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Greater Transparency of Oncologists’ Pharma Relationships Needed

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Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

 

 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

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Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

 

 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

Three-quarters of oncologists participating in a recent global survey failed to identify one or more situations representing a conflict of interest, according to a new study.

The findings reflect limited awareness in low-income countries about what scenarios constitute a conflict of interest, first author, Khalid El Bairi, MD, said during an interview. “There is a lack of training in ethics and integrity in medical schools [in countries in Africa], so people are not informed about conflicts of interest,” continued Dr. El Bairi, who presented the new research at the annual meeting of the American Society of Clinical Oncology. “There is also a lack of policies in universities and hospitals to guide clinicians about conflict of interest reporting.”

Overall, 58.5% of survey participants categorized honoraria as a conflict of interest that required disclosure, while 50% said the same of gifts from pharmaceutical representatives, and 44.5% identified travel grants for attending conferences as conflicts of interests. The report was published in JCO Global Oncology. Less often considered conflicts of interest were personal and institutional research funding, trips to conferences, consulting or advisory roles, food and beverages, expert testimony, and sample drugs provided by the pharmaceutical industry.

Just 24% of participants indicated that all of the listed items were deemed conflicts of interest. The survey — called Oncology Transparency Under Scrutiny and Tracking, or ONCOTRUST-1 — considered the perceptions of 200 oncologists, about 70% of whom practice in low- and middle-income countries.

What’s more, 37.5% of respondents identified fear of losing financial support as a reason not to report a conflict of interest. Still, 75% indicated that industry-sponsored speaking does not affect treatment decisions, and 60% said conflicts of interest do not impair objective appraisal of clinical trials.

Dr. El Bairi, a research associate in the department of medical oncology at Mohammed VI University Hospital, Oujda, Morocco, and his colleagues undertook the study in part because of an editorial published in The Lancet Oncology last year. First author Fidel Rubagumya, MD, a consultant oncologist and director of research at Rwanda Military Hospital, Kigali, and colleagues called for more research on the ties between oncologists and industry in Africa. The ONCOTRUST-1 findings set the stage for a planned follow-up study, which aims to compare views surrounding conflicts of interests between oncologists in different economic settings.
 

Open Payments Houses US Physicians’ Conflicts of Interest

To be sure, many authors of research published in major US journals are based outside of the United States. According to JAMA Network Open, 69% of submissions to the journal are from international authors. However, Dr. El Bairi also raised other potential signs of industry influence that he said need global discussion, such as the role of pharmaceutical companies in presentations of clinical trial findings at large cancer societies’ conferences, a shift toward progression-free survival as the endpoint in clinical cancer trials, and the rise of third-party writing assistance.

“There are two sides of the story,” Dr. El Bairi said. “The good side is that unfortunately, sometimes [industry money is] the only way for African oncologists to go abroad for training, to conferences for their continuous medical education. The bad is now we may harm patients, we might harm science by having conflicts of interest not reported.”

Unlike other countries, the United States has plentiful data on the scale of physicians’ financial conflicts of interest in the form of the Open Payments platform. Championed by Sen. Chuck Grassley (R-Iowa), the federal repository of payments to doctors and teaching hospitals by drug and medical device companies was established as part of the Affordable Care Act (ACA).

The health care reform law, which passed in 2010, requires pharmaceutical companies and medical device makers to report this information.

From 2013 to 2021, the pharmaceutical and medical device industry paid physicians $12.1 billion, according to a research letter published in JAMA in March of 2024 that reviewed Open Payments data.

Ranked by specialty, hematologists and oncologists received the fourth-largest amount of money in aggregate, the study shows. Their total of $825.8 million trailed only physicians in orthopedics ($1.36 billion), neurology and psychiatry ($1.32 billion) and cardiology ($1.29 billion). What’s more, this specialty had the biggest share of physicians taking industry money, with 74.2% of hematologists and oncologists receiving payments.

The payments from industry include fees for consulting services and speaking, as well as food and beverages, travel and lodging, education, gifts, grants, and honoraria.

Joseph S. Ross, MD, MHS, one of the JAMA study’s coauthors, said in an interview that the continued prevalence of such funding runs counter to the expectation behind the measure, which was that transparency would lead to physicians’ becoming less likely to accept a payment.

“We as a profession need to take a cold hard look in the mirror,” he said, referring to physicians in general.

Dr. Ross, professor of medicine at Yale University School of Medicine, New Haven, Connecticut, said he hopes that the profession will self-police, and that patients will make a bigger deal of the issue. Still, he acknowledged that “the vast majority” of patient advocacy groups, too, are funded by the pharmaceutical industry.
 

 

 

Exposing Industry Payments May Have Perverse Effect

A growing body of research explores the effect that physicians’ financial relationships with pharmaceutical companies can have on their prescribing practices. Indeed, oncologists taking industry payments seem to be more likely to prescribe nonrecommended and low-value drugs in some clinical settings, according to a study published in The BMJ last year.

That study’s first author, Aaron P. Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center, New York City, suggested in an interview that exposing industry payments to the sunlight may have had a perverse effect on physicians.

“There’s this idea of having license to do something,” Dr. Mitchell said, speaking broadly about human psychology rather than drawing on empirical data. “You might feel a little less bad about then prescribing more of that company’s drug, because the disclosure has already been done.”

The influence of pharmaceutical industry money on oncologists goes beyond what’s prescribed to which treatments get studied, approved, and recommended by guidelines, Dr. Mitchell said. He was also first author of a 2016 paper published in JAMA Oncology that found 86% of authors of the National Comprehensive Cancer Network guidelines had at least one conflict of interest reported on Open Systems in 2014.

Meanwhile, the fact that physicians’ payments from industry are a matter of public record on Open Systems has not guaranteed that doctors will disclose their conflicts of interest in other forums. A study published in JAMA earlier this year, for which Dr. Mitchell served as first author, found that almost one in three physicians endorsing drugs and devices on the social media platform X failed to disclose that the manufacturer paid them.

The lack of disclosure seems to extend beyond social media. A 2018 study published in JAMA Oncology found that 32% of oncologist authors of clinical drug trials for drugs approved over a 20-month period from 2016 to 2017 did not fully disclose payments from the trial sponsor when checked against the Open Payments database.

A lion’s share of industry payments within oncology appears to be going to a small group of high-profile physicians, suggested a 2022 study published in JCO Oncology Practice. It found that just 1% of all US oncologists accounted for 37% of industry payments, with each receiving more than $100,000 a year.
 

Experts: Professional Societies Should Further Limit Industry Payments

While partnerships between drug companies and physicians are necessary and have often been positive, more than disclosure is needed to minimize the risk of patient harm, according to an editorial published in March in JCO Oncology Practice. In it, Nina Niu Sanford, MD, a radiation oncologist UT Southwestern Medical Center, Dallas, and Bishal Gyawali, MD, PhD, a medical oncologist at Queen’s University, Kingston, Ontario, Canada, argue that following a specific blueprint could help mitigate financial conflicts of interest.

For starters, Dr. Sanford and Dr. Gyawali contend in the editorial that the maximum general payment NCCN members are allowed to receive from industry should be $0, compared with a current bar of $20,000 from a single entity or $50,000 from all external entities combined. They also urge professional societies to follow the current policy of the American Society of Clinical Oncology and ban members serving in their leadership from receiving any general payments from the industry.

The authors further suggest that investigators of clinical trials should be barred from holding stock for the drug or product while it is under study and that editorialists should not have conflicts of interest with the company whose drug or product they are discussing.

