COVID protections suppressed flu season in U.S.

Article Type
Changed
Thu, 08/26/2021 - 15:52

Last fall, health experts said it was possible the United States could experience an easy 2020-21 flu season because health measures to fight COVID-19 would also thwart the spread of influenza.

It looks like that happened – and then some. Numbers are strikingly low for cases of the flu and other common respiratory and gastrointestinal viruses, health experts told the Washington Post.

“It’s crazy,” Lynnette Brammer, MPH, who leads the domestic influenza surveillance team at the Centers for Disease Control and Prevention, told the Washington Post. “This is my 30th flu season. I never would have expected to see flu activity this low.”

Influenza A, influenza B, parainfluenza, norovirus, respiratory syncytial virus, human metapneumovirus, and the bacteria that cause whooping cough and pneumonia are circulating at near-record-low levels.

As an example, the Washington Post said in the third week of December 2019, the CDC’s network of clinical labs reported 16.2% of almost 30,000 samples tested positive for influenza A. During the same period in 2020, only 0.3% tested positive.

But there’s a possible downside to this suppression of viruses, because flu and other viruses may rebound once the coronavirus is brought under control.

“The best analogy is to a forest fire,” Bryan Grenfell, PhD, an epidemiologist and population biologist at Princeton (N.J.) University, told the Washington Post. “For the fire to spread, it needs to have unburned wood. For epidemics to spread, they require people who haven’t previously been infected. So if people don’t get infected this year by these viruses, they likely will at some point later on.”

American health experts like Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said last fall that they noticed Australia and other nations in the southern hemisphere had easy flu seasons, apparently because of COVID protection measures. The flu season there runs March through August.

COVID-19 now has a very low presence in Australia, but in recent months the flu has been making a comeback. Flu cases among children aged 5 and younger rose sixfold by December, when such cases are usually at their lowest, the Washington Post said.

“That’s an important cautionary tale for us,” said Kevin Messacar, MD, an infectious disease doctor at Children’s Hospital Colorado, Aurora. “Just because we get through the winter and don’t see much RSV or influenza doesn’t mean we’ll be out of the woods.”

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

Publications
Topics
Sections

Last fall, health experts said it was possible the United States could experience an easy 2020-21 flu season because health measures to fight COVID-19 would also thwart the spread of influenza.

It looks like that happened – and then some. Numbers are strikingly low for cases of the flu and other common respiratory and gastrointestinal viruses, health experts told the Washington Post.

“It’s crazy,” Lynnette Brammer, MPH, who leads the domestic influenza surveillance team at the Centers for Disease Control and Prevention, told the Washington Post. “This is my 30th flu season. I never would have expected to see flu activity this low.”

Influenza A, influenza B, parainfluenza, norovirus, respiratory syncytial virus, human metapneumovirus, and the bacteria that cause whooping cough and pneumonia are circulating at near-record-low levels.

As an example, the Washington Post said in the third week of December 2019, the CDC’s network of clinical labs reported 16.2% of almost 30,000 samples tested positive for influenza A. During the same period in 2020, only 0.3% tested positive.

But there’s a possible downside to this suppression of viruses, because flu and other viruses may rebound once the coronavirus is brought under control.

“The best analogy is to a forest fire,” Bryan Grenfell, PhD, an epidemiologist and population biologist at Princeton (N.J.) University, told the Washington Post. “For the fire to spread, it needs to have unburned wood. For epidemics to spread, they require people who haven’t previously been infected. So if people don’t get infected this year by these viruses, they likely will at some point later on.”

American health experts like Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said last fall that they noticed Australia and other nations in the southern hemisphere had easy flu seasons, apparently because of COVID protection measures. The flu season there runs March through August.

COVID-19 now has a very low presence in Australia, but in recent months the flu has been making a comeback. Flu cases among children aged 5 and younger rose sixfold by December, when such cases are usually at their lowest, the Washington Post said.

“That’s an important cautionary tale for us,” said Kevin Messacar, MD, an infectious disease doctor at Children’s Hospital Colorado, Aurora. “Just because we get through the winter and don’t see much RSV or influenza doesn’t mean we’ll be out of the woods.”

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

Last fall, health experts said it was possible the United States could experience an easy 2020-21 flu season because health measures to fight COVID-19 would also thwart the spread of influenza.

It looks like that happened – and then some. Numbers are strikingly low for cases of the flu and other common respiratory and gastrointestinal viruses, health experts told the Washington Post.

“It’s crazy,” Lynnette Brammer, MPH, who leads the domestic influenza surveillance team at the Centers for Disease Control and Prevention, told the Washington Post. “This is my 30th flu season. I never would have expected to see flu activity this low.”

Influenza A, influenza B, parainfluenza, norovirus, respiratory syncytial virus, human metapneumovirus, and the bacteria that cause whooping cough and pneumonia are circulating at near-record-low levels.

As an example, the Washington Post said in the third week of December 2019, the CDC’s network of clinical labs reported 16.2% of almost 30,000 samples tested positive for influenza A. During the same period in 2020, only 0.3% tested positive.

But there’s a possible downside to this suppression of viruses, because flu and other viruses may rebound once the coronavirus is brought under control.

“The best analogy is to a forest fire,” Bryan Grenfell, PhD, an epidemiologist and population biologist at Princeton (N.J.) University, told the Washington Post. “For the fire to spread, it needs to have unburned wood. For epidemics to spread, they require people who haven’t previously been infected. So if people don’t get infected this year by these viruses, they likely will at some point later on.”

American health experts like Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Disease, said last fall that they noticed Australia and other nations in the southern hemisphere had easy flu seasons, apparently because of COVID protection measures. The flu season there runs March through August.

COVID-19 now has a very low presence in Australia, but in recent months the flu has been making a comeback. Flu cases among children aged 5 and younger rose sixfold by December, when such cases are usually at their lowest, the Washington Post said.

“That’s an important cautionary tale for us,” said Kevin Messacar, MD, an infectious disease doctor at Children’s Hospital Colorado, Aurora. “Just because we get through the winter and don’t see much RSV or influenza doesn’t mean we’ll be out of the woods.”

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Differences in right vs. left colon in Black vs. White individuals

Article Type
Changed
Thu, 03/25/2021 - 15:01

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m2 vs 28.29 kg/m2).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

"This study’s observations are interesting and important. One additional limitation to consider is how race of the patient was determined, e.g. self-identified or ancestry history. If it was the former, than this study is limited by the fact that individuals who identify as African American may also have European ancestry, similarly European Americans may have African ancestry. As we advance in health disparities research, our work must acknowledge that there is a broad range of degree of European ancestry among Black Americans,” added Byron Cryer, MD, and Sandra Quezada, MD, the cochairs of the AGA Equity Project Advisory Board.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

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

Publications
Topics
Sections

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m2 vs 28.29 kg/m2).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

"This study’s observations are interesting and important. One additional limitation to consider is how race of the patient was determined, e.g. self-identified or ancestry history. If it was the former, than this study is limited by the fact that individuals who identify as African American may also have European ancestry, similarly European Americans may have African ancestry. As we advance in health disparities research, our work must acknowledge that there is a broad range of degree of European ancestry among Black Americans,” added Byron Cryer, MD, and Sandra Quezada, MD, the cochairs of the AGA Equity Project Advisory Board.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

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

The right colon appears to age faster in Black people than in White people, perhaps explaining the higher prevalence of right-side colon cancer among Black Americans, according to results from a biopsy study.

The findings were published online Dec. 30 in the Journal of the National Cancer Institute.

For the study, investigators analyzed colon biopsy specimens from 128 individuals who underwent routine colorectal screening.

The researchers compared DNA methylation levels in right and left colon biopsy samples from the same patient. They then assigned epigenetic ages to the tissue samples using the Hovarth clock, which estimates tissue age on the basis of DNA methylation.

DNA methylation is influenced by age and environmental exposures. Aberrant DNA methylation is a hallmark of colorectal cancer, the researchers explained.

The epigenetic age of the right colon of the 88 Black patients was 1.51 years ahead of their left colon; the right colon of the 44 White patients was epigenetically 1.93 years younger than their left colon.

The right colon was epigenetically older than the left colon in 60.2% of Black patients; it was younger in more than 70% of White patients.

A unique pattern of DNA hypermethylation was found in the right colon of Black patients.

“Our results provide biological plausibility for the observed relative preponderance of right colon cancer and younger age of onset in African Americans as compared to European Americans,” wrote the investigators, led by Matthew Devall, PhD, a research associate at the Center for Public Health Genomics at the University of Virginia, Charlottesville.

“Side-specific colonic epigenetic aging may be a promising marker to guide interventions to reduce CRC [colorectal cancer] burden,” they suggested.

If these findings are “corroborated in African Americans in future studies, these results could potentially explain racial differences in the site predilection of colorectal cancers,”  Amit Joshi, MBBS, PhD, and Andrew Chan, MD, gastrointestinal molecular epidemiologists at Harvard Medical School, Boston, wrote in an accompanying editorial.

However, “it is not clear if the higher epigenetic aging measured using the Horvath clock ... directly translates to a higher risk of colorectal cancer,” they noted.

Some differences between the Black patients and the White patients in the study could explain the methylation differences, they pointed out. A higher proportion of Black patients smoked (37.5% vs. 15%), and Black patients were younger (median age, 55.5 years, vs. 61.7 years). In addition, the study included more Black women than White women (67% vs. 58%), and body mass indexes were higher for Black patients than White patients (31.36 kg/m2 vs 28.29 kg/m2).

“One or more of these factors, or others that were not measured, may be linked to differential methylation in the right compared with left colon,” the editorialists wrote.

Even so, among the Black patients, almost 70% of differentially methylated positions in the right colon were hypermethylated, compared to less than half in the left colon. These included positions previously associated with colorectal cancer, aging, and ancestry, “suggesting a role for genetic variation in contributing to DNA methylation differences in AA right colon,” the investigators said.

"This study’s observations are interesting and important. One additional limitation to consider is how race of the patient was determined, e.g. self-identified or ancestry history. If it was the former, than this study is limited by the fact that individuals who identify as African American may also have European ancestry, similarly European Americans may have African ancestry. As we advance in health disparities research, our work must acknowledge that there is a broad range of degree of European ancestry among Black Americans,” added Byron Cryer, MD, and Sandra Quezada, MD, the cochairs of the AGA Equity Project Advisory Board.

The work was supported the National Cancer Institute Cancer, the Case Comprehensive Cancer Center, and the University of Virginia Cancer Center. The authors and editorialists have disclosed no relevant financial relationships.

AGA applauds researchers who are working to raise our awareness of health disparities in digestive diseases. AGA is committed to addressing this important societal issue head on. Learn more about AGA’s commitment through the AGA Equity Project.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer
Reuters content

Liver disease associated with worse COVID-19 outcomes

Article Type
Changed
Thu, 01/14/2021 - 09:39

A growing body of evidence suggests that patients with COVID-19 and preexisting liver disease face increased risks of decompensation and mortality, according to a review of recent literature.

The review aimed to bring together the best approaches for caring for patients with preexisting liver conditions based on recommendations from three major hepatology societies. Findings in included studies could guide clinical decision-making, but a reliable framework for patient management has yet to be established, most likely because of limited research, according to lead author Abdul Mohammed, MD, of Case Western Reserve University, Cleveland, and colleagues.

The relationship between chronic liver diseases and “COVID-19 is not well documented in the literature,” Dr. Mohammed and colleagues wrote in the Journal of Clinical Gastroenterology. “The intricate interplay between immune dysfunction in preexisting liver diseases and the immune dysregulation triggered by the SARS-CoV-2 virus needs further evaluation.”

Such knowledge gaps likely explain the inconsistencies in recommendations between major hepatology societies, including clinical guidance from the American Association for the Study of Liver Disease, the European Association for the Study of the Liver, and the Asian Pacific Association for the Study of the Liver.

Both the literature review and the societal guidance address nonalcoholic fatty liver disease (NAFLD), hepatitis B virus (HBV) infection, autoimmune hepatitis, hepatocellular carcinoma (HCC), cirrhosis, and liver transplantation.

Dr. Mohammed and colleagues first offered an update of the relationship between COVID-19 and liver pathology. While it is clear that SARS-CoV-2 gains hepatic access through binding to ACE2 receptors in bile duct epithelial cells, it remains unclear whether this results in direct hepatic injury or indirect damage from virus-mediated cytokine release. Regardless, more than 90% of patients hospitalized for COVID-19 may develop increased levels of ALT and AST, and these elevations “appear to mirror disease severity,” the investigators wrote.

They noted that severity of COVID-19 appears to correlate with type of preexisting liver disease. For example, one study in the review associated NAFLD with a significantly increased risk of progressive COVID-19 (odds ratio, 6.4; 95% confidence interval, 1.5-31.2), and it also found that patients with NAFLD had longer duration of viral shedding than those without (17 vs. 12 days). Although the AASLD and APASL give no specific recommendations, the EASL recommends prioritizing COVID-19 patients with NAFLD.

Cirrhosis has been associated with a fourfold increased risk of mortality (relative risk, 4.6; 95% CI, 2.6-8.3) According to data from two international self-reporting registries, COVIDHep.net and COVIDCirrhosis.org, likelihood of death appears to move in tandem with Child-Turcotte-Pugh scores. Decompensated cirrhosis appears to predispose patients to having pulmonary complications, but more studies exploring this correlation need to be performed, according to the review authors. One study found that acute-on-chronic liver failure or acute decompensation occurred in 20% of patients who had COVID-19 and cirrhosis. It’s little surprise, then, that both the AASLD and the EASL recommend prioritizing in person evaluation for patients with decompensated cirrhosis.

Chronic HBV infection has also been associated with a higher COVID-19 mortality rate, although Dr. Mohammed and colleagues suggested that “larger studies are needed.” The review notes that the three societies recommend initiating HBV treatment only if there is clinical suspicion of hepatitis flare.

Findings are also cloudy among patients with autoimmune hepatitis and liver transplant recipients; however, the investigators noted that COVID-19 causes tissue damage primarily through cytokine release, and suggested that “immunosuppression can potentially curb this response.” Even so, recommendations from leading hepatology societies allude to a safe middle ground of immunosuppression, albeit with indistinct borders. All three caution against withdrawing immunosuppression, but the societies each describe tailoring regimens in different ways and for different patients, emphasizing continued corticosteroid treatments, according to the review.

Guidance also varies for management of HCC. “Since the tumor doubling time is 4-8 months and current guidelines recommend screening every 6 months, in patients at lower risk for developing HCC, a 2-month delay in ultrasound surveillance has been suggested by the AASLD,” the review authors noted. “In patients with a high risk of developing HCC, 6-month interval screening should be continued.” The AASLD recommends proceeding with treatment with newly diagnosed HCC, the EASL suggests that checkpoint inhibitors should be withheld and locoregional therapies should be postponed, and the APASL calls for a less frequent schedule of tyrosine kinase inhibitors and immunotherapy.

“COVID-19 patients with the preexisting liver disease face a higher risk of decompensation and mortality,” the review authors concluded. “We presented the most up-to-date literature on preexisting liver disease and its interaction with COVID-19.”

While such discrepancies may remain unresolved until further data are available, Wajahat Mehal, MD, PhD, director of the fatty liver disease program at Yale University, New Haven, Conn., suggested that clinicians remain vigilant for nonalcoholic steatohepatitis (NASH), which is common among overweight and obese individuals, an overrepresented group among those hospitalized for COVID-19.

“This is of great significance because patients with various forms of liver disease have a worse outcome with COVID-19,” Dr. Mehal said. “When seeing a patient with COVID-19 it is therefore important to ask if they have underlying liver disease, with attention paid to NASH. This can be approached by seeing if they have any evidence of abnormal liver function tests before the onset of COVID and any evidence of abnormal liver imaging. The Fib-4 test is a good screening tool for the presence of advanced liver fibrosis and a positive result should lead to more specific tests of liver fibrosis status such as fibroscan.”

The investigators reported no conflicts of interest. Dr. Mehal reported having nothing to disclose.

Publications
Topics
Sections

A growing body of evidence suggests that patients with COVID-19 and preexisting liver disease face increased risks of decompensation and mortality, according to a review of recent literature.

The review aimed to bring together the best approaches for caring for patients with preexisting liver conditions based on recommendations from three major hepatology societies. Findings in included studies could guide clinical decision-making, but a reliable framework for patient management has yet to be established, most likely because of limited research, according to lead author Abdul Mohammed, MD, of Case Western Reserve University, Cleveland, and colleagues.

The relationship between chronic liver diseases and “COVID-19 is not well documented in the literature,” Dr. Mohammed and colleagues wrote in the Journal of Clinical Gastroenterology. “The intricate interplay between immune dysfunction in preexisting liver diseases and the immune dysregulation triggered by the SARS-CoV-2 virus needs further evaluation.”

Such knowledge gaps likely explain the inconsistencies in recommendations between major hepatology societies, including clinical guidance from the American Association for the Study of Liver Disease, the European Association for the Study of the Liver, and the Asian Pacific Association for the Study of the Liver.

Both the literature review and the societal guidance address nonalcoholic fatty liver disease (NAFLD), hepatitis B virus (HBV) infection, autoimmune hepatitis, hepatocellular carcinoma (HCC), cirrhosis, and liver transplantation.

Dr. Mohammed and colleagues first offered an update of the relationship between COVID-19 and liver pathology. While it is clear that SARS-CoV-2 gains hepatic access through binding to ACE2 receptors in bile duct epithelial cells, it remains unclear whether this results in direct hepatic injury or indirect damage from virus-mediated cytokine release. Regardless, more than 90% of patients hospitalized for COVID-19 may develop increased levels of ALT and AST, and these elevations “appear to mirror disease severity,” the investigators wrote.

