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FDA moves to ban menthol in cigarettes
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
The Food and Drug Administration said that within a year it will ban menthol in cigarettes and ban all flavors including menthol in cigars.
Menthol makes it easier to start smoking, and also enhances the effects of nicotine, making it more addictive and harder to quit, the FDA said in announcing its actions on Thursday.
Nineteen organizations – including the American Academy of Pediatrics, American Cancer Society, American College of Chest Physicians, American Medical Association, American Heart Association, and the National Medical Association – have pushed the FDA to ban menthol for years. The agency banned all flavors in cigarettes in 2009 but did not take any action against menthol. In 2013, the groups filed a petition demanding that the FDA ban menthol, too. The agency responded months later with a notice that it would start the process.
But it never took any action. Action on Smoking and Health and the African American Tobacco Control Leadership Council, later joined by the AMA and the NMA, sued in 2020 to compel the agency to do something. Now it has finally agreed to act.
The African American Tobacco Control Leadership Council welcomed the move but said the fight is not over and encouraged tobacco control activists to fight to ban menthol tobacco products at the local, state and federal level. “We know that this rule-making process could take years and we know that the tobacco industry will continue to do everything in their power to derail any attempt to remove their deadly products from the market,” Phillip Gardiner, MD, council cochair, said in a statement.
The AMA is urging the FDA to quickly implement the ban and remove the products “without further delay,” AMA President Susan R. Bailey, MD, said in a statement.
“FDA’s long-awaited decision to take action to eliminate menthol flavoring in cigarettes and all flavors in cigars ends a decades-long deference to the tobacco industry, which has repeatedly demonstrated its willingness to profit from products that result in death,” Lisa Lacasse, president of the American Cancer Society Cancer Action Network, said in her own statement.
Ms. Lacasse said banning menthol will help eliminate health disparities. She said 86% of Black people who smoke use menthol cigarettes, compared with 46% of Hispanic people who smoke, 39% of Asian people who smoke, and 29% of White people who smoke. “FDA’s actions today send a clear message that Big Tobacco’s strategy to profit off addicting Black communities will no longer be tolerated,” she said.
Not all groups are on board, however. The American Civil Liberties Union and several other organizations wrote to the country’s top health officials urging them to reconsider.
“Such a ban will trigger criminal penalties which will disproportionately impact people of color, as well as prioritize criminalization over public health and harm reduction,” the letter says. “A ban will also lead to unconstitutional policing and other negative interactions with local law enforcement.”
The letter calls the proposed ban “well intentioned,” but said any effort to reduce death and disease from tobacco “must avoid solutions that will create yet another reason for armed police to engage citizens on the street based on pretext or conduct that does not pose a threat to public safety.”
Instead of a ban, the organizations said, policy makers should consider increased education for adults and minors, stop-smoking programs, and increased funding for health centers in communities of color.
The Biden administration, however, pressed the point that banning menthol will bring many positives. Acting FDA Commissioner Janet Woodcock, MD said in a statement that banning menthol “will help significantly reduce youth initiation, increase the chances of smoking cessation among current smokers, and address health disparities experienced by communities of color, low-income populations, and LGBTQ-plus individuals, all of whom are far more likely to use these tobacco products.”
The FDA cited data showing that, in the first year or so after a ban goes into effect, an additional 923,000 smokers would quit, including 230,000 African Americans. Another study suggests that 633,000 deaths would be averted, including 237,000 Black Americans.
Dr. Woodcock added that, “armed with strong scientific evidence, and with full support from the [Biden] administration, we believe these actions will launch us on a trajectory toward ending tobacco-related disease and death in the U.S.”
The FDA estimates that 18.6 million Americans who are current smokers use menthol cigarettes, with a disproportionately high number being Black people. Menthol cigarette use among Black and Hispanic youth increased from 2011 to 2018, but declined for non-Hispanic White youth.
Flavored mass-produced cigars and cigarillos are disproportionately popular among youth, especially non-Hispanic Black high school students, who in 2020 reported past 30-day cigar smoking at levels twice as high as their White counterparts, said the FDA. Three-quarters of 12- to 17-year-olds reported they smoke cigars because they like the flavors. In 2020, more young people tried a cigar every day than tried a cigarette, reports the agency.
“This long-overdue decision will protect future generations of young people from nicotine addiction, especially Black children and communities, which have disproportionately suffered from menthol tobacco use due to targeted efforts from the tobacco industry,” Lee Savio Beers, MD, president of the American Academy of Pediatrics, said in a statement.
The FDA’s announcement “is only a first step that must be followed with urgent, comprehensive action to remove these flavored products from the market,” he said.
A version of this article first appeared on WebMD.com.
AHA statement flags CV risk of hormonal cancer therapies
Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.
“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.
The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.
Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.
The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.
The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.
Among the key findings:
- In patients with breast cancer, has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
- Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
- The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
- The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
- Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
- Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.
The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.
The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.
“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.
The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.
“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.
The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.
Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.
The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.
The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.
Among the key findings:
- In patients with breast cancer, has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
- Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
- The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
- The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
- Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
- Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.
The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.
The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.
“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.
The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Hormonal therapies for the treatment of hormone-dependent breast and prostate cancer could raise the risk for myocardial infarction and stroke, and patients need to be closely monitored to allow early detection and treatment of cardiovascular disease (CVD), the American Heart Association says in a new scientific statement.
“The statement provides data on the risks of each type of hormonal therapy so clinicians can use it as a guide to help manage cardiovascular risks during cancer treatment,” Tochi Okwuosa, DO, chair of the writing group, said in a news release.
“A team-based approach to patient care that includes the oncology team, cardiologist, primary care clinician, dietitian, endocrinologist, and other health care professionals as appropriate is needed to work with each patient to manage and reduce the increased risk of heart disease and strokes associated with hormonal therapy in breast and prostate cancer treatment,” said Dr. Okwuosa, director of cardio-oncology services, Rush University Medical Center, Chicago.
The scientific statement was published online April 26 in Circulation: Genomic and Precision Medicine.
Hormone-dependent cancers, such as prostate and breast cancer, are the most common noncutaneous cancers in the United States and around the world. As hormonal therapies have markedly improved survival in these patients, CVD has emerged as a leading cause illness and death.
The increased CVD burden might be explained by the increasing average age of cancer survivors, leading to higher rates of age-related CV risk factors and coronary artery disease.
The writing group reviewed existing evidence from observational studies and randomized controlled trials on the cardiovascular impact of anticancer hormonal therapies.
Among the key findings:
- In patients with breast cancer, has been shown to increase the risk for venous thromboembolic events, but to have somewhat protective to neutral effects on CVD risk burden and CVD events. Conversely, aromatase inhibitors have been shown to increase the risk for CVD risk factors and events, including MI and stroke.
- Androgen-deprivation therapy for prostate cancer appears to increase the risk for CV events, although gonadotrophin-releasing hormone (GnRH) antagonists are associated with a lower risk for CV events than are GnRH agonists. The oral antiandrogens appear to be associated with increased CVD risk as well, particularly when used for complete androgen blockade as combination GnRH/anti-androgen therapy.
- The duration of hormonal therapies has a significant impact on CVD risk; the longer patients receive hormonal therapy, the greater the risk. More research is needed to better define the risks associated with duration of treatment.
- The data are mixed on the impact of preexisting CV risk factors and CVD on CV events associated with hormonal therapy. Although the presence of baseline CV risk factors and CVD can increase CV events associated with aromatase inhibitors, it is not clear that tamoxifen does.
- Studies suggest that patients with prostate cancer and baseline CVD and CV risk factors have increased rates of CV events when treated with androgen-deprivation therapy.
- Although the prolonged use of some hormonal therapies worsens CV risk factors and , the effects of the duration of therapy on CV events are less clear.
The writing group noted that there are no definitive guidelines for the monitoring and management of hormonal therapy-related CVD risks.
The authors encourage clinicians to be alert for worsening CV problems in those with preexisting heart disease or risk factors, and to recognize that even patients without preexisting CV problems are at higher risk because of their exposure to hormonal therapies.
“For patients who have two or more cardiovascular risk factors, it is likely that referral to a cardiologist would be appropriate prior to beginning hormone treatment. For patients already receiving hormonal therapies, a discussion with the oncology team can help to determine if a cardiology referral is recommended,” Dr. Okwuosa said in the news release.
This scientific statement was prepared by the volunteer writing group on behalf of the AHA Cardio-Oncology Subcommittee of the Council on Clinical Cardiology and the Council on Genomic and Precision Medicine; the Council on Arteriosclerosis, Thrombosis, and Vascular Biology; and the Council on Cardiovascular Radiology and Intervention.
The research had no commercial funding. Dr. Okwuosa has disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Tofacitinib: Small study shows big cutaneous sarcoidosis response
Researchers are reporting impressive results in a small, , and all patients improved by an average of 83% via a scoring system.
“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.
Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.
“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.
“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”
Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.
Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.
The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.
In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”
Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.
In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.
She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”
The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.
This article was updated 5/5/21.
Researchers are reporting impressive results in a small, , and all patients improved by an average of 83% via a scoring system.
“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.
Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.
“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.
“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”
Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.
Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.
The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.
In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”
Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.
In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.
She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”
The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.
This article was updated 5/5/21.
Researchers are reporting impressive results in a small, , and all patients improved by an average of 83% via a scoring system.
“Not only did patients get better, but they were in many cases able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate. They’d get off prednisone entirely or, in some cases, decrease it substantially,” study investigator William Damsky, MD, PhD, reported at the American Academy of Dermatology Virtual Meeting Experience.
Sarcoidosis is a common disease that affects an estimated 1 in 25 Black women and is believed to contribute to the deaths of about 4,000 people in the United States each year, noted Dr. Damsky of the department of dermatology, Yale University, New Haven, Conn. One famous patient is comedian Bernie Mac, who died from the condition in 2008.
“Approximately one third of patients have cutaneous involvement,” Dr. Damsky said, and skin may be the only manifestation of the disease. There is no Food and Drug Administration-approved therapy for cutaneous sarcoidosis, he added. Prednisone, the first-line therapy in skin manifestations, is approved only for pulmonary sarcoidosis.
“Oftentimes, there’s an attempt to transition either partially or fully to other therapies, including methotrexate and TNF-alpha blockers. But there’s been mixed success in doing that,” he said. This is not always possible, “so a lot of patients end up on prednisone.”
Earlier, a team at Yale prescribed 5 mg tofacitinib (Xeljanz) for several patients with severe cutaneous sarcoidosis and saw impressive results, Dr. Damsky said, including a patient with pulmonary sarcoidosis that also improved. He noted that there are case reports in the medical literature with similar findings.
Those positive results inspired the new study. Researchers recruited 10 patients with cutaneous sarcoidosis (9 with internal organ involvement) with a Cutaneous Sarcoidosis Activity and Morphology Instrument ( CSAMI ) score of 10 or higher. Nine patients were in their 50s, one was aged 63 years, and five were men. Skin colors of the patients ranged from Fitzpatrick skin types I to VI, and all had been taking at least two medications, typically methotrexate and prednisone.
The patients received 5 mg of tofacitinib twice a day for 6 months. “Everyone got better during the study, and six patients had a complete response, which we defined as a CSAMI score of zero activity,” Dr. Damsky said. “It’s really quite remarkable to see that.” Overall, the patients saw an 83% improvement in CSAMI scores.
In regard to safety, “all patients completed the study,” he said. “Tofacitinib was well tolerated, and there were no serious adverse effects or events.”
Tofacitinib is approved for treating rheumatoid arthritis, psoriatic arthritis, ulcerative colitis, and polyarticular course juvenile idiopathic arthritis.
