago, cases due to COVID-19 have started to rise again in the United States,” he says. “Cases were falling consistently until mid-October, but over the last 3 weeks, cases have started to rise again in most states.

“Cases in Eastern and Central Europe have more than doubled during that time, meaning that the possibility of a winter surge here is very real.”

Even so, Dr. Dowdy believes the rising rates of vaccination could limit the number of Americans who will be hospitalized with severe disease or die this winter.

Still, he warns against being too optimistic, as Americans travel and get together for the winter holidays.

None of us knows the future of this pandemic, but I do think that we are in for an increase of cases, not necessarily of deaths and serious illness, Dr. Dowdy says.”

The upshot?

“People need to realize that it’s not quite over,” Dr. Truelove says. “We still have a substantial amount of infection in our country. We’re still above 200 cases per million [and] 500,000 incident cases per week or so. That’s a lot of death and a lot of hospitalizations. So, we still have to be concerned and do our best to reduce transmission … by wearing masks, getting vaccinated, getting a booster shot, and getting your children vaccinated.”

Johns Hopkins social and behavioral scientist Rupali Limaye, PhD, MPH, adds that while COVID vaccines have been a “game changer” in the pandemic, more than a third of Americans have yet to receive one.

“That’s really what we need to be messaging around -- that people can still get COVID, there can still be breakthrough infections,” says Dr. Limaye, a health communications scholar. “But the great news is if you have been vaccinated, you are very much less likely, I think it’s 12 times, to be hospitalized or have severe COVID compared to those that are un-vaccinated.”

Dr. Topol agrees, adding: “Now is the time for the U.S. to heed the European signal for the first time, to pull out all the stops. Promote primary vaccination and boosters like there’s no tomorrow. Aggressively counter the pervasive misinformation and disinformation. Accelerate and expand the vaccine mandates ...

“Instead of succumbing to yet another major rise in cases and their sequelae, this is a chance for America to finally rise to the occasion, showing an ability to lead and execute.”

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

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

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

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

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

Over the past 2 years, the COVID-19 pandemic has caused numerous disruptions in health care, including in global HIV/AIDS services. But new data presented at the Association of Nurses in AIDS Care (ANAC) 2021 Annual Meeting suggest that practitioners quickly adapted to challenges posed by the pandemic, and care and prevention services around the world have begun to return to prepandemic levels.

These rebounding numbers “show how resilient the HIV system can be,” Jennifer Kates, PhD, senior vice president and director of global health and HIV policy at the Kaiser Family Foundation (KFF), said in an interview. She presented the data during her ANAC plenary talk on Nov. 11. Dr. Kates noted that continued recovery relies on improving global access to and delivery of COVID-19 vaccines. “If we do not have control of COVID, we are going to see endless cycles of impact,” she said during her talk.
 

COVID-19 and HIV services

Although there was concern that the pandemic could disrupt access to antiretrovirals, the Global Fund previously reported a nearly 9% increase in people receiving antiretroviral therapy (ART) from 2019 to 2020. HIV prevention and testing did take a hit: There was a 22% decrease in testing for HIV and an 11% decline in the number of people receiving HIV prevention services over that period.

New data from the President’s Emergency Plan for AIDS Relief (PEPFAR) showed similar trends. Consistent with the Global Fund’s findings, a KFF analysis of PEPFAR data found that the number of people receiving ART grew in 2020, climbing from 16.0 million in the first quarter (Q1) of 2020 to 17.4 million by the end of the year. The most recent data from PEPFAR suggest that the number had climbed to 18.4 million by September 2021.

However, there was a 24% decrease in the number of newly enrolled individuals receiving ART from Q2 to Q3 in 2020. It dipped from 669,436 to 509,509. There was a similar decrease in the number of people being tested for HIV, dropping 25% from an estimated 16,700 to 12,500 from Q2 to Q3. But by the end of the year, both measurements had rebounded: New enrollments in ART grew 31%, and HIV testing grew nearly 41% compared to Q3.

The DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) program, which is focused on adolescent girls and young women, saw a dip in preexposure prophylaxis (PrEP) and other preventive services in Q4 2020, but numbers surpassed prepandemic levels by June 2021.