They noted that severity of COVID-19 appears to correlate with type of preexisting liver disease. For example, one study in the review associated NAFLD with a significantly increased risk of progressive COVID-19 (odds ratio, 6.4; 95% confidence interval, 1.5-31.2), and it also found that patients with NAFLD had longer duration of viral shedding than those without (17 vs. 12 days). Although the AASLD and APASL give no specific recommendations, the EASL recommends prioritizing COVID-19 patients with NAFLD.

Cirrhosis has been associated with a fourfold increased risk of mortality (relative risk, 4.6; 95% CI, 2.6-8.3) According to data from two international self-reporting registries, COVIDHep.net and COVIDCirrhosis.org, likelihood of death appears to move in tandem with Child-Turcotte-Pugh scores. Decompensated cirrhosis appears to predispose patients to having pulmonary complications, but more studies exploring this correlation need to be performed, according to the review authors. One study found that acute-on-chronic liver failure or acute decompensation occurred in 20% of patients who had COVID-19 and cirrhosis. It’s little surprise, then, that both the AASLD and the EASL recommend prioritizing in person evaluation for patients with decompensated cirrhosis.

Chronic HBV infection has also been associated with a higher COVID-19 mortality rate, although Dr. Mohammed and colleagues suggested that “larger studies are needed.” The review notes that the three societies recommend initiating HBV treatment only if there is clinical suspicion of hepatitis flare.

Findings are also cloudy among patients with autoimmune hepatitis and liver transplant recipients; however, the investigators noted that COVID-19 causes tissue damage primarily through cytokine release, and suggested that “immunosuppression can potentially curb this response.” Even so, recommendations from leading hepatology societies allude to a safe middle ground of immunosuppression, albeit with indistinct borders. All three caution against withdrawing immunosuppression, but the societies each describe tailoring regimens in different ways and for different patients, emphasizing continued corticosteroid treatments, according to the review.

Guidance also varies for management of HCC. “Since the tumor doubling time is 4-8 months and current guidelines recommend screening every 6 months, in patients at lower risk for developing HCC, a 2-month delay in ultrasound surveillance has been suggested by the AASLD,” the review authors noted. “In patients with a high risk of developing HCC, 6-month interval screening should be continued.” The AASLD recommends proceeding with treatment with newly diagnosed HCC, the EASL suggests that checkpoint inhibitors should be withheld and locoregional therapies should be postponed, and the APASL calls for a less frequent schedule of tyrosine kinase inhibitors and immunotherapy.

“COVID-19 patients with the preexisting liver disease face a higher risk of decompensation and mortality,” the review authors concluded. “We presented the most up-to-date literature on preexisting liver disease and its interaction with COVID-19.”

While such discrepancies may remain unresolved until further data are available, Wajahat Mehal, MD, PhD, director of the fatty liver disease program at Yale University, New Haven, Conn., suggested that clinicians remain vigilant for nonalcoholic steatohepatitis (NASH), which is common among overweight and obese individuals, an overrepresented group among those hospitalized for COVID-19.

“This is of great significance because patients with various forms of liver disease have a worse outcome with COVID-19,” Dr. Mehal said. “When seeing a patient with COVID-19 it is therefore important to ask if they have underlying liver disease, with attention paid to NASH. This can be approached by seeing if they have any evidence of abnormal liver function tests before the onset of COVID and any evidence of abnormal liver imaging. The Fib-4 test is a good screening tool for the presence of advanced liver fibrosis and a positive result should lead to more specific tests of liver fibrosis status such as fibroscan.”

The investigators reported no conflicts of interest. Dr. Mehal reported having nothing to disclose.

A growing body of evidence suggests that patients with COVID-19 and preexisting liver disease face increased risks of decompensation and mortality, according to a review of recent literature.

The review aimed to bring together the best approaches for caring for patients with preexisting liver conditions based on recommendations from three major hepatology societies. Findings in included studies could guide clinical decision-making, but a reliable framework for patient management has yet to be established, most likely because of limited research, according to lead author Abdul Mohammed, MD, of Case Western Reserve University, Cleveland, and colleagues.

The relationship between chronic liver diseases and “COVID-19 is not well documented in the literature,” Dr. Mohammed and colleagues wrote in the Journal of Clinical Gastroenterology. “The intricate interplay between immune dysfunction in preexisting liver diseases and the immune dysregulation triggered by the SARS-CoV-2 virus needs further evaluation.”

Such knowledge gaps likely explain the inconsistencies in recommendations between major hepatology societies, including clinical guidance from the American Association for the Study of Liver Disease, the European Association for the Study of the Liver, and the Asian Pacific Association for the Study of the Liver.

Both the literature review and the societal guidance address nonalcoholic fatty liver disease (NAFLD), hepatitis B virus (HBV) infection, autoimmune hepatitis, hepatocellular carcinoma (HCC), cirrhosis, and liver transplantation.

Dr. Mohammed and colleagues first offered an update of the relationship between COVID-19 and liver pathology. While it is clear that SARS-CoV-2 gains hepatic access through binding to ACE2 receptors in bile duct epithelial cells, it remains unclear whether this results in direct hepatic injury or indirect damage from virus-mediated cytokine release. Regardless, more than 90% of patients hospitalized for COVID-19 may develop increased levels of ALT and AST, and these elevations “appear to mirror disease severity,” the investigators wrote.

They noted that severity of COVID-19 appears to correlate with type of preexisting liver disease. For example, one study in the review associated NAFLD with a significantly increased risk of progressive COVID-19 (odds ratio, 6.4; 95% confidence interval, 1.5-31.2), and it also found that patients with NAFLD had longer duration of viral shedding than those without (17 vs. 12 days). Although the AASLD and APASL give no specific recommendations, the EASL recommends prioritizing COVID-19 patients with NAFLD.

Cirrhosis has been associated with a fourfold increased risk of mortality (relative risk, 4.6; 95% CI, 2.6-8.3) According to data from two international self-reporting registries, COVIDHep.net and COVIDCirrhosis.org, likelihood of death appears to move in tandem with Child-Turcotte-Pugh scores. Decompensated cirrhosis appears to predispose patients to having pulmonary complications, but more studies exploring this correlation need to be performed, according to the review authors. One study found that acute-on-chronic liver failure or acute decompensation occurred in 20% of patients who had COVID-19 and cirrhosis. It’s little surprise, then, that both the AASLD and the EASL recommend prioritizing in person evaluation for patients with decompensated cirrhosis.

Chronic HBV infection has also been associated with a higher COVID-19 mortality rate, although Dr. Mohammed and colleagues suggested that “larger studies are needed.” The review notes that the three societies recommend initiating HBV treatment only if there is clinical suspicion of hepatitis flare.

Findings are also cloudy among patients with autoimmune hepatitis and liver transplant recipients; however, the investigators noted that COVID-19 causes tissue damage primarily through cytokine release, and suggested that “immunosuppression can potentially curb this response.” Even so, recommendations from leading hepatology societies allude to a safe middle ground of immunosuppression, albeit with indistinct borders. All three caution against withdrawing immunosuppression, but the societies each describe tailoring regimens in different ways and for different patients, emphasizing continued corticosteroid treatments, according to the review.

Guidance also varies for management of HCC. “Since the tumor doubling time is 4-8 months and current guidelines recommend screening every 6 months, in patients at lower risk for developing HCC, a 2-month delay in ultrasound surveillance has been suggested by the AASLD,” the review authors noted. “In patients with a high risk of developing HCC, 6-month interval screening should be continued.” The AASLD recommends proceeding with treatment with newly diagnosed HCC, the EASL suggests that checkpoint inhibitors should be withheld and locoregional therapies should be postponed, and the APASL calls for a less frequent schedule of tyrosine kinase inhibitors and immunotherapy.

“COVID-19 patients with the preexisting liver disease face a higher risk of decompensation and mortality,” the review authors concluded. “We presented the most up-to-date literature on preexisting liver disease and its interaction with COVID-19.”

While such discrepancies may remain unresolved until further data are available, Wajahat Mehal, MD, PhD, director of the fatty liver disease program at Yale University, New Haven, Conn., suggested that clinicians remain vigilant for nonalcoholic steatohepatitis (NASH), which is common among overweight and obese individuals, an overrepresented group among those hospitalized for COVID-19.

“This is of great significance because patients with various forms of liver disease have a worse outcome with COVID-19,” Dr. Mehal said. “When seeing a patient with COVID-19 it is therefore important to ask if they have underlying liver disease, with attention paid to NASH. This can be approached by seeing if they have any evidence of abnormal liver function tests before the onset of COVID and any evidence of abnormal liver imaging. The Fib-4 test is a good screening tool for the presence of advanced liver fibrosis and a positive result should lead to more specific tests of liver fibrosis status such as fibroscan.”

The investigators reported no conflicts of interest. Dr. Mehal reported having nothing to disclose.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE JOURNAL OF CLINICAL GASTROENTEROLOGY

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Childhood smoking and depression contribute to young adult opioid use

Article Type
Changed
Wed, 01/20/2021 - 09:57

Depression and tobacco use in childhood significantly increased the risk for opioid use in young adults, according to data from a prospective study of approximately 1,000 individuals.

Previous research, including the annual Monitoring the Future study, documents opioid use among adolescents in the United States, but childhood risk factors for opioid use in young adults have not been well studied, wrote Lilly Shanahan, PhD, of the University of Zürich, and colleagues.

In a prospective cohort study published in JAMA Pediatrics, the researchers identified 1,252 non-Hispanic White and American Indian opioid-naive individuals aged 9-16 years in rural North Carolina. They interviewed participants and parents up to 7 times between January 1993 and December 2000, and interviewed participants only at ages 19, 21, 25, and 30 years between January 1999 and December 2015.

Overall, 24.2% of study participants had used a nonheroin opioid by age 30 years, and both chronic depression and dysthymia were significantly associated with this use (odds ratios 5.43 and 7.13, respectively).

In addition, 155 participants (8.8%) reported weekly use of a nonheroin opioid, and 95 (6.6%) reported weekly heroin use by age 30 years. Chronic depression and dysthymia also were strongly associated with weekly nonheroin opioid use (OR 8.89 and 11.51, respectively).

In a multivariate analysis, depression, tobacco use, and cannabis use at ages 9-16 years were strongly associated with overall opioid use at ages 19-30 years.

“One possible reason childhood chronic depression increases the risk of later opioid use is self-medication, including the use of psychoactive substances, to alleviate depression,” the researchers noted. In addition, the mood-altering properties of opioids may increase their appeal to depressed youth as a way to relieve impaired reward system function, they said.

Potential mechanisms for the association between early tobacco use and later opioid use include the alterations to neurodevelopment caused by nicotine exposure in adolescence, as well as increased risk for depression, reduced pain thresholds, and use of nicotine as a gateway to harder drugs, the researchers added.

Several childhood risk factors were not associated with young adult opioid use in multivariate analysis in this study, including alcohol use, sociodemographic status, maltreatment, family dysfunction, and anxiety, the researchers wrote. “Previous studies typically measured these risk factors retrospectively or in late adolescence and young adulthood, and most did not consider depressive disorders, which may mediate associations between select childhood risk factors and later opioid use,” they said.

The study findings were limited by several factors, including the inability to distinguish between medical and nonmedical opioid use, the incomplete list of available opioids, and the exclusion of Black participants because of low sample size, the researchers noted. However, the results were strengthened by the longitudinal, community-representative design and the inclusion of up to 11 assessments of opioid use, they said.

“Our findings suggest strong opportunities for early prevention and intervention, including in primary care settings,” using known evidence-based strategies, they concluded.
 

More screening is needed

“Children in the United States are at high risk of serious adult health issues as a result of childhood factors such as ACEs (adverse childhood experiences),” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “This study looks prospectively at other factors in childhood over a long period of time leading to opioid usage, with its serious risks and health consequences including overdose death,” she said. “It is unclear what the effects of COVID-19 will be on the population of children growing up now and how opioid usage might change as a result,” she noted.

“Some of the links to adult usage are predictable, such as depression, tobacco use, and cannabis use in early adolescence,” said Dr. Boulter. “Surprising was the lack of correlation between anxiety, early alcohol use, child mistreatment, and sociodemographic factors with future opioid use,” she said.

The take-home message for clinicians is to screen children and adolescents for factors leading to opioid usage in young adults “with preventive strategies including avoidance of pain medication prescriptions and early referral and treatment for depression and use of cannabis and tobacco products using tools like SBIRT (Screening, Brief Intervention, and Referral to Treatment),” Dr. Boulter emphasized.

As for additional research, “It would be interesting to study e-cigarette usage and see if the correlation with future opioid usage is similar to older tobacco products,” she said. “Also helpful would be to delve deeper into connections between medical or dental diagnoses when opioids were first prescribed and later usage of those products,” Dr. Boulter noted.

The study was supported in part by the by the National Institute of Mental Health and the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Boulter had no disclosures but serves on the Pediatric News Editorial Advisory Board.

Publications
Topics
Sections

Depression and tobacco use in childhood significantly increased the risk for opioid use in young adults, according to data from a prospective study of approximately 1,000 individuals.

Previous research, including the annual Monitoring the Future study, documents opioid use among adolescents in the United States, but childhood risk factors for opioid use in young adults have not been well studied, wrote Lilly Shanahan, PhD, of the University of Zürich, and colleagues.

In a prospective cohort study published in JAMA Pediatrics, the researchers identified 1,252 non-Hispanic White and American Indian opioid-naive individuals aged 9-16 years in rural North Carolina. They interviewed participants and parents up to 7 times between January 1993 and December 2000, and interviewed participants only at ages 19, 21, 25, and 30 years between January 1999 and December 2015.

Overall, 24.2% of study participants had used a nonheroin opioid by age 30 years, and both chronic depression and dysthymia were significantly associated with this use (odds ratios 5.43 and 7.13, respectively).

In addition, 155 participants (8.8%) reported weekly use of a nonheroin opioid, and 95 (6.6%) reported weekly heroin use by age 30 years. Chronic depression and dysthymia also were strongly associated with weekly nonheroin opioid use (OR 8.89 and 11.51, respectively).

In a multivariate analysis, depression, tobacco use, and cannabis use at ages 9-16 years were strongly associated with overall opioid use at ages 19-30 years.

“One possible reason childhood chronic depression increases the risk of later opioid use is self-medication, including the use of psychoactive substances, to alleviate depression,” the researchers noted. In addition, the mood-altering properties of opioids may increase their appeal to depressed youth as a way to relieve impaired reward system function, they said.

Potential mechanisms for the association between early tobacco use and later opioid use include the alterations to neurodevelopment caused by nicotine exposure in adolescence, as well as increased risk for depression, reduced pain thresholds, and use of nicotine as a gateway to harder drugs, the researchers added.

Several childhood risk factors were not associated with young adult opioid use in multivariate analysis in this study, including alcohol use, sociodemographic status, maltreatment, family dysfunction, and anxiety, the researchers wrote. “Previous studies typically measured these risk factors retrospectively or in late adolescence and young adulthood, and most did not consider depressive disorders, which may mediate associations between select childhood risk factors and later opioid use,” they said.

The study findings were limited by several factors, including the inability to distinguish between medical and nonmedical opioid use, the incomplete list of available opioids, and the exclusion of Black participants because of low sample size, the researchers noted. However, the results were strengthened by the longitudinal, community-representative design and the inclusion of up to 11 assessments of opioid use, they said.

“Our findings suggest strong opportunities for early prevention and intervention, including in primary care settings,” using known evidence-based strategies, they concluded.
 

More screening is needed

“Children in the United States are at high risk of serious adult health issues as a result of childhood factors such as ACEs (adverse childhood experiences),” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “This study looks prospectively at other factors in childhood over a long period of time leading to opioid usage, with its serious risks and health consequences including overdose death,” she said. “It is unclear what the effects of COVID-19 will be on the population of children growing up now and how opioid usage might change as a result,” she noted.

“Some of the links to adult usage are predictable, such as depression, tobacco use, and cannabis use in early adolescence,” said Dr. Boulter. “Surprising was the lack of correlation between anxiety, early alcohol use, child mistreatment, and sociodemographic factors with future opioid use,” she said.

The take-home message for clinicians is to screen children and adolescents for factors leading to opioid usage in young adults “with preventive strategies including avoidance of pain medication prescriptions and early referral and treatment for depression and use of cannabis and tobacco products using tools like SBIRT (Screening, Brief Intervention, and Referral to Treatment),” Dr. Boulter emphasized.

As for additional research, “It would be interesting to study e-cigarette usage and see if the correlation with future opioid usage is similar to older tobacco products,” she said. “Also helpful would be to delve deeper into connections between medical or dental diagnoses when opioids were first prescribed and later usage of those products,” Dr. Boulter noted.

The study was supported in part by the by the National Institute of Mental Health and the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Boulter had no disclosures but serves on the Pediatric News Editorial Advisory Board.

Depression and tobacco use in childhood significantly increased the risk for opioid use in young adults, according to data from a prospective study of approximately 1,000 individuals.

Previous research, including the annual Monitoring the Future study, documents opioid use among adolescents in the United States, but childhood risk factors for opioid use in young adults have not been well studied, wrote Lilly Shanahan, PhD, of the University of Zürich, and colleagues.

In a prospective cohort study published in JAMA Pediatrics, the researchers identified 1,252 non-Hispanic White and American Indian opioid-naive individuals aged 9-16 years in rural North Carolina. They interviewed participants and parents up to 7 times between January 1993 and December 2000, and interviewed participants only at ages 19, 21, 25, and 30 years between January 1999 and December 2015.

Overall, 24.2% of study participants had used a nonheroin opioid by age 30 years, and both chronic depression and dysthymia were significantly associated with this use (odds ratios 5.43 and 7.13, respectively).