A month’s supply of twice-daily 5 mg tofacitinib pills would cost $4,900-$5,100 with free coupons, according to information accessed on April 24, 2021, on GoodRx.com. Generics are not available.
In an interview, Sotonye Imadojemu, MD, of the department of dermatology, Brigham and Women’s Hospital, Boston, praised the study, and said “tofacitinib is a reasonable treatment for treatment-refractory or extensive cutaneous sarcoidosis,” although it will be helpful to get results from randomized-controlled trials.
She cautioned that the drug “is a powerful immunosuppressant, so the risk of infection must be discussed with patients before prescribing. Screening for chronic infections such as viral hepatitis, tuberculosis, and HIV should be completed prior to treatment initiation. Blood counts, liver function, and lipid panels should be regularly monitored. The vaccines necessary for those who are immunosuppressed should be administered as able, and age-appropriate cancer screening must be kept up to date.”
The study was funded by Pfizer, the Dermatology Foundation, and the Yale Department of Dermatology. Dr. Damsky disclosed research support (Pfizer), consulting fees (Eli Lilly, Pfizer, TWi Biotechnology), and licensing fees (EMD Millipore/MillporeSigma). Dr. Imadojemu has no disclosures.
This article was updated 5/5/21.
REPORTING FROM AAD VMX 2021
MPL, microaggressions, and more
Dear colleagues,
Welcome to the May edition of The New Gastroenterologist, which is packed with a fantastic line-up of articles! The 1-year mark of the pandemic recently passed, and we now are gearing up for our second virtual Digestive Disease Week (DDW®). While we are all anxious to return to lives that have some semblance of normalcy, we continue to endure the ebbs and flows that characterize life in a pandemic. For over a year now, we spend our days caught in a constant battle between the risk and reward of activities we previously took for granted or considered mundane. Our moods vacillate with the continued rise and fall of COVID-19 cases, but the advent and distribution of vaccines have offered palpable hope for better outcomes.
I’m pleased to introduce this quarter’s content – beginning with our legal section. Dr. John Azizian (UCLA-Olive-View), Dr. James Tabibian (UCLA-Olive-View), Dr. Camellia Dalai (UCLA-Olive-View/University of New Mexico), and Dr. Megan Adams (University of Michigan) contribute a comprehensive piece on medical professional liability (MPL), a topic that is seldom discussed in training but has important implications in clinical practice. This article reviews basic legal concepts, recent trends and details on gastroenterology specific claims, and most importantly, advice on how to mitigate MPL risk as gastroenterologists.
Many trainees and early career gastroenterologists face microaggressions for a variety of different reasons. Dr. Oveia Aktopaire and Dr. Rachel Issaka (University of Washington) present a thought-provoking piece as they delve into structural racism in medicine and how microaggressions are a proxy for bias.
Dyssynergic defecation (DD) affects up to one-half of patients with chronic constipation. The “In Focus” feature for May provides an excellent review of DD written by international expert Dr. Satish Rao and Dr. Asad Jehangir (both, Medical College of Georgia/Augusta University). The article provides guidance on the diagnosis of DD, including high-yield features of physical and digital rectal exams, guidance on interpretation of anorectal manometry testing, and how these can dictate an effective therapeutic plan.
Meaningful mentorship is crucial for young gastroenterologists but at times the nature of the mentor-mentee relationship can be difficult to navigate. Dr. David Fessell and Bridger Rodoni (University of Michigan) explore this dynamic and discuss the notion of mentorship malpractice in a compelling addition to our ethics case series.
Abdominal wall pain is common yet often overlooked diagnosis and a great teaching point for trainees. Dr. Manish Singla (Uniformed Services University/Capital Digestive Care) and Dr. Brian Park (Naval Medical Center) discuss the diagnosis and management and how the early recognition of abdominal wall pain can save both patients and clinicians from a battery of unnecessary diagnostic testing.
The DHPA Private Practice Perspectives article this quarter, written by Dr. Aja McCutchen (Atlanta Gastroenterology Associates), addresses colorectal cancer screening, the disparities that exist, and the important role we have as gastroenterologists in reducing barriers to screening. Lastly, Dr. Bilal Asif (University of Maryland/National Institutes of Health) walks us through a fellow’s perspective on the AGA’s first virtual Advocacy Day – demonstrating that advocacy is still possible even as a trainee and in the setting of a pandemic.
If you have interest in contributing or have ideas for future TNG topics, please contact me (vijayarao@medicine.bsd.uchicago.edu) or Ryan Farrell (rfarrell@gastro.org), managing editor of TNG.
Stay well,
Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition
Dear colleagues,
Welcome to the May edition of The New Gastroenterologist, which is packed with a fantastic line-up of articles! The 1-year mark of the pandemic recently passed, and we now are gearing up for our second virtual Digestive Disease Week (DDW®). While we are all anxious to return to lives that have some semblance of normalcy, we continue to endure the ebbs and flows that characterize life in a pandemic. For over a year now, we spend our days caught in a constant battle between the risk and reward of activities we previously took for granted or considered mundane. Our moods vacillate with the continued rise and fall of COVID-19 cases, but the advent and distribution of vaccines have offered palpable hope for better outcomes.
I’m pleased to introduce this quarter’s content – beginning with our legal section. Dr. John Azizian (UCLA-Olive-View), Dr. James Tabibian (UCLA-Olive-View), Dr. Camellia Dalai (UCLA-Olive-View/University of New Mexico), and Dr. Megan Adams (University of Michigan) contribute a comprehensive piece on medical professional liability (MPL), a topic that is seldom discussed in training but has important implications in clinical practice. This article reviews basic legal concepts, recent trends and details on gastroenterology specific claims, and most importantly, advice on how to mitigate MPL risk as gastroenterologists.
Many trainees and early career gastroenterologists face microaggressions for a variety of different reasons. Dr. Oveia Aktopaire and Dr. Rachel Issaka (University of Washington) present a thought-provoking piece as they delve into structural racism in medicine and how microaggressions are a proxy for bias.
Dyssynergic defecation (DD) affects up to one-half of patients with chronic constipation. The “In Focus” feature for May provides an excellent review of DD written by international expert Dr. Satish Rao and Dr. Asad Jehangir (both, Medical College of Georgia/Augusta University). The article provides guidance on the diagnosis of DD, including high-yield features of physical and digital rectal exams, guidance on interpretation of anorectal manometry testing, and how these can dictate an effective therapeutic plan.
Meaningful mentorship is crucial for young gastroenterologists but at times the nature of the mentor-mentee relationship can be difficult to navigate. Dr. David Fessell and Bridger Rodoni (University of Michigan) explore this dynamic and discuss the notion of mentorship malpractice in a compelling addition to our ethics case series.
Abdominal wall pain is common yet often overlooked diagnosis and a great teaching point for trainees. Dr. Manish Singla (Uniformed Services University/Capital Digestive Care) and Dr. Brian Park (Naval Medical Center) discuss the diagnosis and management and how the early recognition of abdominal wall pain can save both patients and clinicians from a battery of unnecessary diagnostic testing.
The DHPA Private Practice Perspectives article this quarter, written by Dr. Aja McCutchen (Atlanta Gastroenterology Associates), addresses colorectal cancer screening, the disparities that exist, and the important role we have as gastroenterologists in reducing barriers to screening. Lastly, Dr. Bilal Asif (University of Maryland/National Institutes of Health) walks us through a fellow’s perspective on the AGA’s first virtual Advocacy Day – demonstrating that advocacy is still possible even as a trainee and in the setting of a pandemic.
If you have interest in contributing or have ideas for future TNG topics, please contact me (vijayarao@medicine.bsd.uchicago.edu) or Ryan Farrell (rfarrell@gastro.org), managing editor of TNG.
Stay well,
Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition
Dear colleagues,
Welcome to the May edition of The New Gastroenterologist, which is packed with a fantastic line-up of articles! The 1-year mark of the pandemic recently passed, and we now are gearing up for our second virtual Digestive Disease Week (DDW®). While we are all anxious to return to lives that have some semblance of normalcy, we continue to endure the ebbs and flows that characterize life in a pandemic. For over a year now, we spend our days caught in a constant battle between the risk and reward of activities we previously took for granted or considered mundane. Our moods vacillate with the continued rise and fall of COVID-19 cases, but the advent and distribution of vaccines have offered palpable hope for better outcomes.
I’m pleased to introduce this quarter’s content – beginning with our legal section. Dr. John Azizian (UCLA-Olive-View), Dr. James Tabibian (UCLA-Olive-View), Dr. Camellia Dalai (UCLA-Olive-View/University of New Mexico), and Dr. Megan Adams (University of Michigan) contribute a comprehensive piece on medical professional liability (MPL), a topic that is seldom discussed in training but has important implications in clinical practice. This article reviews basic legal concepts, recent trends and details on gastroenterology specific claims, and most importantly, advice on how to mitigate MPL risk as gastroenterologists.
Many trainees and early career gastroenterologists face microaggressions for a variety of different reasons. Dr. Oveia Aktopaire and Dr. Rachel Issaka (University of Washington) present a thought-provoking piece as they delve into structural racism in medicine and how microaggressions are a proxy for bias.
Dyssynergic defecation (DD) affects up to one-half of patients with chronic constipation. The “In Focus” feature for May provides an excellent review of DD written by international expert Dr. Satish Rao and Dr. Asad Jehangir (both, Medical College of Georgia/Augusta University). The article provides guidance on the diagnosis of DD, including high-yield features of physical and digital rectal exams, guidance on interpretation of anorectal manometry testing, and how these can dictate an effective therapeutic plan.
Meaningful mentorship is crucial for young gastroenterologists but at times the nature of the mentor-mentee relationship can be difficult to navigate. Dr. David Fessell and Bridger Rodoni (University of Michigan) explore this dynamic and discuss the notion of mentorship malpractice in a compelling addition to our ethics case series.
Abdominal wall pain is common yet often overlooked diagnosis and a great teaching point for trainees. Dr. Manish Singla (Uniformed Services University/Capital Digestive Care) and Dr. Brian Park (Naval Medical Center) discuss the diagnosis and management and how the early recognition of abdominal wall pain can save both patients and clinicians from a battery of unnecessary diagnostic testing.
The DHPA Private Practice Perspectives article this quarter, written by Dr. Aja McCutchen (Atlanta Gastroenterology Associates), addresses colorectal cancer screening, the disparities that exist, and the important role we have as gastroenterologists in reducing barriers to screening. Lastly, Dr. Bilal Asif (University of Maryland/National Institutes of Health) walks us through a fellow’s perspective on the AGA’s first virtual Advocacy Day – demonstrating that advocacy is still possible even as a trainee and in the setting of a pandemic.
If you have interest in contributing or have ideas for future TNG topics, please contact me (vijayarao@medicine.bsd.uchicago.edu) or Ryan Farrell (rfarrell@gastro.org), managing editor of TNG.
Stay well,
Vijaya L. Rao, MD
Editor in Chief
Assistant Professor of Medicine, University of Chicago, Section of Gastroenterology, Hepatology & Nutrition
PTSD linked to ischemic heart disease
A study using data from Veterans Health Administration (VHA) electronic medical records shows a significant association between posttraumatic stress disorder (PTSD) among female veterans and an increased risk for incident ischemic heart disease (IHD).
The increased risk for IHD was highest among women younger than 40 with PTSD, and among racial and ethnic minorities.
“These women have been emerging as important targets for cardiovascular prevention, and our study suggests that PTSD may be an important psychosocial risk factor for IHD in these individuals,” wrote the researchers, led by Ramin Ebrahimi, MD, department of medicine, cardiology section, Veterans Affairs Greater Los Angeles Health Care System. “With the number of women veterans growing, it is critical to appreciate the health care needs of this relatively young and diverse patient population.”
