Commentary: Appropriate Downstaging and TACE in HCC, September 2022

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Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Patients with hepatocellular carcinoma (HCC) benefit from multidisciplinary care. This month, we will review several articles that report outcomes from various treatment modalities.

Liver transplantation has the opportunity to cure both localized HCC as well as underlying liver cirrhosis. Donor organ shortage has led to the implementation of the Milan criteria as a way to identify patients whose tumor burden is low enough to predict a good outcome. Downstaging liver cancer to fit within Milan criteria has been controversial.

Tabrizian and colleagues undertook a retrospective cohort analysis of 2645 adult patients with HCC who underwent liver transplant. Out of those, 2122 patients always had disease that was within the Milan criteria, 341 patients had HCC that was downstaged to fit within the Milan criteria, and 182 patients had HCC that was outside the Milan criteria at the time of liver transplantation. The authors report that the 10-year post-transplant survival and recurrence rates were 61.5% and 13.3%, respectively, in those always within the Milan criteria, 52.1% and 20.6% among those whose disease was downstaged, and 43.3% and 41.1% in those whose disease was never downstaged. Characteristics that predicted recurrence after downstaging were tumor size > 7 cm at diagnosis (odds ratio [OR] 2.62; 95% CI 1.20-5.75; P = .02), more than three tumors at diagnosis (OR 2.34; 95% CI 1.22-4.50; P = .01), and alpha-fetoprotein (AFP) response ≥ 20 ng/mL with < 50% improvement from maximum AFP before transplantation (OR 1.99; 95% CI 1.14-3.46; P = .02). Additionally, patients with recurrent tumors that were surgically resected had improved 5-year post-recurrence survival (31.6% vs 7.3%; P < .001). The conclusion was that the national downstaging policies were valid and should continue.

For patients who have unresectable HCC, systemic therapy is the mainstay of treatment. Peng and colleagues reported the results of the LAUNCH phase 3 clinical trial that randomized patients to receive lenvatinib alone or lenvatinib plus transarterial chemoembolization (TACE). Out of 338 patients, 170 received lenvatinib plus TACE. Unsurprisingly, the response rate was higher with the combination (54.1% vs 25.0%; P < .001); however, so was the median overall survival (17.8 vs 11.5 months; hazard ratio 0.45; P < .001), and median progression-free survival (10.6 vs 6.4 months; hazard ratio 0.43; P < .001). The investigators concluded that the addition of TACE to lenvatinib had manageable toxicities, improved clinical outcomes, and could be used as a potential first-line treatment for some patients with unresectable HCC.

Finally, in patients whose HCC progressed after a single TACE treatment, the question remains whether repeated TACE is worthwhile. Zhao and colleagues retrospectively reviewed the outcomes of 94 patients who underwent at least one TACE. Of these, 28 (29.8%) had a response to the first TACE, and these patients tended to have a longer OS compared with nonresponders (36.7 vs 21.5 months; P = .071). Of the 43 initial nonresponders who underwent a second TACE, 15 of 43 (34.9%) achieved a response and had an improved median overall survival (47.8 v. 13.6 months; P = .01), suggesting that repeat TACE may offer a benefit to some patients, even after no response to the initial treatment.

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

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Nevena Damjanov, MD, Professor, Department of Medicine, Division of Hematology-Oncology, University of Pennsylvania; Chief, Department of Hematology-Oncology, Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania

Nevena Damjanov, MD, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: QED; Eisai

Received research grant from: Basilea; Bristol-Myers Squibb; Merck

Dr. Damjanov scans the journals, so you don’t have to!
Dr. Damjanov scans the journals, so you don’t have to!

Nevena Damjanov, MD
Patients with hepatocellular carcinoma (HCC) benefit from multidisciplinary care. This month, we will review several articles that report outcomes from various treatment modalities.

Liver transplantation has the opportunity to cure both localized HCC as well as underlying liver cirrhosis. Donor organ shortage has led to the implementation of the Milan criteria as a way to identify patients whose tumor burden is low enough to predict a good outcome. Downstaging liver cancer to fit within Milan criteria has been controversial.

Tabrizian and colleagues undertook a retrospective cohort analysis of 2645 adult patients with HCC who underwent liver transplant. Out of those, 2122 patients always had disease that was within the Milan criteria, 341 patients had HCC that was downstaged to fit within the Milan criteria, and 182 patients had HCC that was outside the Milan criteria at the time of liver transplantation. The authors report that the 10-year post-transplant survival and recurrence rates were 61.5% and 13.3%, respectively, in those always within the Milan criteria, 52.1% and 20.6% among those whose disease was downstaged, and 43.3% and 41.1% in those whose disease was never downstaged. Characteristics that predicted recurrence after downstaging were tumor size > 7 cm at diagnosis (odds ratio [OR] 2.62; 95% CI 1.20-5.75; P = .02), more than three tumors at diagnosis (OR 2.34; 95% CI 1.22-4.50; P = .01), and alpha-fetoprotein (AFP) response ≥ 20 ng/mL with < 50% improvement from maximum AFP before transplantation (OR 1.99; 95% CI 1.14-3.46; P = .02). Additionally, patients with recurrent tumors that were surgically resected had improved 5-year post-recurrence survival (31.6% vs 7.3%; P < .001). The conclusion was that the national downstaging policies were valid and should continue.

For patients who have unresectable HCC, systemic therapy is the mainstay of treatment. Peng and colleagues reported the results of the LAUNCH phase 3 clinical trial that randomized patients to receive lenvatinib alone or lenvatinib plus transarterial chemoembolization (TACE). Out of 338 patients, 170 received lenvatinib plus TACE. Unsurprisingly, the response rate was higher with the combination (54.1% vs 25.0%; P < .001); however, so was the median overall survival (17.8 vs 11.5 months; hazard ratio 0.45; P < .001), and median progression-free survival (10.6 vs 6.4 months; hazard ratio 0.43; P < .001). The investigators concluded that the addition of TACE to lenvatinib had manageable toxicities, improved clinical outcomes, and could be used as a potential first-line treatment for some patients with unresectable HCC.

Finally, in patients whose HCC progressed after a single TACE treatment, the question remains whether repeated TACE is worthwhile. Zhao and colleagues retrospectively reviewed the outcomes of 94 patients who underwent at least one TACE. Of these, 28 (29.8%) had a response to the first TACE, and these patients tended to have a longer OS compared with nonresponders (36.7 vs 21.5 months; P = .071). Of the 43 initial nonresponders who underwent a second TACE, 15 of 43 (34.9%) achieved a response and had an improved median overall survival (47.8 v. 13.6 months; P = .01), suggesting that repeat TACE may offer a benefit to some patients, even after no response to the initial treatment.

Nevena Damjanov, MD
Patients with hepatocellular carcinoma (HCC) benefit from multidisciplinary care. This month, we will review several articles that report outcomes from various treatment modalities.

Liver transplantation has the opportunity to cure both localized HCC as well as underlying liver cirrhosis. Donor organ shortage has led to the implementation of the Milan criteria as a way to identify patients whose tumor burden is low enough to predict a good outcome. Downstaging liver cancer to fit within Milan criteria has been controversial.

Tabrizian and colleagues undertook a retrospective cohort analysis of 2645 adult patients with HCC who underwent liver transplant. Out of those, 2122 patients always had disease that was within the Milan criteria, 341 patients had HCC that was downstaged to fit within the Milan criteria, and 182 patients had HCC that was outside the Milan criteria at the time of liver transplantation. The authors report that the 10-year post-transplant survival and recurrence rates were 61.5% and 13.3%, respectively, in those always within the Milan criteria, 52.1% and 20.6% among those whose disease was downstaged, and 43.3% and 41.1% in those whose disease was never downstaged. Characteristics that predicted recurrence after downstaging were tumor size > 7 cm at diagnosis (odds ratio [OR] 2.62; 95% CI 1.20-5.75; P = .02), more than three tumors at diagnosis (OR 2.34; 95% CI 1.22-4.50; P = .01), and alpha-fetoprotein (AFP) response ≥ 20 ng/mL with < 50% improvement from maximum AFP before transplantation (OR 1.99; 95% CI 1.14-3.46; P = .02). Additionally, patients with recurrent tumors that were surgically resected had improved 5-year post-recurrence survival (31.6% vs 7.3%; P < .001). The conclusion was that the national downstaging policies were valid and should continue.

For patients who have unresectable HCC, systemic therapy is the mainstay of treatment. Peng and colleagues reported the results of the LAUNCH phase 3 clinical trial that randomized patients to receive lenvatinib alone or lenvatinib plus transarterial chemoembolization (TACE). Out of 338 patients, 170 received lenvatinib plus TACE. Unsurprisingly, the response rate was higher with the combination (54.1% vs 25.0%; P < .001); however, so was the median overall survival (17.8 vs 11.5 months; hazard ratio 0.45; P < .001), and median progression-free survival (10.6 vs 6.4 months; hazard ratio 0.43; P < .001). The investigators concluded that the addition of TACE to lenvatinib had manageable toxicities, improved clinical outcomes, and could be used as a potential first-line treatment for some patients with unresectable HCC.

Finally, in patients whose HCC progressed after a single TACE treatment, the question remains whether repeated TACE is worthwhile. Zhao and colleagues retrospectively reviewed the outcomes of 94 patients who underwent at least one TACE. Of these, 28 (29.8%) had a response to the first TACE, and these patients tended to have a longer OS compared with nonresponders (36.7 vs 21.5 months; P = .071). Of the 43 initial nonresponders who underwent a second TACE, 15 of 43 (34.9%) achieved a response and had an improved median overall survival (47.8 v. 13.6 months; P = .01), suggesting that repeat TACE may offer a benefit to some patients, even after no response to the initial treatment.

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Monkeypox virus found in asymptomatic people

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Wed, 08/24/2022 - 16:14

Researchers in France have discovered monkeypox virus in anal samples of men with no symptoms of the disease, advancing the possibility that asymptomatic carriers may be hidden drivers of the global outbreak.

The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.

It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”

In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”

Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.

That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
 

Research methods

For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.

During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.

The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.

In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.

At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
 

Clinical implications of findings are uncertain

Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.

Dr. Monica Gandhi

Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”

Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.

She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”

However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
 

 

 

Non-vaccine interventions are also needed

Other experts stressed the need for nonvaccine interventions.

In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.

Dr. Aileen Marty

Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.

Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”

Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”

Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.

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Researchers in France have discovered monkeypox virus in anal samples of men with no symptoms of the disease, advancing the possibility that asymptomatic carriers may be hidden drivers of the global outbreak.

The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.

It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”

In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”

Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.

That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
 

Research methods

For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.

During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.

The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.

In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.

At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
 

Clinical implications of findings are uncertain

Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.

Dr. Monica Gandhi

Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”

Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.