Pharmaceutical money can harm patients in ways that are not always obvious, Dr. Gyawali said in an interview.

“It can dominate the conversation by removing critical viewpoints from these top people about certain drugs,” he said. “It’s not always about saying good things about the drug.”

For instance, he suggested, a doctor receiving payments from Pfizer might openly criticize perceived flaws in drugs from other companies but refrain from weighing in negatively on a Pfizer drug.

From 2016 to 2018, industry made general payments to more than 52,000 physicians for 137 unique cancer drugs, according to a separate 2021 study published in the Journal of Cancer Policy, for which Dr. Gyawali served as one of the coauthors.

The results suggest that pharmaceutical money affects the entire cancer system, not relatively few oncology leaders. The amounts and dollar values grew each year covered by the study, to nearly 466,000 payments totaling $98.5 million in 2018.

Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, Washington, DC, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices, has called for a ban on industry gifts to physicians.

When a publication asks physicians to disclose relevant conflicts of interest, physicians may choose not to disclose, because they don’t feel that their conflicts are relevant, Dr. Fugh-Berman said. Drug and device makers have also grown sophisticated about how they work with physicians, she suggested. “It’s illegal to market a drug before it comes on the market, but it’s not illegal to market the disease,” said Dr. Fugh-Berman, noting that drugmakers often work on long timelines.

“The doctor is going around saying we don’t have good therapies. They’re not pushing a drug. And so they feel totally fine about it.”

Anecdotally, Dr. Fugh-Berman noted that, if anything, speaking fees and similar payments only improve doctors’ reputations. She said that’s especially true if the physicians are paid by multiple companies, on the supposed theory that their conflicts of interest cancel each other out.

“I’m not defending this,” added Dr. Fugh-Berman, observing that, at the end of the day, such conflicts may go against the interests of patients.

“Sometimes the best drugs are older, generic, cheap drugs, and if oncologists or other specialists are only choosing among the most promoted drugs, they’re not necessarily choosing the best drugs.”

Beyond any prestige, doctors have other possible nonfinancial incentives for receiving industry payments. “It’s the relationships,” Dr. Fugh-Berman said. “Companies are very good at offering friendship.”

Dr. El Bairi reported NCODA leadership and honoraria along with expert testimony through techspert.io. Dr. Ross reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of or the review of the manuscript he authored and discussed in this article. Dr. Ross also reported receiving grants from the Food and Drug Administration, Johnson & Johnson, the Medical Device Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Mitchell reported no relevant financial relationships. Dr. Gyawali reported a consulting or advisory role with Vivio Health. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

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Munchausen Syndrome by Proxy: Be Aware of Cutaneous Signs

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Mon, 07/22/2024 - 11:49

— Be suspicious if a child with a severe dermatologic condition is unresponsive to treatment, especially if their parent or caregiver exhibits deceptive behavior.

These could be red flags for Munchausen syndrome by proxy (MSBP), also known as factitious disorder.

“The No. 1 thing dermatologists can do in situations like this is be open to thinking outside the box and ask themselves the difficult question: Could this be something the parent is inflicting on the child,” Kelly Frasier, DO, a dermatology clinical trials and epidemiology research fellow at Northwell Health, Poughkeepsie, New York, said in an interview.

Kelly Frasier, DO, a dermatology clinical trials and epidemiology research fellow, at Northwell Health, Poughkeepsie, New York
courtesy Pauline Anderson
Dr. Kelly Frasier

She provided a review on advancing the understanding of the dermatologic manifestations of MSBP during a poster session at the annual meeting of the Society for Pediatric Dermatology (SPD). Dr. Frasier has a particular interest in psychodermatology — she was a mental health therapist before going to medical school.

MSBP is a type of abuse intentionally inflicted by a caregiver typically on their child “for some ulterior motive,” usually to seek attention or sympathy and not for material or financial gain, explained Dr. Frasier. People with MSBP seek medical help for exaggerated or fabricated symptoms in their child. They may alter medical tests, falsify medical records, or induce symptoms in their child.

To do this, these abusers may apply any number of caustic household products, including glue, directly to the child’s skin or even in formula. Dr. Frasier shared a picture of a baby whose formula had been doctored with a caustic substance that had dripped onto his neck and face, causing a rash with blisters.

In addition to blistering, cutaneous manifestations of MSBP can include severe bruising. Or the child may present with signs similar to those of granuloma annulare (a benign condition characterized by small, raised bumps) or cicatricial pemphigoid (a rare, chronic autoimmune blistering disorder) or may have recurrent nail avulsion, purpura, or coagulopathy, said Dr. Frasier.

In almost all cases of MSBP (an estimated 96%), the abuse is inflicted by the mother, who may have a preexisting mental illness. “Usually, a psychological disorder is at play, such as depression or anxiety,” said Dr. Frasier.

Some evidence suggests that, in cases of MSBP, the caregiver may have a personality disorder such as borderline or histrionic personality disorder — or may have suffered abuse or neglect as a child or is experiencing major stress, which some evidence suggests can trigger MSPB, she added.

This type of abuse is rarely seen in children older than 6 years, likely because they get wise to what’s going on and are better able to fight back or resist as they get older, Dr. Fraser noted.

High Mortality Rate

It’s critical that cases of MSBP are identified early. While a small proportion of child abuse cases involve MSBP, the mortality rate is extremely high, about 10%, research suggests, said Dr. Frasier.

Dermatologists should be skeptical if the child’s condition hasn’t improved despite trying numerous treatments that normally would have some effect. “If you’re doing everything you can to treat something that’s usually pretty simple in terms of what you normally see clinically and how you treat it, and you’re not seeing any improvement or things continue to get worse, that’s definitely a sign something else may be going on,” Dr. Frasier said.

Another suspicious sign is inflammation that continues “for weeks or months” and “doesn’t match up with actual lab markers and lab values,” said Dr. Frasier.

Other signs of possible MSBP include evidence of chemicals in the child’s blood, stool, or urine, or the child’s condition improves while in the hospital, but symptoms return after returning home.

Also be aware of the interaction between the parent and child, said Dr. Frasier. “See if you can pick up that something else might be going on, especially if the symptoms aren’t lining up very well with what you’re physically seeing and what your clinical impression is.”

And be suspicious of a parent’s inappropriate behavior; for example, they seem to be deliberately making symptoms worse or appear overly distraught. The seemingly caring parent could be overcompensating for what she’s doing at home, “and she wants to make sure it doesn’t appear that way,” said Dr. Frasier.

To help determine if some sort of trauma is occurring at home, the child would ideally be separated from the caregiver, perhaps with a nurse or other member of the interdisciplinary medical team, Dr. Frasier said.

It appears that pediatric dermatologists are already aware of the importance of protecting children from abuse. During a presentation at the meeting on child abuse and maltreatment in dermatology, not specifically on MSBP, Romy Cho, MD, assistant professor, Department of Pediatrics, University of Toronto, who is involved with the SCAN Program at The Hospital for Sick Children, Toronto, Canada, polled the audience on whether they had ever contacted child protective services (CPS). Almost 80% said they had.

That’s good news for Dr. Frasier. “We have to be willing to contact CPS if we think there’s something going on, and be more open to that because it’s better to be safe than sorry, especially in cases involving children.”

Dr. Frasier and Dr. Cho had no relevant disclosures.

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

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— Be suspicious if a child with a severe dermatologic condition is unresponsive to treatment, especially if their parent or caregiver exhibits deceptive behavior.

These could be red flags for Munchausen syndrome by proxy (MSBP), also known as factitious disorder.