The study results also have “important implications for earlier and more aggressive IHD risk assessment, monitoring and management in vulnerable women veterans,” they added. “Indeed, our findings support recent calls for cardiovascular risk screening in younger individuals and for the need to harness a broad range of clinicians who routinely treat younger women to maximize prevention efforts.”
The article was published online in JAMA Cardiology on March 17.
Increasing number of VHA users
“As an interventional cardiologist and the director of the cardiac catheterization laboratory, I noticed a significant number of the patients referred to the cath lab carried a diagnosis of posttraumatic stress disorder,” Dr. Ebrahimi said in an interview. “This intrigued me and started my journey into trying to understand how psychiatric disorders in general, and PTSD, may impact/interact with cardiovascular disorders,” he added.
The number of female veterans in the military has been increasing, and they now make up about 10% of the 20 million American veterans; that number is projected to exceed 2.2 million in the next 20 years, the authors wrote. Female veterans are also the fastest growing group of users of the VHA, they added.
IHD is the leading cause of death in women in the United States, despite the advancements in prevention and treatment. Although women are twice as likely to develop PTSD as are men, and it is even more likely in female veterans, much of the research has predominately been on male veterans, the authors wrote.
For this retrospective study, which used data from the VHA Corporate Data Warehouse, the authors examined a cohort of female veterans who were 18 years or older who had used the VHA health care system between Jan. 1, 2000, and Dec. 31, 2017.
Of the 828,997 female veterans, 151,030 had PTSD. Women excluded from the study were those who did not have any clinical encounters after their index visit, participants who had a diagnosis of IHD at or before the index visit, and those with incident IHD within 90 days of the index visit, allowing time between a PTSD diagnosis and IHD.
Propensity score matching on age at index visit, the number of previous visits, and the presence of traditional and female-specific cardiovascular risk factors, as well as mental and physical health conditions, was conducted to identify female veterans ever diagnosed with PTSD, who were matched in a 1:2 ratio to those never diagnosed with PTSD. In all, 132,923 women with PTSD and 265,846 women without PTSD were included, and data were analyzed for the period of Oct. 1, 2018, to Oct. 30, 2020.
IHD was defined as new-onset coronary artery disease, angina, or myocardial infarction–based ICD-9 and ICD-10 diagnostic codes. Age, race, and ethnicity were self-reported.
The analytic sample consisted of relatively young female veterans (mean [SD] age at baseline, 40.1 [12.2] years) of various races (White, 57.6%; Black, 29.8%) and ethnicities, the authors reported.
Of the 9,940 women who experienced incident IHD during follow-up, 5,559 did not have PTSD (2.1% of the overall population examined) and 4,381 had PTSD (3.3%). PTSD was significantly associated with an increased risk for IHD. Over the median follow-up of 4.9 years, female veterans with PTSD had a 44% higher rate of developing incident IHD compared with the female veterans without PTSD (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.38-1.50).
In addition, those with PTSD who developed IHD were younger at diagnosis (mean [SD] age, 55.5 [9.7]) than were patients without PTSD (mean [SD] age, 57.8 [10.7]). Effect sizes were largest in the group younger than 40 years (HR, 1.72; 95% CI, 1.55-1.90) and decreased for older participants (HR for those ≥60 years, 1.24; 95% CI, 1.12-1.38)
The authors found a 49% to 66% increase in risk for IHD associated with PTSD in Black women (HR, 1.49; 95% CI, 1.38-1.62) and those identified as non-White and non-Black (HR, 1.66; 95%, 1.33-2.08).
Women of all ethnic groups with PTSD were at higher risk of developing IHD, but this was especially true for Hispanic/Latina women (HR, 1.50; 95% CI 1.22-1.84), they noted.
The authors reported some limitations to their findings. The analytic sample could result in a lower ascertainment of certain conditions, such as psychiatric disorders, they wrote. Substance disorders were low in this study, possibly because of the younger age of female veterans in the sample. Because this study used VHA electronic medical records data, medical care outside of the VHA that was not paid for by the VHA could not be considered.
In addition, although this study used a large sample of female veterans, the findings cannot be generalized to female veterans outside of the VHA system, nonveteran women, or men, the researchers wrote.
A call to action
In an accompanying comment, Beth E. Cohen, MD, of the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System, points out that the physical implications for psychosocial conditions, including depression and PTSD, have been recognized for quite some time. For example, results of the INTERHEART case-control study of 30,000 people showed stress, depression, and stressful life events accounted for one-third the population-attributable risk for myocardial infarction.
As was also noted by Dr. Ebrahimi and colleagues, much of the current research has been on male veterans, yet types of trauma differ among genders; women experience higher rates of military sexual trauma but lower rates of combat trauma, Dr. Cohen wrote. The PTSD symptoms, trajectory, and biological effects can differ for women and men, as can the pathogenesis, presentation, and outcomes of cardiovascular disease (CVD).
These findings, she said, “are an important extension of the prior literature and represent the largest study in female veterans to date. Although methods differ across studies, the magnitude of risk associated with PTSD was consistent with that found in prior studies of male veterans and nonveteran samples.”
The assessment of age-specific risk is also a strength of the study, “and has implications for clinical practice, because PTSD-associated risk was greatest in a younger group in whom CVD may be overlooked.”
Dr. Cohen addressed the limitations outlined by the authors, including ascertainment bias, severity of PTSD symptoms, and their chronicity, but added that “even in the context of these limitations, this study illustrates the importance of PTSD to the health of women veterans and the additional work needed to reduce their CVD risk.”
Clinical questions remain, she added. Screens for PTSD are widely used in the VHA, yet no studies have examined whether screening or early detection decrease CVD risk. In addition, no evidence suggests that screening for or treatment of PTSD improves cardiovascular outcomes.
“Given the challenges of answering these questions in observational studies, it will be important to incorporate measures of CVD risk and outcomes in trials of behavioral and medical therapies for patients with PTSD,” she wrote.
She added that collaborations among multidisciplinary patient care teams will be important. “The findings of this study represent a call to action for this important work to understand the cardiovascular effects of PTSD and improve the health and well-being of women veterans,” Dr. Cohen concluded.
This research was supported by Investigator-Initiated Research Award from the Department of Defense U.S. Army Medical Research and Material Command Congressionally Directed Medical Research Programs (Dr. Ebrahimi) and in part by grants from the VA Informatics and Computing Infrastructure and the Offices of Research and Development at the Northport, Durham, and Greater Los Angeles Veterans Affairs medical centers. Dr. Ebrahimi reported receiving grants from the Department of Defense during the conduct of the study. Disclosures for other authors are available in the paper. Dr. Cohen reports no disclosures.
A version of this article first appeared on Medscape.com.
A study using data from Veterans Health Administration (VHA) electronic medical records shows a significant association between posttraumatic stress disorder (PTSD) among female veterans and an increased risk for incident ischemic heart disease (IHD).
The increased risk for IHD was highest among women younger than 40 with PTSD, and among racial and ethnic minorities.
“These women have been emerging as important targets for cardiovascular prevention, and our study suggests that PTSD may be an important psychosocial risk factor for IHD in these individuals,” wrote the researchers, led by Ramin Ebrahimi, MD, department of medicine, cardiology section, Veterans Affairs Greater Los Angeles Health Care System. “With the number of women veterans growing, it is critical to appreciate the health care needs of this relatively young and diverse patient population.”
The study results also have “important implications for earlier and more aggressive IHD risk assessment, monitoring and management in vulnerable women veterans,” they added. “Indeed, our findings support recent calls for cardiovascular risk screening in younger individuals and for the need to harness a broad range of clinicians who routinely treat younger women to maximize prevention efforts.”
The article was published online in JAMA Cardiology on March 17.
Increasing number of VHA users
“As an interventional cardiologist and the director of the cardiac catheterization laboratory, I noticed a significant number of the patients referred to the cath lab carried a diagnosis of posttraumatic stress disorder,” Dr. Ebrahimi said in an interview. “This intrigued me and started my journey into trying to understand how psychiatric disorders in general, and PTSD, may impact/interact with cardiovascular disorders,” he added.
The number of female veterans in the military has been increasing, and they now make up about 10% of the 20 million American veterans; that number is projected to exceed 2.2 million in the next 20 years, the authors wrote. Female veterans are also the fastest growing group of users of the VHA, they added.
IHD is the leading cause of death in women in the United States, despite the advancements in prevention and treatment. Although women are twice as likely to develop PTSD as are men, and it is even more likely in female veterans, much of the research has predominately been on male veterans, the authors wrote.
For this retrospective study, which used data from the VHA Corporate Data Warehouse, the authors examined a cohort of female veterans who were 18 years or older who had used the VHA health care system between Jan. 1, 2000, and Dec. 31, 2017.
Of the 828,997 female veterans, 151,030 had PTSD. Women excluded from the study were those who did not have any clinical encounters after their index visit, participants who had a diagnosis of IHD at or before the index visit, and those with incident IHD within 90 days of the index visit, allowing time between a PTSD diagnosis and IHD.
Propensity score matching on age at index visit, the number of previous visits, and the presence of traditional and female-specific cardiovascular risk factors, as well as mental and physical health conditions, was conducted to identify female veterans ever diagnosed with PTSD, who were matched in a 1:2 ratio to those never diagnosed with PTSD. In all, 132,923 women with PTSD and 265,846 women without PTSD were included, and data were analyzed for the period of Oct. 1, 2018, to Oct. 30, 2020.
IHD was defined as new-onset coronary artery disease, angina, or myocardial infarction–based ICD-9 and ICD-10 diagnostic codes. Age, race, and ethnicity were self-reported.
The analytic sample consisted of relatively young female veterans (mean [SD] age at baseline, 40.1 [12.2] years) of various races (White, 57.6%; Black, 29.8%) and ethnicities, the authors reported.
Of the 9,940 women who experienced incident IHD during follow-up, 5,559 did not have PTSD (2.1% of the overall population examined) and 4,381 had PTSD (3.3%). PTSD was significantly associated with an increased risk for IHD. Over the median follow-up of 4.9 years, female veterans with PTSD had a 44% higher rate of developing incident IHD compared with the female veterans without PTSD (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.38-1.50).
In addition, those with PTSD who developed IHD were younger at diagnosis (mean [SD] age, 55.5 [9.7]) than were patients without PTSD (mean [SD] age, 57.8 [10.7]). Effect sizes were largest in the group younger than 40 years (HR, 1.72; 95% CI, 1.55-1.90) and decreased for older participants (HR for those ≥60 years, 1.24; 95% CI, 1.12-1.38)
The authors found a 49% to 66% increase in risk for IHD associated with PTSD in Black women (HR, 1.49; 95% CI, 1.38-1.62) and those identified as non-White and non-Black (HR, 1.66; 95%, 1.33-2.08).
Women of all ethnic groups with PTSD were at higher risk of developing IHD, but this was especially true for Hispanic/Latina women (HR, 1.50; 95% CI 1.22-1.84), they noted.
The authors reported some limitations to their findings. The analytic sample could result in a lower ascertainment of certain conditions, such as psychiatric disorders, they wrote. Substance disorders were low in this study, possibly because of the younger age of female veterans in the sample. Because this study used VHA electronic medical records data, medical care outside of the VHA that was not paid for by the VHA could not be considered.
In addition, although this study used a large sample of female veterans, the findings cannot be generalized to female veterans outside of the VHA system, nonveteran women, or men, the researchers wrote.