She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”

However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
 

 

 

Non-vaccine interventions are also needed

Other experts stressed the need for nonvaccine interventions.

In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.

Dr. Aileen Marty

Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.

Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”

Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”

Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.

Researchers in France have discovered monkeypox virus in anal samples of men with no symptoms of the disease, advancing the possibility that asymptomatic carriers may be hidden drivers of the global outbreak.

The findings, published in Annals of Internal Medicine, follow a similar, non–peer-reviewed report from Belgium. Researchers in both studies tested swabs for monkeypox in men who have sex with men. These swabs had been collected for routine STI screening.

It’s unclear whether asymptomatic individuals who test positive for monkeypox can spread the virus, the French team wrote. But if so, public health strategies to vaccinate those with known exposure “may not be sufficient to contain spread.”

In an editorial accompanying their paper, Stuart Isaacs, MD, associate professor at the University of Pennsylvania, Philadelphia, said it “raises the question of whether asymptomatic or subclinical infections are contributing to the current worldwide outbreak.”

Historically, transmission of monkeypox and its close relative, smallpox, was thought to be greatest when a rash was present, Dr. Isaacs wrote. “Long chains of human-to-human transmission were rare” with monkeypox.

That’s changed with the current outbreak, which was first detected in May. On Aug. 17, the World Health Organization reported more than 35,000 cases in 92 countries, with 12 deaths.
 

Research methods

For the French study, researchers conducted polymerase chain reaction tests on 200 anorectal swabs from asymptomatic individuals that had been collected from June 5 to July 11 in order to screen for gonorrhea and chlamydia. Of those, 13 (6.5%) were positive for monkeypox.

During the study period, STI testing had been suspended in individuals with monkeypox symptoms because of safety concerns, the researchers reported.

The research team contacted the 13 monkeypox-positive patients and advised them to limit sexual activity for 21 days following their test and notify recent sexual partners. None reported having developed symptoms, but two subsequently returned to the clinic with symptoms – one had an anal rash and the other a sore throat.

In the Belgian report, posted publicly on June 21 as a preprint, 3 of 224 anal samples collected for STI screening in May tested positive for monkeypox. All three of the men who tested positive said they did not have any symptoms in the weeks before and after the sample was taken.

At follow-up testing, 21-37 days after the initial samples were taken, all patients who had previously tested positive were negative. This was “likely as a consequence of spontaneous clearance of the infection,” the authors of that paper wrote.
 

Clinical implications of findings are uncertain

Monica Gandhi, MD, MPH, a professor of medicine at the University of California, San Francisco, said in an interview that the clinical implications of the findings are uncertain because it’s not known how much viral transmission results from asymptomatic individuals.

Dr. Monica Gandhi

Nevertheless, Dr. Gandhi said that “vaccinating all gay men for monkeypox who will accept the vaccine is prudent,” compared with a less aggressive strategy of only vaccinating those with known exposure, which is called ring vaccination. That way, “we can be assured to provide immunity to large swaths of the at-risk population.”

Dr. Gandhi said that movement toward mass vaccination of gay men is occurring in the United States, Canada, Europe, and Australia, despite limited vaccine supply.

She added that, although monkeypox has been concentrated in communities of men who have sex with men, “anyone with multiple sexual partners should be vaccinated given the data.”

However, a WHO official recently cautioned that reports of breakthrough infections in individuals who were vaccinated against monkeypox constitute a reminder that “vaccine is not a silver bullet.”
 

 

 

Non-vaccine interventions are also needed

Other experts stressed the need for nonvaccine interventions.

In his editorial, Dr. Isaacs said an “expanded” ring vaccination strategy in communities of high risk is likely needed, but ultimately the outbreak will only be controlled if vaccination is accompanied by other measures such as identifying and isolating cases, making treatment available, and educating individuals about how to reduce their risk.

Dr. Aileen Marty

Aileen Marty, MD, a professor of infectious diseases at Florida International University, Miami, said in an interview that the new evidence makes it “incredibly important” to inform people that they might be infected by a sex partner even if that person does not have telltale lesions.

Dr. Marty said she has been advising men who have sex with men to “reduce or eliminate situations in which they find themselves with multiple anonymous individuals.”

Although most individuals recover from monkeypox, the disease can lead to hospitalization, disfigurement, blindness, and even death, Dr. Marty noted, adding that monkeypox is “absolutely a disease to avoid.”

Authors of the French study reported financial relationships with Gilead Sciences, Viiv Healthcare, MSD, AstraZeneca, Theratechnologies, Janssen Pharmaceuticals, Pfizer, GlaxoSmithKline, and bioMérieux. Dr. Isaacs reported grants from the Department of Veterans Affairs and the National Institutes of Health and royalties from UpToDate. Dr. Gandhi and Dr. Marty reported no relevant financial interests.

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Screen COPD patients for peripheral neuropathy

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Changed
Tue, 08/23/2022 - 13:10

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

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Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

Polyneuropathy (PNP) remains a common comorbidity among patients with chronic obstructive pulmonary disease (COPD), and better screening strategies are needed to identify the condition and improve patients’ quality of life, according to authors of a recent review.

“Recent advances demonstrate that the relationship between COPD and the nervous system is extensive, and patients are at increased risk of stroke, dementia, depression, and other neurological and psychiatric conditions, even after controlling for the main confounding risk factors, such as age and smoking,” write Irina Odajiu, MD, of Colentina Clinical Hospital, Bucharest, Romania, and colleagues. However, data on the relationship between COPD and peripheral nervous system pathology are limited.

PNP is distinct from peripheral neuropathy and neuropathy, the researchers emphasize.

“Polyneuropathy implies a homogeneous process affecting peripheral nerves, specifically distal nerves, more severely than proximal ones,” while peripheral neuropathy refers to any disorder of the peripheral nervous system, they explain.

In an article published in Respiratory Medicine, the authors summarize the latest data on the association between COPD and polyneuropathy. They reviewed data from 21 studies published between 1981 and 2021. All studies included adults with COPD. The mean age of the patients was 55-65 years.

Peripheral neuropathy represents a significant comorbidity among patients with COPD. The percentage of cases of peripheral neuropathy among patients in the study populations ranged from 15% to 93.8%. Of these cases, the majority were of axonal sensory polyneuropathy. In most of the studies, the neuropathy affected the lower limbs more than the upper limbs.

“Additionally, in most presented studies, peripheral neuropathy correlated with disease duration and hypoxemia severity; the longer the duration and the more severe hypoxia, the more severe peripheral neuropathy was,” the researchers note.

Overall, potential predisposing factors for PNP among patients with COPD (in addition to chronic hypoxemia) included older age, poor nutrition, systemic inflammation, COPD medications, smoking, and increased partial pressure of carbon dioxide (hypercapnia).

Several strategies for managing peripheral neuropathy for patients with COPD were described. Prophylaxis options include neuroprotection with hormones such as progesterone, neuronal growth factors, and corticosteroids, although none have shown high levels of effectiveness, the researchers write. Topical treatment with muscarinic antagonists has shown some potential and may be a practical therapeutic choice, they say. Oxygen support, including hyperbaric oxygen therapy, has demonstrated healing of diabetic leg ulcers associated with PNP and has led to improvements in pain-related symptoms and quality-of-life scores, they add.

Although PNP is often present in patients with COPD, no association between COPD severity and PNP has been determined, the researchers write in their discussion section.

“Moreover, the current data do not indicate a relationship between COPD stages, GOLD classification, or degree of obstruction and PNP,” they say.

The data support screening of all COPD patients for PNP, both clinically and with electrodiagnostic studies, despite the absence of current specific COPD-related PNP screening tools, they write.

The study received no outside funding. The researchers have disclosed no relevant financial relationships.

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

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Consider essential oil allergy in patient with dermatitis

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– When patients present to Brandon L. Adler, MD, with dermatitis on the eyelid, face, or neck, he routinely asks them if they apply essential oils on their skin, or if they have an essential oil diffuser or nebulizer in their home.

“The answer is frequently ‘yes,’ ” Dr. Adler, clinical assistant professor of dermatology at the University of Southern California, Los Angeles, said at the annual meeting of the Pacific Dermatologic Association. “Essential oils are widely used throughout the wellness industry. They are contained in personal care products, beauty products, natural cleaning products, and they’re being diffused by our patients into the air. More than 75 essential oils are reported to cause allergic contact dermatitis.”

yangna/iStock/Getty Images

Natural chemical components contained in essential oils can cause skin reactions, especially linalool and limonene. “Linalool is most classically associated with lavender, while limonene is associated with citrus, but they’re found in many different plants,” said Dr. Adler, who directs USC’s contact dermatitis clinic. “On their own, linalool and limonene are not particularly allergenic; they’re not a big deal in the patch test clinic. The problem comes when we add air to the mix, because they oxidize to hydroperoxides of linalool and limonene. These are quite potent allergens.”

According to the most recent North American Contact Dermatitis Group data, 8.9% of patients undergoing patch testing tested positive to linalool hydroperoxides and 2.6% were positive to limonene hydroperoxides.

Dr. Adler discussed the case of a female massage therapist who presented with refractory hand dermatitis and was on methotrexate and dupilumab at the time of consultation but was still symptomatic. She patch-tested positive to limonene and linalool hydroperoxides as well as multiple essential oils that she had been using with her clients, ranging from sacred frankincense oil to basil oil, and she was advised to massage using only coconut or vegetable oils.

Dr. Brandon L. Adler

Essential oil allergy may also be related to cannabis allergy. According to Dr. Adler, allergic contact dermatitis to cannabis has been rarely reported, but in an analysis of 103 commercial topical cannabinoid preparations that he published with Vincent DeLeo, MD, also with USC, 84% contained a NACDG allergen, frequently essential oils.

More recently, Dr. Adler and colleagues reported the case of a 40-year-old woman who was referred for patch testing for nummular dermatitis that wasn’t responding to treatment. The patient was found to be using topical cannabis and also grew cannabis at home. “She asked to be patch-tested to her homegrown cannabis and had a strong positive patch test to the cannabis, linalool and limonene hydroperoxides, and other essential oils,” Dr. Adler recalled. “We sent her cannabis sample for analysis at a commercial lab and found that it contained limonene and other allergenic terpene chemicals.



“We’re just starting to unravel what this means in terms of our patients and how to manage them, but many are using topical cannabis and topical CBD. I suspect this is a lot less rare than we realize.”

Another recent case from Europe reported allergic contact dermatitis to Cannabis sativa (hemp) seed oil following topical application, with positive patch testing.

Dr. Adler disclosed that he has received research grants from the American Contact Dermatitis Society. He is also an investigator for AbbVie and a consultant for the Skin Research Institute.