“The No. 1 thing dermatologists can do in situations like this is be open to thinking outside the box and ask themselves the difficult question: Could this be something the parent is inflicting on the child,” Kelly Frasier, DO, a dermatology clinical trials and epidemiology research fellow at Northwell Health, Poughkeepsie, New York, said in an interview.

Kelly Frasier, DO, a dermatology clinical trials and epidemiology research fellow, at Northwell Health, Poughkeepsie, New York
courtesy Pauline Anderson
Dr. Kelly Frasier

She provided a review on advancing the understanding of the dermatologic manifestations of MSBP during a poster session at the annual meeting of the Society for Pediatric Dermatology (SPD). Dr. Frasier has a particular interest in psychodermatology — she was a mental health therapist before going to medical school.

MSBP is a type of abuse intentionally inflicted by a caregiver typically on their child “for some ulterior motive,” usually to seek attention or sympathy and not for material or financial gain, explained Dr. Frasier. People with MSBP seek medical help for exaggerated or fabricated symptoms in their child. They may alter medical tests, falsify medical records, or induce symptoms in their child.

To do this, these abusers may apply any number of caustic household products, including glue, directly to the child’s skin or even in formula. Dr. Frasier shared a picture of a baby whose formula had been doctored with a caustic substance that had dripped onto his neck and face, causing a rash with blisters.

In addition to blistering, cutaneous manifestations of MSBP can include severe bruising. Or the child may present with signs similar to those of granuloma annulare (a benign condition characterized by small, raised bumps) or cicatricial pemphigoid (a rare, chronic autoimmune blistering disorder) or may have recurrent nail avulsion, purpura, or coagulopathy, said Dr. Frasier.

In almost all cases of MSBP (an estimated 96%), the abuse is inflicted by the mother, who may have a preexisting mental illness. “Usually, a psychological disorder is at play, such as depression or anxiety,” said Dr. Frasier.

Some evidence suggests that, in cases of MSBP, the caregiver may have a personality disorder such as borderline or histrionic personality disorder — or may have suffered abuse or neglect as a child or is experiencing major stress, which some evidence suggests can trigger MSPB, she added.

This type of abuse is rarely seen in children older than 6 years, likely because they get wise to what’s going on and are better able to fight back or resist as they get older, Dr. Fraser noted.

High Mortality Rate

It’s critical that cases of MSBP are identified early. While a small proportion of child abuse cases involve MSBP, the mortality rate is extremely high, about 10%, research suggests, said Dr. Frasier.

Dermatologists should be skeptical if the child’s condition hasn’t improved despite trying numerous treatments that normally would have some effect. “If you’re doing everything you can to treat something that’s usually pretty simple in terms of what you normally see clinically and how you treat it, and you’re not seeing any improvement or things continue to get worse, that’s definitely a sign something else may be going on,” Dr. Frasier said.

Another suspicious sign is inflammation that continues “for weeks or months” and “doesn’t match up with actual lab markers and lab values,” said Dr. Frasier.

Other signs of possible MSBP include evidence of chemicals in the child’s blood, stool, or urine, or the child’s condition improves while in the hospital, but symptoms return after returning home.

Also be aware of the interaction between the parent and child, said Dr. Frasier. “See if you can pick up that something else might be going on, especially if the symptoms aren’t lining up very well with what you’re physically seeing and what your clinical impression is.”

And be suspicious of a parent’s inappropriate behavior; for example, they seem to be deliberately making symptoms worse or appear overly distraught. The seemingly caring parent could be overcompensating for what she’s doing at home, “and she wants to make sure it doesn’t appear that way,” said Dr. Frasier.

To help determine if some sort of trauma is occurring at home, the child would ideally be separated from the caregiver, perhaps with a nurse or other member of the interdisciplinary medical team, Dr. Frasier said.

It appears that pediatric dermatologists are already aware of the importance of protecting children from abuse. During a presentation at the meeting on child abuse and maltreatment in dermatology, not specifically on MSBP, Romy Cho, MD, assistant professor, Department of Pediatrics, University of Toronto, who is involved with the SCAN Program at The Hospital for Sick Children, Toronto, Canada, polled the audience on whether they had ever contacted child protective services (CPS). Almost 80% said they had.

That’s good news for Dr. Frasier. “We have to be willing to contact CPS if we think there’s something going on, and be more open to that because it’s better to be safe than sorry, especially in cases involving children.”

Dr. Frasier and Dr. Cho had no relevant disclosures.

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

— Be suspicious if a child with a severe dermatologic condition is unresponsive to treatment, especially if their parent or caregiver exhibits deceptive behavior.

These could be red flags for Munchausen syndrome by proxy (MSBP), also known as factitious disorder.

“The No. 1 thing dermatologists can do in situations like this is be open to thinking outside the box and ask themselves the difficult question: Could this be something the parent is inflicting on the child,” Kelly Frasier, DO, a dermatology clinical trials and epidemiology research fellow at Northwell Health, Poughkeepsie, New York, said in an interview.

Kelly Frasier, DO, a dermatology clinical trials and epidemiology research fellow, at Northwell Health, Poughkeepsie, New York
courtesy Pauline Anderson
Dr. Kelly Frasier

She provided a review on advancing the understanding of the dermatologic manifestations of MSBP during a poster session at the annual meeting of the Society for Pediatric Dermatology (SPD). Dr. Frasier has a particular interest in psychodermatology — she was a mental health therapist before going to medical school.

MSBP is a type of abuse intentionally inflicted by a caregiver typically on their child “for some ulterior motive,” usually to seek attention or sympathy and not for material or financial gain, explained Dr. Frasier. People with MSBP seek medical help for exaggerated or fabricated symptoms in their child. They may alter medical tests, falsify medical records, or induce symptoms in their child.

To do this, these abusers may apply any number of caustic household products, including glue, directly to the child’s skin or even in formula. Dr. Frasier shared a picture of a baby whose formula had been doctored with a caustic substance that had dripped onto his neck and face, causing a rash with blisters.

In addition to blistering, cutaneous manifestations of MSBP can include severe bruising. Or the child may present with signs similar to those of granuloma annulare (a benign condition characterized by small, raised bumps) or cicatricial pemphigoid (a rare, chronic autoimmune blistering disorder) or may have recurrent nail avulsion, purpura, or coagulopathy, said Dr. Frasier.

In almost all cases of MSBP (an estimated 96%), the abuse is inflicted by the mother, who may have a preexisting mental illness. “Usually, a psychological disorder is at play, such as depression or anxiety,” said Dr. Frasier.

Some evidence suggests that, in cases of MSBP, the caregiver may have a personality disorder such as borderline or histrionic personality disorder — or may have suffered abuse or neglect as a child or is experiencing major stress, which some evidence suggests can trigger MSPB, she added.

This type of abuse is rarely seen in children older than 6 years, likely because they get wise to what’s going on and are better able to fight back or resist as they get older, Dr. Fraser noted.

High Mortality Rate

It’s critical that cases of MSBP are identified early. While a small proportion of child abuse cases involve MSBP, the mortality rate is extremely high, about 10%, research suggests, said Dr. Frasier.

Dermatologists should be skeptical if the child’s condition hasn’t improved despite trying numerous treatments that normally would have some effect. “If you’re doing everything you can to treat something that’s usually pretty simple in terms of what you normally see clinically and how you treat it, and you’re not seeing any improvement or things continue to get worse, that’s definitely a sign something else may be going on,” Dr. Frasier said.

Another suspicious sign is inflammation that continues “for weeks or months” and “doesn’t match up with actual lab markers and lab values,” said Dr. Frasier.