A call to action
In an accompanying comment, Beth E. Cohen, MD, of the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System, points out that the physical implications for psychosocial conditions, including depression and PTSD, have been recognized for quite some time. For example, results of the INTERHEART case-control study of 30,000 people showed stress, depression, and stressful life events accounted for one-third the population-attributable risk for myocardial infarction.
As was also noted by Dr. Ebrahimi and colleagues, much of the current research has been on male veterans, yet types of trauma differ among genders; women experience higher rates of military sexual trauma but lower rates of combat trauma, Dr. Cohen wrote. The PTSD symptoms, trajectory, and biological effects can differ for women and men, as can the pathogenesis, presentation, and outcomes of cardiovascular disease (CVD).
These findings, she said, “are an important extension of the prior literature and represent the largest study in female veterans to date. Although methods differ across studies, the magnitude of risk associated with PTSD was consistent with that found in prior studies of male veterans and nonveteran samples.”
The assessment of age-specific risk is also a strength of the study, “and has implications for clinical practice, because PTSD-associated risk was greatest in a younger group in whom CVD may be overlooked.”
Dr. Cohen addressed the limitations outlined by the authors, including ascertainment bias, severity of PTSD symptoms, and their chronicity, but added that “even in the context of these limitations, this study illustrates the importance of PTSD to the health of women veterans and the additional work needed to reduce their CVD risk.”
Clinical questions remain, she added. Screens for PTSD are widely used in the VHA, yet no studies have examined whether screening or early detection decrease CVD risk. In addition, no evidence suggests that screening for or treatment of PTSD improves cardiovascular outcomes.
“Given the challenges of answering these questions in observational studies, it will be important to incorporate measures of CVD risk and outcomes in trials of behavioral and medical therapies for patients with PTSD,” she wrote.
She added that collaborations among multidisciplinary patient care teams will be important. “The findings of this study represent a call to action for this important work to understand the cardiovascular effects of PTSD and improve the health and well-being of women veterans,” Dr. Cohen concluded.
This research was supported by Investigator-Initiated Research Award from the Department of Defense U.S. Army Medical Research and Material Command Congressionally Directed Medical Research Programs (Dr. Ebrahimi) and in part by grants from the VA Informatics and Computing Infrastructure and the Offices of Research and Development at the Northport, Durham, and Greater Los Angeles Veterans Affairs medical centers. Dr. Ebrahimi reported receiving grants from the Department of Defense during the conduct of the study. Disclosures for other authors are available in the paper. Dr. Cohen reports no disclosures.
A version of this article first appeared on Medscape.com.
A study using data from Veterans Health Administration (VHA) electronic medical records shows a significant association between posttraumatic stress disorder (PTSD) among female veterans and an increased risk for incident ischemic heart disease (IHD).
The increased risk for IHD was highest among women younger than 40 with PTSD, and among racial and ethnic minorities.
“These women have been emerging as important targets for cardiovascular prevention, and our study suggests that PTSD may be an important psychosocial risk factor for IHD in these individuals,” wrote the researchers, led by Ramin Ebrahimi, MD, department of medicine, cardiology section, Veterans Affairs Greater Los Angeles Health Care System. “With the number of women veterans growing, it is critical to appreciate the health care needs of this relatively young and diverse patient population.”
The study results also have “important implications for earlier and more aggressive IHD risk assessment, monitoring and management in vulnerable women veterans,” they added. “Indeed, our findings support recent calls for cardiovascular risk screening in younger individuals and for the need to harness a broad range of clinicians who routinely treat younger women to maximize prevention efforts.”
The article was published online in JAMA Cardiology on March 17.
Increasing number of VHA users
“As an interventional cardiologist and the director of the cardiac catheterization laboratory, I noticed a significant number of the patients referred to the cath lab carried a diagnosis of posttraumatic stress disorder,” Dr. Ebrahimi said in an interview. “This intrigued me and started my journey into trying to understand how psychiatric disorders in general, and PTSD, may impact/interact with cardiovascular disorders,” he added.
The number of female veterans in the military has been increasing, and they now make up about 10% of the 20 million American veterans; that number is projected to exceed 2.2 million in the next 20 years, the authors wrote. Female veterans are also the fastest growing group of users of the VHA, they added.
IHD is the leading cause of death in women in the United States, despite the advancements in prevention and treatment. Although women are twice as likely to develop PTSD as are men, and it is even more likely in female veterans, much of the research has predominately been on male veterans, the authors wrote.
For this retrospective study, which used data from the VHA Corporate Data Warehouse, the authors examined a cohort of female veterans who were 18 years or older who had used the VHA health care system between Jan. 1, 2000, and Dec. 31, 2017.
Of the 828,997 female veterans, 151,030 had PTSD. Women excluded from the study were those who did not have any clinical encounters after their index visit, participants who had a diagnosis of IHD at or before the index visit, and those with incident IHD within 90 days of the index visit, allowing time between a PTSD diagnosis and IHD.
Propensity score matching on age at index visit, the number of previous visits, and the presence of traditional and female-specific cardiovascular risk factors, as well as mental and physical health conditions, was conducted to identify female veterans ever diagnosed with PTSD, who were matched in a 1:2 ratio to those never diagnosed with PTSD. In all, 132,923 women with PTSD and 265,846 women without PTSD were included, and data were analyzed for the period of Oct. 1, 2018, to Oct. 30, 2020.
IHD was defined as new-onset coronary artery disease, angina, or myocardial infarction–based ICD-9 and ICD-10 diagnostic codes. Age, race, and ethnicity were self-reported.
The analytic sample consisted of relatively young female veterans (mean [SD] age at baseline, 40.1 [12.2] years) of various races (White, 57.6%; Black, 29.8%) and ethnicities, the authors reported.
Of the 9,940 women who experienced incident IHD during follow-up, 5,559 did not have PTSD (2.1% of the overall population examined) and 4,381 had PTSD (3.3%). PTSD was significantly associated with an increased risk for IHD. Over the median follow-up of 4.9 years, female veterans with PTSD had a 44% higher rate of developing incident IHD compared with the female veterans without PTSD (hazard ratio [HR], 1.44; 95% confidence interval [CI], 1.38-1.50).
In addition, those with PTSD who developed IHD were younger at diagnosis (mean [SD] age, 55.5 [9.7]) than were patients without PTSD (mean [SD] age, 57.8 [10.7]). Effect sizes were largest in the group younger than 40 years (HR, 1.72; 95% CI, 1.55-1.90) and decreased for older participants (HR for those ≥60 years, 1.24; 95% CI, 1.12-1.38)
The authors found a 49% to 66% increase in risk for IHD associated with PTSD in Black women (HR, 1.49; 95% CI, 1.38-1.62) and those identified as non-White and non-Black (HR, 1.66; 95%, 1.33-2.08).
Women of all ethnic groups with PTSD were at higher risk of developing IHD, but this was especially true for Hispanic/Latina women (HR, 1.50; 95% CI 1.22-1.84), they noted.
The authors reported some limitations to their findings. The analytic sample could result in a lower ascertainment of certain conditions, such as psychiatric disorders, they wrote. Substance disorders were low in this study, possibly because of the younger age of female veterans in the sample. Because this study used VHA electronic medical records data, medical care outside of the VHA that was not paid for by the VHA could not be considered.
In addition, although this study used a large sample of female veterans, the findings cannot be generalized to female veterans outside of the VHA system, nonveteran women, or men, the researchers wrote.
A call to action
In an accompanying comment, Beth E. Cohen, MD, of the University of California, San Francisco, and the San Francisco Veterans Affairs Health Care System, points out that the physical implications for psychosocial conditions, including depression and PTSD, have been recognized for quite some time. For example, results of the INTERHEART case-control study of 30,000 people showed stress, depression, and stressful life events accounted for one-third the population-attributable risk for myocardial infarction.
As was also noted by Dr. Ebrahimi and colleagues, much of the current research has been on male veterans, yet types of trauma differ among genders; women experience higher rates of military sexual trauma but lower rates of combat trauma, Dr. Cohen wrote. The PTSD symptoms, trajectory, and biological effects can differ for women and men, as can the pathogenesis, presentation, and outcomes of cardiovascular disease (CVD).
These findings, she said, “are an important extension of the prior literature and represent the largest study in female veterans to date. Although methods differ across studies, the magnitude of risk associated with PTSD was consistent with that found in prior studies of male veterans and nonveteran samples.”
The assessment of age-specific risk is also a strength of the study, “and has implications for clinical practice, because PTSD-associated risk was greatest in a younger group in whom CVD may be overlooked.”
Dr. Cohen addressed the limitations outlined by the authors, including ascertainment bias, severity of PTSD symptoms, and their chronicity, but added that “even in the context of these limitations, this study illustrates the importance of PTSD to the health of women veterans and the additional work needed to reduce their CVD risk.”
Clinical questions remain, she added. Screens for PTSD are widely used in the VHA, yet no studies have examined whether screening or early detection decrease CVD risk. In addition, no evidence suggests that screening for or treatment of PTSD improves cardiovascular outcomes.
“Given the challenges of answering these questions in observational studies, it will be important to incorporate measures of CVD risk and outcomes in trials of behavioral and medical therapies for patients with PTSD,” she wrote.
She added that collaborations among multidisciplinary patient care teams will be important. “The findings of this study represent a call to action for this important work to understand the cardiovascular effects of PTSD and improve the health and well-being of women veterans,” Dr. Cohen concluded.
This research was supported by Investigator-Initiated Research Award from the Department of Defense U.S. Army Medical Research and Material Command Congressionally Directed Medical Research Programs (Dr. Ebrahimi) and in part by grants from the VA Informatics and Computing Infrastructure and the Offices of Research and Development at the Northport, Durham, and Greater Los Angeles Veterans Affairs medical centers. Dr. Ebrahimi reported receiving grants from the Department of Defense during the conduct of the study. Disclosures for other authors are available in the paper. Dr. Cohen reports no disclosures.
A version of this article first appeared on Medscape.com.
Correlating hospitalist work schedules with patient outcomes
Background: Studies show better outcomes, decreased length of stay, increased patient satisfaction, improved quality, and decreased readmission rates when hospitalist services are used. This study looks at how hospitalist schedules affect these outcomes.
Study design: Retrospective cohort study.
Setting: 229 hospitals in Texas.
Synopsis: This cohort study used 3 years of Medicare data from 229 hospitals in Texas. It included 114,777 medical admissions of patients with a 3- to 6-day length of stay. The study used the percentage of hospitalist working days that were blocks of 7 days or longer. ICU stays and patients requiring two or more E&M codes were excluded since they are associated with greater illness severity.
The primary outcome was mortality within 30 days of discharge and secondary outcomes were 30-day readmission rates, discharge destination, and 30-day postdischarge costs.
Patients receiving care from hospitalists working several days in a row had better outcomes. It is postulated that continuity of care by one hospitalist is important for several reasons. Most importantly, the development of rapport with patient and family is key to deciding the plan of care and destination post discharge as it is quite challenging to effectively transfer all important information during verbal or written handoffs.
Bottom line: Care provided by hospitalists working more days in a row improved patient outcomes. A variety of hospitalist schedules are being practiced currently; however, these findings must be taken into account as schedules are designed.
Citation: Goodwin JS et al. Association of the work schedules of hospitalists with patient outcomes of hospitalization. JAMA Intern Med. 2020;180(2):215-22. doi: 10.1001/jamainternmed.2019.5193.
Dr. Ahmed is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Studies show better outcomes, decreased length of stay, increased patient satisfaction, improved quality, and decreased readmission rates when hospitalist services are used. This study looks at how hospitalist schedules affect these outcomes.
Study design: Retrospective cohort study.
Setting: 229 hospitals in Texas.