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– When patients present to Brandon L. Adler, MD, with dermatitis on the eyelid, face, or neck, he routinely asks them if they apply essential oils on their skin, or if they have an essential oil diffuser or nebulizer in their home.

“The answer is frequently ‘yes,’ ” Dr. Adler, clinical assistant professor of dermatology at the University of Southern California, Los Angeles, said at the annual meeting of the Pacific Dermatologic Association. “Essential oils are widely used throughout the wellness industry. They are contained in personal care products, beauty products, natural cleaning products, and they’re being diffused by our patients into the air. More than 75 essential oils are reported to cause allergic contact dermatitis.”

yangna/iStock/Getty Images

Natural chemical components contained in essential oils can cause skin reactions, especially linalool and limonene. “Linalool is most classically associated with lavender, while limonene is associated with citrus, but they’re found in many different plants,” said Dr. Adler, who directs USC’s contact dermatitis clinic. “On their own, linalool and limonene are not particularly allergenic; they’re not a big deal in the patch test clinic. The problem comes when we add air to the mix, because they oxidize to hydroperoxides of linalool and limonene. These are quite potent allergens.”

According to the most recent North American Contact Dermatitis Group data, 8.9% of patients undergoing patch testing tested positive to linalool hydroperoxides and 2.6% were positive to limonene hydroperoxides.

Dr. Adler discussed the case of a female massage therapist who presented with refractory hand dermatitis and was on methotrexate and dupilumab at the time of consultation but was still symptomatic. She patch-tested positive to limonene and linalool hydroperoxides as well as multiple essential oils that she had been using with her clients, ranging from sacred frankincense oil to basil oil, and she was advised to massage using only coconut or vegetable oils.

Dr. Brandon L. Adler

Essential oil allergy may also be related to cannabis allergy. According to Dr. Adler, allergic contact dermatitis to cannabis has been rarely reported, but in an analysis of 103 commercial topical cannabinoid preparations that he published with Vincent DeLeo, MD, also with USC, 84% contained a NACDG allergen, frequently essential oils.

More recently, Dr. Adler and colleagues reported the case of a 40-year-old woman who was referred for patch testing for nummular dermatitis that wasn’t responding to treatment. The patient was found to be using topical cannabis and also grew cannabis at home. “She asked to be patch-tested to her homegrown cannabis and had a strong positive patch test to the cannabis, linalool and limonene hydroperoxides, and other essential oils,” Dr. Adler recalled. “We sent her cannabis sample for analysis at a commercial lab and found that it contained limonene and other allergenic terpene chemicals.



“We’re just starting to unravel what this means in terms of our patients and how to manage them, but many are using topical cannabis and topical CBD. I suspect this is a lot less rare than we realize.”

Another recent case from Europe reported allergic contact dermatitis to Cannabis sativa (hemp) seed oil following topical application, with positive patch testing.

Dr. Adler disclosed that he has received research grants from the American Contact Dermatitis Society. He is also an investigator for AbbVie and a consultant for the Skin Research Institute.

– When patients present to Brandon L. Adler, MD, with dermatitis on the eyelid, face, or neck, he routinely asks them if they apply essential oils on their skin, or if they have an essential oil diffuser or nebulizer in their home.

“The answer is frequently ‘yes,’ ” Dr. Adler, clinical assistant professor of dermatology at the University of Southern California, Los Angeles, said at the annual meeting of the Pacific Dermatologic Association. “Essential oils are widely used throughout the wellness industry. They are contained in personal care products, beauty products, natural cleaning products, and they’re being diffused by our patients into the air. More than 75 essential oils are reported to cause allergic contact dermatitis.”

yangna/iStock/Getty Images

Natural chemical components contained in essential oils can cause skin reactions, especially linalool and limonene. “Linalool is most classically associated with lavender, while limonene is associated with citrus, but they’re found in many different plants,” said Dr. Adler, who directs USC’s contact dermatitis clinic. “On their own, linalool and limonene are not particularly allergenic; they’re not a big deal in the patch test clinic. The problem comes when we add air to the mix, because they oxidize to hydroperoxides of linalool and limonene. These are quite potent allergens.”

According to the most recent North American Contact Dermatitis Group data, 8.9% of patients undergoing patch testing tested positive to linalool hydroperoxides and 2.6% were positive to limonene hydroperoxides.

Dr. Adler discussed the case of a female massage therapist who presented with refractory hand dermatitis and was on methotrexate and dupilumab at the time of consultation but was still symptomatic. She patch-tested positive to limonene and linalool hydroperoxides as well as multiple essential oils that she had been using with her clients, ranging from sacred frankincense oil to basil oil, and she was advised to massage using only coconut or vegetable oils.

Dr. Brandon L. Adler

Essential oil allergy may also be related to cannabis allergy. According to Dr. Adler, allergic contact dermatitis to cannabis has been rarely reported, but in an analysis of 103 commercial topical cannabinoid preparations that he published with Vincent DeLeo, MD, also with USC, 84% contained a NACDG allergen, frequently essential oils.

More recently, Dr. Adler and colleagues reported the case of a 40-year-old woman who was referred for patch testing for nummular dermatitis that wasn’t responding to treatment. The patient was found to be using topical cannabis and also grew cannabis at home. “She asked to be patch-tested to her homegrown cannabis and had a strong positive patch test to the cannabis, linalool and limonene hydroperoxides, and other essential oils,” Dr. Adler recalled. “We sent her cannabis sample for analysis at a commercial lab and found that it contained limonene and other allergenic terpene chemicals.



“We’re just starting to unravel what this means in terms of our patients and how to manage them, but many are using topical cannabis and topical CBD. I suspect this is a lot less rare than we realize.”

Another recent case from Europe reported allergic contact dermatitis to Cannabis sativa (hemp) seed oil following topical application, with positive patch testing.

Dr. Adler disclosed that he has received research grants from the American Contact Dermatitis Society. He is also an investigator for AbbVie and a consultant for the Skin Research Institute.

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Why it’s important for dermatologists to learn about JAK inhibitors

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For those who hesitate to prescribe Janus kinase inhibitors for patients with moderate to severe atopic dermatitis (AD) because of the boxed warnings on currently approved agents, it’s time to reconsider, according to Andrew Blauvelt, MD, MBA.

“In dermatology, you need to know about JAK inhibitors, and you need to know how to use them,” Dr. Blauvelt, president of Oregon Medical Research Center, Portland, said at the annual meeting of the Pacific Dermatologic Association. “Making the choice, ‘I’m not going to use those drugs because of safety concerns,’ may be okay in 2022, but we are going to be getting a lot more indications for these drugs. So instead of avoiding JAK inhibitors, I would say try to learn [about] them, understand them, and get your messaging out on safety.”

It’s difficult to imagine a clinician-researcher who has more experience with the use of biologics and JAK inhibitors in AD than Dr. Blauvelt, who has been the international investigator on several important trials of treatments that include dupilumab, tralokinumab, abrocitinib, and upadacitinib for AD such as CHRONOS, ECZTEND, JADE REGIMEN, and HEADS UP. At the meeting, he discussed his clinical approach to selecting systemic agents for AD and shared prescribing tips. He began by noting that the approval of dupilumab for moderate to severe AD in 2017 ushered in a new era of treating the disease systemically.

“When it was approved, experts went right to dupilumab if they could, and avoided the use of cyclosporine or methotrexate,” said Dr. Blauvelt, who is also an elected member of the American Society for Clinical Investigation and the International Eczema Council. “I still think that dupilumab is a great agent to start with. We’ve had a bit of difficulty improving upon it.”

Following dupilumab’s approval, three other systemic options became available for patients with moderate to severe AD: the human IgG4 monoclonal antibody tralokinumab that binds to interleukin-13, which is administered subcutaneously; and, more recently, the oral JAK inhibitors abrocitinib and upadacitinib, approved in January for moderate to severe AD.

“I’m a big fan of JAK inhibitors because I think they offer things that biologic and topical therapies can’t offer,” Dr. Blauvelt said. “Patients like the pills versus shots. They also like the speed; JAK inhibitors work faster than dupilumab and tralokinumab. So, if you have a patient with bad AD who wants to get better quickly, that would be a reason to choose a JAK inhibitor over a biologic if you can.”

When Dr. Blauvelt has asked AD clinical trial participants if they’d rather be treated with a biologic agent or with a JAK inhibitor, about half choose one over the other.

“Patients who shy away from the safety issues would choose the biologic trial while the ones who wanted the fast relief would choose the JAK trial,” he said. “But if you present both options and the patients prefer a pill, I think the JAK inhibitors do better with a rapid control of inflammation as well as pruritus – the latter within 2 days of taking the pills.”



When counseling patients initiating a JAK inhibitor, Dr. Blauvelt mentioned three advantages, compared with biologics: the pill formulation, the rapidity of response in pruritus control, and better efficacy. “The downside is the safety,” he said. “Safety is the elephant in the room for the JAK inhibitors.”

The risks listed in the boxed warning in the labeling for JAK inhibitors include: an increased risk of serious bacterial, fungal, and opportunistic infections such as TB; a higher rate of all-cause mortality, including cardiovascular death; a higher rate of MACE (major adverse cardiovascular events, defined as cardiovascular death, MI, and stroke); the potential for malignancy, including lymphoma; and the potential for thrombosis, including an increased incidence of pulmonary embolism (PE).

“Risk of thrombosis seems to be a class effect for all JAK inhibitors,” Dr. Blauvelt said. “As far as I know, it’s idiosyncratic. For nearly all the DVT [deep vein thrombosis] cases that have been reported, patients had baseline risk factors for DVT and PE, which are obesity, smoking, and use of oral contraceptives.”

Dr. Blauvelt pointed out that the boxed warning related to mortality, malignancies, and MACE stemmed from a long-term trial of the JAK inhibitor tofacitinib in RA patients. “Those patients had to be at least 50 years old, 75% of them were on concomitant methotrexate and/or prednisone, and they had to have at least one cardiac risk factor to get into the trial,” he said.

“I’m not saying those things can’t happen in dermatology patients, but if you look at the safety data of JAK inhibitors in the AD studies and in the alopecia areata studies, we are seeing a few cases of these things here and there, but not major signals,” he said. To date, “they look safer in dermatologic diseases compared to tofacitinib in RA data in older populations.”

He emphasized the importance of discussing each of the risks in the boxed warning with patients who are candidates for JAK inhibitor therapy.

Dr. Blauvelt likened the lab monitoring required for JAK inhibitors to that required for methotrexate. This means ordering at baseline, a CBC with differential, a chem-20, a lipid panel, and a QuantiFERON-TB Gold test. The JAK inhibitor labels do not include information on the frequency of monitoring, “but I have a distinct opinion on this because of my blood test monitoring experience in the trials for many years,” he said.