In addition, 155 participants (8.8%) reported weekly use of a nonheroin opioid, and 95 (6.6%) reported weekly heroin use by age 30 years. Chronic depression and dysthymia also were strongly associated with weekly nonheroin opioid use (OR 8.89 and 11.51, respectively).

In a multivariate analysis, depression, tobacco use, and cannabis use at ages 9-16 years were strongly associated with overall opioid use at ages 19-30 years.

“One possible reason childhood chronic depression increases the risk of later opioid use is self-medication, including the use of psychoactive substances, to alleviate depression,” the researchers noted. In addition, the mood-altering properties of opioids may increase their appeal to depressed youth as a way to relieve impaired reward system function, they said.

Potential mechanisms for the association between early tobacco use and later opioid use include the alterations to neurodevelopment caused by nicotine exposure in adolescence, as well as increased risk for depression, reduced pain thresholds, and use of nicotine as a gateway to harder drugs, the researchers added.

Several childhood risk factors were not associated with young adult opioid use in multivariate analysis in this study, including alcohol use, sociodemographic status, maltreatment, family dysfunction, and anxiety, the researchers wrote. “Previous studies typically measured these risk factors retrospectively or in late adolescence and young adulthood, and most did not consider depressive disorders, which may mediate associations between select childhood risk factors and later opioid use,” they said.

The study findings were limited by several factors, including the inability to distinguish between medical and nonmedical opioid use, the incomplete list of available opioids, and the exclusion of Black participants because of low sample size, the researchers noted. However, the results were strengthened by the longitudinal, community-representative design and the inclusion of up to 11 assessments of opioid use, they said.

“Our findings suggest strong opportunities for early prevention and intervention, including in primary care settings,” using known evidence-based strategies, they concluded.
 

More screening is needed

“Children in the United States are at high risk of serious adult health issues as a result of childhood factors such as ACEs (adverse childhood experiences),” said Suzanne C. Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H. “This study looks prospectively at other factors in childhood over a long period of time leading to opioid usage, with its serious risks and health consequences including overdose death,” she said. “It is unclear what the effects of COVID-19 will be on the population of children growing up now and how opioid usage might change as a result,” she noted.

“Some of the links to adult usage are predictable, such as depression, tobacco use, and cannabis use in early adolescence,” said Dr. Boulter. “Surprising was the lack of correlation between anxiety, early alcohol use, child mistreatment, and sociodemographic factors with future opioid use,” she said.

The take-home message for clinicians is to screen children and adolescents for factors leading to opioid usage in young adults “with preventive strategies including avoidance of pain medication prescriptions and early referral and treatment for depression and use of cannabis and tobacco products using tools like SBIRT (Screening, Brief Intervention, and Referral to Treatment),” Dr. Boulter emphasized.

As for additional research, “It would be interesting to study e-cigarette usage and see if the correlation with future opioid usage is similar to older tobacco products,” she said. “Also helpful would be to delve deeper into connections between medical or dental diagnoses when opioids were first prescribed and later usage of those products,” Dr. Boulter noted.

The study was supported in part by the by the National Institute of Mental Health and the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Boulter had no disclosures but serves on the Pediatric News Editorial Advisory Board.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM JAMA PEDIATRICS

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Endocrine Society calls for action to reduce insulin costs

Article Type
Changed
Tue, 05/03/2022 - 15:07

The Endocrine Society has issued a new position statement calling on all stakeholders, including clinicians, to play a role in reducing the cost of insulin for patients with diabetes in the United States.

“Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” was published online Jan. 12 in the Journal of Clinical Endocrinology and Metabolism.

“The society believes all stakeholders across the supply chain have a role to play in addressing the high price of insulin,” said the 11 authors, who are all members of the society’s advocacy and public outreach core committee.  

This is the first such statement from a major professional organization in 2021, which is the 100th anniversary of the discovery of insulin.

And the call for action was issued just a week prior to the inauguration of incoming U.S. President Joe Biden, who has pledged to “build on the Affordable Care Act by giving Americans more choice, reducing health care costs, and making our health care system less complex to navigate.”

The cost of insulin has nearly tripled in the past 15 years in the United States, and a lack of transparency in the drug supply chain has made it challenging to identify and address the causes of soaring costs.

The high cost of insulin has made access particularly difficult for people with diabetes with a low income, who have high-deductible health plans, are Medicare beneficiaries using Part B to cover insulin delivered via pump, or are in the Medicare Part D “donut hole,” as well as young adults once they reach their 26th birthday and can no longer be covered under their parents’ insurance.

Dr. Carol Wysham

“Inventors Frederick Banting and Charles Best sold the insulin patent for a mere $1 in the 1920s because they wanted their discovery to save lives and for insulin to be affordable and accessible to everyone who needed it,” said Endocrine Society President-elect Carol Wysham, MD, of the Rockwood/MultiCare Health Systems, Spokane, Wash.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” she said.

The society’s statement called for allowing government negotiation of drug prices and greater transparency across the supply chain to elucidate the reasons for rising insulin costs.  

For physicians in particular, they advised training in use of lower-cost human NPH and regular insulin for appropriate patients with type 2 diabetes, and considering patients’ individual financial and coverage status when prescribing insulin.

Pharmacists are advised to learn about and share information with patients about lower-cost options offered by manufacturers.

Other policy recommendations for relevant stakeholders include:

  • Limit future insulin list price increases to the rate of inflation.
  • Limit out-of-pocket costs without increasing premiums or deductibles by limiting cost sharing to copays of no more than $35, providing first-dollar coverage, or capping costs at no more than $100 per month.
  • Eliminate rebates or pass savings from rebates along to consumers without increasing premiums or deductibles.
  • Expedite approval of insulin biosimilars to create market competition.
  • Include real-time benefit information in electronic medical records.
  • Develop a payment model for Medicare Part B beneficiaries, as well as Part D, to lower out-of-pocket copays.

For manufacturers, the society also recommended improving patient assistance programs to be less restrictive and more accountable. And employers, they said, should limit copays without increasing premiums or deductibles, and seek plan options that benefit people with diabetes and provide education about these options during open enrollment.   

Of the 11 writing panel members, 4 have pharmaceutical industry disclosures.

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

Publications
Topics
Sections

The Endocrine Society has issued a new position statement calling on all stakeholders, including clinicians, to play a role in reducing the cost of insulin for patients with diabetes in the United States.

“Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” was published online Jan. 12 in the Journal of Clinical Endocrinology and Metabolism.

“The society believes all stakeholders across the supply chain have a role to play in addressing the high price of insulin,” said the 11 authors, who are all members of the society’s advocacy and public outreach core committee.  

This is the first such statement from a major professional organization in 2021, which is the 100th anniversary of the discovery of insulin.

And the call for action was issued just a week prior to the inauguration of incoming U.S. President Joe Biden, who has pledged to “build on the Affordable Care Act by giving Americans more choice, reducing health care costs, and making our health care system less complex to navigate.”

The cost of insulin has nearly tripled in the past 15 years in the United States, and a lack of transparency in the drug supply chain has made it challenging to identify and address the causes of soaring costs.

The high cost of insulin has made access particularly difficult for people with diabetes with a low income, who have high-deductible health plans, are Medicare beneficiaries using Part B to cover insulin delivered via pump, or are in the Medicare Part D “donut hole,” as well as young adults once they reach their 26th birthday and can no longer be covered under their parents’ insurance.

Dr. Carol Wysham

“Inventors Frederick Banting and Charles Best sold the insulin patent for a mere $1 in the 1920s because they wanted their discovery to save lives and for insulin to be affordable and accessible to everyone who needed it,” said Endocrine Society President-elect Carol Wysham, MD, of the Rockwood/MultiCare Health Systems, Spokane, Wash.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” she said.

The society’s statement called for allowing government negotiation of drug prices and greater transparency across the supply chain to elucidate the reasons for rising insulin costs.  

For physicians in particular, they advised training in use of lower-cost human NPH and regular insulin for appropriate patients with type 2 diabetes, and considering patients’ individual financial and coverage status when prescribing insulin.

Pharmacists are advised to learn about and share information with patients about lower-cost options offered by manufacturers.

Other policy recommendations for relevant stakeholders include:

  • Limit future insulin list price increases to the rate of inflation.
  • Limit out-of-pocket costs without increasing premiums or deductibles by limiting cost sharing to copays of no more than $35, providing first-dollar coverage, or capping costs at no more than $100 per month.
  • Eliminate rebates or pass savings from rebates along to consumers without increasing premiums or deductibles.
  • Expedite approval of insulin biosimilars to create market competition.
  • Include real-time benefit information in electronic medical records.
  • Develop a payment model for Medicare Part B beneficiaries, as well as Part D, to lower out-of-pocket copays.

For manufacturers, the society also recommended improving patient assistance programs to be less restrictive and more accountable. And employers, they said, should limit copays without increasing premiums or deductibles, and seek plan options that benefit people with diabetes and provide education about these options during open enrollment.   

Of the 11 writing panel members, 4 have pharmaceutical industry disclosures.

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

The Endocrine Society has issued a new position statement calling on all stakeholders, including clinicians, to play a role in reducing the cost of insulin for patients with diabetes in the United States.

“Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” was published online Jan. 12 in the Journal of Clinical Endocrinology and Metabolism.

“The society believes all stakeholders across the supply chain have a role to play in addressing the high price of insulin,” said the 11 authors, who are all members of the society’s advocacy and public outreach core committee.  

This is the first such statement from a major professional organization in 2021, which is the 100th anniversary of the discovery of insulin.

And the call for action was issued just a week prior to the inauguration of incoming U.S. President Joe Biden, who has pledged to “build on the Affordable Care Act by giving Americans more choice, reducing health care costs, and making our health care system less complex to navigate.”

The cost of insulin has nearly tripled in the past 15 years in the United States, and a lack of transparency in the drug supply chain has made it challenging to identify and address the causes of soaring costs.

The high cost of insulin has made access particularly difficult for people with diabetes with a low income, who have high-deductible health plans, are Medicare beneficiaries using Part B to cover insulin delivered via pump, or are in the Medicare Part D “donut hole,” as well as young adults once they reach their 26th birthday and can no longer be covered under their parents’ insurance.

Dr. Carol Wysham

“Inventors Frederick Banting and Charles Best sold the insulin patent for a mere $1 in the 1920s because they wanted their discovery to save lives and for insulin to be affordable and accessible to everyone who needed it,” said Endocrine Society President-elect Carol Wysham, MD, of the Rockwood/MultiCare Health Systems, Spokane, Wash.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” she said.

The society’s statement called for allowing government negotiation of drug prices and greater transparency across the supply chain to elucidate the reasons for rising insulin costs.  

For physicians in particular, they advised training in use of lower-cost human NPH and regular insulin for appropriate patients with type 2 diabetes, and considering patients’ individual financial and coverage status when prescribing insulin.

Pharmacists are advised to learn about and share information with patients about lower-cost options offered by manufacturers.

Other policy recommendations for relevant stakeholders include:

  • Limit future insulin list price increases to the rate of inflation.
  • Limit out-of-pocket costs without increasing premiums or deductibles by limiting cost sharing to copays of no more than $35, providing first-dollar coverage, or capping costs at no more than $100 per month.
  • Eliminate rebates or pass savings from rebates along to consumers without increasing premiums or deductibles.
  • Expedite approval of insulin biosimilars to create market competition.
  • Include real-time benefit information in electronic medical records.
  • Develop a payment model for Medicare Part B beneficiaries, as well as Part D, to lower out-of-pocket copays.

For manufacturers, the society also recommended improving patient assistance programs to be less restrictive and more accountable. And employers, they said, should limit copays without increasing premiums or deductibles, and seek plan options that benefit people with diabetes and provide education about these options during open enrollment.   

Of the 11 writing panel members, 4 have pharmaceutical industry disclosures.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Helping interracial couples navigate racism

Article Type
Changed
Thu, 01/14/2021 - 09:24

Joe and Esi were in the therapist’s office wanting help with their relationship. The therapist had just asked the BIG question: How does race impact your lives?”

Esi began with her story about her ethics class, a story that was at sufficient distance from her life. Depending on her husband’s response, she would move in closer. His somewhat patronizing response made her feel both angry and that he lacked any real understanding.

Dr. Alison Heru
Dr. Alison M. Heru


“Me and a mulatto girl were in ethics class,” said Esi, who grew in Kenya. We had a White professor. He seemed to think I had no education. If you are a woman of color, you are automatically thought to have no education and that you don’t know what you are talking about. He tried to shut me up. When I persisted, I know he thought from the tone of my voice that I was an angry Black woman, even although I am not Black and I am not angry! In this country, if you have any color to your skin, you are called Black and relegated to a certain place: The bottom. I was excited about what he was teaching us, but when everyone looked at me with a certain gaze, like something bad was going to happen, all those White people, just looking, I tightened up inside and sat back down.”

Lynette Ramsingh Barros


Esi looked down at her folded hands. Her husband, who was White, reached over and reassuringly patted her hands.

“Yes, Esi, they are wrong. They shouldn’t have treated you that way. White people can be insensitive.”

Then, she continued, “Joe, you do the same to me!”

“What do you mean, Esi?” responded Joe, with an innocent and anxious look scanning back and forth between her and the White male therapist.

“Well, Joe, do you really want to hear how I felt last week after we came back from that party at your sister’s house?”

“Yes, Esi.”

“But do you really? Are you sure you want to hear this?”

“Yes, Esi.”

“Remember when we went over, me and the kids sat with the other people of color and you sat with your sister and her side of the family?

“Yes, I remember. What is wrong with that?”

“Well, me and my colored friends got loud and excited, and you shot me a look, like ‘pipe down over there.’ THEN, after we got home, the next day, your sister called you and said that you had better control your wife; she is too loud. Do you remember all that?

“Yes, well you do get loud – especially when you are around your people.”

“So why is it I have to fit in with your relatives and not the other way round? Why do I have to conform to the whiteness in your sister’s world, not the other way round?”

“Well, we were in her house.”

“So if they came to our house and were too quiet, how would you feel if I called them up and said they needed to participate with more enthusiasm?”

“Esi, that’s not fair, and you know it isn’t.”

Esi stops and looks at the therapist.

“So I check myself. It is the same all over, White people imposing their values and beliefs on me, on us. I am not an angry Black woman. I am just frustrated. People, White people, always want an explanation for what they think is my loss of control. You can see when their demeanor changes, they pull back, sit up, back away, fidget, and won’t look you in the eye. All these little tics that show that they are trying to get out of the situation.”

Esi took a breath and saw that her husband and the therapist were listening.

“These signs are ingrained in your brain ... these signs ... I saw it when I first came here to this country. The first time I had a good dose of it ... was in that ethics class in college. You can’t use words that you are accustomed to, ’cause they mean something else here, something bad.”

“Oh, Esi, I am so sorry,” said Joe, looking concerned.

“You may be sorry but you are not willing to stand up for me against your sister and her White values. You want me to conform.”

“What do you want me to do?”

“I want you to call your sister out.”

“But she may not ever speak to me again!”

“OK, don’t then,” and Esi looked down at her hands. She was finished talking. Joe looked at the therapist, waiting for something.

The therapist resisted intervening on the issue. “Keep talking this through,” he instructed them.

Joe could see that Esi had done talking and that it was his move.

“Do you really want me to call my sister out, even if it means that she will not talk to me again?”

“Yes.”

“I don’t know if I can do that.”

The therapist now intervened: “What does that mean to you, Esi, that he doesn’t know if he can do that.”

“It means he doesn’t really love me or value me or even value our mulatto children. What do think our daughter is learning?”

“That’s not true, Esi.”

The therapist, Dr. Swarthmore, watched Esi, who has very a dark, blue-black skin tone, with a flawless complexion and a shapely body. She wears her hair cropped and she looks like that Black model, what’s her name. Joe was short, a little plump with ultra White skin and freckles on his nose. He had been brought up in the Midwest and had had little exposure to Africans before his internship abroad in Kenya. Dr. S. thought he had probably not really thought much about Esi’s dilemma.

Dr. Swarthmore encouraged Esi to talk about her immigration experience.

“Esi, can you talk more about what it is like to be an immigrant from Africa?”

“Well, I just have to check myself so that I can fit in with this White culture. If you want to see how I feel about it, you will have to see an angry Black woman and I have learned not to give you that satisfaction. You will just dismiss me. Please Dr. Swarthmore, can we move on?”

Dr. Swarthmore was caught between his desire to accept her wish to move on and his wish to have her express herself fully. He realized that it was not his desire that mattered; that the couple had to work this out between them if they were going to move forward. So he punted it back to them.

“Esi and Joe, you are both caught in an important dilemma. Esi, you want more respect from your husband and his family. Joe, you do not want to upset your family by confronting them. Is that right? You are both dammed if you do and dammed if you don’t.”

“I agree,” Joe and Esi both said, nodding.

“Do you want to work on this issue?”

They both agreed with equal enthusiasm.

“Ok, can you spend the next 10 minutes to work on this?”

They agreed.

“Ok, let’s start. What skills do you have that can help you resolve this important issue?”

Dr. Swarthmore framed the issue as one to be solved by the couple. The couple discussed that they are usually good at communication and solving problems. This problem is about whether or not Joe is more aligned with his White family than with Esi and their children.

Dr. Swarthmore encouraged them to think about this more deeply and over time; that this is such an important issue that it requires time and deep conversation.

“How do you think you can educate yourselves about the issues at hand?”

Esi suggested several books to Joe, and he agreed to read one of them.
 

Esi’s reading list

1. “Why I’m No Longer Talking to White People About Race” by Reni Eddo-Lodge (London: Bloomsbury, 2018).

2. “Americanah” by Chimamanda Ngozi Adichie (New York: Alfred A. Knopf, 2013).

3. “How to be an Antiracist” by Ibram X. Kendi (New York: Random House, 2019).
 