Synopsis: This cohort study used 3 years of Medicare data from 229 hospitals in Texas. It included 114,777 medical admissions of patients with a 3- to 6-day length of stay. The study used the percentage of hospitalist working days that were blocks of 7 days or longer. ICU stays and patients requiring two or more E&M codes were excluded since they are associated with greater illness severity.
The primary outcome was mortality within 30 days of discharge and secondary outcomes were 30-day readmission rates, discharge destination, and 30-day postdischarge costs.
Patients receiving care from hospitalists working several days in a row had better outcomes. It is postulated that continuity of care by one hospitalist is important for several reasons. Most importantly, the development of rapport with patient and family is key to deciding the plan of care and destination post discharge as it is quite challenging to effectively transfer all important information during verbal or written handoffs.
Bottom line: Care provided by hospitalists working more days in a row improved patient outcomes. A variety of hospitalist schedules are being practiced currently; however, these findings must be taken into account as schedules are designed.
Citation: Goodwin JS et al. Association of the work schedules of hospitalists with patient outcomes of hospitalization. JAMA Intern Med. 2020;180(2):215-22. doi: 10.1001/jamainternmed.2019.5193.
Dr. Ahmed is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
Background: Studies show better outcomes, decreased length of stay, increased patient satisfaction, improved quality, and decreased readmission rates when hospitalist services are used. This study looks at how hospitalist schedules affect these outcomes.
Study design: Retrospective cohort study.
Setting: 229 hospitals in Texas.
Synopsis: This cohort study used 3 years of Medicare data from 229 hospitals in Texas. It included 114,777 medical admissions of patients with a 3- to 6-day length of stay. The study used the percentage of hospitalist working days that were blocks of 7 days or longer. ICU stays and patients requiring two or more E&M codes were excluded since they are associated with greater illness severity.
The primary outcome was mortality within 30 days of discharge and secondary outcomes were 30-day readmission rates, discharge destination, and 30-day postdischarge costs.
Patients receiving care from hospitalists working several days in a row had better outcomes. It is postulated that continuity of care by one hospitalist is important for several reasons. Most importantly, the development of rapport with patient and family is key to deciding the plan of care and destination post discharge as it is quite challenging to effectively transfer all important information during verbal or written handoffs.
Bottom line: Care provided by hospitalists working more days in a row improved patient outcomes. A variety of hospitalist schedules are being practiced currently; however, these findings must be taken into account as schedules are designed.
Citation: Goodwin JS et al. Association of the work schedules of hospitalists with patient outcomes of hospitalization. JAMA Intern Med. 2020;180(2):215-22. doi: 10.1001/jamainternmed.2019.5193.
Dr. Ahmed is assistant professor in the division of hospital medicine, Loyola University Medical Center, Maywood, Ill.
VEXAS syndrome: Implications for dermatologists
When I was a medical student, I always found it gratifying when there was a unifying mechanism that explained the symptoms of a disease. Part of the reason I chose dermatology as a specialty was how frequently we are able to “see” these mechanisms in the skin, both clinically and histologically. What’s even more interesting is that this condition is caused by a postzygotic somatic mutation, an apparently underrecognized cause of disease that we are just now beginning to understand. An example of a postzygotic somatic mutation causing a disease that we all learned about in medical school is paroxysmal nocturnal hemoglobinuria.
Using a “bottom-up” approach, researchers at the National Institutes of Health and in the United Kingdom identified 25 patients with somatic UBA1 mutations and noticed that they had strikingly similar autoinflammatory syndromes. UBA1 encodes ubiquitin E1, which is part of the pathway the breaks down proteins as part of the normal cellular machine. It is localized to the X chromosome, so all 25 affected patients were males, and most were aged between 40 and 70 years. These patients had an autoinflammatory syndrome characterized by fever, chondritis (similar to relapsing polychondritis), vasculitis, and neutrophilic dermatoses. Many patients also had features of myelodysplastic syndrome and plasma cell dyscrasia. The inflammatory pattern in this condition seems to show elevations in tumor necrosis factor, interleukin-6, and interferon-gamma.
So why is this syndrome relevant to dermatology? We are often asked to evaluate patients for neutrophilic dermatosis and vasculitis, and many affected patients had clinical and histologic findings compatible with polyarteritis nodosa and Sweet syndrome. When confronted with a neutrophilic dermatosis, we’ve all been taught to evaluate for myelodysplastic syndrome, which many of these patients appeared to have, at least on the surface. When bone marrow biopsies were done, the myeloid cell precursors that give rise to neutrophils were noted to have prominent cytoplasmic vacuoles, hence the “V” in VEXAS.
In reading the article describing 25 patients with this syndrome, which was published in the New England Journal of Medicine, I was struck by how refractory they were to treatment. Most patients had been treated with systemic steroids, multiple biologics, and several nonbiologic medications that are mainstays of treatment for neutrophilic dermatosis like dapsone and colchicine. I was fortunate enough to speak to Amanda Ombrello, MD, of the National Human Genome Research Institute, one of the lead authors of the paper, who drew my attention to the supplementary appendix, which showed the marked injection-site reactions some patients had to anakinra – yet another reason why a patient might end up in a dermatology clinic. In my mind, all of these features could be a clue to a diagnosis of VEXAS syndrome.
Many patients seemed to fare poorly, with 40% of patients dying before the completion of the study. When it comes to extremely rare diseases, it seems that the more physicians who are aware of the existence of a particular syndrome, the more likely it is a patient will come under our care and be correctly diagnosed.
Dr. Saardi is a dermatologist and internist, and is director of the inpatient dermatology service at the George Washington University Hospital, Washington. He has no disclosures.
When I was a medical student, I always found it gratifying when there was a unifying mechanism that explained the symptoms of a disease. Part of the reason I chose dermatology as a specialty was how frequently we are able to “see” these mechanisms in the skin, both clinically and histologically. What’s even more interesting is that this condition is caused by a postzygotic somatic mutation, an apparently underrecognized cause of disease that we are just now beginning to understand. An example of a postzygotic somatic mutation causing a disease that we all learned about in medical school is paroxysmal nocturnal hemoglobinuria.
Using a “bottom-up” approach, researchers at the National Institutes of Health and in the United Kingdom identified 25 patients with somatic UBA1 mutations and noticed that they had strikingly similar autoinflammatory syndromes. UBA1 encodes ubiquitin E1, which is part of the pathway the breaks down proteins as part of the normal cellular machine. It is localized to the X chromosome, so all 25 affected patients were males, and most were aged between 40 and 70 years. These patients had an autoinflammatory syndrome characterized by fever, chondritis (similar to relapsing polychondritis), vasculitis, and neutrophilic dermatoses. Many patients also had features of myelodysplastic syndrome and plasma cell dyscrasia. The inflammatory pattern in this condition seems to show elevations in tumor necrosis factor, interleukin-6, and interferon-gamma.
So why is this syndrome relevant to dermatology? We are often asked to evaluate patients for neutrophilic dermatosis and vasculitis, and many affected patients had clinical and histologic findings compatible with polyarteritis nodosa and Sweet syndrome. When confronted with a neutrophilic dermatosis, we’ve all been taught to evaluate for myelodysplastic syndrome, which many of these patients appeared to have, at least on the surface. When bone marrow biopsies were done, the myeloid cell precursors that give rise to neutrophils were noted to have prominent cytoplasmic vacuoles, hence the “V” in VEXAS.
In reading the article describing 25 patients with this syndrome, which was published in the New England Journal of Medicine, I was struck by how refractory they were to treatment. Most patients had been treated with systemic steroids, multiple biologics, and several nonbiologic medications that are mainstays of treatment for neutrophilic dermatosis like dapsone and colchicine. I was fortunate enough to speak to Amanda Ombrello, MD, of the National Human Genome Research Institute, one of the lead authors of the paper, who drew my attention to the supplementary appendix, which showed the marked injection-site reactions some patients had to anakinra – yet another reason why a patient might end up in a dermatology clinic. In my mind, all of these features could be a clue to a diagnosis of VEXAS syndrome.
Many patients seemed to fare poorly, with 40% of patients dying before the completion of the study. When it comes to extremely rare diseases, it seems that the more physicians who are aware of the existence of a particular syndrome, the more likely it is a patient will come under our care and be correctly diagnosed.
Dr. Saardi is a dermatologist and internist, and is director of the inpatient dermatology service at the George Washington University Hospital, Washington. He has no disclosures.
When I was a medical student, I always found it gratifying when there was a unifying mechanism that explained the symptoms of a disease. Part of the reason I chose dermatology as a specialty was how frequently we are able to “see” these mechanisms in the skin, both clinically and histologically. What’s even more interesting is that this condition is caused by a postzygotic somatic mutation, an apparently underrecognized cause of disease that we are just now beginning to understand. An example of a postzygotic somatic mutation causing a disease that we all learned about in medical school is paroxysmal nocturnal hemoglobinuria.
Using a “bottom-up” approach, researchers at the National Institutes of Health and in the United Kingdom identified 25 patients with somatic UBA1 mutations and noticed that they had strikingly similar autoinflammatory syndromes. UBA1 encodes ubiquitin E1, which is part of the pathway the breaks down proteins as part of the normal cellular machine. It is localized to the X chromosome, so all 25 affected patients were males, and most were aged between 40 and 70 years. These patients had an autoinflammatory syndrome characterized by fever, chondritis (similar to relapsing polychondritis), vasculitis, and neutrophilic dermatoses. Many patients also had features of myelodysplastic syndrome and plasma cell dyscrasia. The inflammatory pattern in this condition seems to show elevations in tumor necrosis factor, interleukin-6, and interferon-gamma.
So why is this syndrome relevant to dermatology? We are often asked to evaluate patients for neutrophilic dermatosis and vasculitis, and many affected patients had clinical and histologic findings compatible with polyarteritis nodosa and Sweet syndrome. When confronted with a neutrophilic dermatosis, we’ve all been taught to evaluate for myelodysplastic syndrome, which many of these patients appeared to have, at least on the surface. When bone marrow biopsies were done, the myeloid cell precursors that give rise to neutrophils were noted to have prominent cytoplasmic vacuoles, hence the “V” in VEXAS.
In reading the article describing 25 patients with this syndrome, which was published in the New England Journal of Medicine, I was struck by how refractory they were to treatment. Most patients had been treated with systemic steroids, multiple biologics, and several nonbiologic medications that are mainstays of treatment for neutrophilic dermatosis like dapsone and colchicine. I was fortunate enough to speak to Amanda Ombrello, MD, of the National Human Genome Research Institute, one of the lead authors of the paper, who drew my attention to the supplementary appendix, which showed the marked injection-site reactions some patients had to anakinra – yet another reason why a patient might end up in a dermatology clinic. In my mind, all of these features could be a clue to a diagnosis of VEXAS syndrome.
Many patients seemed to fare poorly, with 40% of patients dying before the completion of the study. When it comes to extremely rare diseases, it seems that the more physicians who are aware of the existence of a particular syndrome, the more likely it is a patient will come under our care and be correctly diagnosed.
Dr. Saardi is a dermatologist and internist, and is director of the inpatient dermatology service at the George Washington University Hospital, Washington. He has no disclosures.
Dr. G. Gayle Stephens was a teacher, progressive force, and ‘poet laureate of family medicine’
G. Gayle Stephens, MD, who is roundly regarded as one of the founders of family medicine, gave his talk “Family Medicine as Counterculture” at the Society of Teachers of Family Medicine annual conference in 1979, 10 years after the specialty’s establishment.
The speech was then published, republished 10 years later, and, like many of Dr. Stephen’s other essays and articles, remains very much alive in the minds of practicing family physicians, in the teachings of FP academicians, and in the Google searches of budding FPs.