“I think it’s good to do follow-up testing at 1 month, then every 3 months in the first year. In my experience, the people who drop blood cell counts or increase their lipids tend to do it in the first year.”

After 1 year of treatment, he continued, follow-up testing once every 6 months is reasonable. “If CPK [creatine phosphokinase] goes up, I don’t worry about it; it’s not clinically relevant. There is no recommendation for CPK monitoring, so if you’re getting that on your chem-20, I’d say don’t worry about it.”

Dr. Blauvelt reported that he is an investigator and a scientific adviser for several pharmaceutical companies developing treatments for AD, including companies that are evaluating or marketing JAK inhibitors for AD, including AbbVie, Incyte, and Pfizer, as well as dupilumab’s joint developers Sanofi and Regeneron.

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For those who hesitate to prescribe Janus kinase inhibitors for patients with moderate to severe atopic dermatitis (AD) because of the boxed warnings on currently approved agents, it’s time to reconsider, according to Andrew Blauvelt, MD, MBA.

“In dermatology, you need to know about JAK inhibitors, and you need to know how to use them,” Dr. Blauvelt, president of Oregon Medical Research Center, Portland, said at the annual meeting of the Pacific Dermatologic Association. “Making the choice, ‘I’m not going to use those drugs because of safety concerns,’ may be okay in 2022, but we are going to be getting a lot more indications for these drugs. So instead of avoiding JAK inhibitors, I would say try to learn [about] them, understand them, and get your messaging out on safety.”

It’s difficult to imagine a clinician-researcher who has more experience with the use of biologics and JAK inhibitors in AD than Dr. Blauvelt, who has been the international investigator on several important trials of treatments that include dupilumab, tralokinumab, abrocitinib, and upadacitinib for AD such as CHRONOS, ECZTEND, JADE REGIMEN, and HEADS UP. At the meeting, he discussed his clinical approach to selecting systemic agents for AD and shared prescribing tips. He began by noting that the approval of dupilumab for moderate to severe AD in 2017 ushered in a new era of treating the disease systemically.

“When it was approved, experts went right to dupilumab if they could, and avoided the use of cyclosporine or methotrexate,” said Dr. Blauvelt, who is also an elected member of the American Society for Clinical Investigation and the International Eczema Council. “I still think that dupilumab is a great agent to start with. We’ve had a bit of difficulty improving upon it.”

Following dupilumab’s approval, three other systemic options became available for patients with moderate to severe AD: the human IgG4 monoclonal antibody tralokinumab that binds to interleukin-13, which is administered subcutaneously; and, more recently, the oral JAK inhibitors abrocitinib and upadacitinib, approved in January for moderate to severe AD.

“I’m a big fan of JAK inhibitors because I think they offer things that biologic and topical therapies can’t offer,” Dr. Blauvelt said. “Patients like the pills versus shots. They also like the speed; JAK inhibitors work faster than dupilumab and tralokinumab. So, if you have a patient with bad AD who wants to get better quickly, that would be a reason to choose a JAK inhibitor over a biologic if you can.”

When Dr. Blauvelt has asked AD clinical trial participants if they’d rather be treated with a biologic agent or with a JAK inhibitor, about half choose one over the other.

“Patients who shy away from the safety issues would choose the biologic trial while the ones who wanted the fast relief would choose the JAK trial,” he said. “But if you present both options and the patients prefer a pill, I think the JAK inhibitors do better with a rapid control of inflammation as well as pruritus – the latter within 2 days of taking the pills.”



When counseling patients initiating a JAK inhibitor, Dr. Blauvelt mentioned three advantages, compared with biologics: the pill formulation, the rapidity of response in pruritus control, and better efficacy. “The downside is the safety,” he said. “Safety is the elephant in the room for the JAK inhibitors.”

The risks listed in the boxed warning in the labeling for JAK inhibitors include: an increased risk of serious bacterial, fungal, and opportunistic infections such as TB; a higher rate of all-cause mortality, including cardiovascular death; a higher rate of MACE (major adverse cardiovascular events, defined as cardiovascular death, MI, and stroke); the potential for malignancy, including lymphoma; and the potential for thrombosis, including an increased incidence of pulmonary embolism (PE).

“Risk of thrombosis seems to be a class effect for all JAK inhibitors,” Dr. Blauvelt said. “As far as I know, it’s idiosyncratic. For nearly all the DVT [deep vein thrombosis] cases that have been reported, patients had baseline risk factors for DVT and PE, which are obesity, smoking, and use of oral contraceptives.”

Dr. Blauvelt pointed out that the boxed warning related to mortality, malignancies, and MACE stemmed from a long-term trial of the JAK inhibitor tofacitinib in RA patients. “Those patients had to be at least 50 years old, 75% of them were on concomitant methotrexate and/or prednisone, and they had to have at least one cardiac risk factor to get into the trial,” he said.

“I’m not saying those things can’t happen in dermatology patients, but if you look at the safety data of JAK inhibitors in the AD studies and in the alopecia areata studies, we are seeing a few cases of these things here and there, but not major signals,” he said. To date, “they look safer in dermatologic diseases compared to tofacitinib in RA data in older populations.”

He emphasized the importance of discussing each of the risks in the boxed warning with patients who are candidates for JAK inhibitor therapy.

Dr. Blauvelt likened the lab monitoring required for JAK inhibitors to that required for methotrexate. This means ordering at baseline, a CBC with differential, a chem-20, a lipid panel, and a QuantiFERON-TB Gold test. The JAK inhibitor labels do not include information on the frequency of monitoring, “but I have a distinct opinion on this because of my blood test monitoring experience in the trials for many years,” he said.

“I think it’s good to do follow-up testing at 1 month, then every 3 months in the first year. In my experience, the people who drop blood cell counts or increase their lipids tend to do it in the first year.”

After 1 year of treatment, he continued, follow-up testing once every 6 months is reasonable. “If CPK [creatine phosphokinase] goes up, I don’t worry about it; it’s not clinically relevant. There is no recommendation for CPK monitoring, so if you’re getting that on your chem-20, I’d say don’t worry about it.”

Dr. Blauvelt reported that he is an investigator and a scientific adviser for several pharmaceutical companies developing treatments for AD, including companies that are evaluating or marketing JAK inhibitors for AD, including AbbVie, Incyte, and Pfizer, as well as dupilumab’s joint developers Sanofi and Regeneron.

For those who hesitate to prescribe Janus kinase inhibitors for patients with moderate to severe atopic dermatitis (AD) because of the boxed warnings on currently approved agents, it’s time to reconsider, according to Andrew Blauvelt, MD, MBA.

“In dermatology, you need to know about JAK inhibitors, and you need to know how to use them,” Dr. Blauvelt, president of Oregon Medical Research Center, Portland, said at the annual meeting of the Pacific Dermatologic Association. “Making the choice, ‘I’m not going to use those drugs because of safety concerns,’ may be okay in 2022, but we are going to be getting a lot more indications for these drugs. So instead of avoiding JAK inhibitors, I would say try to learn [about] them, understand them, and get your messaging out on safety.”

It’s difficult to imagine a clinician-researcher who has more experience with the use of biologics and JAK inhibitors in AD than Dr. Blauvelt, who has been the international investigator on several important trials of treatments that include dupilumab, tralokinumab, abrocitinib, and upadacitinib for AD such as CHRONOS, ECZTEND, JADE REGIMEN, and HEADS UP. At the meeting, he discussed his clinical approach to selecting systemic agents for AD and shared prescribing tips. He began by noting that the approval of dupilumab for moderate to severe AD in 2017 ushered in a new era of treating the disease systemically.

“When it was approved, experts went right to dupilumab if they could, and avoided the use of cyclosporine or methotrexate,” said Dr. Blauvelt, who is also an elected member of the American Society for Clinical Investigation and the International Eczema Council. “I still think that dupilumab is a great agent to start with. We’ve had a bit of difficulty improving upon it.”

Following dupilumab’s approval, three other systemic options became available for patients with moderate to severe AD: the human IgG4 monoclonal antibody tralokinumab that binds to interleukin-13, which is administered subcutaneously; and, more recently, the oral JAK inhibitors abrocitinib and upadacitinib, approved in January for moderate to severe AD.

“I’m a big fan of JAK inhibitors because I think they offer things that biologic and topical therapies can’t offer,” Dr. Blauvelt said. “Patients like the pills versus shots. They also like the speed; JAK inhibitors work faster than dupilumab and tralokinumab. So, if you have a patient with bad AD who wants to get better quickly, that would be a reason to choose a JAK inhibitor over a biologic if you can.”

When Dr. Blauvelt has asked AD clinical trial participants if they’d rather be treated with a biologic agent or with a JAK inhibitor, about half choose one over the other.

“Patients who shy away from the safety issues would choose the biologic trial while the ones who wanted the fast relief would choose the JAK trial,” he said. “But if you present both options and the patients prefer a pill, I think the JAK inhibitors do better with a rapid control of inflammation as well as pruritus – the latter within 2 days of taking the pills.”



When counseling patients initiating a JAK inhibitor, Dr. Blauvelt mentioned three advantages, compared with biologics: the pill formulation, the rapidity of response in pruritus control, and better efficacy. “The downside is the safety,” he said. “Safety is the elephant in the room for the JAK inhibitors.”

The risks listed in the boxed warning in the labeling for JAK inhibitors include: an increased risk of serious bacterial, fungal, and opportunistic infections such as TB; a higher rate of all-cause mortality, including cardiovascular death; a higher rate of MACE (major adverse cardiovascular events, defined as cardiovascular death, MI, and stroke); the potential for malignancy, including lymphoma; and the potential for thrombosis, including an increased incidence of pulmonary embolism (PE).

“Risk of thrombosis seems to be a class effect for all JAK inhibitors,” Dr. Blauvelt said. “As far as I know, it’s idiosyncratic. For nearly all the DVT [deep vein thrombosis] cases that have been reported, patients had baseline risk factors for DVT and PE, which are obesity, smoking, and use of oral contraceptives.”

Dr. Blauvelt pointed out that the boxed warning related to mortality, malignancies, and MACE stemmed from a long-term trial of the JAK inhibitor tofacitinib in RA patients. “Those patients had to be at least 50 years old, 75% of them were on concomitant methotrexate and/or prednisone, and they had to have at least one cardiac risk factor to get into the trial,” he said.

“I’m not saying those things can’t happen in dermatology patients, but if you look at the safety data of JAK inhibitors in the AD studies and in the alopecia areata studies, we are seeing a few cases of these things here and there, but not major signals,” he said. To date, “they look safer in dermatologic diseases compared to tofacitinib in RA data in older populations.”

He emphasized the importance of discussing each of the risks in the boxed warning with patients who are candidates for JAK inhibitor therapy.