Joe suggests that Esi think about what it might mean if his sister and their children were no longer part of their lives. She agrees to do this.

Dr. Swarthmore asks if they can each do their homework before they come back. They agree and thought they could manage that and the book for 2 weeks out.

Dr. Swarthmore decides that he will read one of the books Esi suggested, as he does not know much about racism and White privilege and he wants to learn more. Dr. Swarthmore demonstrates his desire to become more racially sensitive. The following steps can be taken by therapists who want to become more racially sensitive, according to TA Laszloffy and KV Hardy (Fam Process. 2000 Spring;39[1]:35-50):
 

1. Read and watch movies that address the experience of other cultural groups.

2. Go to and participate in cross-cultural events.

3. Engage in a racial self-exploration process. The following questions can begin the racial identity exploration process:

  • How do I define myself racially?
  • When did I first become aware of race/skin color in general, and mine in particular?
  • What messages did I learn about race/skin color based on that first experience?
  • What direct and indirect messages did I receive about race/skin color?
  • How did the messages that I received about race/skin color affect how I thought and felt about myself racially?
  • What benefits did I gain because of my race/skin color?
  • What did I lose because of my race/skin?
  • Have I ever dated cross-racially? Why or why not?
  • How many friends of a different race do I have?

4. Internal commitment. This means committing to addressing racism in therapeutic encounters.
 

Lessons learned for psychiatrists

1. Therapeutic space is allocated to discuss the issue.

2. The time is strictly limited to 10 minutes, so the couple won’t feel that their emotions will overwhelm them.

3. The space is to focus on the strengths that they can bring to resolving the issue.

4. Give patients the impression that they can solve this and that it is an important issue.

5. Do not put yourself in the patients’ argument; take neither side.
 

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest. Dr. Heru wrote the article in collaboration with Lynette Ramsingh Barros, artist and social commentator.

Publications
Topics
Sections

Joe and Esi were in the therapist’s office wanting help with their relationship. The therapist had just asked the BIG question: How does race impact your lives?”

Esi began with her story about her ethics class, a story that was at sufficient distance from her life. Depending on her husband’s response, she would move in closer. His somewhat patronizing response made her feel both angry and that he lacked any real understanding.

Dr. Alison Heru
Dr. Alison M. Heru


“Me and a mulatto girl were in ethics class,” said Esi, who grew in Kenya. We had a White professor. He seemed to think I had no education. If you are a woman of color, you are automatically thought to have no education and that you don’t know what you are talking about. He tried to shut me up. When I persisted, I know he thought from the tone of my voice that I was an angry Black woman, even although I am not Black and I am not angry! In this country, if you have any color to your skin, you are called Black and relegated to a certain place: The bottom. I was excited about what he was teaching us, but when everyone looked at me with a certain gaze, like something bad was going to happen, all those White people, just looking, I tightened up inside and sat back down.”

Lynette Ramsingh Barros


Esi looked down at her folded hands. Her husband, who was White, reached over and reassuringly patted her hands.

“Yes, Esi, they are wrong. They shouldn’t have treated you that way. White people can be insensitive.”

Then, she continued, “Joe, you do the same to me!”

“What do you mean, Esi?” responded Joe, with an innocent and anxious look scanning back and forth between her and the White male therapist.

“Well, Joe, do you really want to hear how I felt last week after we came back from that party at your sister’s house?”

“Yes, Esi.”

“But do you really? Are you sure you want to hear this?”

“Yes, Esi.”

“Remember when we went over, me and the kids sat with the other people of color and you sat with your sister and her side of the family?

“Yes, I remember. What is wrong with that?”

“Well, me and my colored friends got loud and excited, and you shot me a look, like ‘pipe down over there.’ THEN, after we got home, the next day, your sister called you and said that you had better control your wife; she is too loud. Do you remember all that?

“Yes, well you do get loud – especially when you are around your people.”

“So why is it I have to fit in with your relatives and not the other way round? Why do I have to conform to the whiteness in your sister’s world, not the other way round?”

“Well, we were in her house.”

“So if they came to our house and were too quiet, how would you feel if I called them up and said they needed to participate with more enthusiasm?”

“Esi, that’s not fair, and you know it isn’t.”

Esi stops and looks at the therapist.

“So I check myself. It is the same all over, White people imposing their values and beliefs on me, on us. I am not an angry Black woman. I am just frustrated. People, White people, always want an explanation for what they think is my loss of control. You can see when their demeanor changes, they pull back, sit up, back away, fidget, and won’t look you in the eye. All these little tics that show that they are trying to get out of the situation.”

Esi took a breath and saw that her husband and the therapist were listening.

“These signs are ingrained in your brain ... these signs ... I saw it when I first came here to this country. The first time I had a good dose of it ... was in that ethics class in college. You can’t use words that you are accustomed to, ’cause they mean something else here, something bad.”

“Oh, Esi, I am so sorry,” said Joe, looking concerned.

“You may be sorry but you are not willing to stand up for me against your sister and her White values. You want me to conform.”

“What do you want me to do?”

“I want you to call your sister out.”

“But she may not ever speak to me again!”

“OK, don’t then,” and Esi looked down at her hands. She was finished talking. Joe looked at the therapist, waiting for something.

The therapist resisted intervening on the issue. “Keep talking this through,” he instructed them.

Joe could see that Esi had done talking and that it was his move.

“Do you really want me to call my sister out, even if it means that she will not talk to me again?”

“Yes.”

“I don’t know if I can do that.”

The therapist now intervened: “What does that mean to you, Esi, that he doesn’t know if he can do that.”

“It means he doesn’t really love me or value me or even value our mulatto children. What do think our daughter is learning?”

“That’s not true, Esi.”

The therapist, Dr. Swarthmore, watched Esi, who has very a dark, blue-black skin tone, with a flawless complexion and a shapely body. She wears her hair cropped and she looks like that Black model, what’s her name. Joe was short, a little plump with ultra White skin and freckles on his nose. He had been brought up in the Midwest and had had little exposure to Africans before his internship abroad in Kenya. Dr. S. thought he had probably not really thought much about Esi’s dilemma.

Dr. Swarthmore encouraged Esi to talk about her immigration experience.

“Esi, can you talk more about what it is like to be an immigrant from Africa?”

“Well, I just have to check myself so that I can fit in with this White culture. If you want to see how I feel about it, you will have to see an angry Black woman and I have learned not to give you that satisfaction. You will just dismiss me. Please Dr. Swarthmore, can we move on?”

Dr. Swarthmore was caught between his desire to accept her wish to move on and his wish to have her express herself fully. He realized that it was not his desire that mattered; that the couple had to work this out between them if they were going to move forward. So he punted it back to them.

“Esi and Joe, you are both caught in an important dilemma. Esi, you want more respect from your husband and his family. Joe, you do not want to upset your family by confronting them. Is that right? You are both dammed if you do and dammed if you don’t.”

“I agree,” Joe and Esi both said, nodding.

“Do you want to work on this issue?”

They both agreed with equal enthusiasm.

“Ok, can you spend the next 10 minutes to work on this?”

They agreed.

“Ok, let’s start. What skills do you have that can help you resolve this important issue?”

Dr. Swarthmore framed the issue as one to be solved by the couple. The couple discussed that they are usually good at communication and solving problems. This problem is about whether or not Joe is more aligned with his White family than with Esi and their children.

Dr. Swarthmore encouraged them to think about this more deeply and over time; that this is such an important issue that it requires time and deep conversation.

“How do you think you can educate yourselves about the issues at hand?”

Esi suggested several books to Joe, and he agreed to read one of them.
 

Esi’s reading list

1. “Why I’m No Longer Talking to White People About Race” by Reni Eddo-Lodge (London: Bloomsbury, 2018).

2. “Americanah” by Chimamanda Ngozi Adichie (New York: Alfred A. Knopf, 2013).

3. “How to be an Antiracist” by Ibram X. Kendi (New York: Random House, 2019).
 

Joe suggests that Esi think about what it might mean if his sister and their children were no longer part of their lives. She agrees to do this.

Dr. Swarthmore asks if they can each do their homework before they come back. They agree and thought they could manage that and the book for 2 weeks out.

Dr. Swarthmore decides that he will read one of the books Esi suggested, as he does not know much about racism and White privilege and he wants to learn more. Dr. Swarthmore demonstrates his desire to become more racially sensitive. The following steps can be taken by therapists who want to become more racially sensitive, according to TA Laszloffy and KV Hardy (Fam Process. 2000 Spring;39[1]:35-50):
 

1. Read and watch movies that address the experience of other cultural groups.

2. Go to and participate in cross-cultural events.

3. Engage in a racial self-exploration process. The following questions can begin the racial identity exploration process:

  • How do I define myself racially?
  • When did I first become aware of race/skin color in general, and mine in particular?
  • What messages did I learn about race/skin color based on that first experience?
  • What direct and indirect messages did I receive about race/skin color?
  • How did the messages that I received about race/skin color affect how I thought and felt about myself racially?
  • What benefits did I gain because of my race/skin color?
  • What did I lose because of my race/skin?
  • Have I ever dated cross-racially? Why or why not?
  • How many friends of a different race do I have?

4. Internal commitment. This means committing to addressing racism in therapeutic encounters.
 

Lessons learned for psychiatrists

1. Therapeutic space is allocated to discuss the issue.

2. The time is strictly limited to 10 minutes, so the couple won’t feel that their emotions will overwhelm them.

3. The space is to focus on the strengths that they can bring to resolving the issue.

4. Give patients the impression that they can solve this and that it is an important issue.

5. Do not put yourself in the patients’ argument; take neither side.
 

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest. Dr. Heru wrote the article in collaboration with Lynette Ramsingh Barros, artist and social commentator.

Joe and Esi were in the therapist’s office wanting help with their relationship. The therapist had just asked the BIG question: How does race impact your lives?”

Esi began with her story about her ethics class, a story that was at sufficient distance from her life. Depending on her husband’s response, she would move in closer. His somewhat patronizing response made her feel both angry and that he lacked any real understanding.

Dr. Alison Heru
Dr. Alison M. Heru


“Me and a mulatto girl were in ethics class,” said Esi, who grew in Kenya. We had a White professor. He seemed to think I had no education. If you are a woman of color, you are automatically thought to have no education and that you don’t know what you are talking about. He tried to shut me up. When I persisted, I know he thought from the tone of my voice that I was an angry Black woman, even although I am not Black and I am not angry! In this country, if you have any color to your skin, you are called Black and relegated to a certain place: The bottom. I was excited about what he was teaching us, but when everyone looked at me with a certain gaze, like something bad was going to happen, all those White people, just looking, I tightened up inside and sat back down.”

Lynette Ramsingh Barros


Esi looked down at her folded hands. Her husband, who was White, reached over and reassuringly patted her hands.

“Yes, Esi, they are wrong. They shouldn’t have treated you that way. White people can be insensitive.”

Then, she continued, “Joe, you do the same to me!”

“What do you mean, Esi?” responded Joe, with an innocent and anxious look scanning back and forth between her and the White male therapist.

“Well, Joe, do you really want to hear how I felt last week after we came back from that party at your sister’s house?”

“Yes, Esi.”

“But do you really? Are you sure you want to hear this?”

“Yes, Esi.”

“Remember when we went over, me and the kids sat with the other people of color and you sat with your sister and her side of the family?

“Yes, I remember. What is wrong with that?”

“Well, me and my colored friends got loud and excited, and you shot me a look, like ‘pipe down over there.’ THEN, after we got home, the next day, your sister called you and said that you had better control your wife; she is too loud. Do you remember all that?

“Yes, well you do get loud – especially when you are around your people.”

“So why is it I have to fit in with your relatives and not the other way round? Why do I have to conform to the whiteness in your sister’s world, not the other way round?”

“Well, we were in her house.”

“So if they came to our house and were too quiet, how would you feel if I called them up and said they needed to participate with more enthusiasm?”

“Esi, that’s not fair, and you know it isn’t.”

Esi stops and looks at the therapist.

“So I check myself. It is the same all over, White people imposing their values and beliefs on me, on us. I am not an angry Black woman. I am just frustrated. People, White people, always want an explanation for what they think is my loss of control. You can see when their demeanor changes, they pull back, sit up, back away, fidget, and won’t look you in the eye. All these little tics that show that they are trying to get out of the situation.”

Esi took a breath and saw that her husband and the therapist were listening.

“These signs are ingrained in your brain ... these signs ... I saw it when I first came here to this country. The first time I had a good dose of it ... was in that ethics class in college. You can’t use words that you are accustomed to, ’cause they mean something else here, something bad.”

“Oh, Esi, I am so sorry,” said Joe, looking concerned.

“You may be sorry but you are not willing to stand up for me against your sister and her White values. You want me to conform.”

“What do you want me to do?”

“I want you to call your sister out.”

“But she may not ever speak to me again!”

“OK, don’t then,” and Esi looked down at her hands. She was finished talking. Joe looked at the therapist, waiting for something.

The therapist resisted intervening on the issue. “Keep talking this through,” he instructed them.

Joe could see that Esi had done talking and that it was his move.

“Do you really want me to call my sister out, even if it means that she will not talk to me again?”

“Yes.”

“I don’t know if I can do that.”

The therapist now intervened: “What does that mean to you, Esi, that he doesn’t know if he can do that.”

“It means he doesn’t really love me or value me or even value our mulatto children. What do think our daughter is learning?”

“That’s not true, Esi.”

The therapist, Dr. Swarthmore, watched Esi, who has very a dark, blue-black skin tone, with a flawless complexion and a shapely body. She wears her hair cropped and she looks like that Black model, what’s her name. Joe was short, a little plump with ultra White skin and freckles on his nose. He had been brought up in the Midwest and had had little exposure to Africans before his internship abroad in Kenya. Dr. S. thought he had probably not really thought much about Esi’s dilemma.

Dr. Swarthmore encouraged Esi to talk about her immigration experience.

“Esi, can you talk more about what it is like to be an immigrant from Africa?”

“Well, I just have to check myself so that I can fit in with this White culture. If you want to see how I feel about it, you will have to see an angry Black woman and I have learned not to give you that satisfaction. You will just dismiss me. Please Dr. Swarthmore, can we move on?”

Dr. Swarthmore was caught between his desire to accept her wish to move on and his wish to have her express herself fully. He realized that it was not his desire that mattered; that the couple had to work this out between them if they were going to move forward. So he punted it back to them.

“Esi and Joe, you are both caught in an important dilemma. Esi, you want more respect from your husband and his family. Joe, you do not want to upset your family by confronting them. Is that right? You are both dammed if you do and dammed if you don’t.”

“I agree,” Joe and Esi both said, nodding.

“Do you want to work on this issue?”

They both agreed with equal enthusiasm.

“Ok, can you spend the next 10 minutes to work on this?”

They agreed.

“Ok, let’s start. What skills do you have that can help you resolve this important issue?”

Dr. Swarthmore framed the issue as one to be solved by the couple. The couple discussed that they are usually good at communication and solving problems. This problem is about whether or not Joe is more aligned with his White family than with Esi and their children.

Dr. Swarthmore encouraged them to think about this more deeply and over time; that this is such an important issue that it requires time and deep conversation.

“How do you think you can educate yourselves about the issues at hand?”

Esi suggested several books to Joe, and he agreed to read one of them.
 

Esi’s reading list

1. “Why I’m No Longer Talking to White People About Race” by Reni Eddo-Lodge (London: Bloomsbury, 2018).

2. “Americanah” by Chimamanda Ngozi Adichie (New York: Alfred A. Knopf, 2013).

3. “How to be an Antiracist” by Ibram X. Kendi (New York: Random House, 2019).
 

Joe suggests that Esi think about what it might mean if his sister and their children were no longer part of their lives. She agrees to do this.

Dr. Swarthmore asks if they can each do their homework before they come back. They agree and thought they could manage that and the book for 2 weeks out.

Dr. Swarthmore decides that he will read one of the books Esi suggested, as he does not know much about racism and White privilege and he wants to learn more. Dr. Swarthmore demonstrates his desire to become more racially sensitive. The following steps can be taken by therapists who want to become more racially sensitive, according to TA Laszloffy and KV Hardy (Fam Process. 2000 Spring;39[1]:35-50):
 

1. Read and watch movies that address the experience of other cultural groups.

2. Go to and participate in cross-cultural events.

3. Engage in a racial self-exploration process. The following questions can begin the racial identity exploration process:

  • How do I define myself racially?
  • When did I first become aware of race/skin color in general, and mine in particular?
  • What messages did I learn about race/skin color based on that first experience?
  • What direct and indirect messages did I receive about race/skin color?
  • How did the messages that I received about race/skin color affect how I thought and felt about myself racially?
  • What benefits did I gain because of my race/skin color?
  • What did I lose because of my race/skin?
  • Have I ever dated cross-racially? Why or why not?
  • How many friends of a different race do I have?

4. Internal commitment. This means committing to addressing racism in therapeutic encounters.
 

Lessons learned for psychiatrists

1. Therapeutic space is allocated to discuss the issue.

2. The time is strictly limited to 10 minutes, so the couple won’t feel that their emotions will overwhelm them.

3. The space is to focus on the strengths that they can bring to resolving the issue.

4. Give patients the impression that they can solve this and that it is an important issue.

5. Do not put yourself in the patients’ argument; take neither side.
 

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). She has no conflicts of interest. Dr. Heru wrote the article in collaboration with Lynette Ramsingh Barros, artist and social commentator.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Another lot of extended-release metformin is recalled in the U.S.

Article Type
Changed
Tue, 05/03/2022 - 15:07

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Publications
Topics
Sections

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

‘The Undoing’: A dramatization of ‘You Should Have Known’

Article Type
Changed
Thu, 01/14/2021 - 09:12

Jean Hanff Korelitz’s ironic psychological thriller, “You Should Have Known,” (New York: Grand Central Publishing, 2014) was transformed into an HBO miniseries called “The Undoing,” written and produced by David E. Kelley and directed by Susanne Bier, which premiered on Oct. 25, 2020.