Other signs of possible MSBP include evidence of chemicals in the child’s blood, stool, or urine, or the child’s condition improves while in the hospital, but symptoms return after returning home.

Also be aware of the interaction between the parent and child, said Dr. Frasier. “See if you can pick up that something else might be going on, especially if the symptoms aren’t lining up very well with what you’re physically seeing and what your clinical impression is.”

And be suspicious of a parent’s inappropriate behavior; for example, they seem to be deliberately making symptoms worse or appear overly distraught. The seemingly caring parent could be overcompensating for what she’s doing at home, “and she wants to make sure it doesn’t appear that way,” said Dr. Frasier.

To help determine if some sort of trauma is occurring at home, the child would ideally be separated from the caregiver, perhaps with a nurse or other member of the interdisciplinary medical team, Dr. Frasier said.

It appears that pediatric dermatologists are already aware of the importance of protecting children from abuse. During a presentation at the meeting on child abuse and maltreatment in dermatology, not specifically on MSBP, Romy Cho, MD, assistant professor, Department of Pediatrics, University of Toronto, who is involved with the SCAN Program at The Hospital for Sick Children, Toronto, Canada, polled the audience on whether they had ever contacted child protective services (CPS). Almost 80% said they had.

That’s good news for Dr. Frasier. “We have to be willing to contact CPS if we think there’s something going on, and be more open to that because it’s better to be safe than sorry, especially in cases involving children.”

Dr. Frasier and Dr. Cho had no relevant disclosures.

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

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More Illnesses Possible Related Linked to Counterfeit Botulinum Toxin Reported

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Mon, 07/22/2024 - 09:56

In March 2024, four women in Tennessee and three in New York City fell ill after receiving botulinum neurotoxin (BoNT) injections in nonmedical settings, and four of the women required hospitalization — two in the intensive care unit. None of the cases required intubation, according to an announcement of an investigation into these reports in by the Centers for Disease Control and Prevention (CDC).

The report, published online in the Morbidity and Mortality Weekly Report, notes that the four patients in Tennessee received counterfeit BoNT, while product information was not available for the three cases in New York City. “However, one person reported paying less than US wholesale acquisition cost for the administered product, and another reported that the product had been purchased overseas,” the authors of the report wrote. The development underscores that BoNT injections “should be administered only by licensed and trained providers using recommended doses of FDA [Food and Drug Admininstration]-approved products.”

This report follows a CDC advisory published in April 2024 of at least 22 people from 11 states who reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in nonhealthcare settings, such as homes and spas.



The median age of the women in the July report was 48 years, and signs and symptoms included ptosis, dry mouth, dysphagia, shortness of breath, and weakness. Onset occurred between February 23 and March 7, 2024.

“This investigation did not determine why these illnesses occurred after cosmetic BoNT injections; potential reasons might include use of counterfeit BoNT, which might be more potent or contain harmful additional ingredients or higher susceptibility to BoNT effects among some persons,” the investigators wrote. They recommended further studies to describe the clinical spectrum of cosmetic BoNT injection effects such as severity of signs and symptoms.

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

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

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In March 2024, four women in Tennessee and three in New York City fell ill after receiving botulinum neurotoxin (BoNT) injections in nonmedical settings, and four of the women required hospitalization — two in the intensive care unit. None of the cases required intubation, according to an announcement of an investigation into these reports in by the Centers for Disease Control and Prevention (CDC).

The report, published online in the Morbidity and Mortality Weekly Report, notes that the four patients in Tennessee received counterfeit BoNT, while product information was not available for the three cases in New York City. “However, one person reported paying less than US wholesale acquisition cost for the administered product, and another reported that the product had been purchased overseas,” the authors of the report wrote. The development underscores that BoNT injections “should be administered only by licensed and trained providers using recommended doses of FDA [Food and Drug Admininstration]-approved products.”

This report follows a CDC advisory published in April 2024 of at least 22 people from 11 states who reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in nonhealthcare settings, such as homes and spas.



The median age of the women in the July report was 48 years, and signs and symptoms included ptosis, dry mouth, dysphagia, shortness of breath, and weakness. Onset occurred between February 23 and March 7, 2024.

“This investigation did not determine why these illnesses occurred after cosmetic BoNT injections; potential reasons might include use of counterfeit BoNT, which might be more potent or contain harmful additional ingredients or higher susceptibility to BoNT effects among some persons,” the investigators wrote. They recommended further studies to describe the clinical spectrum of cosmetic BoNT injection effects such as severity of signs and symptoms.

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

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

In March 2024, four women in Tennessee and three in New York City fell ill after receiving botulinum neurotoxin (BoNT) injections in nonmedical settings, and four of the women required hospitalization — two in the intensive care unit. None of the cases required intubation, according to an announcement of an investigation into these reports in by the Centers for Disease Control and Prevention (CDC).

The report, published online in the Morbidity and Mortality Weekly Report, notes that the four patients in Tennessee received counterfeit BoNT, while product information was not available for the three cases in New York City. “However, one person reported paying less than US wholesale acquisition cost for the administered product, and another reported that the product had been purchased overseas,” the authors of the report wrote. The development underscores that BoNT injections “should be administered only by licensed and trained providers using recommended doses of FDA [Food and Drug Admininstration]-approved products.”

This report follows a CDC advisory published in April 2024 of at least 22 people from 11 states who reported serious reactions after receiving botulinum toxin injections from unlicensed or untrained individuals or in nonhealthcare settings, such as homes and spas.



The median age of the women in the July report was 48 years, and signs and symptoms included ptosis, dry mouth, dysphagia, shortness of breath, and weakness. Onset occurred between February 23 and March 7, 2024.

“This investigation did not determine why these illnesses occurred after cosmetic BoNT injections; potential reasons might include use of counterfeit BoNT, which might be more potent or contain harmful additional ingredients or higher susceptibility to BoNT effects among some persons,” the investigators wrote. They recommended further studies to describe the clinical spectrum of cosmetic BoNT injection effects such as severity of signs and symptoms.

For cases of suspected systemic botulism, the CDC recommends calling the local or state health department for consultation and antitoxin release (as well as information on reporting adverse events). Alternatively, the 24/7 phone number for the CDC clinical botulism service is 770-488-7100.

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

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Push, Fail, Push Harder: Olympic Athletes Who Became MDs

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Fri, 07/19/2024 - 16:45

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

 

 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

 

 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

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Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

 

 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

 

 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

Your odds are 1 in 562,400.

Or, as Bill Mallon, the past president and cofounder of the International Society of Olympic Historians, has said, aspiring athletes have a 0.00000178% chance of making the Games.

Now imagine the odds of making the Olympics and then going on to become a physician. And maybe it’s not surprising that those who have done it credit the training they received as Olympic athletes as key to their success in medicine.

“Dealing with poor outcomes and having to get back up and try again,” said Olympian-turned-physician Ogonna Nnamani Silva, MD, “that reiterative process of trying to obtain perfection in your craft — that’s athletics 101.”

This connection isn’t just anecdotal. It has been discussed in medical journals and examined in surveys. The consensus is that, yes, there are specific characteristics elite athletes develop that physicians — regardless of their athletic background — can learn to apply to their work in medicine.

Maybe it’s something else, too: Certain mindsets don’t worry about long odds. They seek out crucibles again and again without concern for the heat involved. Because the outcome is worth it.

Here are four athletes who became high-performing physicians and how they did it.
 

The Gymnast/The Pediatric Surgeon

“Gymnastics helped me build a skill set for my career,” said Canadian Olympic gymnast-turned-pediatric orthopedic surgeon Lise Leveille, MD. “It led me to be successful as a medical student and ultimately obtain the job that I want in the area that I want working with the people that I want.”