PEPFAR helped speed recovery, Dr. Kates said, by providing guidance on COVID-19 protocols to the field and implementing innovations, such as accelerated 3- and 6-month medication dispensing, virtual platforms, and decentralized drug delivery. In addition, the U.S. Congress allocated $3.8 billion in emergency funding in fiscal year 2021 to help mitigate the effects of COVID-19 on HIV and AIDS care.
 

Longer-term outcomes still unclear

Although these numbers are encouraging, some of the effects of COVID-19 on the HIV epidemic are still unknown – in particular, whether these documented dips in preventive services will translate to an increase in new infections. This will not be clear until a year or 2 from now, Dr. Kates noted. Increased use of ART as well as an increase in some behaviors associated with the pandemic, such as decreased social contact, are factors that mitigate an increase in the rate of infections, she said, but “how that all is going to play out we don’t know for sure.”

Other conference attendees expressed anxiety about the possibility of an increase in the rate of infections. “I’m waiting for the other shoe to drop, as it were,” Barb Cardell, training and technical assistance director at Positive Women’s Network–USA, in Oakland, Calif., said in an interview. The Positive Women’s Network is a national organization of women living with HIV. “Starting late in 2019, we have been cautioning public health officials in states and federally that there will likely be an uptick in HIV diagnosis as we return to whatever ‘normal’ looks like these days,” Ms. Cardell noted, adding, “We have all heard stories of folks that had an exposure and weren’t able to access PrEP during the pandemic and hence seroconverted.”

Kara McGee, associate clinical professor at Duke University School of Nursing, Durham, N.C., shared similar sentiments. “Many people at risk of acquiring HIV had trouble accessing testing and prevention prior to the pandemic, and service interruptions due to the COVID-19 pandemic have only worsened access – especially in rural areas,” she told this news organization.

Need for equitable vaccine access

For HIV services to continue to rebound, COVID-19 vaccination needs to be made a priority globally, Dr. Kates said. But data suggest lower-income countries are being left behind. In high-income countries, 65% of the population has been fully vaccinated, compared to 2% of people in the lowest-income countries. A KFF analysis projected that at the current rates of vaccination, these disparities will widen over time. COVID-19 testing rates in lower-income countries also lag. In high-income countries, 740 tests per 100,000 individuals are conducted daily; in low-income countries, that rate is 13 daily tests per 100,000 people. Until we can achieve more equitable access globally, the documented recovery of HIV is “precarious,” Dr. Kates said.

Ms. McGee agreed with Dr. Kates and was surprised by the extent of global inequities in the COVID-19 response. She said these issues should be a focus for the HIV health care community moving forward. “I think there are lot of us who have worked in the HIV field for many years – both domestically and internationally – who did not fully grasp the global disparities and need to consider how we can advocate for more equal access and distribution,” she said.

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

Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.

“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.

In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”

To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.

Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”

More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.

The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.

Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.

“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.

Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”

Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.

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

Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.

“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.

In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”

To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.

Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”

More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.

The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.

Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.

“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.

Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”

Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.

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

Religion and masculine ideology remain significant social cultural barriers to sexual health in Hispanic gay or bisexual men, according to new qualitative research presented at the 2021 Association of Nurses in AIDS Care conference. The pilot study also found that these men learned more sexual health information from friends and social networks than from their health care professionals.

“There’s still so much we do not know about cultural factors and the different levels of influence that shape sexual health promotion beliefs among Latinos, but moreover in Latino same-gender–loving men,” lead author Lisvel Matos, MSN, FNP-C, WHNP-BC, a PhD candidate at Duke University’s School of Nursing, Durham, N.C., said in an interview. Ms. Matos prefers the term same-gender–loving men (SGLM) over men who have sex with men, as the latter term is more clinical and can be stigmatizing.

In Ms. Matos’ 10 years of working in nursing, she noticed that this lack of understanding about sexual health in Hispanic SGLM impeded culturally relevant interventions in this population. “When we don’t have the evidence to show what’s effective for these populations,” she said, “then we’re kind of working blind.”