Dr. Blauvelt likened the lab monitoring required for JAK inhibitors to that required for methotrexate. This means ordering at baseline, a CBC with differential, a chem-20, a lipid panel, and a QuantiFERON-TB Gold test. The JAK inhibitor labels do not include information on the frequency of monitoring, “but I have a distinct opinion on this because of my blood test monitoring experience in the trials for many years,” he said.

“I think it’s good to do follow-up testing at 1 month, then every 3 months in the first year. In my experience, the people who drop blood cell counts or increase their lipids tend to do it in the first year.”

After 1 year of treatment, he continued, follow-up testing once every 6 months is reasonable. “If CPK [creatine phosphokinase] goes up, I don’t worry about it; it’s not clinically relevant. There is no recommendation for CPK monitoring, so if you’re getting that on your chem-20, I’d say don’t worry about it.”

Dr. Blauvelt reported that he is an investigator and a scientific adviser for several pharmaceutical companies developing treatments for AD, including companies that are evaluating or marketing JAK inhibitors for AD, including AbbVie, Incyte, and Pfizer, as well as dupilumab’s joint developers Sanofi and Regeneron.

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Brief Psychiatric Rating Scale succeeds as transdiagnostic measure

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Tue, 08/23/2022 - 11:18

The Brief Psychiatric Rating Scale (BPRS) was an effective tool for measuring general and specific psychiatric symptoms across the diagnostic spectrum, based on data from 600 psychiatric inpatients.

“Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned,” wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.

The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.

In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.

Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).

Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated “markedly ill” to “severely ill” patients, the researchers said.

The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.

The symptoms using BPRS and the functionality domains using the mini-ICF-APP “showed a close interplay,” the researchers noted.

“The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance,” they wrote in their discussion.

The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.

However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.

“Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

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The Brief Psychiatric Rating Scale (BPRS) was an effective tool for measuring general and specific psychiatric symptoms across the diagnostic spectrum, based on data from 600 psychiatric inpatients.

“Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned,” wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.

The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.

In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.

Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).

Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated “markedly ill” to “severely ill” patients, the researchers said.

The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.

The symptoms using BPRS and the functionality domains using the mini-ICF-APP “showed a close interplay,” the researchers noted.

“The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance,” they wrote in their discussion.

The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.

However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.

“Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

The Brief Psychiatric Rating Scale (BPRS) was an effective tool for measuring general and specific psychiatric symptoms across the diagnostic spectrum, based on data from 600 psychiatric inpatients.

“Current DSM and ICD diagnoses do not depict psychopathology accurately, therefore their validity in research and utility in clinical practice is questioned,” wrote Andreas B. Hofmann, PhD, of the University of Zürich and colleagues.

The BPRS was developed to assess changes in psychopathology across a range of severe psychiatric disorders, but its potential to assess symptoms in nonpsychotic disorders has not been explored, the researchers said.

In a study published in Psychiatry Research, the investigators analyzed data from 600 adult psychiatric inpatients divided equally into six diagnostic categories: alcohol use disorder, major depressive disorder, anxiety disorders, bipolar disorder, schizophrenia, and personality disorders. The mean age of the patients was 41.5 years and 45.5% were women. The demographic characteristics were similar across most groups, although patients with a personality disorder were significantly more likely than other patients to be younger and female.

Patients were assessed using the BPRS based on their main diagnosis. The mini-ICF-APP, another validated measure for assessing psychiatric disorders, served as a comparator, and both were compared to the Clinical Global Impression Scale (CGI).

Overall, the BPRS and mini-ICF-APP showed moderate correlation and good agreement, the researchers said. The Pearson correlation coefficient for the BPRS and mini-ICF-APP scales was 0.53 and the concordance correlation coefficient was 0.52. The mean sum scores for the BPRS, the mini-ICF-APP, and the CGI were 45.4 (standard deviation, 14.4), 19.93 (SD, 8.21), and 5.55 (SD, 0.84), respectively, which indicated “markedly ill” to “severely ill” patients, the researchers said.

The researchers were able to detect three clusters of symptoms corresponding to externalizing, internalizing, and thought disturbance domains using the BPRS, and four clusters using the mini-ICF-APP.

The symptoms using BPRS and the functionality domains using the mini-ICF-APP “showed a close interplay,” the researchers noted.

“The symptoms and functional domains we found to be central within the network structure are among the first targets of any psychiatric or psychotherapeutic intervention, namely the building of a common language and understanding as well as the establishment of confidence in relationships and a trustworthy therapeutic alliance,” they wrote in their discussion.

The study findings were limited by several factors including the collection of data from routine practice rather than clinical trials, the focus on only the main diagnosis without comorbidities, and the inclusion only of patients requiring hospitalization, the researchers noted.

However, the results were strengthened by the large sample size, and demonstrate the validity of the BPRS as a measurement tool across a range of psychiatric diagnoses, they said.

“Since the BPRS is a widely known and readily available psychometric scale, our results support its use as a transdiagnostic measurement instrument of psychopathology,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

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Pervasive ‘forever chemical’ linked to liver cancer

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Thu, 09/01/2022 - 13:18

People exposed to high levels of perfluorooctane sulfonic acid (PFOS) – a widely used synthetic chemical – run an increased risk of hepatocellular carcinoma, researchers say.

The correlation does not prove that PFOS causes this cancer, and more research is needed, but in the meantime, people should limit their exposure to it and others in its class, said Jesse Goodrich, PhD, a postdoctoral scholar in environmental medicine at the University of Southern California, Los Angeles.

“If you’re at risk for liver cancer because you have other risk factors, then these chemicals have the potential to kind of send you over the edge,” he told this news organization.

Dr. Goodrich and colleagues published their research online in JHEP Reports.

Dubbed “forever chemicals” because they can take thousands of years to break down, polyfluoroalkyl substances (PFAS) figure in makeup, food packaging, waterproof clothing, nonstick cookware, firefighting foams, and groundwater. They have spread through the atmosphere into rain and can be found in the blood of most Americans. PFOS is one of the most widely used PFAS.

“You can’t really escape them,” Dr. Goodrich said.

Previous research has linked PFAS to infertility, pregnancy complications, learning and behavioral problems in children, immune system issues, and higher cholesterol, as well as other cancers. Some experiments in animals suggested PFAS could cause liver cancer, and others showed a correlation between PFAS serum levels and biomarkers associated with liver cancer. But many of these health effects take a long time to develop.

“It wasn’t until we started to get really highly exposed groups of people that we started, as scientists, to be able to figure out what was going on,” said Dr. Goodrich.
 

High exposure, increased incidence

To measure the relationship between PFAS exposure and the incidence of hepatocellular carcinoma more definitively, Dr. Goodrich and colleagues analyzed data from the Multiethnic Cohort Study, a cohort of more than 200,000 people of African, Latin, Native Hawaiian, Japanese, and European ancestry tracked since the early 1990s in California and Hawaii. About 67,000 participants provided blood samples from 2001 to 2007.

From this cohort, the researchers found 50 people who later developed hepatocellular carcinoma. The researchers matched these patients with 50 controls of similar age at blood collection, sex, race, ethnicity, and study area who did not develop the cancer.

They found that people with more than 54.9 mcg/L of PFOS in their blood before any diagnosis of hepatocellular carcinoma were almost five times more likely to get the cancer (odds ratio 4.5; 95% confidence interval, 1.2-16.0), which was statistically significant (P = .02).

This level of PFOS corresponds to the 90th percentile found in the U.S. National Health and Nutrition Examination Survey (NHANES).

To get some idea of the mechanism by which PFOS might do its damage, the researchers also looked for linkage to levels of metabolites.

They found an overlap among high PFOS levels, hepatocellular carcinoma, and high levels of glucose, butyric acid (a short chain fatty acid), alpha-Ketoisovaleric acid (alpha branched-chain alpha-keto acid), and 7alpha-Hydroxy-3-oxo-4-cholestenoate (a bile acid). These metabolites have been associated in previous studies with metabolic disorders and liver disease.

Similarly, the researchers identified an association among the cancer, PFOS, and alterations in amino acid and glycan biosynthesis pathways.
 

 

 

Risk mitigation

The half-life of PFAS in the human body is about 3-7 years, said Dr. Goodrich.

“There’s not much you can do once they’re in there,” he said. “So, the focus needs to be on preventing the exposure in the first place.”

People can limit exposure by avoiding water contaminated with PFAS or filtering it out, Dr. Goodrich said. He recommended avoiding fish from contaminated waterways and nonstick cookware. The Environmental Protection Agency has more detailed recommendations.

But giving patients individualized recommendations is difficult, said Vincent Chen, MD, MS, a clinical instructor in gastroenterology at the University of Michigan, Ann Arbor, who was not involved in the study. Most clinicians don’t know their patients’ PFOS levels.

“It’s not that easy to get a test,” Dr. Chen told this news organization.

People can also mitigate their risk factors for hepatocellular carcinoma, such as a poor diet, a lack of exercise, and smoking, said Dr. Goodrich.

The researchers found that patients with hepatocellular carcinoma were more likely to be overweight and have diabetes, and PFOS was associated with higher fasting glucose levels. This raises the possibility that PFOS increases the risk for hepatocellular carcinoma by causing diabetes and obesity.

Dr. Goodrich and his colleagues tried to address this question by adjusting for baseline body mass index (BMI) and diabetes diagnosis in their statistical analysis.

After adjusting for BMI, they found that the association between PFOS and hepatocellular carcinoma diminished to a threefold risk (OR, 2.90; 95% CI, 0.78-10.00) and was no longer statistically significant (P = .11).

On the other hand, adjusting for diabetes did not change the significance of the relationship between PFOS and the cancer (OR, 5.7; 95% CI, 1.10-30.00; P = .04).

The sample size was probably too small to adequately tease out this relationship, Dr. Chen said. Still, he said, “I thought it was a very, very important study.”

The levels of PFOS found in the blood of Americans has been declining since the 1999-2000 NHANES, Dr. Chen pointed out. But that’s not as reassuring as it sounds.

“The problem is that if you put a regulation limiting the use of one PFAS, what people can do is just substitute with another PFAS or another molecule, which for all we know could be equally harmful,” Dr. Chen said.

Funding was provided by the Southern California Environmental Health Science Center supported by the National Institutes of Health. Dr. Goodrich and Dr. Chen report no relevant financial relationships.

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

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People exposed to high levels of perfluorooctane sulfonic acid (PFOS) – a widely used synthetic chemical – run an increased risk of hepatocellular carcinoma, researchers say.

The correlation does not prove that PFOS causes this cancer, and more research is needed, but in the meantime, people should limit their exposure to it and others in its class, said Jesse Goodrich, PhD, a postdoctoral scholar in environmental medicine at the University of Southern California, Los Angeles.

“If you’re at risk for liver cancer because you have other risk factors, then these chemicals have the potential to kind of send you over the edge,” he told this news organization.