Dr. Karen B. Rosenbaum

The television drama differed from the novel in fundamental ways, but both have themes related to the therapeutic process. In the novel, a New York City–based couples therapist, Grace Reinhart Sachs, had recently written a book called “You Should Have Known,” about women who married their spouses disregarding their gut instinct that their partner was not fundamentally right for them, or might potentially cheat on them, or whose stories contained contradictions. In the miniseries, Grace (played by Nicole Kidman), is a therapist but there is no mention of her having written a book. Grace in both the novel and the miniseries is married to a pediatric oncologist, Jonathan (his ethnicity and surname were changed in the miniseries from a Jewish New Yorker in the novel to a British Dr. Jonathan Fraser in the series, played by Hugh Grant).

[Spoiler alert]: Prepandemic New York City’s Upper East Side is scandalized when a murdered mother is found by her young son the day after a lavish fund-raising auction party for a private school. Grace and Jonathan’s son, Henry, attends this school as well, and Grace had served on the auction committee with the murdered mother. When two detectives question Grace in the course of their investigation, she assumes that they are questioning her as they would any parent in the school. However, when she tries to reach her husband about the news and the investigation, she cannot. She thought he was at a medical conference in Cleveland, but she realizes that she does not know exactly what conference and exactly where. After many failed attempts at calling and texting, she hears a familiar alert sound coming from his nightstand drawer where she retrieves the cell phone that had been deliberately placed.

In the novel, Jonathan never reappears from “Cleveland,” and although it takes Grace a while to understand that her husband is not who she thought he was, she eventually does. In the miniseries, Jonathan appears in their lake house and a trial ensues with Jonathan adamantly proclaiming his innocence despite all evidence to the contrary.

Undoing in psychoanalysis is a defense mechanism initially described by Freud. The Oxford Reference defines undoing as “an emotional conflict associated with an action is dealt with by negating the action or attempting ‘magically’ to cause it not to have occurred by substituting an approximately opposite action.” It is not that the consequences of the action are attempted to be negated (as in making amends or showing remorse), but the action itself. In this way, the miniseries is aptly named since both main characters, Grace and Jonathan, use this defense mechanism. Grace has difficulty acknowledging that her husband could be capable of any wrongdoing, even as she is faced with fact after fact that contradicts this premise – and counsels others about their relationship choices. Similarly, Jonathan’s choice of profession is likely an attempt to undo his 4-year-old sister’s death that occurred on his watch when he was 14. However, even treating children’s cancer cannot undo the many indiscretions he has apparently committed in his adult life.

Dr. Susan Hatters Friedman

In the portrayal of a doctor with narcissistic, and possibly psychopathic, traits, “The Undoing” joins multiple recent podcasts that document real-life bad doctors, including Wondery’s “The Shrink Next Door,” “Dr. Death” (seasons 1 and 2), and “Do No Harm.” While most physicians go into medicine to heal and improve peoples’ lives, others, such as the character of Dr. Jonathan Fraser, appear to become physicians for ulterior and sinister motivations. Jonathan’s difficulty with empathy was present when he was a child as a character trait – rather than being attributable to any childhood traumatic event, as Grace had let herself believe.

In a Dec. 11, 2020, New York Times op-ed, Richard A. Friedman, MD, a psychiatrist affiliated with New York Presbyterian-Cornell University, discussed three “dangerous doctors” during the pandemic who are potentially harming the nation. Scott Atlas, MD, a radiologist on leave from Stanford (Calif.) University, advised President Trump on the coronavirus despite having no training in public health or infectious disease. Before resigning, he questioned the use of face masks, contradicting scientific proof of their prevention of disease. Another doctor, a cardiologist in Washington, also publicly disputed scientific evidence of the efficacy of face masks and social distancing, and a third physician promoted hydroxychloroquine as a treatment for coronavirus despite scientific evidence that it has been ineffective and possibly even harmful to patients with the virus.

Both the novel “You Should Have Known” and the series “The Undoing” will be of interest to psychiatrists, especially therapists and forensic psychiatrists, because of the themes portrayed, such as defense mechanisms, therapeutic process, and a homicide investigation – as well as the common human experience of being an expert in something in one’s professional life, yet occasionally falling short of recognizing the same phenomena in one’s personal life.
 

Dr. Rosenbaum is a clinical and forensic psychiatrist in private practice in New York. She is an assistant clinical professor at New York University Langone Medical Center and is on the faculty at Weill-Cornell Medical Center. She has no conflicts of interest. Dr. Friedman serves as the Phillip Resnick Professor of Forensic Psychiatry at Case Western Reserve University, Cleveland. She is also editor of Family Murder: Pathologies of Love and Hate (Washington: American Psychiatric Publishing, 2019), which was written by the Group for the Advancement of Psychiatry’s Committee on Psychiatry & Law, and which was awarded the 2020 Manfred Gutmacher Award by the American Psychiatric Association. She has no conflicts of interest.

Publications
Topics
Sections

Jean Hanff Korelitz’s ironic psychological thriller, “You Should Have Known,” (New York: Grand Central Publishing, 2014) was transformed into an HBO miniseries called “The Undoing,” written and produced by David E. Kelley and directed by Susanne Bier, which premiered on Oct. 25, 2020.

Dr. Karen B. Rosenbaum

The television drama differed from the novel in fundamental ways, but both have themes related to the therapeutic process. In the novel, a New York City–based couples therapist, Grace Reinhart Sachs, had recently written a book called “You Should Have Known,” about women who married their spouses disregarding their gut instinct that their partner was not fundamentally right for them, or might potentially cheat on them, or whose stories contained contradictions. In the miniseries, Grace (played by Nicole Kidman), is a therapist but there is no mention of her having written a book. Grace in both the novel and the miniseries is married to a pediatric oncologist, Jonathan (his ethnicity and surname were changed in the miniseries from a Jewish New Yorker in the novel to a British Dr. Jonathan Fraser in the series, played by Hugh Grant).

[Spoiler alert]: Prepandemic New York City’s Upper East Side is scandalized when a murdered mother is found by her young son the day after a lavish fund-raising auction party for a private school. Grace and Jonathan’s son, Henry, attends this school as well, and Grace had served on the auction committee with the murdered mother. When two detectives question Grace in the course of their investigation, she assumes that they are questioning her as they would any parent in the school. However, when she tries to reach her husband about the news and the investigation, she cannot. She thought he was at a medical conference in Cleveland, but she realizes that she does not know exactly what conference and exactly where. After many failed attempts at calling and texting, she hears a familiar alert sound coming from his nightstand drawer where she retrieves the cell phone that had been deliberately placed.

In the novel, Jonathan never reappears from “Cleveland,” and although it takes Grace a while to understand that her husband is not who she thought he was, she eventually does. In the miniseries, Jonathan appears in their lake house and a trial ensues with Jonathan adamantly proclaiming his innocence despite all evidence to the contrary.

Undoing in psychoanalysis is a defense mechanism initially described by Freud. The Oxford Reference defines undoing as “an emotional conflict associated with an action is dealt with by negating the action or attempting ‘magically’ to cause it not to have occurred by substituting an approximately opposite action.” It is not that the consequences of the action are attempted to be negated (as in making amends or showing remorse), but the action itself. In this way, the miniseries is aptly named since both main characters, Grace and Jonathan, use this defense mechanism. Grace has difficulty acknowledging that her husband could be capable of any wrongdoing, even as she is faced with fact after fact that contradicts this premise – and counsels others about their relationship choices. Similarly, Jonathan’s choice of profession is likely an attempt to undo his 4-year-old sister’s death that occurred on his watch when he was 14. However, even treating children’s cancer cannot undo the many indiscretions he has apparently committed in his adult life.

Dr. Susan Hatters Friedman

In the portrayal of a doctor with narcissistic, and possibly psychopathic, traits, “The Undoing” joins multiple recent podcasts that document real-life bad doctors, including Wondery’s “The Shrink Next Door,” “Dr. Death” (seasons 1 and 2), and “Do No Harm.” While most physicians go into medicine to heal and improve peoples’ lives, others, such as the character of Dr. Jonathan Fraser, appear to become physicians for ulterior and sinister motivations. Jonathan’s difficulty with empathy was present when he was a child as a character trait – rather than being attributable to any childhood traumatic event, as Grace had let herself believe.

In a Dec. 11, 2020, New York Times op-ed, Richard A. Friedman, MD, a psychiatrist affiliated with New York Presbyterian-Cornell University, discussed three “dangerous doctors” during the pandemic who are potentially harming the nation. Scott Atlas, MD, a radiologist on leave from Stanford (Calif.) University, advised President Trump on the coronavirus despite having no training in public health or infectious disease. Before resigning, he questioned the use of face masks, contradicting scientific proof of their prevention of disease. Another doctor, a cardiologist in Washington, also publicly disputed scientific evidence of the efficacy of face masks and social distancing, and a third physician promoted hydroxychloroquine as a treatment for coronavirus despite scientific evidence that it has been ineffective and possibly even harmful to patients with the virus.

Both the novel “You Should Have Known” and the series “The Undoing” will be of interest to psychiatrists, especially therapists and forensic psychiatrists, because of the themes portrayed, such as defense mechanisms, therapeutic process, and a homicide investigation – as well as the common human experience of being an expert in something in one’s professional life, yet occasionally falling short of recognizing the same phenomena in one’s personal life.
 

Dr. Rosenbaum is a clinical and forensic psychiatrist in private practice in New York. She is an assistant clinical professor at New York University Langone Medical Center and is on the faculty at Weill-Cornell Medical Center. She has no conflicts of interest. Dr. Friedman serves as the Phillip Resnick Professor of Forensic Psychiatry at Case Western Reserve University, Cleveland. She is also editor of Family Murder: Pathologies of Love and Hate (Washington: American Psychiatric Publishing, 2019), which was written by the Group for the Advancement of Psychiatry’s Committee on Psychiatry & Law, and which was awarded the 2020 Manfred Gutmacher Award by the American Psychiatric Association. She has no conflicts of interest.

Jean Hanff Korelitz’s ironic psychological thriller, “You Should Have Known,” (New York: Grand Central Publishing, 2014) was transformed into an HBO miniseries called “The Undoing,” written and produced by David E. Kelley and directed by Susanne Bier, which premiered on Oct. 25, 2020.

Dr. Karen B. Rosenbaum

The television drama differed from the novel in fundamental ways, but both have themes related to the therapeutic process. In the novel, a New York City–based couples therapist, Grace Reinhart Sachs, had recently written a book called “You Should Have Known,” about women who married their spouses disregarding their gut instinct that their partner was not fundamentally right for them, or might potentially cheat on them, or whose stories contained contradictions. In the miniseries, Grace (played by Nicole Kidman), is a therapist but there is no mention of her having written a book. Grace in both the novel and the miniseries is married to a pediatric oncologist, Jonathan (his ethnicity and surname were changed in the miniseries from a Jewish New Yorker in the novel to a British Dr. Jonathan Fraser in the series, played by Hugh Grant).

[Spoiler alert]: Prepandemic New York City’s Upper East Side is scandalized when a murdered mother is found by her young son the day after a lavish fund-raising auction party for a private school. Grace and Jonathan’s son, Henry, attends this school as well, and Grace had served on the auction committee with the murdered mother. When two detectives question Grace in the course of their investigation, she assumes that they are questioning her as they would any parent in the school. However, when she tries to reach her husband about the news and the investigation, she cannot. She thought he was at a medical conference in Cleveland, but she realizes that she does not know exactly what conference and exactly where. After many failed attempts at calling and texting, she hears a familiar alert sound coming from his nightstand drawer where she retrieves the cell phone that had been deliberately placed.

In the novel, Jonathan never reappears from “Cleveland,” and although it takes Grace a while to understand that her husband is not who she thought he was, she eventually does. In the miniseries, Jonathan appears in their lake house and a trial ensues with Jonathan adamantly proclaiming his innocence despite all evidence to the contrary.

Undoing in psychoanalysis is a defense mechanism initially described by Freud. The Oxford Reference defines undoing as “an emotional conflict associated with an action is dealt with by negating the action or attempting ‘magically’ to cause it not to have occurred by substituting an approximately opposite action.” It is not that the consequences of the action are attempted to be negated (as in making amends or showing remorse), but the action itself. In this way, the miniseries is aptly named since both main characters, Grace and Jonathan, use this defense mechanism. Grace has difficulty acknowledging that her husband could be capable of any wrongdoing, even as she is faced with fact after fact that contradicts this premise – and counsels others about their relationship choices. Similarly, Jonathan’s choice of profession is likely an attempt to undo his 4-year-old sister’s death that occurred on his watch when he was 14. However, even treating children’s cancer cannot undo the many indiscretions he has apparently committed in his adult life.

Dr. Susan Hatters Friedman

In the portrayal of a doctor with narcissistic, and possibly psychopathic, traits, “The Undoing” joins multiple recent podcasts that document real-life bad doctors, including Wondery’s “The Shrink Next Door,” “Dr. Death” (seasons 1 and 2), and “Do No Harm.” While most physicians go into medicine to heal and improve peoples’ lives, others, such as the character of Dr. Jonathan Fraser, appear to become physicians for ulterior and sinister motivations. Jonathan’s difficulty with empathy was present when he was a child as a character trait – rather than being attributable to any childhood traumatic event, as Grace had let herself believe.

In a Dec. 11, 2020, New York Times op-ed, Richard A. Friedman, MD, a psychiatrist affiliated with New York Presbyterian-Cornell University, discussed three “dangerous doctors” during the pandemic who are potentially harming the nation. Scott Atlas, MD, a radiologist on leave from Stanford (Calif.) University, advised President Trump on the coronavirus despite having no training in public health or infectious disease. Before resigning, he questioned the use of face masks, contradicting scientific proof of their prevention of disease. Another doctor, a cardiologist in Washington, also publicly disputed scientific evidence of the efficacy of face masks and social distancing, and a third physician promoted hydroxychloroquine as a treatment for coronavirus despite scientific evidence that it has been ineffective and possibly even harmful to patients with the virus.

Both the novel “You Should Have Known” and the series “The Undoing” will be of interest to psychiatrists, especially therapists and forensic psychiatrists, because of the themes portrayed, such as defense mechanisms, therapeutic process, and a homicide investigation – as well as the common human experience of being an expert in something in one’s professional life, yet occasionally falling short of recognizing the same phenomena in one’s personal life.
 

Dr. Rosenbaum is a clinical and forensic psychiatrist in private practice in New York. She is an assistant clinical professor at New York University Langone Medical Center and is on the faculty at Weill-Cornell Medical Center. She has no conflicts of interest. Dr. Friedman serves as the Phillip Resnick Professor of Forensic Psychiatry at Case Western Reserve University, Cleveland. She is also editor of Family Murder: Pathologies of Love and Hate (Washington: American Psychiatric Publishing, 2019), which was written by the Group for the Advancement of Psychiatry’s Committee on Psychiatry & Law, and which was awarded the 2020 Manfred Gutmacher Award by the American Psychiatric Association. She has no conflicts of interest.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article

Diversification of dermatology workforce takes shape

Article Type
Changed
Wed, 03/03/2021 - 15:13

Stephanie Florez-Pollack, MD, a dermatology resident at the University of Pennsylvania, Philadelphia, began considering the field of dermatology when, as part of the Latino Medical Students Association, she was invited by Amit Pandya, MD, to a pizza party and dermatology discussion during her first year of medical school at the University of Texas Southwestern Medical Center, Dallas.

Courtesy Dr. Stephanie Flores-Pollack
Dr. Stephanie Flores-Pollack

There, she met three Latinx residents who were part of the University of Texas Southwestern dermatology program. “I was so excited to hear their stories, where they came from, and how they ended up in dermatology,” she said. Dermatology had not been on her radar screen. Now there was a spark.

Volunteering at the free Agape dermatology clinic in Dallas later that year sharpened her interest. “For the first time, I really saw myself working in the field. Hearing patients’ stories and what they went through with what many people might think are very simple skin diseases made me realize there was potential to make a big impact in a person’s life,” said Dr. Florez-Pollack, who immigrated from Colombia with her family when she was 15.

Dr. Florez-Pollack’s journey into dermatology as an underrepresented-in-medicine (UIM) physician-in-training offers a window into a movement underway that aims to create a diverse dermatology workforce – one that reflects the ethnic and racial make-up of the population. It’s a movement that involves early outreach to medical students, stepped-up mentorship and sponsorship, implicit bias training, and holistic review of residency applicants.

Dr. Nada Elbuluk

There is no published study of all the changes being made – of how many dermatology programs have new outreach programs, for instance, or new approaches to resident application reviews. However, participation in the American Academy of Dermatology Diversity Champions program increased significantly between 2019 and 2020, and a sizable body of articles and editorials on diversity have been published in the dermatology literature in recent years, including at least several on holistic review of resident applications. Five years ago, there were few publications, sources said.

“The conversation is happening now at multiple levels, including in our peer-reviewed literature, where people are looking objectively at ... how we can make changes for the better,” said Nada Elbuluk, MD, director of the dermatology diversity and inclusion program at the University of Southern California, Los Angeles.

Dr. Kanade Shinkai

Unpublished findings also indicate that the number of UIM dermatology residents is inching upward. “Residency selection may not be on everyone’s mind, but an understanding of how we select people into our specialty is something every derm should know about and care about,” said Kanade Shinkai, MD, PhD, professor of dermatology at the University of California, San Francisco, and editor in chief of JAMA Dermatology.
 