The skills Dr. Leveille prizes include time management, teamwork, goal setting, and a strong work ethic, all of which propel an athlete to the crucial moment of “performance.”

“I miss performing,” said Dr. Leveille. “It defines who I was at that time. I miss being able to work toward something and then deliver when it counted” — like when she qualified for the 1998 Commonwealth games in Kuala Lumpur at 16.

The Canadian national team came third at that event, and Dr. Leveille built on that success at the Pan American Games, taking gold on the balance beam and as a team, and then qualifying for the Olympics at the 1999 World Championships. She competed in the team and five individual events at the 2000 Olympic Games in Sydney.

Though Dr. Leveille started gymnastics at age 3, her parents, both teachers, instilled in her the importance of education. Gymnastics opened academic doors for her, like being recruited to Stanford where she completed her undergraduate degree in biomedical engineering and human biology in 2004 before entering medical school at the University of British Columbia in Vancouver.

Now 41, Dr. Leveille accepts that she’ll never nail another gymnastics routine, but she channels that love of sticking the landing into the operating room at British Columbia Children’s Hospital, also in Vancouver.

“Some of the unknown variables within the operating room and how you deal with those unknown variables is exactly like showing up for a competition,” Dr. Leveille said. “When I have one of those cases where I have to perform under pressure and everything comes together, that’s exactly like nailing your routine when it counts most.”
 

 

 

The Pole Vaulter/The Emergency Medicine Physician

Tunisian American pole vaulter Leila Ben-Youssef, MD, had what could be considered a disappointing showing at the 2008 Olympic Games in Beijing. She collapsed from severe abdominal pain during the opening ceremony and had to be carried out. On the day of competition, she was still suffering. “I could barely run down the runway,” she recalled. “I cleared one bar. I was just happy to have been able to do that.”

When Dr. Ben-Youssef, who grew up in Montana, returned home, she underwent emergency surgery to remove the source of the pain: A large, benign tumor.

While some might be devastated by such bad luck, Dr. Ben-Youssef focuses on the success of her journey — the fact that she qualified and competed at the Olympics in the first place. The ability to accept setbacks is something she said comes with the territory.

“As an athlete, you’re always facing injury, and someone told me early in my career that the best athletes are the ones that know how to manage their expectations because it’s bound to happen,” she said. “So, there is disappointment. But recognizing that I did qualify for the Olympics despite being uncomfortable and having issues, I was still able to meet my goal.”

Prior to the games, Dr. Ben-Youssef had been accepted into medical school at the University of Washington School of Medicine at Montana State University in Bozeman, Montana. Thankfully, the school was supportive of Dr. Ben-Youssef’s Olympic dreams and allowed her to begin her studies a month behind her class. Upon her return from Beijing, she spent the rest of her medical school training with her head down, grinding.

“Medicine is hard,” said Dr. Ben-Youssef. “It’s grueling both physically and emotionally, and I think that’s similar to any elite sport. You’re going to deal with challenges and disappointment. I think having gone through that as an athlete really prepares you for the medical education system, for residency, and even for day-to-day work.”

Now a physician working in emergency medicine in Hawaii, Dr. Ben-Youssef feels the setbacks she experienced as an athlete help her connect with her patients as they deal with health challenges.

And as a volunteer pole vaulting coach for a local high school, Dr. Ben-Youssef has been able to surround herself with the positive, joyful energy of athletes. “Emergency medicine is often a sad place,” she said. “But in a sports environment, if people don’t succeed or are injured, there is still that energy there that strives for something, and it’s so fun to be around.”
 

The Rower/The Sports Medicine Specialist

Three-time US Olympic rower Genevra “Gevvie” Stone, MD, wanted to be a doctor even before she gave a thought to rowing. She was in eighth grade when she dislocated her knee for the third time. Her parents took her to a pediatric orthopedist, and Dr. Stone, according to her mom, declared: “That’s what I want to do when I grow up.”

“I’m a very stubborn person, and when I make a decision like that, I usually don’t veer from it,” Dr. Stone said.

That laser focus combined with a deep love of both sports and medicine has served Dr. Stone well. “Becoming a doctor and becoming an Olympian require you to dedicate not just your time and your energy but also your passion to that focus,” she said. “In both, you aren’t going to be successful if you don’t love what you’re doing. Finding the reward in it is what makes it achievable.”

Dr. Stone actually resisted rowing until she was 16 because both of her parents were Olympians in the sport and met on the US team. “It was their thing, and I didn’t want it to be my thing,” she recalled.

Nonetheless, Dr. Stone easily fell into the sport in her late teens and was recruited by Princeton University. “I had grown up around Olympians and kind of took it for granted that if you worked hard enough and were decent at rowing, then you could be one of the best in the world, without really realizing how difficult it would be to achieve that,” she said.

Dr. Stone’s team won the NCAA Championship in 2006 and was invited to try out for the 2008 Olympic team at the US training center after she graduated from college. But she didn’t make it.

Instead, Dr. Stone entered medical school at Tufts University School of Medicine, Boston, thinking her competitive rowing career had come to end. But her love for the sport was still strong, and she realized she wasn’t finished.

After 2 years of medical school, Dr. Stone requested 2 years off so she might have another shot at making the Olympic team. The timing was right. She went to the London Olympics in 2012, graduated from medical school in 2014, and then took 2 more years off to train full time for the 2016 Olympics in Rio where she won silver.

At the 2020 Olympic Games in Tokyo, Dr. Stone took fifth place in the double sculls. While she continues to race the master’s circuit, she’s primarily dedicated to completing her sports medicine fellowship at University of Utah Health.

Fortunately, Dr. Stone’s parents, coaches, and teachers always supported her goals. “No one turned to me and told me I was crazy, just choose medicine or rowing,” she said. “Everyone said that if this is what you want to do, we’re here to support you, and I wouldn’t have been able to do it without that support.”
 

 

 

The Volleyball Player/The Plastic Surgeon

Dr. Nnamani Silva’s journey to the Olympics was also paved with an extensive list of supporters, beginning with her parents. And she has taken that sense of collaboration, coordination, and teamwork into her medical career.

The daughter of Nigerian immigrants who came to the United States to escape civil war, Dr. Nnamani Silva said her parents embraced the American dream. “To see what they were able to do with hard work, dedication, and sacrifice, I had no choice but to work hard because I saw their example. And that love for and belief in America was so strong in my house growing up,” she said.

Dreams of practicing medicine came first. A severe asthmatic growing up, Dr. Nnamani Silva recalled having wonderful doctors. “I had so many emergency room visits and hospitalizations,” she said. “But the doctors always gave me hope, and they literally transformed my life. I thought if I could pass that on to my future patients, that would be the greatest honor of my life.”

Volleyball gave Dr. Nnamani Silva the opportunity to attend Stanford, and she took time off during her junior year to train and compete in the 2004 Olympic Games in Athens. She also played for the United States at the 2008 Olympic Games in Beijing where the team took silver. Afterward, she continued to play overseas for several years.

At 33, and with a newborn daughter, Dr. Nnamani Silva returned to her original goal of becoming a doctor. She attended the University of California, San Francisco, and is currently a resident in the Harvard Plastic Surgery Program. She includes her husband, parents, and in-laws in this achievement, whom she said “saved” her. “There is no chance I would have finished medical school and survived residency without them.”