Dr. Goodrich and colleagues published their research online in JHEP Reports.

Dubbed “forever chemicals” because they can take thousands of years to break down, polyfluoroalkyl substances (PFAS) figure in makeup, food packaging, waterproof clothing, nonstick cookware, firefighting foams, and groundwater. They have spread through the atmosphere into rain and can be found in the blood of most Americans. PFOS is one of the most widely used PFAS.

“You can’t really escape them,” Dr. Goodrich said.

Previous research has linked PFAS to infertility, pregnancy complications, learning and behavioral problems in children, immune system issues, and higher cholesterol, as well as other cancers. Some experiments in animals suggested PFAS could cause liver cancer, and others showed a correlation between PFAS serum levels and biomarkers associated with liver cancer. But many of these health effects take a long time to develop.

“It wasn’t until we started to get really highly exposed groups of people that we started, as scientists, to be able to figure out what was going on,” said Dr. Goodrich.
 

High exposure, increased incidence

To measure the relationship between PFAS exposure and the incidence of hepatocellular carcinoma more definitively, Dr. Goodrich and colleagues analyzed data from the Multiethnic Cohort Study, a cohort of more than 200,000 people of African, Latin, Native Hawaiian, Japanese, and European ancestry tracked since the early 1990s in California and Hawaii. About 67,000 participants provided blood samples from 2001 to 2007.

From this cohort, the researchers found 50 people who later developed hepatocellular carcinoma. The researchers matched these patients with 50 controls of similar age at blood collection, sex, race, ethnicity, and study area who did not develop the cancer.

They found that people with more than 54.9 mcg/L of PFOS in their blood before any diagnosis of hepatocellular carcinoma were almost five times more likely to get the cancer (odds ratio 4.5; 95% confidence interval, 1.2-16.0), which was statistically significant (P = .02).

This level of PFOS corresponds to the 90th percentile found in the U.S. National Health and Nutrition Examination Survey (NHANES).

To get some idea of the mechanism by which PFOS might do its damage, the researchers also looked for linkage to levels of metabolites.

They found an overlap among high PFOS levels, hepatocellular carcinoma, and high levels of glucose, butyric acid (a short chain fatty acid), alpha-Ketoisovaleric acid (alpha branched-chain alpha-keto acid), and 7alpha-Hydroxy-3-oxo-4-cholestenoate (a bile acid). These metabolites have been associated in previous studies with metabolic disorders and liver disease.

Similarly, the researchers identified an association among the cancer, PFOS, and alterations in amino acid and glycan biosynthesis pathways.
 

 

 

Risk mitigation

The half-life of PFAS in the human body is about 3-7 years, said Dr. Goodrich.

“There’s not much you can do once they’re in there,” he said. “So, the focus needs to be on preventing the exposure in the first place.”

People can limit exposure by avoiding water contaminated with PFAS or filtering it out, Dr. Goodrich said. He recommended avoiding fish from contaminated waterways and nonstick cookware. The Environmental Protection Agency has more detailed recommendations.

But giving patients individualized recommendations is difficult, said Vincent Chen, MD, MS, a clinical instructor in gastroenterology at the University of Michigan, Ann Arbor, who was not involved in the study. Most clinicians don’t know their patients’ PFOS levels.

“It’s not that easy to get a test,” Dr. Chen told this news organization.

People can also mitigate their risk factors for hepatocellular carcinoma, such as a poor diet, a lack of exercise, and smoking, said Dr. Goodrich.

The researchers found that patients with hepatocellular carcinoma were more likely to be overweight and have diabetes, and PFOS was associated with higher fasting glucose levels. This raises the possibility that PFOS increases the risk for hepatocellular carcinoma by causing diabetes and obesity.

Dr. Goodrich and his colleagues tried to address this question by adjusting for baseline body mass index (BMI) and diabetes diagnosis in their statistical analysis.

After adjusting for BMI, they found that the association between PFOS and hepatocellular carcinoma diminished to a threefold risk (OR, 2.90; 95% CI, 0.78-10.00) and was no longer statistically significant (P = .11).

On the other hand, adjusting for diabetes did not change the significance of the relationship between PFOS and the cancer (OR, 5.7; 95% CI, 1.10-30.00; P = .04).

The sample size was probably too small to adequately tease out this relationship, Dr. Chen said. Still, he said, “I thought it was a very, very important study.”

The levels of PFOS found in the blood of Americans has been declining since the 1999-2000 NHANES, Dr. Chen pointed out. But that’s not as reassuring as it sounds.

“The problem is that if you put a regulation limiting the use of one PFAS, what people can do is just substitute with another PFAS or another molecule, which for all we know could be equally harmful,” Dr. Chen said.

Funding was provided by the Southern California Environmental Health Science Center supported by the National Institutes of Health. Dr. Goodrich and Dr. Chen report no relevant financial relationships.

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

People exposed to high levels of perfluorooctane sulfonic acid (PFOS) – a widely used synthetic chemical – run an increased risk of hepatocellular carcinoma, researchers say.

The correlation does not prove that PFOS causes this cancer, and more research is needed, but in the meantime, people should limit their exposure to it and others in its class, said Jesse Goodrich, PhD, a postdoctoral scholar in environmental medicine at the University of Southern California, Los Angeles.

“If you’re at risk for liver cancer because you have other risk factors, then these chemicals have the potential to kind of send you over the edge,” he told this news organization.

Dr. Goodrich and colleagues published their research online in JHEP Reports.

Dubbed “forever chemicals” because they can take thousands of years to break down, polyfluoroalkyl substances (PFAS) figure in makeup, food packaging, waterproof clothing, nonstick cookware, firefighting foams, and groundwater. They have spread through the atmosphere into rain and can be found in the blood of most Americans. PFOS is one of the most widely used PFAS.

“You can’t really escape them,” Dr. Goodrich said.

Previous research has linked PFAS to infertility, pregnancy complications, learning and behavioral problems in children, immune system issues, and higher cholesterol, as well as other cancers. Some experiments in animals suggested PFAS could cause liver cancer, and others showed a correlation between PFAS serum levels and biomarkers associated with liver cancer. But many of these health effects take a long time to develop.

“It wasn’t until we started to get really highly exposed groups of people that we started, as scientists, to be able to figure out what was going on,” said Dr. Goodrich.
 

High exposure, increased incidence

To measure the relationship between PFAS exposure and the incidence of hepatocellular carcinoma more definitively, Dr. Goodrich and colleagues analyzed data from the Multiethnic Cohort Study, a cohort of more than 200,000 people of African, Latin, Native Hawaiian, Japanese, and European ancestry tracked since the early 1990s in California and Hawaii. About 67,000 participants provided blood samples from 2001 to 2007.

From this cohort, the researchers found 50 people who later developed hepatocellular carcinoma. The researchers matched these patients with 50 controls of similar age at blood collection, sex, race, ethnicity, and study area who did not develop the cancer.

They found that people with more than 54.9 mcg/L of PFOS in their blood before any diagnosis of hepatocellular carcinoma were almost five times more likely to get the cancer (odds ratio 4.5; 95% confidence interval, 1.2-16.0), which was statistically significant (P = .02).

This level of PFOS corresponds to the 90th percentile found in the U.S. National Health and Nutrition Examination Survey (NHANES).

To get some idea of the mechanism by which PFOS might do its damage, the researchers also looked for linkage to levels of metabolites.

They found an overlap among high PFOS levels, hepatocellular carcinoma, and high levels of glucose, butyric acid (a short chain fatty acid), alpha-Ketoisovaleric acid (alpha branched-chain alpha-keto acid), and 7alpha-Hydroxy-3-oxo-4-cholestenoate (a bile acid). These metabolites have been associated in previous studies with metabolic disorders and liver disease.

Similarly, the researchers identified an association among the cancer, PFOS, and alterations in amino acid and glycan biosynthesis pathways.
 

 

 

Risk mitigation

The half-life of PFAS in the human body is about 3-7 years, said Dr. Goodrich.

“There’s not much you can do once they’re in there,” he said. “So, the focus needs to be on preventing the exposure in the first place.”

People can limit exposure by avoiding water contaminated with PFAS or filtering it out, Dr. Goodrich said. He recommended avoiding fish from contaminated waterways and nonstick cookware. The Environmental Protection Agency has more detailed recommendations.

But giving patients individualized recommendations is difficult, said Vincent Chen, MD, MS, a clinical instructor in gastroenterology at the University of Michigan, Ann Arbor, who was not involved in the study. Most clinicians don’t know their patients’ PFOS levels.

“It’s not that easy to get a test,” Dr. Chen told this news organization.

People can also mitigate their risk factors for hepatocellular carcinoma, such as a poor diet, a lack of exercise, and smoking, said Dr. Goodrich.

The researchers found that patients with hepatocellular carcinoma were more likely to be overweight and have diabetes, and PFOS was associated with higher fasting glucose levels. This raises the possibility that PFOS increases the risk for hepatocellular carcinoma by causing diabetes and obesity.

Dr. Goodrich and his colleagues tried to address this question by adjusting for baseline body mass index (BMI) and diabetes diagnosis in their statistical analysis.

After adjusting for BMI, they found that the association between PFOS and hepatocellular carcinoma diminished to a threefold risk (OR, 2.90; 95% CI, 0.78-10.00) and was no longer statistically significant (P = .11).

On the other hand, adjusting for diabetes did not change the significance of the relationship between PFOS and the cancer (OR, 5.7; 95% CI, 1.10-30.00; P = .04).

The sample size was probably too small to adequately tease out this relationship, Dr. Chen said. Still, he said, “I thought it was a very, very important study.”

The levels of PFOS found in the blood of Americans has been declining since the 1999-2000 NHANES, Dr. Chen pointed out. But that’s not as reassuring as it sounds.

“The problem is that if you put a regulation limiting the use of one PFAS, what people can do is just substitute with another PFAS or another molecule, which for all we know could be equally harmful,” Dr. Chen said.

Funding was provided by the Southern California Environmental Health Science Center supported by the National Institutes of Health. Dr. Goodrich and Dr. Chen report no relevant financial relationships.

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

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FDA clears new neurostimulation system for chronic pain

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Tue, 08/23/2022 - 12:17

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

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The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

The Food and Drug Administration has approved Abbott Laboratories’ new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360 therapy for the treatment of patients with chronic pain, the company announced Aug. 23.

The “next generation” of its proprietary BurstDR stimulation, FlexBurst360 therapy, provides pain coverage across up to six areas of the trunk and limbs, with programming that can be adjusted as a patient’s individual therapeutic needs evolve, the manufacturer noted.

“Using FlexBurst360 therapy on the Proclaim Plus system, physicians can identify the lowest effective dose of stimulation for each patient and adapt it based on evolving pain needs,” the company said in a news release.