The late Dr. Stephens saw family medicine as a counterculture within medicine, rooted in social change. In his speech he examined these roots – in reform initiatives in the 1960s, and in certain philosophies and “minority” movements such as agrarianism and the preservation of rural life, utopianism, humanism, consumerism, and feminism.
He also looked forward, challenging the specialty to remain true to itself and its roots – to its belief in “uninhibited access” to medical care for everyone, for instance, and to continual whole-person and family-oriented care – and cautioned against moving to resemble the “rest of the medical bureaucracy.”
“Clearly we have been on the side of change in American life. We have identified ourselves with certain minorities and minority positions ... [and] been counter to many of the dominant forces in society,” Dr. Stephens said in his talk. Family practice “succeeded in the decade just past because we were identified with reforms that are more pervasive and powerful than ourselves.”
The family practice movement has “more in common with [the] counterculture than it does with the dominant scientific medical establishment,” he said.
A teacher and founder of medical education programs
Larry A. Green, MD, who was pursuing his own residency training as Dr. Stephens was leading a department of family practice, said
“It was from this philosophical position that he became a synthesizer and observer and interpreter of what was going on in the development of family medicine,” said Dr. Green, Distinguished Professor and Epperson Zorn Chair for Innovation in Family Medicine and Primary Care at the University of Colorado at Denver, Aurora.
Dr. Stephens, who died at home in 2014 at the age of 85, was “probably the most important person in exposing what I now consider to be a fact – that family medicine was the product of social changes ... of social movements related to women’s rights, civil rights, and social responsibility,” Dr. Green said. “He could recall lessons from the past and forecast the challenges of the future. And there was no one more effective in clarifying the importance of personal [doctor-patient] relationships in family medicine.”
After years of general practice in rural Wichita, Kan., his wife Eula Jean’s hometown, Dr. Stephens founded and led one of the first family medicine residencies at Wesley Hospital in Wichita in 1967. His core principles, as described on today’s Wesley Family Medicine Residency website, included that a family physician consider the whole person, be honest, have a full scope of training including behavioral and mental health, and be “reflective about him/herself ... [learning about] his/her assets, liabilities, foibles, and idiosyncrasies.” Dr. Stephens, who had grown up in rural Ashburn, Mo., later became the founding dean of the School of Primary Medical Care at the University of Alabama in Huntsville and then chaired the department of family practice at the University of Alabama at Birmingham.
A thought leader for family medicine
He held numerous state and national leadership positions, and initiated what became the Keystone Conference Series – an invitational gathering of leaders in family medicine that examined and discuss the specialty’s ongoing development. In 2006, he was elected to the Institute of Medicine of the National Academies of Science.
Dr. Stephens authored a textbook, The Intellectual Basis of Family Medicine (Tucson, Ariz.: Winter Publishing Company, 1982), and authored essays, which Dr. Green said will stand the test of time.
“Some of us refer to him as the poet laureate of family medicine,” Dr. Green noted.
In a 1974 article on clinical wisdom, Dr. Stephens wrote that “it is not enough to determine what condition the patient has, but also what patient has the condition.” In another of these essays, which was published in 1979, Dr. Stephens wrote that “physicians need to keep in touch with their own tradition and with public welfare if they are to be considered moral by the society that sponsors them, and from which they take their strength and privilege.”
These excerpts are featured in an article by John P. Geyman, MD, published in 2011 in Family Medicine, called “G. Gayle Stephens Festschrift”.
A ‘progressive force’
Linda Prine, MD, professor of family and community medicine at the Icahn School of Medicine at Mount Sinai, New York, knows of Dr. Stephens from her teachers. “The people I looked up to when I was a younger physician were quoting his Counterculture article,” she said.
“It’s not that I studied him. But whenever I heard someone speak about the values of family medicine, his name would come up [and] the values of universal health care and community care and putting the patients’ interests first ahead of the insurance companies and being a doctor for the whole family,” Dr. Prine said. Dr. Stephens was a “progressive force that our specialty has not always lived up to.”
Dr. Stephens voiced serious concerns about the impact of managed care in the 1980s and of “gatekeeping,” a practice intended to control access to specialists and reduce costs.
“He was many times not welcomed by family medicine [for his warnings] against the temptations that managed care presented,” said Dr. Green, the founding director of the Robert Graham Center, Washington. “He saw the conflict of interest of being a gatekeeper, how that would erode trust in a personal relationship with your personal doctor.”
“Gayle thought it was a disaster waiting to happen, and it was,” he said, referring to the eventual rejection by the public of barriers to direct access to specialists.
Through the 1990s and more recently, Dr. Stephens expressed frustration with the “medical-industrial complex” and the decline of family medicine after its surge in the 1970s and 1980s, Dr. Green said. “But in my opinion, near the end of his life, he was encouraged by young leaders who he saw grasped the important ideas from the ages.”
Dr. Stephens’ interest in medical education extended to nurses and nurse practitioners (the latter of whom had begun their discipline in the mid-1960s), and to optometrists, for whom he taught a recurring course in “physical diagnosis.”
A listener and proponent of listening
Linda Tompkins, RN, FNP, of Newton, Kan., trained with Dr. Stephens at part of a year-long nurse education program in the early 1970s at Wichita (Kan.) State University, where he was leading the department of family practice (prior to moving to Alabama). “You couldn’t ask too many questions,” she said. “And he never talked down to us, he wasn’t condescending. There were not a lot of doctors like that.”
Dr. Stephens spoke and wrote often about the importance of listening –about how it was vital to the “durable clinical relationship.” It was also vital to his writing and to his impact on the teachers of family medicine, said Dan Ostergaard, MD, who served as a residency director and in various staff leadership positions at the American Academy of Family Physicians, including in its division of education.
“He created a lot of aha moments for me, about where we came from and what we really need to be [as a specialty] and where we need to go,” said Dr. Ostergaard. “To be such a great thinker and a great writer, you have to be a great listener.”
“I can just visualize him,” he said, “leaning back in his chair while we were talking about residency criteria [or other issues], with a half-smile on his face and his reading glasses down his note, smoking his pipe and just looking at all of us, listening.”
Dr. Stephens’ papers are housed in the Center for the History of Family Medicine, a project of the AAFP Foundation.
G. Gayle Stephens, MD, who is roundly regarded as one of the founders of family medicine, gave his talk “Family Medicine as Counterculture” at the Society of Teachers of Family Medicine annual conference in 1979, 10 years after the specialty’s establishment.
The speech was then published, republished 10 years later, and, like many of Dr. Stephen’s other essays and articles, remains very much alive in the minds of practicing family physicians, in the teachings of FP academicians, and in the Google searches of budding FPs.
The late Dr. Stephens saw family medicine as a counterculture within medicine, rooted in social change. In his speech he examined these roots – in reform initiatives in the 1960s, and in certain philosophies and “minority” movements such as agrarianism and the preservation of rural life, utopianism, humanism, consumerism, and feminism.
He also looked forward, challenging the specialty to remain true to itself and its roots – to its belief in “uninhibited access” to medical care for everyone, for instance, and to continual whole-person and family-oriented care – and cautioned against moving to resemble the “rest of the medical bureaucracy.”
“Clearly we have been on the side of change in American life. We have identified ourselves with certain minorities and minority positions ... [and] been counter to many of the dominant forces in society,” Dr. Stephens said in his talk. Family practice “succeeded in the decade just past because we were identified with reforms that are more pervasive and powerful than ourselves.”
The family practice movement has “more in common with [the] counterculture than it does with the dominant scientific medical establishment,” he said.
A teacher and founder of medical education programs
Larry A. Green, MD, who was pursuing his own residency training as Dr. Stephens was leading a department of family practice, said
“It was from this philosophical position that he became a synthesizer and observer and interpreter of what was going on in the development of family medicine,” said Dr. Green, Distinguished Professor and Epperson Zorn Chair for Innovation in Family Medicine and Primary Care at the University of Colorado at Denver, Aurora.
Dr. Stephens, who died at home in 2014 at the age of 85, was “probably the most important person in exposing what I now consider to be a fact – that family medicine was the product of social changes ... of social movements related to women’s rights, civil rights, and social responsibility,” Dr. Green said. “He could recall lessons from the past and forecast the challenges of the future. And there was no one more effective in clarifying the importance of personal [doctor-patient] relationships in family medicine.”
After years of general practice in rural Wichita, Kan., his wife Eula Jean’s hometown, Dr. Stephens founded and led one of the first family medicine residencies at Wesley Hospital in Wichita in 1967. His core principles, as described on today’s Wesley Family Medicine Residency website, included that a family physician consider the whole person, be honest, have a full scope of training including behavioral and mental health, and be “reflective about him/herself ... [learning about] his/her assets, liabilities, foibles, and idiosyncrasies.” Dr. Stephens, who had grown up in rural Ashburn, Mo., later became the founding dean of the School of Primary Medical Care at the University of Alabama in Huntsville and then chaired the department of family practice at the University of Alabama at Birmingham.
A thought leader for family medicine
He held numerous state and national leadership positions, and initiated what became the Keystone Conference Series – an invitational gathering of leaders in family medicine that examined and discuss the specialty’s ongoing development. In 2006, he was elected to the Institute of Medicine of the National Academies of Science.
Dr. Stephens authored a textbook, The Intellectual Basis of Family Medicine (Tucson, Ariz.: Winter Publishing Company, 1982), and authored essays, which Dr. Green said will stand the test of time.
“Some of us refer to him as the poet laureate of family medicine,” Dr. Green noted.
In a 1974 article on clinical wisdom, Dr. Stephens wrote that “it is not enough to determine what condition the patient has, but also what patient has the condition.” In another of these essays, which was published in 1979, Dr. Stephens wrote that “physicians need to keep in touch with their own tradition and with public welfare if they are to be considered moral by the society that sponsors them, and from which they take their strength and privilege.”
These excerpts are featured in an article by John P. Geyman, MD, published in 2011 in Family Medicine, called “G. Gayle Stephens Festschrift”.
A ‘progressive force’
Linda Prine, MD, professor of family and community medicine at the Icahn School of Medicine at Mount Sinai, New York, knows of Dr. Stephens from her teachers. “The people I looked up to when I was a younger physician were quoting his Counterculture article,” she said.
“It’s not that I studied him. But whenever I heard someone speak about the values of family medicine, his name would come up [and] the values of universal health care and community care and putting the patients’ interests first ahead of the insurance companies and being a doctor for the whole family,” Dr. Prine said. Dr. Stephens was a “progressive force that our specialty has not always lived up to.”
Dr. Stephens voiced serious concerns about the impact of managed care in the 1980s and of “gatekeeping,” a practice intended to control access to specialists and reduce costs.
“He was many times not welcomed by family medicine [for his warnings] against the temptations that managed care presented,” said Dr. Green, the founding director of the Robert Graham Center, Washington. “He saw the conflict of interest of being a gatekeeper, how that would erode trust in a personal relationship with your personal doctor.”
“Gayle thought it was a disaster waiting to happen, and it was,” he said, referring to the eventual rejection by the public of barriers to direct access to specialists.
Through the 1990s and more recently, Dr. Stephens expressed frustration with the “medical-industrial complex” and the decline of family medicine after its surge in the 1970s and 1980s, Dr. Green said. “But in my opinion, near the end of his life, he was encouraged by young leaders who he saw grasped the important ideas from the ages.”
Dr. Stephens’ interest in medical education extended to nurses and nurse practitioners (the latter of whom had begun their discipline in the mid-1960s), and to optometrists, for whom he taught a recurring course in “physical diagnosis.”