The wake-up calls

The impetus for current changes first came in 2015, when Bruce Wintroub, MD, professor and chair of dermatology at UCSF, and interim dean of the medical school at the time, delivered a passionate plenary lecture at the annual AAD meeting about the lack of equity, diversity and inclusion in the specialty and the role of unconscious bias. Moved in part by a “White Coats for Black Lives” die-in by medical students on his campus following the killing of unarmed Black men, Dr. Wintroub called on his colleagues to recruit more UIM physicians into the specialty and to make the field more inclusive.

In 2016, Dr. Wintroub joined Dr. Pandya and two other academic dermatologists in authoring a commentary, published in the Journal of the American Academy of Dermatology, about the need to step up efforts and make diversity a priority. Dermatology was among the least ethnically and racially diverse specialties, second only to orthopedics, they wrote, with black dermatologists making up only 3% of all dermatologists and Hispanics only 4.2% in the United States, compared with 12.8% and 16.3% in the U.S. population, respectively.

Dr. Amit Pandya

For the next year or so, they and others from six academic institutions formed an incubator of sorts, actively tracking and sharing actions they were taking to improve diversity and the practice environment. “We wanted to learn from each other, then disseminate information to other programs,” said Dr. Pandya, who chaired the AAD diversity task force and led the self-branded “diversity champions.” (Dr. Pandya maintains his appointment at UTSW but now practices at the Palo Alto Foundation Medical Group in Sunnyvale, Calif.)

In 2017, at a President’s Conference on Diversity in Dermatology called for by then-AAD president Henry Lim, MD, leaders of the Association of Professors of Dermatology, the Society for Investigative Dermatology, and other dermatology organizations agreed on key action items, which they described in JAAD in 2018: Helping to increase the pipeline of UIM students applying to medical school, increasing UIM medical students’ early exposure to dermatology, and increasing the number of UIM students recruited into dermatology residency programs.

Diversity in the physician workforce has been shown to improve outcomes for all patients, and is important for ameliorating health care disparities and improving satisfaction and care for all patients, the authors of the 2018 paper wrote. “Multiple studies,” they noted, “have shown that UIM physicians are more likely to practice in areas where health care disparities exist.”

For specific proposed actions, the leaders attending the diversity conference drew largely upon the “diversity champions’” experiences, and agreed to fund and officially develop a diversity champions program. They also decided to invest in “bioskills” workshops for undergraduates and medical students at historically black colleges and universities, and other institutions at historically black colleges and universities at medical schools through a partnership with Nth Dimension – an organization founded in 2004 to bring more women and underrepresented minorities into orthopedic surgery.

In the last 2 years, more than 450 UIM students have attended these bioskills workshops, getting a taste of basic dermatology procedures and interacting with dermatologists.

And in September 2020, 157 dermatologists representing 80 programs throughout the country attended the second AAD Diversity Champions conference, up from 84 attendees and 30 programs in 2019. On the agenda: Discussions of holistic application review, mentorship, recruitment of UIM faculty, and a 2-hour session on microaggressions. Similar programs are being led by other dermatology organizations.

(UIM was coined by the American Association of Medical Colleges to describe racial and ethnic populations that are underrepresented in medicine relative to their numbers in the general population.)

Achievement of racial/ethnic diversity “won’t happen unless the field actively encourages people to look at it – which is not what we were doing,” Dr. Wintroub said in an interview. “I think that’s been the major change. We’re opening the door and saying: ‘We want you and we welcome you.’ ”


 

 

 

Rethinking traditional mentorship

For Dr. Florez-Pollack, the door almost shut when she began to hear from fellow medical students that dermatology is “too competitive ... a field for only the top people in the class.” She felt doubt settling in.

“I had peers who were throwing a lot of money toward prep materials ... peers who had siblings in medicine and had started studying from day one [for the step 1 exam],” she said. “I thought, was it really worth the effort? Do I really want to be perfect to get into the field when other fields would be happy to have me as I am right now?”

Her immense enjoyment of an “Art of Observation” elective course helped renew her interest in the field; it reinforced her visual abilities as well as the potential for her to address implicit bias as a dermatologist. She sought Dr. Pandya’s guidance and sponsorship to help her grow connections, polish her resume, and present herself to other faculty.

Doors were opened, she said, for her to secure a 1-year research experience before her final year of medical school with UTSW faculty, and then a 1-month rotation/mentorship with William D. James, MD, professor of dermatology at the University of Pennsylvania, an institution with a history of diversity initiatives and a longstanding skin of color program.



Dr. Florez-Pollack sees her experience reflected in the findings of a recently published study – a thematic content analysis of telephone interviews with applicants to the UTSW dermatology residency program during the 2013-14 and 2014-15 application cycles. Of the 44 applicants who participated in the study, 13 were UIM applicants.

Six of the seven UIM applicants who matched were involved in a pipeline or enrichment program – and were exposed to the field early – compared with one or two of the six UIM applicants who did not match. Underrepresented applicants were more often discouraged from applying (54%) – told, for instance, that they could better serve their communities through other specialties – than were non-UIM applicants (13%). They also were affected more often by a lack of equitable resources, according to comments made by 70% of applicants (UIM and non-UIM).

Also notably, the investigators said, all of the UIM applicants who matched (and the majority of non-UIMs who matched) reported having a mentor during the process of applying, compared with 44% of those who didn’t match.

Rebecca Vasquez, MD, assistant professor of dermatology at UTSW, who led the study, was herself a mentee of Dr. Pandya. “He believed in me and gave me the courage to consider dermatology,” she said. (Dr. Vasquez was one of the Latinx women who inspired Dr. Florez-Pollack, in turn, when they met at Dr. Pandya’s pizza party. Dr. Florez-Pollack assisted with the research and was a coauthor of the study.)

Dr. Amy McMichael

Amy McMichael, MD, professor and chair of dermatology at Wake Forest University, Winston-Salem, N.C., said that dermatology as a field has traditionally been “very good at mentoring.” Many of the dermatology societies have long had mentorship programs, for instance, that guide medical students, and sometimes residents, through defined experiences or through periods of time.

But she advocates going deeper. “When it comes to sponsorship, we fall a little short,” she said. “Sponsorship is about promoting that person to the next level, making sure they achieve what they want to achieve ... putting them up for opportunities they may not have known existed. It’s continuous and focused.”

Dr. Olabola Awosika
Dr. Olabola Awosika

Olabola Awosika, MD, a fourth-year dermatology resident at Henry Ford Health System, Detroit, said her interest in dermatology was solidified during her participation in the AAD’s month-long mentorship program after her second year of medical school at Howard University, Washington. However, it wasn’t until her fourth year, when she did an away rotation at Wake Forest, that she realized that “gaining access to the field” takes years of mentorship, research opportunities, and networking. It was too late.

After initially not matching, she did a rotation at Johns Hopkins in dermatology during an internship year, followed by a 2-year research fellowship at George Washington University, Washington. As does Dr. Florez-Pollack, who now mentors medical students. She also serves on the Women’s Dermatologic Society diversity committee, which is now developing initiatives to help UIM dermatologists “become upwardly mobile in dermatology [after residency], so they have a seat at the table in various settings.”
 

 

 

Holistic review for residency

Dr. Vasquez, who grew up in South Texas in an uninsured family that received most of its medical care across the border in Mexico, believes that the “biggest stride being made today” with respect to diversity in the dermatology workforce – and in the larger physician workforce – is increased understanding of the role of social and cultural capital.

Dr. Vasquez?
Dr. Rebecca Vasquez with students after meeting with them and discussing careers in medicine (and dermatology)

“We’d never really talked about this concept ... about how, if you don’t have the same upbringing, education, and resources, you’re already behind … and you may not do as well on standardized tests,” she said. “Now people are listening to it and understand it. That’s why more programs are looking at how to practice a more holistic approach to selecting applicants to interview.”

Some dermatology programs – at Wake Forest, UCSF, USC, Vanderbilt, and George Washington University for instance – have eliminated the use of U.S. Medical Licensing Examination step 1 scores and Alpha Omega Alpha Medical Honor Society status as filtering/screening metrics. Some also take a “second look” at UIM applicants.

Overall, those making changes are looking “at everything the applicant brings to the table – their story, their experiences,” said Dr. Elbuluk. “We want to understand the full picture of who they are and their journey to becoming a physician.”

Dr. Sharon E. Albers

Implicit bias training for members of residency review committees is becoming more common, as is such training across the board in dermatology departments. “We have to bring it to the forefront so that we can create more inclusive environments,” said Sharon E. Albers, MD, a dermatologist at Vanderbilt University Medical Center, Nashville, Tenn., who serves as the dermatology department’s diversity liaison to the medical school, and who, as a former faculty member of Meharry Medical College, remains engaged with the historically black institution.

One of her recent efforts, inspired by participation in the diversity champions program, has been developing pipeline programs to speak to middle and high school students about medicine and dermatology. For now, however, she credits a holistic review process for change. Last year, three of the five matched dermatology residents at Vanderbilt were UIM physicians – unprecedented for the institution, Dr. Albers said, and “evidence that holistic review works if you’re very intentional about it.”

Dr. Vasquez?
Dr. Rebecca Vasquez with colleagues (including students, Dr. Obrien, and Dr. Ayoade) at the free Agape dermatology clinic in Dallas

Dr. Vasquez has analyzed data from the Accreditation Council of Graduate Medical Education and says that UIM dermatology residents comprised 8.0% of the total in 2019, marking an improvement over the prior 7 years. “We’ve introduced so many changes at the same time,” making it difficult to discern what’s most impactful, she said. “But something is working.”

(The AAMC, which has invested in pipeline programs for more than a decade and has championed holistic medical school admissions, states in its 2019 diversity data report that efforts to improve diversity in medicine have made “only marginal differences” – and that Black males in particular continue to be significantly underrepresented in medical schools. Persistent, structural racism was a common theme in the association’s 2015 report on Black males in medicine.)

Efforts to diversify the workforce – particularly holistic review – haven’t been without detractors. “It brings reaction,” Dr. Wintroub said. “Some people think you’re lowering quality in the field ... but that’s just not true.”

Diversity in the dermatology workforce is important not only for the care of patients from diverse backgrounds, but “perhaps more importantly, it brings new ideas and views and experiences into the field,” he said. “It pushes us to think in new directions ... that can only make our field better and richer.”

“We need to make sure our workforce is representative of the patients we serve – but also that all derms can manage patients of all skin types and demographics,” Dr. Shinkai said. “And we need more diversity in the leadership of our departments and dermatology organizations ... inclusivity needs to extend all the way to the highest reaches of our specialty.”

Dr. Adam Friedman

Adam Friedman, MD, professor and interim chair of dermatology at George Washington University and director of the department’s diversity, equity, and inclusion committee, agreed. “We need to both make sure our workforce mirrors the patients we serve, and said workforce is prepared to manage patients of all skin types and demographics. We need to cover the spectrum, from revamping medical education and mentorship opportunities to advancing diversity in the leadership of our departments, institutions, and societies. Addressing only part of the puzzle will not and can not be enough.”

 

Correction, 3/3/21: An earlier version of this article misstated Dr. Stephanie Florez-Pollack's name.

Publications
Topics
Sections

Stephanie Florez-Pollack, MD, a dermatology resident at the University of Pennsylvania, Philadelphia, began considering the field of dermatology when, as part of the Latino Medical Students Association, she was invited by Amit Pandya, MD, to a pizza party and dermatology discussion during her first year of medical school at the University of Texas Southwestern Medical Center, Dallas.

Courtesy Dr. Stephanie Flores-Pollack
Dr. Stephanie Flores-Pollack

There, she met three Latinx residents who were part of the University of Texas Southwestern dermatology program. “I was so excited to hear their stories, where they came from, and how they ended up in dermatology,” she said. Dermatology had not been on her radar screen. Now there was a spark.

Volunteering at the free Agape dermatology clinic in Dallas later that year sharpened her interest. “For the first time, I really saw myself working in the field. Hearing patients’ stories and what they went through with what many people might think are very simple skin diseases made me realize there was potential to make a big impact in a person’s life,” said Dr. Florez-Pollack, who immigrated from Colombia with her family when she was 15.

Dr. Florez-Pollack’s journey into dermatology as an underrepresented-in-medicine (UIM) physician-in-training offers a window into a movement underway that aims to create a diverse dermatology workforce – one that reflects the ethnic and racial make-up of the population. It’s a movement that involves early outreach to medical students, stepped-up mentorship and sponsorship, implicit bias training, and holistic review of residency applicants.

Dr. Nada Elbuluk

There is no published study of all the changes being made – of how many dermatology programs have new outreach programs, for instance, or new approaches to resident application reviews. However, participation in the American Academy of Dermatology Diversity Champions program increased significantly between 2019 and 2020, and a sizable body of articles and editorials on diversity have been published in the dermatology literature in recent years, including at least several on holistic review of resident applications. Five years ago, there were few publications, sources said.

“The conversation is happening now at multiple levels, including in our peer-reviewed literature, where people are looking objectively at ... how we can make changes for the better,” said Nada Elbuluk, MD, director of the dermatology diversity and inclusion program at the University of Southern California, Los Angeles.

Dr. Kanade Shinkai

Unpublished findings also indicate that the number of UIM dermatology residents is inching upward. “Residency selection may not be on everyone’s mind, but an understanding of how we select people into our specialty is something every derm should know about and care about,” said Kanade Shinkai, MD, PhD, professor of dermatology at the University of California, San Francisco, and editor in chief of JAMA Dermatology.
 

The wake-up calls

The impetus for current changes first came in 2015, when Bruce Wintroub, MD, professor and chair of dermatology at UCSF, and interim dean of the medical school at the time, delivered a passionate plenary lecture at the annual AAD meeting about the lack of equity, diversity and inclusion in the specialty and the role of unconscious bias. Moved in part by a “White Coats for Black Lives” die-in by medical students on his campus following the killing of unarmed Black men, Dr. Wintroub called on his colleagues to recruit more UIM physicians into the specialty and to make the field more inclusive.

In 2016, Dr. Wintroub joined Dr. Pandya and two other academic dermatologists in authoring a commentary, published in the Journal of the American Academy of Dermatology, about the need to step up efforts and make diversity a priority. Dermatology was among the least ethnically and racially diverse specialties, second only to orthopedics, they wrote, with black dermatologists making up only 3% of all dermatologists and Hispanics only 4.2% in the United States, compared with 12.8% and 16.3% in the U.S. population, respectively.

Dr. Amit Pandya

For the next year or so, they and others from six academic institutions formed an incubator of sorts, actively tracking and sharing actions they were taking to improve diversity and the practice environment. “We wanted to learn from each other, then disseminate information to other programs,” said Dr. Pandya, who chaired the AAD diversity task force and led the self-branded “diversity champions.” (Dr. Pandya maintains his appointment at UTSW but now practices at the Palo Alto Foundation Medical Group in Sunnyvale, Calif.)

In 2017, at a President’s Conference on Diversity in Dermatology called for by then-AAD president Henry Lim, MD, leaders of the Association of Professors of Dermatology, the Society for Investigative Dermatology, and other dermatology organizations agreed on key action items, which they described in JAAD in 2018: Helping to increase the pipeline of UIM students applying to medical school, increasing UIM medical students’ early exposure to dermatology, and increasing the number of UIM students recruited into dermatology residency programs.

Diversity in the physician workforce has been shown to improve outcomes for all patients, and is important for ameliorating health care disparities and improving satisfaction and care for all patients, the authors of the 2018 paper wrote. “Multiple studies,” they noted, “have shown that UIM physicians are more likely to practice in areas where health care disparities exist.”

For specific proposed actions, the leaders attending the diversity conference drew largely upon the “diversity champions’” experiences, and agreed to fund and officially develop a diversity champions program. They also decided to invest in “bioskills” workshops for undergraduates and medical students at historically black colleges and universities, and other institutions at historically black colleges and universities at medical schools through a partnership with Nth Dimension – an organization founded in 2004 to bring more women and underrepresented minorities into orthopedic surgery.

In the last 2 years, more than 450 UIM students have attended these bioskills workshops, getting a taste of basic dermatology procedures and interacting with dermatologists.

And in September 2020, 157 dermatologists representing 80 programs throughout the country attended the second AAD Diversity Champions conference, up from 84 attendees and 30 programs in 2019. On the agenda: Discussions of holistic application review, mentorship, recruitment of UIM faculty, and a 2-hour session on microaggressions. Similar programs are being led by other dermatology organizations.

(UIM was coined by the American Association of Medical Colleges to describe racial and ethnic populations that are underrepresented in medicine relative to their numbers in the general population.)

Achievement of racial/ethnic diversity “won’t happen unless the field actively encourages people to look at it – which is not what we were doing,” Dr. Wintroub said in an interview. “I think that’s been the major change. We’re opening the door and saying: ‘We want you and we welcome you.’ ”


 

 

 

Rethinking traditional mentorship

For Dr. Florez-Pollack, the door almost shut when she began to hear from fellow medical students that dermatology is “too competitive ... a field for only the top people in the class.” She felt doubt settling in.

“I had peers who were throwing a lot of money toward prep materials ... peers who had siblings in medicine and had started studying from day one [for the step 1 exam],” she said. “I thought, was it really worth the effort? Do I really want to be perfect to get into the field when other fields would be happy to have me as I am right now?”

Her immense enjoyment of an “Art of Observation” elective course helped renew her interest in the field; it reinforced her visual abilities as well as the potential for her to address implicit bias as a dermatologist. She sought Dr. Pandya’s guidance and sponsorship to help her grow connections, polish her resume, and present herself to other faculty.

Doors were opened, she said, for her to secure a 1-year research experience before her final year of medical school with UTSW faculty, and then a 1-month rotation/mentorship with William D. James, MD, professor of dermatology at the University of Pennsylvania, an institution with a history of diversity initiatives and a longstanding skin of color program.