As a volleyball player, Dr. Nnamani Silva said she “believes in teams wholeheartedly,” valuing the exchange of energy and skill that she feels brings out the best in people. As a medical student, she initially didn’t realize how her previous life would apply to teamwork in the operating room. But it soon became clear.

“In surgery, when you harness the talents of everyone around you and you create that synergy, it’s an amazing feeling,” she said. And the stakes are often high. “It requires a lot of focus, discipline, determination, and resilience because you’re going to be humbled all the time.” Something athletes know a little bit about.

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

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Study Detects Bacteria in Tattoo, Permanent Makeup Inks

Article Type
Changed
Mon, 08/12/2024 - 13:17

Commercial tattoo and permanent makeup inks are too often contaminated with microbes that can lead to infection, warn investigators of a first-of-its-kind study testing the products. 

When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.

Gloved hands applying tattoo needle to skin
Venerala/gettyimages


They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.

“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release. 

The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.

New Body Art Culture

Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.

This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.

Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains. 

Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.

Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria. 

There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.

“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.

The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.

The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.

Counseling Patients

Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.

Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization. 

Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.

“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.” 

Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.

The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.

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

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Commercial tattoo and permanent makeup inks are too often contaminated with microbes that can lead to infection, warn investigators of a first-of-its-kind study testing the products. 

When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.

Gloved hands applying tattoo needle to skin
Venerala/gettyimages


They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.

“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release. 

The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.

New Body Art Culture

Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.

This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.

Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains. 

Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.

Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria. 

There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.

“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.

The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.

The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.

Counseling Patients

Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.

Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization. 

Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.

“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.” 

Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.

The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.

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

Commercial tattoo and permanent makeup inks are too often contaminated with microbes that can lead to infection, warn investigators of a first-of-its-kind study testing the products. 

When US researchers tested 75 unopened and sealed tattoo and permanent makeup inks from 14 different manufacturers, they discovered that about 35% of the products were contaminated with bacteria.

Gloved hands applying tattoo needle to skin
Venerala/gettyimages


They detected both aerobic bacteria and anaerobic bacteria, which thrive in low-oxygen environments like the dermal layer of the skin.

“This suggests that contaminated tattoo inks could be a source of infection from both types of bacteria,” Seong-Jae Peter Kim, PhD, a microbiologist with the Division of Microbiology, National Center for Toxicological Research, US Food and Drug Administration, who worked on the study, said in a news release. 

The findings “are concerning,” said Waleed Javaid, MD, professor of medicine and director of infection prevention and control for the Mount Sinai Health System in New York City. “This contamination poses a significant health risk, as these inks are injected into the dermal layer of the skin, creating an environment conducive to bacterial infections,” said Dr. Javaid, who wasn’t involved in the study, which was published online in Applied and Environmental Microbiology.

New Body Art Culture

Tattoos are more popular than ever, and it is estimated that at least 32% of people in the United States have at least one tattoo. And the rise in popularity has coincided with an increase in ink-related infections.

This new research joins previous studies that have demonstrated that commercial tattoo and permanent makeup inks are often contaminated with pathogenic microorganisms.

Of the 75 ink samples that Dr. Kim and colleagues tested, 26 were contaminated with 34 bacterial isolates classified into 14 genera and 22 species. Among the 34 bacterial isolates, 19 were identified as possibly pathogenic bacterial strains. 

Two species — Cutibacterium acnes (four strains) and Staphylococcus epidermidis (two strains) — were isolated under anaerobic conditions.

Two possibly pathogenic bacterial strains — Staphylococcus saprophyticus and C acnes — were isolated from the same two ink samples, indicating that tattoo and permanent makeup inks can harbor both aerobic (S saprophyticus) and anaerobic (C acnes) bacteria. 

There was no significant association between sterility claims on the ink label and the absence of bacterial contamination.

“The presence of bacteria like Cutibacterium acnes and Staphylococcus epidermidis, which can cause skin infections and other complications, underscores the potential danger to individuals receiving tattoos or permanent makeup,” Dr. Javaid explained.

The results “emphasize the importance of monitoring these products for both aerobic and anaerobic bacteria, including possibly pathogenic microorganisms,” Dr. Kim said in the news release.

The next steps, according to the researchers, include developing more efficient and accurate microbial detection methods for tattoo inks to streamline the monitoring process and examining the occurrence, co-occurrence, and diversity of microbial contaminants in tattoo inks to prevent future contamination.

Counseling Patients

Healthcare professionals play a “crucial role in counseling patients about the risks associated with tattoos. They should inform patients about the potential for infections, allergic reactions, and other complications related to tattooing and permanent ink,” said Dr. Javaid.

Specific advice can include ensuring that the tattoo parlor adheres to strict hygiene practices and verifying that tattoo inks are from reputable sources and, if possible, have undergone sterilization. 

Clinicians should discuss the importance of proper aftercare to minimize the risk for infection, recommend patients with compromised immune systems or skin conditions to reconsider getting a tattoo, and encourage patients to be aware of the signs of infection and to seek medical attention promptly if any symptoms arise.

“Enhanced regulatory measures would help reduce the risk of infections and ensure safer tattooing practices for consumers,” Dr. Javaid said. The findings of Dr. Kim and colleagues “indicate that current manufacturing and sterilization processes are inadequate.” 

Regulations could include stricter manufacturing standards to ensure sterility, the mandatory testing of inks for microbial contamination before they reach the market, clear labeling requirements that accurately reflect the sterility and safety of products, and regular inspections and audits of tattoo ink manufacturers, he said, which could encourage the development of more effective sterilization techniques to eliminate bacterial contamination.

The FDA has created a document — Think Before You Ink: Tattoo Safety — for consumers who are considering getting a tattoo.

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

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In Some Patients, Antiseizure Medications Can Cause Severe Skin Reactions

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Thu, 07/18/2024 - 10:53

Avoiding severe skin reactions to antiseizure medications (ASMs) requires assessing patient risk factors and prescribing lower-risk drugs wherever possible, according to authors of a recent review. And if putting higher-risk patients on drugs most associated with human leukocyte antigen (HLA)–related reaction risk before test results are available, authors advised starting at low doses and titrating slowly.

“When someone is having a seizure drug prescribed,” said senior author Ram Mani, MD, MSCE, chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, “it’s often a tense clinical situation because the patient has either had the first few seizures of their life, or they’ve had a worsening in their seizures.”

Ram Mani, MD, MSCE, is chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.
courtesy Rutgers Robert Wood Johnson Medical School
Dr. Ram Mani

To help physicians optimize choices, Dr. Mani and colleagues reviewed literature regarding 31 ASMs. Their study was published in Current Treatment Options in Neurology.

Overall, said Dr. Mani, incidence of benign skin reactions such as morbilliform exanthematous eruptions, which account for 95% of cutaneous adverse drug reactions (CADRs), ranges from a few percent up to 15%. “It’s a somewhat common occurrence. Fortunately, the reactions that can lead to morbidity and mortality are fairly rare.”
 

Severe Cutaneous Adverse Reactions

Among the five ASMs approved by the Food and Drug Administration since 2018, cenobamate has sparked the greatest concern. In early clinical development for epilepsy, a fast titration schedule (starting at 50 mg/day and increasing by 50 mg every 2 weeks to at least 200 mg/day) resulted in three cases of drug reaction with eosinophilia and systemic symptoms (DRESS, also called drug-induced hypersensitivity reaction/DIHS), including one fatal case. Based on a phase 3 trial, the drug’s manufacturer now recommends starting at 12.5 mg and titrating more slowly.