A listener and proponent of listening
Linda Tompkins, RN, FNP, of Newton, Kan., trained with Dr. Stephens at part of a year-long nurse education program in the early 1970s at Wichita (Kan.) State University, where he was leading the department of family practice (prior to moving to Alabama). “You couldn’t ask too many questions,” she said. “And he never talked down to us, he wasn’t condescending. There were not a lot of doctors like that.”
Dr. Stephens spoke and wrote often about the importance of listening –about how it was vital to the “durable clinical relationship.” It was also vital to his writing and to his impact on the teachers of family medicine, said Dan Ostergaard, MD, who served as a residency director and in various staff leadership positions at the American Academy of Family Physicians, including in its division of education.
“He created a lot of aha moments for me, about where we came from and what we really need to be [as a specialty] and where we need to go,” said Dr. Ostergaard. “To be such a great thinker and a great writer, you have to be a great listener.”
“I can just visualize him,” he said, “leaning back in his chair while we were talking about residency criteria [or other issues], with a half-smile on his face and his reading glasses down his note, smoking his pipe and just looking at all of us, listening.”
Dr. Stephens’ papers are housed in the Center for the History of Family Medicine, a project of the AAFP Foundation.
G. Gayle Stephens, MD, who is roundly regarded as one of the founders of family medicine, gave his talk “Family Medicine as Counterculture” at the Society of Teachers of Family Medicine annual conference in 1979, 10 years after the specialty’s establishment.
The speech was then published, republished 10 years later, and, like many of Dr. Stephen’s other essays and articles, remains very much alive in the minds of practicing family physicians, in the teachings of FP academicians, and in the Google searches of budding FPs.
The late Dr. Stephens saw family medicine as a counterculture within medicine, rooted in social change. In his speech he examined these roots – in reform initiatives in the 1960s, and in certain philosophies and “minority” movements such as agrarianism and the preservation of rural life, utopianism, humanism, consumerism, and feminism.
He also looked forward, challenging the specialty to remain true to itself and its roots – to its belief in “uninhibited access” to medical care for everyone, for instance, and to continual whole-person and family-oriented care – and cautioned against moving to resemble the “rest of the medical bureaucracy.”
“Clearly we have been on the side of change in American life. We have identified ourselves with certain minorities and minority positions ... [and] been counter to many of the dominant forces in society,” Dr. Stephens said in his talk. Family practice “succeeded in the decade just past because we were identified with reforms that are more pervasive and powerful than ourselves.”
The family practice movement has “more in common with [the] counterculture than it does with the dominant scientific medical establishment,” he said.
A teacher and founder of medical education programs
Larry A. Green, MD, who was pursuing his own residency training as Dr. Stephens was leading a department of family practice, said
“It was from this philosophical position that he became a synthesizer and observer and interpreter of what was going on in the development of family medicine,” said Dr. Green, Distinguished Professor and Epperson Zorn Chair for Innovation in Family Medicine and Primary Care at the University of Colorado at Denver, Aurora.
Dr. Stephens, who died at home in 2014 at the age of 85, was “probably the most important person in exposing what I now consider to be a fact – that family medicine was the product of social changes ... of social movements related to women’s rights, civil rights, and social responsibility,” Dr. Green said. “He could recall lessons from the past and forecast the challenges of the future. And there was no one more effective in clarifying the importance of personal [doctor-patient] relationships in family medicine.”
After years of general practice in rural Wichita, Kan., his wife Eula Jean’s hometown, Dr. Stephens founded and led one of the first family medicine residencies at Wesley Hospital in Wichita in 1967. His core principles, as described on today’s Wesley Family Medicine Residency website, included that a family physician consider the whole person, be honest, have a full scope of training including behavioral and mental health, and be “reflective about him/herself ... [learning about] his/her assets, liabilities, foibles, and idiosyncrasies.” Dr. Stephens, who had grown up in rural Ashburn, Mo., later became the founding dean of the School of Primary Medical Care at the University of Alabama in Huntsville and then chaired the department of family practice at the University of Alabama at Birmingham.
A thought leader for family medicine
He held numerous state and national leadership positions, and initiated what became the Keystone Conference Series – an invitational gathering of leaders in family medicine that examined and discuss the specialty’s ongoing development. In 2006, he was elected to the Institute of Medicine of the National Academies of Science.
Dr. Stephens authored a textbook, The Intellectual Basis of Family Medicine (Tucson, Ariz.: Winter Publishing Company, 1982), and authored essays, which Dr. Green said will stand the test of time.
“Some of us refer to him as the poet laureate of family medicine,” Dr. Green noted.
In a 1974 article on clinical wisdom, Dr. Stephens wrote that “it is not enough to determine what condition the patient has, but also what patient has the condition.” In another of these essays, which was published in 1979, Dr. Stephens wrote that “physicians need to keep in touch with their own tradition and with public welfare if they are to be considered moral by the society that sponsors them, and from which they take their strength and privilege.”
These excerpts are featured in an article by John P. Geyman, MD, published in 2011 in Family Medicine, called “G. Gayle Stephens Festschrift”.
A ‘progressive force’
Linda Prine, MD, professor of family and community medicine at the Icahn School of Medicine at Mount Sinai, New York, knows of Dr. Stephens from her teachers. “The people I looked up to when I was a younger physician were quoting his Counterculture article,” she said.
“It’s not that I studied him. But whenever I heard someone speak about the values of family medicine, his name would come up [and] the values of universal health care and community care and putting the patients’ interests first ahead of the insurance companies and being a doctor for the whole family,” Dr. Prine said. Dr. Stephens was a “progressive force that our specialty has not always lived up to.”
Dr. Stephens voiced serious concerns about the impact of managed care in the 1980s and of “gatekeeping,” a practice intended to control access to specialists and reduce costs.
“He was many times not welcomed by family medicine [for his warnings] against the temptations that managed care presented,” said Dr. Green, the founding director of the Robert Graham Center, Washington. “He saw the conflict of interest of being a gatekeeper, how that would erode trust in a personal relationship with your personal doctor.”
“Gayle thought it was a disaster waiting to happen, and it was,” he said, referring to the eventual rejection by the public of barriers to direct access to specialists.
Through the 1990s and more recently, Dr. Stephens expressed frustration with the “medical-industrial complex” and the decline of family medicine after its surge in the 1970s and 1980s, Dr. Green said. “But in my opinion, near the end of his life, he was encouraged by young leaders who he saw grasped the important ideas from the ages.”
Dr. Stephens’ interest in medical education extended to nurses and nurse practitioners (the latter of whom had begun their discipline in the mid-1960s), and to optometrists, for whom he taught a recurring course in “physical diagnosis.”
A listener and proponent of listening
Linda Tompkins, RN, FNP, of Newton, Kan., trained with Dr. Stephens at part of a year-long nurse education program in the early 1970s at Wichita (Kan.) State University, where he was leading the department of family practice (prior to moving to Alabama). “You couldn’t ask too many questions,” she said. “And he never talked down to us, he wasn’t condescending. There were not a lot of doctors like that.”
Dr. Stephens spoke and wrote often about the importance of listening –about how it was vital to the “durable clinical relationship.” It was also vital to his writing and to his impact on the teachers of family medicine, said Dan Ostergaard, MD, who served as a residency director and in various staff leadership positions at the American Academy of Family Physicians, including in its division of education.
“He created a lot of aha moments for me, about where we came from and what we really need to be [as a specialty] and where we need to go,” said Dr. Ostergaard. “To be such a great thinker and a great writer, you have to be a great listener.”
“I can just visualize him,” he said, “leaning back in his chair while we were talking about residency criteria [or other issues], with a half-smile on his face and his reading glasses down his note, smoking his pipe and just looking at all of us, listening.”
Dr. Stephens’ papers are housed in the Center for the History of Family Medicine, a project of the AAFP Foundation.
Survey finds Mohs surgeons favor nicotinamide for chemoprevention
, in a survey of members of the American College of Mohs Surgeons.
Although nicotinamide, a vitamin B3 derivative, has been shown to reduce keratinocyte carcinoma (KC) in high-risk patients, it is not approved by the Food and Drug Administration for chemoprevention, and no safe upper limit has been established in clinical trials to date, wrote Sheena Desai of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
The investigators emailed an anonymous 12-question survey to 1,500 members of the American College of Mohs Surgeons. Of the 170 who responded, 10 were excluded for discordant responses, leaving 160 participants whose replies were included in a multiple logistic regression analysis. The respondents were mainly U.S. board-certified dermatologists and Mohs surgeons (99.4% for both); 86.9% were in clinical practice, including 78.8% in private practice, according to the report of the results, published in Dermatologic Surgery.
Overall, 76.9% of the respondents said they recommended nicotinamide for preventing KC, and 20% said they had recommended nicotinamide to more than 100 patients in the past year. In addition, 45% of respondents reported patients who had been taking nicotinamide for 2 years or more. Overall, 63.8% of the respondents expressed no concerns about long-term safety of nicotinamide, compared with 28.1% who said they were uncertain about long-term safety. Those who expressed concern or uncertainty about long-term safety were significantly less likely to recommend nicotinamide for KC prevention in the past year (odds ratio, 0.30; 95% confidence interval [CI] 0.13-0.71). Clinicians with more than 10 years in practice were significantly less likely to recommend nicotinamide for chemoprevention (OR, 0.20; 95% CI 0.05-0.82).
The study findings were limited by several factors, including the low number of responses and the potential lack of generalizability to clinicians other than Mohs surgeons, the researchers noted. “Additional studies on nicotinamide safety and use patterns, including cost-effectiveness analyses, are needed given the widespread use identified in this study,” they concluded.
Limited safety data highlight research gaps
The study is particularly important at this time because nicotinamide has been increasingly used for KC chemoprevention since a randomized, controlled trial published in 2015 in the New England Journal of Medicine showed benefits, corresponding author Rebecca I. Hartman, MD, of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, said in an interview. That study of high-risk patients found that nicotinamide, 500 mg twice a day, was safe and effective in lowering the rates of new nonmelanoma skin cancers and AKs after 12 months .
“However, because this is not a prescription medication, but rather an OTC vitamin supplement, data on its use are not available,” she said.
Dr. Hartman said she was not surprised that nicotinamide is being used frequently by a majority of the survey respondents. “Most are using this if someone has two KCs over 2 years, which is a quite common occurrence,” she noted. However, “I was a bit surprised that nearly two-thirds had no safety concerns with long-term use, even though this has not been well-studied,” she added.
“Like anything we recommend, we must consider the risks and benefits,” Dr. Hartman said of nicotinamide. “Unfortunately, we don’t know the risks well, since this hasn’t been well-characterized with regular long-term use in these doses,” and more research is needed, she said. “The risks are likely low, as this is a vitamin that has been used for years in various OTC supplements,” she added. “However, there are some data showing slightly increased all-cause mortality with similar doses of a related medicine, niacin, in cardiovascular patients. For this reason, I recommend the medication when a patient’s KCs are really becoming burdensome – several KCs in a year or two – or when they are high-risk due to immunosuppression,” she explained.
“We also must consider the individual patient. For a healthy younger patient who has a public-facing job and as a result is very averse to developing any KCs on his or her face and very motivated to try prevention, it may make sense to try nicotinamide,” Dr. Hartman said. But for an older patient with cardiovascular comorbidities who is not bothered by a KC on his or her back or extremities, “this medication may not have a favorable risk-benefit profile.”
To address safety concerns, “researchers need to examine whether there are any harms in long-term regular nicotinamide use for KC prevention,” Dr. Hartman said. “This is something we hope to do in our patients; however, it is challenging to study in a retrospective way since the harm is likely small and there are so many other features that influence mortality as an outcome,” she noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
, in a survey of members of the American College of Mohs Surgeons.