The system also has therapy settings accessed with a mobile device.

Through their mobile devices, patients can access the manufacturer’s NeuroSphere Virtual Clinic, which allows them to communicate with their providers and receive remote adjustments to their therapeutic settings as needed.
 

Game changer?

The newly approved system has a battery life of up to 10 years, akin to the company’s Proclaim XR neurostimulation system for chronic pain. As reported at the time by this news organization, that system was approved by the FDA in 2019.

More than 50 million people in the United States experience chronic pain and most have pain in more than one area of the body. Steven Falowski, MD, with Argires Marotti Neurosurgical Associates of Lancaster, Pa., noted in the release that spinal cord stimulation has provided “tremendous relief” for patients with chronic pain.

Dr. Falowski added that “with its ability to mimic natural patterns found in the brain, the Abbott BurstDR platform has been a game changer” for these patients.

“However, despite the many benefits of BurstDR, such as being effective as a low-energy stimulation therapy, some patients continue to be burdened ... because of multiple painful areas and evolving pain,” he said.

“Now, with Proclaim Plus and FlexBurst360, an already established platform has been improved to treat more patients who suffer from pain across different body parts and changing pain over time,” said Dr. Falowski.

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

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California wants to snip costs for vasectomies and condoms

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Wed, 08/24/2022 - 16:15

SACRAMENTO – California is trying to ease the pain of vasectomies by making them free for millions of residents.

Federal law and state law require most health insurers to cover prescription contraceptives at no cost to the patient. But those provisions apply to only 18 Food and Drug Administration–approved birth control options for women, so anyone with testicles is out of luck.

California lawmakers are now considering a bill that would expand that requirement to male sterilization and non-prescription birth control, including condoms and contraceptive sponges. If the Contraceptive Equity Act of 2022 passes, commercial insurance plans regulated by the state won’t be allowed to impose out-of-pocket costs, like copays, coinsurance, and deductibles, on those modes of birth control.

“It’s pretty groundbreaking in that way – it’s a whole new framework to think about contraception as something that is relevant for people of all genders,” said Liz McCaman Taylor, a senior attorney with the National Health Law Program, a group that advocates for the health rights of low-income people.

A vasectomy is an outpatient surgical procedure in which the patient’s supply of sperm is cut off from his semen by sealing or snipping the tubes that transport sperm from the testes to the penis. Most men need to recover on the couch with an ice pack for a day or 2, and a test a few months later determines whether the procedure worked.

Because vasectomies are elective procedures and usually not urgent, price can be a deciding factor.

For Nathan Songne, cost was the most stressful part of the procedure. For several years, the 31-year-old had known he didn’t want to have kids biologically. Better to adopt a 4-year-old and skip the diaper stage, he thought. He was adopted by his stepfather as a child and knew he didn’t need to be genetically related to his children to love them.

“My only concern was that I had no idea how much it was going to cost me because nobody told me,” said Mr. Songne, who lives in Mission Viejo, in Orange County. If the procedure cost $1,000, as he expected, he wouldn’t be able to afford it.

Mr. Songne’s insurance, which he gets through his work assembling guitars, covered 70% of the Aug. 8 procedure, leaving him with a bill of just under $200. “Cost did affect my decision, but because it was only $200, it made me feel a lot more relieved about continuing on with the vasectomy.”

There are two hot times of year in the vasectomy business, according to Mary Samplaski, MD, an associate professor of urology at the University of Southern California, Los Angeles. First, she sees an uptick during the March Madness college basketball tournament, when men choose to recover on the couch watching hoops.

The end of the year is also busy, she said, because many patients have finally met their annual insurance deductible and can afford the procedure.

Patients discuss out-of-pocket costs in about 20% of her vasectomy consultations. “It’s obviously a nerve-wracking procedure,” Dr. Samplaski said. “And on top of that, if your copay is high, there’s even less reason to want to do it.”

In April, Jacob Elert comparison-shopped for a vasectomy near his home in Sacramento because his health plan doesn’t cover the procedure. He had hoped to schedule one with his regular urologist, but that would have come with a $1,500 price tag.

Instead, he found a chain of vasectomy clinics where he could get the procedure for $850. Three months later, a test confirmed the vasectomy was a success.

Mr. Elert has no regrets, but had price not been a factor, he would have preferred to go to his regular urologist. “That’s the doctor I trust,” Mr. Elert said. “But it was just way too expensive.”

In November, California voters will decide whether to lock rights to abortion and contraception into the state constitution. But Proposition 1 doesn’t address issues such as cost and coverage, said Amy Moy, a spokesperson for Essential Access Health, a group that runs California’s Title X family planning program.

“The constitutional amendment is kind of the long-term protection, and we are still working to reduce barriers for Californians on the short-term and day-to-day level regardless of their gender,” she said.

SB 523 has sailed through preliminary votes in the state legislature, which faces an end-of-August deadline to act on bills. If the measure passes, it would take effect in 2024, and California would join a handful of states that require plans they regulate to completely cover vasectomies or nonprescription birth control.

The California Association of Health Plans is still evaluating the measure, which may be amended in the final days of the legislative session. But the association generally opposes bills that require additional insurance benefits because they could lead to higher premiums, spokesperson Mary Ellen Grant said.

SB 523 applies to more than 14 million Californians who work for the state, have a student health plan through a university, or have state-regulated commercial health plans. They would become eligible to receive free over-the-counter birth control – such as emergency contraception, condoms, spermicide, and contraceptive sponges – in addition to vasectomies. The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government.

The specifics of how the benefit would work, including the frequency and amount of birth control that insurers must cover and whether patients would have to pay upfront and be reimbursed later, would be hammered out after the measure is adopted. Ms. McCaman Taylor said allowing people to simply present their insurance card at a pharmacy counter and walk away with the birth control they need would be preferable.

“We kind of learned from the national experiment with COVID over-the-counter tests that reimbursement wasn’t the best model,” she said. “If people can’t afford to pay out of pocket for it, they’re just not going to get it.”

The California Health Benefits Review Program, which analyzes legislation, projected that roughly 14,200 people with state-regulated commercial insurance would get vasectomies in California in 2022. Eliminating cost sharing would increase the number of vasectomies by 252 in the law’s first year, the program estimated.

It’s a small increase. But that, plus a jump in the use of other contraceptives covered by the bill, particularly condoms, could add up to a big reduction in unintended pregnancies. Roughly 12,300 unplanned pregnancies might be averted each year if the mandate takes effect, a reduction of more than 11%, according to the analysis.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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SACRAMENTO – California is trying to ease the pain of vasectomies by making them free for millions of residents.

Federal law and state law require most health insurers to cover prescription contraceptives at no cost to the patient. But those provisions apply to only 18 Food and Drug Administration–approved birth control options for women, so anyone with testicles is out of luck.

California lawmakers are now considering a bill that would expand that requirement to male sterilization and non-prescription birth control, including condoms and contraceptive sponges. If the Contraceptive Equity Act of 2022 passes, commercial insurance plans regulated by the state won’t be allowed to impose out-of-pocket costs, like copays, coinsurance, and deductibles, on those modes of birth control.

“It’s pretty groundbreaking in that way – it’s a whole new framework to think about contraception as something that is relevant for people of all genders,” said Liz McCaman Taylor, a senior attorney with the National Health Law Program, a group that advocates for the health rights of low-income people.

A vasectomy is an outpatient surgical procedure in which the patient’s supply of sperm is cut off from his semen by sealing or snipping the tubes that transport sperm from the testes to the penis. Most men need to recover on the couch with an ice pack for a day or 2, and a test a few months later determines whether the procedure worked.

Because vasectomies are elective procedures and usually not urgent, price can be a deciding factor.

For Nathan Songne, cost was the most stressful part of the procedure. For several years, the 31-year-old had known he didn’t want to have kids biologically. Better to adopt a 4-year-old and skip the diaper stage, he thought. He was adopted by his stepfather as a child and knew he didn’t need to be genetically related to his children to love them.

“My only concern was that I had no idea how much it was going to cost me because nobody told me,” said Mr. Songne, who lives in Mission Viejo, in Orange County. If the procedure cost $1,000, as he expected, he wouldn’t be able to afford it.

Mr. Songne’s insurance, which he gets through his work assembling guitars, covered 70% of the Aug. 8 procedure, leaving him with a bill of just under $200. “Cost did affect my decision, but because it was only $200, it made me feel a lot more relieved about continuing on with the vasectomy.”

There are two hot times of year in the vasectomy business, according to Mary Samplaski, MD, an associate professor of urology at the University of Southern California, Los Angeles. First, she sees an uptick during the March Madness college basketball tournament, when men choose to recover on the couch watching hoops.

The end of the year is also busy, she said, because many patients have finally met their annual insurance deductible and can afford the procedure.

Patients discuss out-of-pocket costs in about 20% of her vasectomy consultations. “It’s obviously a nerve-wracking procedure,” Dr. Samplaski said. “And on top of that, if your copay is high, there’s even less reason to want to do it.”

In April, Jacob Elert comparison-shopped for a vasectomy near his home in Sacramento because his health plan doesn’t cover the procedure. He had hoped to schedule one with his regular urologist, but that would have come with a $1,500 price tag.

Instead, he found a chain of vasectomy clinics where he could get the procedure for $850. Three months later, a test confirmed the vasectomy was a success.

Mr. Elert has no regrets, but had price not been a factor, he would have preferred to go to his regular urologist. “That’s the doctor I trust,” Mr. Elert said. “But it was just way too expensive.”

In November, California voters will decide whether to lock rights to abortion and contraception into the state constitution. But Proposition 1 doesn’t address issues such as cost and coverage, said Amy Moy, a spokesperson for Essential Access Health, a group that runs California’s Title X family planning program.

“The constitutional amendment is kind of the long-term protection, and we are still working to reduce barriers for Californians on the short-term and day-to-day level regardless of their gender,” she said.

SB 523 has sailed through preliminary votes in the state legislature, which faces an end-of-August deadline to act on bills. If the measure passes, it would take effect in 2024, and California would join a handful of states that require plans they regulate to completely cover vasectomies or nonprescription birth control.

The California Association of Health Plans is still evaluating the measure, which may be amended in the final days of the legislative session. But the association generally opposes bills that require additional insurance benefits because they could lead to higher premiums, spokesperson Mary Ellen Grant said.

SB 523 applies to more than 14 million Californians who work for the state, have a student health plan through a university, or have state-regulated commercial health plans. They would become eligible to receive free over-the-counter birth control – such as emergency contraception, condoms, spermicide, and contraceptive sponges – in addition to vasectomies. The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government.