DRESS/DIHS appears within 2-6 weeks of drug exposure. Along with malaise, fever, and conjunctivitis, symptoms can include skin eruptions ranging from morbilliform to hemorrhagic and bullous. “Facial edema and early facial rash are classic findings,” the authors added. DRESS also can involve painful lymphadenopathy and potentially life-threatening damage to the liver, heart, and other organs.

Stevens-Johnson syndrome (SJS), which is characterized by detached skin measuring less than 10% of the entire body surface area, typically happens within the first month of drug exposure. Flu-like symptoms can appear 1-3 days before erythematous to dusky macules, commonly on the chest, as well as cutaneous and mucosal erosions. Along with the skin and conjunctiva, SJS can affect the eyes, lungs, liver, bone marrow, and gastrointestinal tract.

When patients present with possible DRESS or SJS, the authors recommended inpatient multidisciplinary care. Having ready access to blood tests can help assess severity and prognosis, Dr. Mani explained. Inpatient evaluation and treatment also may allow faster access to other specialists as needed, and monitoring of potential seizure exacerbation in patients with uncontrolled seizures for whom the drug provided benefit but required abrupt discontinuation.

Often, he added, all hope is not lost for future use of the medication after a minor skin reaction. A case series and literature review of mild lamotrigine-associated CADRs showed that most patients could reintroduce and titrate lamotrigine by waiting at least 4 weeks, beginning at 5 mg/day, and gradually increasing to 25 mg/day.
 

 

 

Identifying Those at Risk

With millions of patients being newly prescribed ASMs annually, accurately screening out all people at risk of severe cutaneous adverse reactions based on available genetic information is impossible. The complexity of evolving recommendations for HLA testing makes them hard to remember, Dr. Mani said. “Development and better use of clinical decision support systems can help.”

Accordingly, he starts with a thorough history and physical examination, inquiring about prior skin reactions or hypersensitivity, which are risk factors for future reactions to drugs such as carbamazepine, phenytoin, phenobarbital, oxcarbazepine, lamotrigine, rufinamide, and zonisamide. “Most of the medicines that the HLA tests are being done for are not the initial medicines I typically prescribe for a patient with newly diagnosed epilepsy,” said Dr. Mani. For ASM-naive patients with moderate or high risk of skin hypersensitivity reactions, he usually starts with lacosamide, levetiracetam, or brivaracetam. Additional low-risk drugs he considers in more complex cases include valproate, topiramate, and clobazam.

Only if a patient’s initial ASM causes problems will Dr. Mani consider higher-risk options and order HLA tests for patients belonging to indicated groups — such as testing for HLA-B*15:02 in Asian patients being considered for carbamazepine. About once weekly, he must put a patient on a potentially higher-risk drug before test results are available. If after a thorough risk-benefit discussion, he and the patient agree that the higher-risk drug is warranted, Dr. Mani starts at a lower-than-labeled dose, with a slower titration schedule that typically extends the ramp-up period by 1 week.

Fortunately, Dr. Mani said that, in 20 years of practice, he has seen more misdiagnoses — involving rashes from poison ivy, viral infections, or allergies — than actual ASM-induced reactions. “That’s why the patient, family, and practitioner need to be open-minded about what could be causing the rash.”

Dr. Mani reported no relevant conflicts. The study authors reported no funding sources.

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Avoiding severe skin reactions to antiseizure medications (ASMs) requires assessing patient risk factors and prescribing lower-risk drugs wherever possible, according to authors of a recent review. And if putting higher-risk patients on drugs most associated with human leukocyte antigen (HLA)–related reaction risk before test results are available, authors advised starting at low doses and titrating slowly.

“When someone is having a seizure drug prescribed,” said senior author Ram Mani, MD, MSCE, chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, “it’s often a tense clinical situation because the patient has either had the first few seizures of their life, or they’ve had a worsening in their seizures.”

Ram Mani, MD, MSCE, is chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.
courtesy Rutgers Robert Wood Johnson Medical School
Dr. Ram Mani

To help physicians optimize choices, Dr. Mani and colleagues reviewed literature regarding 31 ASMs. Their study was published in Current Treatment Options in Neurology.

Overall, said Dr. Mani, incidence of benign skin reactions such as morbilliform exanthematous eruptions, which account for 95% of cutaneous adverse drug reactions (CADRs), ranges from a few percent up to 15%. “It’s a somewhat common occurrence. Fortunately, the reactions that can lead to morbidity and mortality are fairly rare.”
 

Severe Cutaneous Adverse Reactions

Among the five ASMs approved by the Food and Drug Administration since 2018, cenobamate has sparked the greatest concern. In early clinical development for epilepsy, a fast titration schedule (starting at 50 mg/day and increasing by 50 mg every 2 weeks to at least 200 mg/day) resulted in three cases of drug reaction with eosinophilia and systemic symptoms (DRESS, also called drug-induced hypersensitivity reaction/DIHS), including one fatal case. Based on a phase 3 trial, the drug’s manufacturer now recommends starting at 12.5 mg and titrating more slowly.

DRESS/DIHS appears within 2-6 weeks of drug exposure. Along with malaise, fever, and conjunctivitis, symptoms can include skin eruptions ranging from morbilliform to hemorrhagic and bullous. “Facial edema and early facial rash are classic findings,” the authors added. DRESS also can involve painful lymphadenopathy and potentially life-threatening damage to the liver, heart, and other organs.

Stevens-Johnson syndrome (SJS), which is characterized by detached skin measuring less than 10% of the entire body surface area, typically happens within the first month of drug exposure. Flu-like symptoms can appear 1-3 days before erythematous to dusky macules, commonly on the chest, as well as cutaneous and mucosal erosions. Along with the skin and conjunctiva, SJS can affect the eyes, lungs, liver, bone marrow, and gastrointestinal tract.

When patients present with possible DRESS or SJS, the authors recommended inpatient multidisciplinary care. Having ready access to blood tests can help assess severity and prognosis, Dr. Mani explained. Inpatient evaluation and treatment also may allow faster access to other specialists as needed, and monitoring of potential seizure exacerbation in patients with uncontrolled seizures for whom the drug provided benefit but required abrupt discontinuation.

Often, he added, all hope is not lost for future use of the medication after a minor skin reaction. A case series and literature review of mild lamotrigine-associated CADRs showed that most patients could reintroduce and titrate lamotrigine by waiting at least 4 weeks, beginning at 5 mg/day, and gradually increasing to 25 mg/day.
 

 

 

Identifying Those at Risk

With millions of patients being newly prescribed ASMs annually, accurately screening out all people at risk of severe cutaneous adverse reactions based on available genetic information is impossible. The complexity of evolving recommendations for HLA testing makes them hard to remember, Dr. Mani said. “Development and better use of clinical decision support systems can help.”

Accordingly, he starts with a thorough history and physical examination, inquiring about prior skin reactions or hypersensitivity, which are risk factors for future reactions to drugs such as carbamazepine, phenytoin, phenobarbital, oxcarbazepine, lamotrigine, rufinamide, and zonisamide. “Most of the medicines that the HLA tests are being done for are not the initial medicines I typically prescribe for a patient with newly diagnosed epilepsy,” said Dr. Mani. For ASM-naive patients with moderate or high risk of skin hypersensitivity reactions, he usually starts with lacosamide, levetiracetam, or brivaracetam. Additional low-risk drugs he considers in more complex cases include valproate, topiramate, and clobazam.

Only if a patient’s initial ASM causes problems will Dr. Mani consider higher-risk options and order HLA tests for patients belonging to indicated groups — such as testing for HLA-B*15:02 in Asian patients being considered for carbamazepine. About once weekly, he must put a patient on a potentially higher-risk drug before test results are available. If after a thorough risk-benefit discussion, he and the patient agree that the higher-risk drug is warranted, Dr. Mani starts at a lower-than-labeled dose, with a slower titration schedule that typically extends the ramp-up period by 1 week.