Dr. Florez-Pollack sees her experience reflected in the findings of a recently published study – a thematic content analysis of telephone interviews with applicants to the UTSW dermatology residency program during the 2013-14 and 2014-15 application cycles. Of the 44 applicants who participated in the study, 13 were UIM applicants.

Six of the seven UIM applicants who matched were involved in a pipeline or enrichment program – and were exposed to the field early – compared with one or two of the six UIM applicants who did not match. Underrepresented applicants were more often discouraged from applying (54%) – told, for instance, that they could better serve their communities through other specialties – than were non-UIM applicants (13%). They also were affected more often by a lack of equitable resources, according to comments made by 70% of applicants (UIM and non-UIM).

Also notably, the investigators said, all of the UIM applicants who matched (and the majority of non-UIMs who matched) reported having a mentor during the process of applying, compared with 44% of those who didn’t match.

Rebecca Vasquez, MD, assistant professor of dermatology at UTSW, who led the study, was herself a mentee of Dr. Pandya. “He believed in me and gave me the courage to consider dermatology,” she said. (Dr. Vasquez was one of the Latinx women who inspired Dr. Florez-Pollack, in turn, when they met at Dr. Pandya’s pizza party. Dr. Florez-Pollack assisted with the research and was a coauthor of the study.)

Dr. Amy McMichael

Amy McMichael, MD, professor and chair of dermatology at Wake Forest University, Winston-Salem, N.C., said that dermatology as a field has traditionally been “very good at mentoring.” Many of the dermatology societies have long had mentorship programs, for instance, that guide medical students, and sometimes residents, through defined experiences or through periods of time.

But she advocates going deeper. “When it comes to sponsorship, we fall a little short,” she said. “Sponsorship is about promoting that person to the next level, making sure they achieve what they want to achieve ... putting them up for opportunities they may not have known existed. It’s continuous and focused.”

Dr. Olabola Awosika
Dr. Olabola Awosika

Olabola Awosika, MD, a fourth-year dermatology resident at Henry Ford Health System, Detroit, said her interest in dermatology was solidified during her participation in the AAD’s month-long mentorship program after her second year of medical school at Howard University, Washington. However, it wasn’t until her fourth year, when she did an away rotation at Wake Forest, that she realized that “gaining access to the field” takes years of mentorship, research opportunities, and networking. It was too late.

After initially not matching, she did a rotation at Johns Hopkins in dermatology during an internship year, followed by a 2-year research fellowship at George Washington University, Washington. As does Dr. Florez-Pollack, who now mentors medical students. She also serves on the Women’s Dermatologic Society diversity committee, which is now developing initiatives to help UIM dermatologists “become upwardly mobile in dermatology [after residency], so they have a seat at the table in various settings.”
 

 

 

Holistic review for residency

Dr. Vasquez, who grew up in South Texas in an uninsured family that received most of its medical care across the border in Mexico, believes that the “biggest stride being made today” with respect to diversity in the dermatology workforce – and in the larger physician workforce – is increased understanding of the role of social and cultural capital.

Dr. Vasquez?
Dr. Rebecca Vasquez with students after meeting with them and discussing careers in medicine (and dermatology)

“We’d never really talked about this concept ... about how, if you don’t have the same upbringing, education, and resources, you’re already behind … and you may not do as well on standardized tests,” she said. “Now people are listening to it and understand it. That’s why more programs are looking at how to practice a more holistic approach to selecting applicants to interview.”

Some dermatology programs – at Wake Forest, UCSF, USC, Vanderbilt, and George Washington University for instance – have eliminated the use of U.S. Medical Licensing Examination step 1 scores and Alpha Omega Alpha Medical Honor Society status as filtering/screening metrics. Some also take a “second look” at UIM applicants.

Overall, those making changes are looking “at everything the applicant brings to the table – their story, their experiences,” said Dr. Elbuluk. “We want to understand the full picture of who they are and their journey to becoming a physician.”

Dr. Sharon E. Albers

Implicit bias training for members of residency review committees is becoming more common, as is such training across the board in dermatology departments. “We have to bring it to the forefront so that we can create more inclusive environments,” said Sharon E. Albers, MD, a dermatologist at Vanderbilt University Medical Center, Nashville, Tenn., who serves as the dermatology department’s diversity liaison to the medical school, and who, as a former faculty member of Meharry Medical College, remains engaged with the historically black institution.

One of her recent efforts, inspired by participation in the diversity champions program, has been developing pipeline programs to speak to middle and high school students about medicine and dermatology. For now, however, she credits a holistic review process for change. Last year, three of the five matched dermatology residents at Vanderbilt were UIM physicians – unprecedented for the institution, Dr. Albers said, and “evidence that holistic review works if you’re very intentional about it.”

Dr. Vasquez?
Dr. Rebecca Vasquez with colleagues (including students, Dr. Obrien, and Dr. Ayoade) at the free Agape dermatology clinic in Dallas

Dr. Vasquez has analyzed data from the Accreditation Council of Graduate Medical Education and says that UIM dermatology residents comprised 8.0% of the total in 2019, marking an improvement over the prior 7 years. “We’ve introduced so many changes at the same time,” making it difficult to discern what’s most impactful, she said. “But something is working.”

(The AAMC, which has invested in pipeline programs for more than a decade and has championed holistic medical school admissions, states in its 2019 diversity data report that efforts to improve diversity in medicine have made “only marginal differences” – and that Black males in particular continue to be significantly underrepresented in medical schools. Persistent, structural racism was a common theme in the association’s 2015 report on Black males in medicine.)

Efforts to diversify the workforce – particularly holistic review – haven’t been without detractors. “It brings reaction,” Dr. Wintroub said. “Some people think you’re lowering quality in the field ... but that’s just not true.”

Diversity in the dermatology workforce is important not only for the care of patients from diverse backgrounds, but “perhaps more importantly, it brings new ideas and views and experiences into the field,” he said. “It pushes us to think in new directions ... that can only make our field better and richer.”

“We need to make sure our workforce is representative of the patients we serve – but also that all derms can manage patients of all skin types and demographics,” Dr. Shinkai said. “And we need more diversity in the leadership of our departments and dermatology organizations ... inclusivity needs to extend all the way to the highest reaches of our specialty.”

Dr. Adam Friedman

Adam Friedman, MD, professor and interim chair of dermatology at George Washington University and director of the department’s diversity, equity, and inclusion committee, agreed. “We need to both make sure our workforce mirrors the patients we serve, and said workforce is prepared to manage patients of all skin types and demographics. We need to cover the spectrum, from revamping medical education and mentorship opportunities to advancing diversity in the leadership of our departments, institutions, and societies. Addressing only part of the puzzle will not and can not be enough.”

 

Correction, 3/3/21: An earlier version of this article misstated Dr. Stephanie Florez-Pollack's name.

Stephanie Florez-Pollack, MD, a dermatology resident at the University of Pennsylvania, Philadelphia, began considering the field of dermatology when, as part of the Latino Medical Students Association, she was invited by Amit Pandya, MD, to a pizza party and dermatology discussion during her first year of medical school at the University of Texas Southwestern Medical Center, Dallas.

Courtesy Dr. Stephanie Flores-Pollack
Dr. Stephanie Flores-Pollack

There, she met three Latinx residents who were part of the University of Texas Southwestern dermatology program. “I was so excited to hear their stories, where they came from, and how they ended up in dermatology,” she said. Dermatology had not been on her radar screen. Now there was a spark.

Volunteering at the free Agape dermatology clinic in Dallas later that year sharpened her interest. “For the first time, I really saw myself working in the field. Hearing patients’ stories and what they went through with what many people might think are very simple skin diseases made me realize there was potential to make a big impact in a person’s life,” said Dr. Florez-Pollack, who immigrated from Colombia with her family when she was 15.

Dr. Florez-Pollack’s journey into dermatology as an underrepresented-in-medicine (UIM) physician-in-training offers a window into a movement underway that aims to create a diverse dermatology workforce – one that reflects the ethnic and racial make-up of the population. It’s a movement that involves early outreach to medical students, stepped-up mentorship and sponsorship, implicit bias training, and holistic review of residency applicants.

Dr. Nada Elbuluk

There is no published study of all the changes being made – of how many dermatology programs have new outreach programs, for instance, or new approaches to resident application reviews. However, participation in the American Academy of Dermatology Diversity Champions program increased significantly between 2019 and 2020, and a sizable body of articles and editorials on diversity have been published in the dermatology literature in recent years, including at least several on holistic review of resident applications. Five years ago, there were few publications, sources said.

“The conversation is happening now at multiple levels, including in our peer-reviewed literature, where people are looking objectively at ... how we can make changes for the better,” said Nada Elbuluk, MD, director of the dermatology diversity and inclusion program at the University of Southern California, Los Angeles.

Dr. Kanade Shinkai

Unpublished findings also indicate that the number of UIM dermatology residents is inching upward. “Residency selection may not be on everyone’s mind, but an understanding of how we select people into our specialty is something every derm should know about and care about,” said Kanade Shinkai, MD, PhD, professor of dermatology at the University of California, San Francisco, and editor in chief of JAMA Dermatology.
 

The wake-up calls

The impetus for current changes first came in 2015, when Bruce Wintroub, MD, professor and chair of dermatology at UCSF, and interim dean of the medical school at the time, delivered a passionate plenary lecture at the annual AAD meeting about the lack of equity, diversity and inclusion in the specialty and the role of unconscious bias. Moved in part by a “White Coats for Black Lives” die-in by medical students on his campus following the killing of unarmed Black men, Dr. Wintroub called on his colleagues to recruit more UIM physicians into the specialty and to make the field more inclusive.

In 2016, Dr. Wintroub joined Dr. Pandya and two other academic dermatologists in authoring a commentary, published in the Journal of the American Academy of Dermatology, about the need to step up efforts and make diversity a priority. Dermatology was among the least ethnically and racially diverse specialties, second only to orthopedics, they wrote, with black dermatologists making up only 3% of all dermatologists and Hispanics only 4.2% in the United States, compared with 12.8% and 16.3% in the U.S. population, respectively.

Dr. Amit Pandya

For the next year or so, they and others from six academic institutions formed an incubator of sorts, actively tracking and sharing actions they were taking to improve diversity and the practice environment. “We wanted to learn from each other, then disseminate information to other programs,” said Dr. Pandya, who chaired the AAD diversity task force and led the self-branded “diversity champions.” (Dr. Pandya maintains his appointment at UTSW but now practices at the Palo Alto Foundation Medical Group in Sunnyvale, Calif.)

In 2017, at a President’s Conference on Diversity in Dermatology called for by then-AAD president Henry Lim, MD, leaders of the Association of Professors of Dermatology, the Society for Investigative Dermatology, and other dermatology organizations agreed on key action items, which they described in JAAD in 2018: Helping to increase the pipeline of UIM students applying to medical school, increasing UIM medical students’ early exposure to dermatology, and increasing the number of UIM students recruited into dermatology residency programs.

Diversity in the physician workforce has been shown to improve outcomes for all patients, and is important for ameliorating health care disparities and improving satisfaction and care for all patients, the authors of the 2018 paper wrote. “Multiple studies,” they noted, “have shown that UIM physicians are more likely to practice in areas where health care disparities exist.”

For specific proposed actions, the leaders attending the diversity conference drew largely upon the “diversity champions’” experiences, and agreed to fund and officially develop a diversity champions program. They also decided to invest in “bioskills” workshops for undergraduates and medical students at historically black colleges and universities, and other institutions at historically black colleges and universities at medical schools through a partnership with Nth Dimension – an organization founded in 2004 to bring more women and underrepresented minorities into orthopedic surgery.

In the last 2 years, more than 450 UIM students have attended these bioskills workshops, getting a taste of basic dermatology procedures and interacting with dermatologists.

And in September 2020, 157 dermatologists representing 80 programs throughout the country attended the second AAD Diversity Champions conference, up from 84 attendees and 30 programs in 2019. On the agenda: Discussions of holistic application review, mentorship, recruitment of UIM faculty, and a 2-hour session on microaggressions. Similar programs are being led by other dermatology organizations.

(UIM was coined by the American Association of Medical Colleges to describe racial and ethnic populations that are underrepresented in medicine relative to their numbers in the general population.)

Achievement of racial/ethnic diversity “won’t happen unless the field actively encourages people to look at it – which is not what we were doing,” Dr. Wintroub said in an interview. “I think that’s been the major change. We’re opening the door and saying: ‘We want you and we welcome you.’ ”


 

 

 

Rethinking traditional mentorship

For Dr. Florez-Pollack, the door almost shut when she began to hear from fellow medical students that dermatology is “too competitive ... a field for only the top people in the class.” She felt doubt settling in.

“I had peers who were throwing a lot of money toward prep materials ... peers who had siblings in medicine and had started studying from day one [for the step 1 exam],” she said. “I thought, was it really worth the effort? Do I really want to be perfect to get into the field when other fields would be happy to have me as I am right now?”

Her immense enjoyment of an “Art of Observation” elective course helped renew her interest in the field; it reinforced her visual abilities as well as the potential for her to address implicit bias as a dermatologist. She sought Dr. Pandya’s guidance and sponsorship to help her grow connections, polish her resume, and present herself to other faculty.

Doors were opened, she said, for her to secure a 1-year research experience before her final year of medical school with UTSW faculty, and then a 1-month rotation/mentorship with William D. James, MD, professor of dermatology at the University of Pennsylvania, an institution with a history of diversity initiatives and a longstanding skin of color program.



Dr. Florez-Pollack sees her experience reflected in the findings of a recently published study – a thematic content analysis of telephone interviews with applicants to the UTSW dermatology residency program during the 2013-14 and 2014-15 application cycles. Of the 44 applicants who participated in the study, 13 were UIM applicants.

Six of the seven UIM applicants who matched were involved in a pipeline or enrichment program – and were exposed to the field early – compared with one or two of the six UIM applicants who did not match. Underrepresented applicants were more often discouraged from applying (54%) – told, for instance, that they could better serve their communities through other specialties – than were non-UIM applicants (13%). They also were affected more often by a lack of equitable resources, according to comments made by 70% of applicants (UIM and non-UIM).

Also notably, the investigators said, all of the UIM applicants who matched (and the majority of non-UIMs who matched) reported having a mentor during the process of applying, compared with 44% of those who didn’t match.

Rebecca Vasquez, MD, assistant professor of dermatology at UTSW, who led the study, was herself a mentee of Dr. Pandya. “He believed in me and gave me the courage to consider dermatology,” she said. (Dr. Vasquez was one of the Latinx women who inspired Dr. Florez-Pollack, in turn, when they met at Dr. Pandya’s pizza party. Dr. Florez-Pollack assisted with the research and was a coauthor of the study.)

Dr. Amy McMichael

Amy McMichael, MD, professor and chair of dermatology at Wake Forest University, Winston-Salem, N.C., said that dermatology as a field has traditionally been “very good at mentoring.” Many of the dermatology societies have long had mentorship programs, for instance, that guide medical students, and sometimes residents, through defined experiences or through periods of time.

But she advocates going deeper. “When it comes to sponsorship, we fall a little short,” she said. “Sponsorship is about promoting that person to the next level, making sure they achieve what they want to achieve ... putting them up for opportunities they may not have known existed. It’s continuous and focused.”

Dr. Olabola Awosika
Dr. Olabola Awosika

Olabola Awosika, MD, a fourth-year dermatology resident at Henry Ford Health System, Detroit, said her interest in dermatology was solidified during her participation in the AAD’s month-long mentorship program after her second year of medical school at Howard University, Washington. However, it wasn’t until her fourth year, when she did an away rotation at Wake Forest, that she realized that “gaining access to the field” takes years of mentorship, research opportunities, and networking. It was too late.

After initially not matching, she did a rotation at Johns Hopkins in dermatology during an internship year, followed by a 2-year research fellowship at George Washington University, Washington. As does Dr. Florez-Pollack, who now mentors medical students. She also serves on the Women’s Dermatologic Society diversity committee, which is now developing initiatives to help UIM dermatologists “become upwardly mobile in dermatology [after residency], so they have a seat at the table in various settings.”
 

 

 

Holistic review for residency

Dr. Vasquez, who grew up in South Texas in an uninsured family that received most of its medical care across the border in Mexico, believes that the “biggest stride being made today” with respect to diversity in the dermatology workforce – and in the larger physician workforce – is increased understanding of the role of social and cultural capital.

Dr. Vasquez?
Dr. Rebecca Vasquez with students after meeting with them and discussing careers in medicine (and dermatology)

“We’d never really talked about this concept ... about how, if you don’t have the same upbringing, education, and resources, you’re already behind … and you may not do as well on standardized tests,” she said. “Now people are listening to it and understand it. That’s why more programs are looking at how to practice a more holistic approach to selecting applicants to interview.”

Some dermatology programs – at Wake Forest, UCSF, USC, Vanderbilt, and George Washington University for instance – have eliminated the use of U.S. Medical Licensing Examination step 1 scores and Alpha Omega Alpha Medical Honor Society status as filtering/screening metrics. Some also take a “second look” at UIM applicants.

Overall, those making changes are looking “at everything the applicant brings to the table – their story, their experiences,” said Dr. Elbuluk. “We want to understand the full picture of who they are and their journey to becoming a physician.”

Dr. Sharon E. Albers

Implicit bias training for members of residency review committees is becoming more common, as is such training across the board in dermatology departments. “We have to bring it to the forefront so that we can create more inclusive environments,” said Sharon E. Albers, MD, a dermatologist at Vanderbilt University Medical Center, Nashville, Tenn., who serves as the dermatology department’s diversity liaison to the medical school, and who, as a former faculty member of Meharry Medical College, remains engaged with the historically black institution.