To get a better sense of social cultural barriers that influence sexual health, Ms. Matos and colleagues conducted 60- to 75-minute interviews with Hispanic SGLM through the secure web conferencing app WebEx from October 2020 to October 2021. The study used the World Health Organization’s definition of sexual health: “a state of physical, emotional, mental and social well-being in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity.” The pilot study included 15 individuals, 8 of whom were born outside of the United States. The mean age of participants was 31.4 years, and 47% reported being single and sexually active. 93% of participants said they were aware of pre-exposure prophylaxis (PrEP), and 47% reported using PrEP.

Ms. Matos identified three common themes in barriers to sexual health in these men: sexual silence, religion, and machismo, a term meaning aggressive masculine pride and patriarchal ideas of manhood. “Because of social constructs, because of what it meant to be a man, [sexual health] was a very difficult subject in adolescence,” said one participant in a quote included on the poster. “I definitely believe in Christianity, and I think that has affected my sexual preference,” said another quoted individual. “It came into that Catholic guilt where you always feel bad.”

More than half of the study participants reported not having access to health care at one time in their life, because of lack of insurance or other factors such as feeling uncomfortable or even dehumanized by health care professionals. Most men said they learned about sexual health, including PrEP, from dating apps like Grindr or friend-based social media platforms rather than in care settings. Ms. Matos, who presented the study at the conference, received the Student Poster Research Award for her work.

The findings are “a good reminder for providers” that these barriers, which have been identified for decades, are still major impediments to sexual health in Hispanic SGLM, both individually and at the clinic level, Dalmacio Dennis Flores, PhD, ACRN, an assistant professor at the University of Pennsylvania School of Nursing, Philadelphia, said in an interview. He was not involved with the work. “We need to be in a space to normalize their attractions, behaviors, and identities and then help them to be more confident about it,” he noted.

Self-confidence as well as trust in sexual partners and health providers were factors that helped these men overcome this negative messaging and sociocultural stigmas, Ms. Matos found.

“The fact that [the researchers] have individual level data about the experiences of this group of men can inform how we develop clinic-level structures that can, for example, promote trust with the provider,” added Kamila Alexander, PhD, MPH, RN, an assistant professor and associate director of PhD and postdoctoral programs at Johns Hopkins University’s School of Nursing, Baltimore.

Dr. Alexander, who was not involved with the research, added that the small study is a good starting point to better inform culturally relevant care for populations marginalized by society, like Hispanic SGLM, and to challenge ingrained stereotypes around religion, masculinity, and sexuality. The researchers “highlighted these intersectional stigmas that have a lot to do with structural factors,” she said, “and those things are really ripe for intervention.”

Ms. Matos, Dr. Flores, and Dr. Alexander disclosed no relevant financial relationships.

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

Background: The timing and need for ERCP in the setting of gallstone pancreatitis without acute cholangitis has been debated widely. Guidelines recommend urgent ERCP for patients with gallstone pancreatitis with concurrent cholangitis, severe cholestasis, or a visualized stone in the duct, but it is unclear if ERCP benefits those with gallstone pancreatitis without those clear indicators.

Dr. Reddy is a hospitalist at Northwestern Memorial Hospital and instructor of medicine, Feinberg School of Medicine, both in Chicago.

Background: The timing and need for ERCP in the setting of gallstone pancreatitis without acute cholangitis has been debated widely. Guidelines recommend urgent ERCP for patients with gallstone pancreatitis with concurrent cholangitis, severe cholestasis, or a visualized stone in the duct, but it is unclear if ERCP benefits those with gallstone pancreatitis without those clear indicators.

Dr. Reddy is a hospitalist at Northwestern Memorial Hospital and instructor of medicine, Feinberg School of Medicine, both in Chicago.

Background: The timing and need for ERCP in the setting of gallstone pancreatitis without acute cholangitis has been debated widely. Guidelines recommend urgent ERCP for patients with gallstone pancreatitis with concurrent cholangitis, severe cholestasis, or a visualized stone in the duct, but it is unclear if ERCP benefits those with gallstone pancreatitis without those clear indicators.

Dr. Reddy is a hospitalist at Northwestern Memorial Hospital and instructor of medicine, Feinberg School of Medicine, both in Chicago.