The specifics of how the benefit would work, including the frequency and amount of birth control that insurers must cover and whether patients would have to pay upfront and be reimbursed later, would be hammered out after the measure is adopted. Ms. McCaman Taylor said allowing people to simply present their insurance card at a pharmacy counter and walk away with the birth control they need would be preferable.

“We kind of learned from the national experiment with COVID over-the-counter tests that reimbursement wasn’t the best model,” she said. “If people can’t afford to pay out of pocket for it, they’re just not going to get it.”

The California Health Benefits Review Program, which analyzes legislation, projected that roughly 14,200 people with state-regulated commercial insurance would get vasectomies in California in 2022. Eliminating cost sharing would increase the number of vasectomies by 252 in the law’s first year, the program estimated.

It’s a small increase. But that, plus a jump in the use of other contraceptives covered by the bill, particularly condoms, could add up to a big reduction in unintended pregnancies. Roughly 12,300 unplanned pregnancies might be averted each year if the mandate takes effect, a reduction of more than 11%, according to the analysis.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

SACRAMENTO – California is trying to ease the pain of vasectomies by making them free for millions of residents.

Federal law and state law require most health insurers to cover prescription contraceptives at no cost to the patient. But those provisions apply to only 18 Food and Drug Administration–approved birth control options for women, so anyone with testicles is out of luck.

California lawmakers are now considering a bill that would expand that requirement to male sterilization and non-prescription birth control, including condoms and contraceptive sponges. If the Contraceptive Equity Act of 2022 passes, commercial insurance plans regulated by the state won’t be allowed to impose out-of-pocket costs, like copays, coinsurance, and deductibles, on those modes of birth control.

“It’s pretty groundbreaking in that way – it’s a whole new framework to think about contraception as something that is relevant for people of all genders,” said Liz McCaman Taylor, a senior attorney with the National Health Law Program, a group that advocates for the health rights of low-income people.

A vasectomy is an outpatient surgical procedure in which the patient’s supply of sperm is cut off from his semen by sealing or snipping the tubes that transport sperm from the testes to the penis. Most men need to recover on the couch with an ice pack for a day or 2, and a test a few months later determines whether the procedure worked.

Because vasectomies are elective procedures and usually not urgent, price can be a deciding factor.

For Nathan Songne, cost was the most stressful part of the procedure. For several years, the 31-year-old had known he didn’t want to have kids biologically. Better to adopt a 4-year-old and skip the diaper stage, he thought. He was adopted by his stepfather as a child and knew he didn’t need to be genetically related to his children to love them.

“My only concern was that I had no idea how much it was going to cost me because nobody told me,” said Mr. Songne, who lives in Mission Viejo, in Orange County. If the procedure cost $1,000, as he expected, he wouldn’t be able to afford it.

Mr. Songne’s insurance, which he gets through his work assembling guitars, covered 70% of the Aug. 8 procedure, leaving him with a bill of just under $200. “Cost did affect my decision, but because it was only $200, it made me feel a lot more relieved about continuing on with the vasectomy.”

There are two hot times of year in the vasectomy business, according to Mary Samplaski, MD, an associate professor of urology at the University of Southern California, Los Angeles. First, she sees an uptick during the March Madness college basketball tournament, when men choose to recover on the couch watching hoops.

The end of the year is also busy, she said, because many patients have finally met their annual insurance deductible and can afford the procedure.

Patients discuss out-of-pocket costs in about 20% of her vasectomy consultations. “It’s obviously a nerve-wracking procedure,” Dr. Samplaski said. “And on top of that, if your copay is high, there’s even less reason to want to do it.”

In April, Jacob Elert comparison-shopped for a vasectomy near his home in Sacramento because his health plan doesn’t cover the procedure. He had hoped to schedule one with his regular urologist, but that would have come with a $1,500 price tag.

Instead, he found a chain of vasectomy clinics where he could get the procedure for $850. Three months later, a test confirmed the vasectomy was a success.

Mr. Elert has no regrets, but had price not been a factor, he would have preferred to go to his regular urologist. “That’s the doctor I trust,” Mr. Elert said. “But it was just way too expensive.”

In November, California voters will decide whether to lock rights to abortion and contraception into the state constitution. But Proposition 1 doesn’t address issues such as cost and coverage, said Amy Moy, a spokesperson for Essential Access Health, a group that runs California’s Title X family planning program.

“The constitutional amendment is kind of the long-term protection, and we are still working to reduce barriers for Californians on the short-term and day-to-day level regardless of their gender,” she said.

SB 523 has sailed through preliminary votes in the state legislature, which faces an end-of-August deadline to act on bills. If the measure passes, it would take effect in 2024, and California would join a handful of states that require plans they regulate to completely cover vasectomies or nonprescription birth control.

The California Association of Health Plans is still evaluating the measure, which may be amended in the final days of the legislative session. But the association generally opposes bills that require additional insurance benefits because they could lead to higher premiums, spokesperson Mary Ellen Grant said.

SB 523 applies to more than 14 million Californians who work for the state, have a student health plan through a university, or have state-regulated commercial health plans. They would become eligible to receive free over-the-counter birth control – such as emergency contraception, condoms, spermicide, and contraceptive sponges – in addition to vasectomies. The bill would not apply to the millions of Californians whose health insurance plans are regulated by the federal government.

The specifics of how the benefit would work, including the frequency and amount of birth control that insurers must cover and whether patients would have to pay upfront and be reimbursed later, would be hammered out after the measure is adopted. Ms. McCaman Taylor said allowing people to simply present their insurance card at a pharmacy counter and walk away with the birth control they need would be preferable.

“We kind of learned from the national experiment with COVID over-the-counter tests that reimbursement wasn’t the best model,” she said. “If people can’t afford to pay out of pocket for it, they’re just not going to get it.”

The California Health Benefits Review Program, which analyzes legislation, projected that roughly 14,200 people with state-regulated commercial insurance would get vasectomies in California in 2022. Eliminating cost sharing would increase the number of vasectomies by 252 in the law’s first year, the program estimated.

It’s a small increase. But that, plus a jump in the use of other contraceptives covered by the bill, particularly condoms, could add up to a big reduction in unintended pregnancies. Roughly 12,300 unplanned pregnancies might be averted each year if the mandate takes effect, a reduction of more than 11%, according to the analysis.

This story was produced by KHN, which publishes California Healthline, an editorially independent service of the California Health Care Foundation. KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Leukemia rates two to three times higher in children born near fracking

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Thu, 12/15/2022 - 14:28

Children born near fracking and other “unconventional” drilling sites are at two to three times greater risk of developing childhood leukemia, according to new research.

The study, published in the journal Environmental Health Perspectives, compared proximity of homes to unconventional oil and gas development (UOGD) sites and risk of the most common form of childhood leukemia, acute lymphoblastic leukemia (ALL).

Researchers looked at 405 children aged 2-7 diagnosed with ALL in Pennsylvania from 2009 to 2017. These children were compared to a control group of 2,080 without the disease matched on the year of birth.

“Unconventional oil and gas development can both use and release chemicals that have been linked to cancer,” study coauthor Nicole Deziel, PhD, of the Yale School of Public Health, New Haven, Conn., said in a  statement . She noted that the possibility that children living in close proximity to such sites are “exposed to these chemical carcinogens is a major public health concern.”

About 17 million Americans live within a half-mile of active oil and gas production, according to the Oil & Gas Threat Map, Common Dreams reports. That number includes 4 million children.

The Yale study also found that drinking water could be an important pathway of exposure to oil- and gas-related chemicals used in the UOGD methods of extraction.

Researchers used a new metric that measures exposure to contaminated drinking water and distance to a well. They were able to identify UOGD-affected wells that fell within watersheds where children and their families likely obtained their water.

“Previous health studies have found links between proximity to oil and gas drilling and various children’s health outcomes,” said Dr. Deziel. “This study is among the few to focus on drinking water specifically and the first to apply a novel metric designed to capture potential exposure through this pathway.”

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

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Children born near fracking and other “unconventional” drilling sites are at two to three times greater risk of developing childhood leukemia, according to new research.

The study, published in the journal Environmental Health Perspectives, compared proximity of homes to unconventional oil and gas development (UOGD) sites and risk of the most common form of childhood leukemia, acute lymphoblastic leukemia (ALL).

Researchers looked at 405 children aged 2-7 diagnosed with ALL in Pennsylvania from 2009 to 2017. These children were compared to a control group of 2,080 without the disease matched on the year of birth.

“Unconventional oil and gas development can both use and release chemicals that have been linked to cancer,” study coauthor Nicole Deziel, PhD, of the Yale School of Public Health, New Haven, Conn., said in a  statement . She noted that the possibility that children living in close proximity to such sites are “exposed to these chemical carcinogens is a major public health concern.”

About 17 million Americans live within a half-mile of active oil and gas production, according to the Oil & Gas Threat Map, Common Dreams reports. That number includes 4 million children.

The Yale study also found that drinking water could be an important pathway of exposure to oil- and gas-related chemicals used in the UOGD methods of extraction.

Researchers used a new metric that measures exposure to contaminated drinking water and distance to a well. They were able to identify UOGD-affected wells that fell within watersheds where children and their families likely obtained their water.

“Previous health studies have found links between proximity to oil and gas drilling and various children’s health outcomes,” said Dr. Deziel. “This study is among the few to focus on drinking water specifically and the first to apply a novel metric designed to capture potential exposure through this pathway.”

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

Children born near fracking and other “unconventional” drilling sites are at two to three times greater risk of developing childhood leukemia, according to new research.

The study, published in the journal Environmental Health Perspectives, compared proximity of homes to unconventional oil and gas development (UOGD) sites and risk of the most common form of childhood leukemia, acute lymphoblastic leukemia (ALL).

Researchers looked at 405 children aged 2-7 diagnosed with ALL in Pennsylvania from 2009 to 2017. These children were compared to a control group of 2,080 without the disease matched on the year of birth.

“Unconventional oil and gas development can both use and release chemicals that have been linked to cancer,” study coauthor Nicole Deziel, PhD, of the Yale School of Public Health, New Haven, Conn., said in a  statement . She noted that the possibility that children living in close proximity to such sites are “exposed to these chemical carcinogens is a major public health concern.”

About 17 million Americans live within a half-mile of active oil and gas production, according to the Oil & Gas Threat Map, Common Dreams reports. That number includes 4 million children.

The Yale study also found that drinking water could be an important pathway of exposure to oil- and gas-related chemicals used in the UOGD methods of extraction.

Researchers used a new metric that measures exposure to contaminated drinking water and distance to a well. They were able to identify UOGD-affected wells that fell within watersheds where children and their families likely obtained their water.

“Previous health studies have found links between proximity to oil and gas drilling and various children’s health outcomes,” said Dr. Deziel. “This study is among the few to focus on drinking water specifically and the first to apply a novel metric designed to capture potential exposure through this pathway.”

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

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