One of her recent efforts, inspired by participation in the diversity champions program, has been developing pipeline programs to speak to middle and high school students about medicine and dermatology. For now, however, she credits a holistic review process for change. Last year, three of the five matched dermatology residents at Vanderbilt were UIM physicians – unprecedented for the institution, Dr. Albers said, and “evidence that holistic review works if you’re very intentional about it.”

Dr. Vasquez?
Dr. Rebecca Vasquez with colleagues (including students, Dr. Obrien, and Dr. Ayoade) at the free Agape dermatology clinic in Dallas

Dr. Vasquez has analyzed data from the Accreditation Council of Graduate Medical Education and says that UIM dermatology residents comprised 8.0% of the total in 2019, marking an improvement over the prior 7 years. “We’ve introduced so many changes at the same time,” making it difficult to discern what’s most impactful, she said. “But something is working.”

(The AAMC, which has invested in pipeline programs for more than a decade and has championed holistic medical school admissions, states in its 2019 diversity data report that efforts to improve diversity in medicine have made “only marginal differences” – and that Black males in particular continue to be significantly underrepresented in medical schools. Persistent, structural racism was a common theme in the association’s 2015 report on Black males in medicine.)

Efforts to diversify the workforce – particularly holistic review – haven’t been without detractors. “It brings reaction,” Dr. Wintroub said. “Some people think you’re lowering quality in the field ... but that’s just not true.”

Diversity in the dermatology workforce is important not only for the care of patients from diverse backgrounds, but “perhaps more importantly, it brings new ideas and views and experiences into the field,” he said. “It pushes us to think in new directions ... that can only make our field better and richer.”

“We need to make sure our workforce is representative of the patients we serve – but also that all derms can manage patients of all skin types and demographics,” Dr. Shinkai said. “And we need more diversity in the leadership of our departments and dermatology organizations ... inclusivity needs to extend all the way to the highest reaches of our specialty.”

Dr. Adam Friedman

Adam Friedman, MD, professor and interim chair of dermatology at George Washington University and director of the department’s diversity, equity, and inclusion committee, agreed. “We need to both make sure our workforce mirrors the patients we serve, and said workforce is prepared to manage patients of all skin types and demographics. We need to cover the spectrum, from revamping medical education and mentorship opportunities to advancing diversity in the leadership of our departments, institutions, and societies. Addressing only part of the puzzle will not and can not be enough.”

 

Correction, 3/3/21: An earlier version of this article misstated Dr. Stephanie Florez-Pollack's name.

Publications
Publications
Topics
Article Type
Sections
Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article
Display survey writer

Treprostinil offers some benefits for patients with ILD-associated pulmonary hypertension

Article Type
Changed
Thu, 01/14/2021 - 15:20

 

Inhaled treprostinil improved the exercise capacity of patients with pulmonary hypertension attributable to interstitial lung disease and was associated with some additional clinical benefits, according to a new study published in the New England Journal of Medicine.

To investigate treprostinil therapy for pulmonary hypertension in this subset of patients with lung disease, Aaron Waxman, MD, PhD, of Brigham and Women’s Hospital in Boston, and his fellow researchers launched the multicenter, randomized, double-blind, placebo-controlled INCREASE trial. They assigned 163 patients to the inhaled treprostinil group – administered via an ultrasonic, pulsed-delivery nebulizer over 16 weeks – and 163 patients to the placebo group. Their average age was 66.5 years, 73% were white, and 47% were female

At baseline, the mean 6-minute walk distance (6MWD) for all patients was 259.6 m. After 16 weeks, the treprostinil group gained a mean of 21.08 m in 6MWD, and the placebo group lost 10.04 m. The least-squares mean difference between the groups from baseline in the 6MWD was 31.12 m (95% confidence interval, 16.85-45.39; P < .001). After sensitivity analysis with multiple imputation, the difference remained significant at 30.97 m (95% CI, 16.53-45.41; P < .001).

In a comparison of N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels from baseline to 16 weeks, the treprostinil group saw a decrease of 15% while the placebo group’s levels increased by 46% (treatment ratio 0.58; 95% CI, 0.47-0.72; P < .001). Clinical worsening occurred in 37 patients (23%) in the treprostinil group and 54 patients (33%) in the placebo group (hazard ratio, 0.61; 95% CI, 0.40-0.92; P = .04), while serious adverse events occurred in 23.3% of the patients on treprostinil and 25.8% of the patients on placebo. There was no significant difference between groups in patient-reported quality of life, as assessed via the St. George’s Respiratory Questionnaire.

“There was no guarantee that this was going to work in this condition,” said Adriano Tonelli, MD, of the department of pulmonary medicine at the Cleveland Clinic, in an interview. “Several small studies have tried different medications, for pulmonary hypertension or otherwise, in patients with interstitial lung disease with minimal effect, if any. Given that all the prior studies were not categorically positive, the expectation, at least on my end, was that we needed to wait and see.” Dr. Tonelli and coauthors published a post hoc analysis of inhaled treprostinil studied in the TRIUMPH and BEAT trials.

Next steps: Assess clinical outcomes after inhaled treprostinil

Although the results of this study by Waxman et al, are encouraging, and the need for a treatment in this type of pulmonary hypertension is very real, more narrowing down will be needed to confirm the benefits of inhaled treprostinil, wrote Darren B. Taichman, MD, PhD, of the University of Pennsylvania in an accompanying editorial. He wrote, “After all, patients and physicians may reason, ‘It can’t hurt.’ Unfortunately, however, it could. Therapies approved for pulmonary arterial hypertension have been studied in patients with [ILD]-associated pulmonary hypertension and have shown inconsistent results, with some studies showing no benefit or suggesting harm.”

 

 

While the 6MWD has been used as an end point in previous drug trials for pulmonary arterial hypertension, Dr. Taichman wrote that improvements in such a variable were “probably too modest to be unequivocally consequential for many patients.” To confirm the benefits – and detriments – of treatments like inhaled treprostinil, it’s time for studies to focus on clinical end points, he stated, including hospitalizations, disease progression, and death.

He also highlighted the disparity between a treatment that led to increased walk distance and decreased clinical worsening yet did not register an improvement in health-related quality of life. He noted that the oft-cited minimal clinically important difference for 6MWD is approximately 30 m – similar to the difference recorded here. That said, he wrote, “prevention of deterioration is not to be ignored, even if it does not make a patient feel better.”

Regarding quality of life, Dr. Tonelli observed that this questionnaire, standard fare in respiratory research, may not have been perfectly suited for this particular study.

“You have to put it in the context of, ‘How good is the questionnaire to capture a difference in this particular disease over a 16-week period?’ ” he said. “It might not be sensitive enough to capture a significant change. The questionnaire was not developed for pulmonary hypertension in interstitial lung disease, of course. It was developed more generically. It may not capture all that you need to show significance.”

The investigators acknowledged the study’s other potential limitations, including a short duration, a notable percentage of patients who discontinued the trial early, and the fact that clinical worsening and exacerbation of disease were investigator reported and not confirmed by an independent committee.

As for next steps in assessing pulmonary hypertension treatments, Dr. Tonelli pointed to the direction of future research. “The other big study that needs to come out in our field, and I believe it’s being worked on, is inhaled treprostinil in pulmonary hypertension due to chronic obstructive pulmonary disease [COPD],” he said. “That’s a major unmet need; the COPD population is larger than the population for interstitial lung disease, and one would wonder whether inhaled treprostinil would benefit those patients as well. At the moment, we have no treatments for that condition. In the future, a COPD study will be needed.”

The study was supported by United Therapeutics. Author disclosures are listed on the New England Journal of Medicine website.

Publications
Topics
Sections

 

Inhaled treprostinil improved the exercise capacity of patients with pulmonary hypertension attributable to interstitial lung disease and was associated with some additional clinical benefits, according to a new study published in the New England Journal of Medicine.

To investigate treprostinil therapy for pulmonary hypertension in this subset of patients with lung disease, Aaron Waxman, MD, PhD, of Brigham and Women’s Hospital in Boston, and his fellow researchers launched the multicenter, randomized, double-blind, placebo-controlled INCREASE trial. They assigned 163 patients to the inhaled treprostinil group – administered via an ultrasonic, pulsed-delivery nebulizer over 16 weeks – and 163 patients to the placebo group. Their average age was 66.5 years, 73% were white, and 47% were female

At baseline, the mean 6-minute walk distance (6MWD) for all patients was 259.6 m. After 16 weeks, the treprostinil group gained a mean of 21.08 m in 6MWD, and the placebo group lost 10.04 m. The least-squares mean difference between the groups from baseline in the 6MWD was 31.12 m (95% confidence interval, 16.85-45.39; P < .001). After sensitivity analysis with multiple imputation, the difference remained significant at 30.97 m (95% CI, 16.53-45.41; P < .001).

In a comparison of N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels from baseline to 16 weeks, the treprostinil group saw a decrease of 15% while the placebo group’s levels increased by 46% (treatment ratio 0.58; 95% CI, 0.47-0.72; P < .001). Clinical worsening occurred in 37 patients (23%) in the treprostinil group and 54 patients (33%) in the placebo group (hazard ratio, 0.61; 95% CI, 0.40-0.92; P = .04), while serious adverse events occurred in 23.3% of the patients on treprostinil and 25.8% of the patients on placebo. There was no significant difference between groups in patient-reported quality of life, as assessed via the St. George’s Respiratory Questionnaire.

“There was no guarantee that this was going to work in this condition,” said Adriano Tonelli, MD, of the department of pulmonary medicine at the Cleveland Clinic, in an interview. “Several small studies have tried different medications, for pulmonary hypertension or otherwise, in patients with interstitial lung disease with minimal effect, if any. Given that all the prior studies were not categorically positive, the expectation, at least on my end, was that we needed to wait and see.” Dr. Tonelli and coauthors published a post hoc analysis of inhaled treprostinil studied in the TRIUMPH and BEAT trials.

Next steps: Assess clinical outcomes after inhaled treprostinil

Although the results of this study by Waxman et al, are encouraging, and the need for a treatment in this type of pulmonary hypertension is very real, more narrowing down will be needed to confirm the benefits of inhaled treprostinil, wrote Darren B. Taichman, MD, PhD, of the University of Pennsylvania in an accompanying editorial. He wrote, “After all, patients and physicians may reason, ‘It can’t hurt.’ Unfortunately, however, it could. Therapies approved for pulmonary arterial hypertension have been studied in patients with [ILD]-associated pulmonary hypertension and have shown inconsistent results, with some studies showing no benefit or suggesting harm.”

 

 

While the 6MWD has been used as an end point in previous drug trials for pulmonary arterial hypertension, Dr. Taichman wrote that improvements in such a variable were “probably too modest to be unequivocally consequential for many patients.” To confirm the benefits – and detriments – of treatments like inhaled treprostinil, it’s time for studies to focus on clinical end points, he stated, including hospitalizations, disease progression, and death.

He also highlighted the disparity between a treatment that led to increased walk distance and decreased clinical worsening yet did not register an improvement in health-related quality of life. He noted that the oft-cited minimal clinically important difference for 6MWD is approximately 30 m – similar to the difference recorded here. That said, he wrote, “prevention of deterioration is not to be ignored, even if it does not make a patient feel better.”

Regarding quality of life, Dr. Tonelli observed that this questionnaire, standard fare in respiratory research, may not have been perfectly suited for this particular study.

“You have to put it in the context of, ‘How good is the questionnaire to capture a difference in this particular disease over a 16-week period?’ ” he said. “It might not be sensitive enough to capture a significant change. The questionnaire was not developed for pulmonary hypertension in interstitial lung disease, of course. It was developed more generically. It may not capture all that you need to show significance.”

The investigators acknowledged the study’s other potential limitations, including a short duration, a notable percentage of patients who discontinued the trial early, and the fact that clinical worsening and exacerbation of disease were investigator reported and not confirmed by an independent committee.

As for next steps in assessing pulmonary hypertension treatments, Dr. Tonelli pointed to the direction of future research. “The other big study that needs to come out in our field, and I believe it’s being worked on, is inhaled treprostinil in pulmonary hypertension due to chronic obstructive pulmonary disease [COPD],” he said. “That’s a major unmet need; the COPD population is larger than the population for interstitial lung disease, and one would wonder whether inhaled treprostinil would benefit those patients as well. At the moment, we have no treatments for that condition. In the future, a COPD study will be needed.”

The study was supported by United Therapeutics. Author disclosures are listed on the New England Journal of Medicine website.

 

Inhaled treprostinil improved the exercise capacity of patients with pulmonary hypertension attributable to interstitial lung disease and was associated with some additional clinical benefits, according to a new study published in the New England Journal of Medicine.

To investigate treprostinil therapy for pulmonary hypertension in this subset of patients with lung disease, Aaron Waxman, MD, PhD, of Brigham and Women’s Hospital in Boston, and his fellow researchers launched the multicenter, randomized, double-blind, placebo-controlled INCREASE trial. They assigned 163 patients to the inhaled treprostinil group – administered via an ultrasonic, pulsed-delivery nebulizer over 16 weeks – and 163 patients to the placebo group. Their average age was 66.5 years, 73% were white, and 47% were female

At baseline, the mean 6-minute walk distance (6MWD) for all patients was 259.6 m. After 16 weeks, the treprostinil group gained a mean of 21.08 m in 6MWD, and the placebo group lost 10.04 m. The least-squares mean difference between the groups from baseline in the 6MWD was 31.12 m (95% confidence interval, 16.85-45.39; P < .001). After sensitivity analysis with multiple imputation, the difference remained significant at 30.97 m (95% CI, 16.53-45.41; P < .001).

In a comparison of N-terminal pro–B-type natriuretic peptide (NT-proBNP) levels from baseline to 16 weeks, the treprostinil group saw a decrease of 15% while the placebo group’s levels increased by 46% (treatment ratio 0.58; 95% CI, 0.47-0.72; P < .001). Clinical worsening occurred in 37 patients (23%) in the treprostinil group and 54 patients (33%) in the placebo group (hazard ratio, 0.61; 95% CI, 0.40-0.92; P = .04), while serious adverse events occurred in 23.3% of the patients on treprostinil and 25.8% of the patients on placebo. There was no significant difference between groups in patient-reported quality of life, as assessed via the St. George’s Respiratory Questionnaire.

“There was no guarantee that this was going to work in this condition,” said Adriano Tonelli, MD, of the department of pulmonary medicine at the Cleveland Clinic, in an interview. “Several small studies have tried different medications, for pulmonary hypertension or otherwise, in patients with interstitial lung disease with minimal effect, if any. Given that all the prior studies were not categorically positive, the expectation, at least on my end, was that we needed to wait and see.” Dr. Tonelli and coauthors published a post hoc analysis of inhaled treprostinil studied in the TRIUMPH and BEAT trials.

Next steps: Assess clinical outcomes after inhaled treprostinil

Although the results of this study by Waxman et al, are encouraging, and the need for a treatment in this type of pulmonary hypertension is very real, more narrowing down will be needed to confirm the benefits of inhaled treprostinil, wrote Darren B. Taichman, MD, PhD, of the University of Pennsylvania in an accompanying editorial. He wrote, “After all, patients and physicians may reason, ‘It can’t hurt.’ Unfortunately, however, it could. Therapies approved for pulmonary arterial hypertension have been studied in patients with [ILD]-associated pulmonary hypertension and have shown inconsistent results, with some studies showing no benefit or suggesting harm.”

 

 

While the 6MWD has been used as an end point in previous drug trials for pulmonary arterial hypertension, Dr. Taichman wrote that improvements in such a variable were “probably too modest to be unequivocally consequential for many patients.” To confirm the benefits – and detriments – of treatments like inhaled treprostinil, it’s time for studies to focus on clinical end points, he stated, including hospitalizations, disease progression, and death.

He also highlighted the disparity between a treatment that led to increased walk distance and decreased clinical worsening yet did not register an improvement in health-related quality of life. He noted that the oft-cited minimal clinically important difference for 6MWD is approximately 30 m – similar to the difference recorded here. That said, he wrote, “prevention of deterioration is not to be ignored, even if it does not make a patient feel better.”

Regarding quality of life, Dr. Tonelli observed that this questionnaire, standard fare in respiratory research, may not have been perfectly suited for this particular study.

“You have to put it in the context of, ‘How good is the questionnaire to capture a difference in this particular disease over a 16-week period?’ ” he said. “It might not be sensitive enough to capture a significant change. The questionnaire was not developed for pulmonary hypertension in interstitial lung disease, of course. It was developed more generically. It may not capture all that you need to show significance.”

The investigators acknowledged the study’s other potential limitations, including a short duration, a notable percentage of patients who discontinued the trial early, and the fact that clinical worsening and exacerbation of disease were investigator reported and not confirmed by an independent committee.

As for next steps in assessing pulmonary hypertension treatments, Dr. Tonelli pointed to the direction of future research. “The other big study that needs to come out in our field, and I believe it’s being worked on, is inhaled treprostinil in pulmonary hypertension due to chronic obstructive pulmonary disease [COPD],” he said. “That’s a major unmet need; the COPD population is larger than the population for interstitial lung disease, and one would wonder whether inhaled treprostinil would benefit those patients as well. At the moment, we have no treatments for that condition. In the future, a COPD study will be needed.”

The study was supported by United Therapeutics. Author disclosures are listed on the New England Journal of Medicine website.

Publications
Publications
Topics
Article Type
Sections
Article Source

FROM THE NEW ENGLAND JOURNAL OF MEDICINE

Disallow All Ads
Content Gating
No Gating (article Unlocked/Free)
Alternative CME
Disqus Comments
Default
Use ProPublica
Hide sidebar & use full width
render the right sidebar.
Conference Recap Checkbox
Not Conference Recap
Clinical Edge
Display the Slideshow in this Article
Medscape Article