Although nicotinamide, a vitamin B3 derivative, has been shown to reduce keratinocyte carcinoma (KC) in high-risk patients, it is not approved by the Food and Drug Administration for chemoprevention, and no safe upper limit has been established in clinical trials to date, wrote Sheena Desai of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
The investigators emailed an anonymous 12-question survey to 1,500 members of the American College of Mohs Surgeons. Of the 170 who responded, 10 were excluded for discordant responses, leaving 160 participants whose replies were included in a multiple logistic regression analysis. The respondents were mainly U.S. board-certified dermatologists and Mohs surgeons (99.4% for both); 86.9% were in clinical practice, including 78.8% in private practice, according to the report of the results, published in Dermatologic Surgery.
Overall, 76.9% of the respondents said they recommended nicotinamide for preventing KC, and 20% said they had recommended nicotinamide to more than 100 patients in the past year. In addition, 45% of respondents reported patients who had been taking nicotinamide for 2 years or more. Overall, 63.8% of the respondents expressed no concerns about long-term safety of nicotinamide, compared with 28.1% who said they were uncertain about long-term safety. Those who expressed concern or uncertainty about long-term safety were significantly less likely to recommend nicotinamide for KC prevention in the past year (odds ratio, 0.30; 95% confidence interval [CI] 0.13-0.71). Clinicians with more than 10 years in practice were significantly less likely to recommend nicotinamide for chemoprevention (OR, 0.20; 95% CI 0.05-0.82).
The study findings were limited by several factors, including the low number of responses and the potential lack of generalizability to clinicians other than Mohs surgeons, the researchers noted. “Additional studies on nicotinamide safety and use patterns, including cost-effectiveness analyses, are needed given the widespread use identified in this study,” they concluded.
Limited safety data highlight research gaps
The study is particularly important at this time because nicotinamide has been increasingly used for KC chemoprevention since a randomized, controlled trial published in 2015 in the New England Journal of Medicine showed benefits, corresponding author Rebecca I. Hartman, MD, of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, said in an interview. That study of high-risk patients found that nicotinamide, 500 mg twice a day, was safe and effective in lowering the rates of new nonmelanoma skin cancers and AKs after 12 months .
“However, because this is not a prescription medication, but rather an OTC vitamin supplement, data on its use are not available,” she said.
Dr. Hartman said she was not surprised that nicotinamide is being used frequently by a majority of the survey respondents. “Most are using this if someone has two KCs over 2 years, which is a quite common occurrence,” she noted. However, “I was a bit surprised that nearly two-thirds had no safety concerns with long-term use, even though this has not been well-studied,” she added.
“Like anything we recommend, we must consider the risks and benefits,” Dr. Hartman said of nicotinamide. “Unfortunately, we don’t know the risks well, since this hasn’t been well-characterized with regular long-term use in these doses,” and more research is needed, she said. “The risks are likely low, as this is a vitamin that has been used for years in various OTC supplements,” she added. “However, there are some data showing slightly increased all-cause mortality with similar doses of a related medicine, niacin, in cardiovascular patients. For this reason, I recommend the medication when a patient’s KCs are really becoming burdensome – several KCs in a year or two – or when they are high-risk due to immunosuppression,” she explained.
“We also must consider the individual patient. For a healthy younger patient who has a public-facing job and as a result is very averse to developing any KCs on his or her face and very motivated to try prevention, it may make sense to try nicotinamide,” Dr. Hartman said. But for an older patient with cardiovascular comorbidities who is not bothered by a KC on his or her back or extremities, “this medication may not have a favorable risk-benefit profile.”
To address safety concerns, “researchers need to examine whether there are any harms in long-term regular nicotinamide use for KC prevention,” Dr. Hartman said. “This is something we hope to do in our patients; however, it is challenging to study in a retrospective way since the harm is likely small and there are so many other features that influence mortality as an outcome,” she noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
, in a survey of members of the American College of Mohs Surgeons.
Although nicotinamide, a vitamin B3 derivative, has been shown to reduce keratinocyte carcinoma (KC) in high-risk patients, it is not approved by the Food and Drug Administration for chemoprevention, and no safe upper limit has been established in clinical trials to date, wrote Sheena Desai of Brigham and Women’s Hospital and Harvard Medical School, Boston, and colleagues.
The investigators emailed an anonymous 12-question survey to 1,500 members of the American College of Mohs Surgeons. Of the 170 who responded, 10 were excluded for discordant responses, leaving 160 participants whose replies were included in a multiple logistic regression analysis. The respondents were mainly U.S. board-certified dermatologists and Mohs surgeons (99.4% for both); 86.9% were in clinical practice, including 78.8% in private practice, according to the report of the results, published in Dermatologic Surgery.
Overall, 76.9% of the respondents said they recommended nicotinamide for preventing KC, and 20% said they had recommended nicotinamide to more than 100 patients in the past year. In addition, 45% of respondents reported patients who had been taking nicotinamide for 2 years or more. Overall, 63.8% of the respondents expressed no concerns about long-term safety of nicotinamide, compared with 28.1% who said they were uncertain about long-term safety. Those who expressed concern or uncertainty about long-term safety were significantly less likely to recommend nicotinamide for KC prevention in the past year (odds ratio, 0.30; 95% confidence interval [CI] 0.13-0.71). Clinicians with more than 10 years in practice were significantly less likely to recommend nicotinamide for chemoprevention (OR, 0.20; 95% CI 0.05-0.82).
The study findings were limited by several factors, including the low number of responses and the potential lack of generalizability to clinicians other than Mohs surgeons, the researchers noted. “Additional studies on nicotinamide safety and use patterns, including cost-effectiveness analyses, are needed given the widespread use identified in this study,” they concluded.
Limited safety data highlight research gaps
The study is particularly important at this time because nicotinamide has been increasingly used for KC chemoprevention since a randomized, controlled trial published in 2015 in the New England Journal of Medicine showed benefits, corresponding author Rebecca I. Hartman, MD, of the department of dermatology, Brigham and Women’s Hospital and Harvard University, Boston, said in an interview. That study of high-risk patients found that nicotinamide, 500 mg twice a day, was safe and effective in lowering the rates of new nonmelanoma skin cancers and AKs after 12 months .
“However, because this is not a prescription medication, but rather an OTC vitamin supplement, data on its use are not available,” she said.
Dr. Hartman said she was not surprised that nicotinamide is being used frequently by a majority of the survey respondents. “Most are using this if someone has two KCs over 2 years, which is a quite common occurrence,” she noted. However, “I was a bit surprised that nearly two-thirds had no safety concerns with long-term use, even though this has not been well-studied,” she added.
“Like anything we recommend, we must consider the risks and benefits,” Dr. Hartman said of nicotinamide. “Unfortunately, we don’t know the risks well, since this hasn’t been well-characterized with regular long-term use in these doses,” and more research is needed, she said. “The risks are likely low, as this is a vitamin that has been used for years in various OTC supplements,” she added. “However, there are some data showing slightly increased all-cause mortality with similar doses of a related medicine, niacin, in cardiovascular patients. For this reason, I recommend the medication when a patient’s KCs are really becoming burdensome – several KCs in a year or two – or when they are high-risk due to immunosuppression,” she explained.
“We also must consider the individual patient. For a healthy younger patient who has a public-facing job and as a result is very averse to developing any KCs on his or her face and very motivated to try prevention, it may make sense to try nicotinamide,” Dr. Hartman said. But for an older patient with cardiovascular comorbidities who is not bothered by a KC on his or her back or extremities, “this medication may not have a favorable risk-benefit profile.”
To address safety concerns, “researchers need to examine whether there are any harms in long-term regular nicotinamide use for KC prevention,” Dr. Hartman said. “This is something we hope to do in our patients; however, it is challenging to study in a retrospective way since the harm is likely small and there are so many other features that influence mortality as an outcome,” she noted.
The study received no outside funding. The researchers had no financial conflicts to disclose.
FROM DERMATOLOGIC SURGERY
AGA News
AGAF applications now open
Applications are now open for the 2022 American Gastroenterological Association Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.
Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- International acknowledgment at Digestive Disease Week® (DDW).
- A listing on the AGA website alongside esteemed peers.
- A prewritten, fill-in press release and a digital badge to inform others of your accomplishment.
Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.
Call for new AGA guideline topics
The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing this online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.
It’s easy – just take the following 3 steps to submit a guideline idea:
- Check out the guidelines that AGA has already developed or are in progress.
- Complete the survey. You can submit more than one guideline topic by filling out the form multiple times.
- Stay tuned for follow-up questions in case the committee needs more information on your recommendations.
The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission
Get to know DDW® 2021 Virtual
The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.
AGAF applications now open
Applications are now open for the 2022 American Gastroenterological Association Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.
Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- International acknowledgment at Digestive Disease Week® (DDW).
- A listing on the AGA website alongside esteemed peers.
- A prewritten, fill-in press release and a digital badge to inform others of your accomplishment.
Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.
Call for new AGA guideline topics
The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing this online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.
It’s easy – just take the following 3 steps to submit a guideline idea:
- Check out the guidelines that AGA has already developed or are in progress.
- Complete the survey. You can submit more than one guideline topic by filling out the form multiple times.
- Stay tuned for follow-up questions in case the committee needs more information on your recommendations.
The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission
Get to know DDW® 2021 Virtual
The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.
AGAF applications now open
Applications are now open for the 2022 American Gastroenterological Association Fellowship cohort. AGA is proud to formally recognize its exemplary members whose accomplishments and contributions demonstrate a deep commitment to gastroenterology through the AGA Fellows Program. Those in clinical practice, education, or research (basic or clinical) are encouraged to apply today.
Longstanding members who apply and meet the program criteria are granted the distinguished honor of AGA Fellowship and receive the following:
- The privilege of using the designation “AGAF” in professional activities.
- An official certificate and pin denoting your status.
- International acknowledgment at Digestive Disease Week® (DDW).
- A listing on the AGA website alongside esteemed peers.
- A prewritten, fill-in press release and a digital badge to inform others of your accomplishment.
Apply for consideration and gain recognition worldwide for your commitment to the field. The deadline is Aug. 24.
Call for new AGA guideline topics
The AGA Institute Clinical Guidelines Committee wants your input on the next set of guidelines to be developed. By completing this online form, you can submit recommendations for guideline topics that will be developed within the next two years. The deadline to submit your ideas is Monday, May 3.
It’s easy – just take the following 3 steps to submit a guideline idea:
- Check out the guidelines that AGA has already developed or are in progress.
- Complete the survey. You can submit more than one guideline topic by filling out the form multiple times.
- Stay tuned for follow-up questions in case the committee needs more information on your recommendations.
The AGA Institute Clinical Guidelines Committee will review guideline topics in May, prioritizing and ranking topics based on the following criteria: prevalence of disease, resource utilization, variation in care, other existing guidelines, new data/changes in diagnosis or treatment, and potential for measure/quality development. Once vetted, four or more new guidelines will be recommended for development throughout the year. Complete the online survey at www.surveymonkey.com/r/AGAtopicsubmission
Get to know DDW® 2021 Virtual
The world’s premier meeting for gastroenterology, hepatology, endoscopy, and gastrointestinal surgery professionals will be a fully virtual event, May 21-23, 2021. We invite you to take advantage of this unique opportunity to exchange knowledge with colleagues from all over the world and explore the latest advances in the field – all from the convenience of your home. Plus, your registration grants you access to everything offered at Digestive Disease Week® (DDW) this year (no additional ticketed sessions). Learn more and register at ddw.org.