Fortunately, Dr. Mani said that, in 20 years of practice, he has seen more misdiagnoses — involving rashes from poison ivy, viral infections, or allergies — than actual ASM-induced reactions. “That’s why the patient, family, and practitioner need to be open-minded about what could be causing the rash.”

Dr. Mani reported no relevant conflicts. The study authors reported no funding sources.

Avoiding severe skin reactions to antiseizure medications (ASMs) requires assessing patient risk factors and prescribing lower-risk drugs wherever possible, according to authors of a recent review. And if putting higher-risk patients on drugs most associated with human leukocyte antigen (HLA)–related reaction risk before test results are available, authors advised starting at low doses and titrating slowly.

“When someone is having a seizure drug prescribed,” said senior author Ram Mani, MD, MSCE, chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey, “it’s often a tense clinical situation because the patient has either had the first few seizures of their life, or they’ve had a worsening in their seizures.”

Ram Mani, MD, MSCE, is chief of epilepsy at Rutgers Robert Wood Johnson Medical School in New Brunswick, New Jersey.
courtesy Rutgers Robert Wood Johnson Medical School
Dr. Ram Mani

To help physicians optimize choices, Dr. Mani and colleagues reviewed literature regarding 31 ASMs. Their study was published in Current Treatment Options in Neurology.

Overall, said Dr. Mani, incidence of benign skin reactions such as morbilliform exanthematous eruptions, which account for 95% of cutaneous adverse drug reactions (CADRs), ranges from a few percent up to 15%. “It’s a somewhat common occurrence. Fortunately, the reactions that can lead to morbidity and mortality are fairly rare.”
 

Severe Cutaneous Adverse Reactions

Among the five ASMs approved by the Food and Drug Administration since 2018, cenobamate has sparked the greatest concern. In early clinical development for epilepsy, a fast titration schedule (starting at 50 mg/day and increasing by 50 mg every 2 weeks to at least 200 mg/day) resulted in three cases of drug reaction with eosinophilia and systemic symptoms (DRESS, also called drug-induced hypersensitivity reaction/DIHS), including one fatal case. Based on a phase 3 trial, the drug’s manufacturer now recommends starting at 12.5 mg and titrating more slowly.

DRESS/DIHS appears within 2-6 weeks of drug exposure. Along with malaise, fever, and conjunctivitis, symptoms can include skin eruptions ranging from morbilliform to hemorrhagic and bullous. “Facial edema and early facial rash are classic findings,” the authors added. DRESS also can involve painful lymphadenopathy and potentially life-threatening damage to the liver, heart, and other organs.

Stevens-Johnson syndrome (SJS), which is characterized by detached skin measuring less than 10% of the entire body surface area, typically happens within the first month of drug exposure. Flu-like symptoms can appear 1-3 days before erythematous to dusky macules, commonly on the chest, as well as cutaneous and mucosal erosions. Along with the skin and conjunctiva, SJS can affect the eyes, lungs, liver, bone marrow, and gastrointestinal tract.

When patients present with possible DRESS or SJS, the authors recommended inpatient multidisciplinary care. Having ready access to blood tests can help assess severity and prognosis, Dr. Mani explained. Inpatient evaluation and treatment also may allow faster access to other specialists as needed, and monitoring of potential seizure exacerbation in patients with uncontrolled seizures for whom the drug provided benefit but required abrupt discontinuation.

Often, he added, all hope is not lost for future use of the medication after a minor skin reaction. A case series and literature review of mild lamotrigine-associated CADRs showed that most patients could reintroduce and titrate lamotrigine by waiting at least 4 weeks, beginning at 5 mg/day, and gradually increasing to 25 mg/day.
 

 

 

Identifying Those at Risk

With millions of patients being newly prescribed ASMs annually, accurately screening out all people at risk of severe cutaneous adverse reactions based on available genetic information is impossible. The complexity of evolving recommendations for HLA testing makes them hard to remember, Dr. Mani said. “Development and better use of clinical decision support systems can help.”

Accordingly, he starts with a thorough history and physical examination, inquiring about prior skin reactions or hypersensitivity, which are risk factors for future reactions to drugs such as carbamazepine, phenytoin, phenobarbital, oxcarbazepine, lamotrigine, rufinamide, and zonisamide. “Most of the medicines that the HLA tests are being done for are not the initial medicines I typically prescribe for a patient with newly diagnosed epilepsy,” said Dr. Mani. For ASM-naive patients with moderate or high risk of skin hypersensitivity reactions, he usually starts with lacosamide, levetiracetam, or brivaracetam. Additional low-risk drugs he considers in more complex cases include valproate, topiramate, and clobazam.

Only if a patient’s initial ASM causes problems will Dr. Mani consider higher-risk options and order HLA tests for patients belonging to indicated groups — such as testing for HLA-B*15:02 in Asian patients being considered for carbamazepine. About once weekly, he must put a patient on a potentially higher-risk drug before test results are available. If after a thorough risk-benefit discussion, he and the patient agree that the higher-risk drug is warranted, Dr. Mani starts at a lower-than-labeled dose, with a slower titration schedule that typically extends the ramp-up period by 1 week.

Fortunately, Dr. Mani said that, in 20 years of practice, he has seen more misdiagnoses — involving rashes from poison ivy, viral infections, or allergies — than actual ASM-induced reactions. “That’s why the patient, family, and practitioner need to be open-minded about what could be causing the rash.”

Dr. Mani reported no relevant conflicts. The study authors reported no funding sources.

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‘Emerging Threat’ Xylazine Use Continues to Spread Across the United States

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Wed, 09/04/2024 - 10:19

 

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

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Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

 

Illicit use of the veterinary tranquilizer xylazine continues to spread across the United States. The drug, which is increasingly mixed with fentanyl, often fails to respond to the opioid overdose reversal medication naloxone and can cause severe necrotic lesions.

A report released by Millennium Health, a specialty lab that provides medication monitoring for pain management, drug treatment, and behavioral and substance use disorder treatment centers across the country, showed the number of urine specimens collected and tested at the US drug treatment centers were positive for xylazine in the most recent 6 months.

As previously reported by this news organization, in late 2022, the US Food and Drug Administration (FDA) issued a communication alerting clinicians about the special management required for opioid overdoses tainted with xylazine, which is also known as “tranq” or “tranq dope.”

Subsequently, in early 2023, The White House Office of National Drug Control Policy designated xylazine combined with fentanyl as an emerging threat to the United States.

Both the FDA and the Drug Enforcement Administration have taken steps to try to stop trafficking of the combination. However, despite these efforts, xylazine use has continued to spread.

The Millennium Health Signals report showed that the greatest increase in xylazine use was largely in the western United States. In the first 6 months of 2023, 3% of urine drug tests (UDTs) in Washington, Oregon, California, Hawaii, and Alaska were positive for xylazine. From November 2023 to April 2024, this rose to 8%, a 147% increase. In the Mountain West, xylazine-positive UDTs increased from 2% in 2023 to 4% in 2024, an increase of 94%. In addition to growth in the West, the report showed that xylazine use increased by more than 100% in New England — from 14% in 2023 to 28% in 2024.

Nationally, 16% of all urine specimens were positive for xylazine from late 2023 to April 2024, up slightly from 14% from April to October 2023.

Xylazine use was highest in the East and in the mid-Atlantic United States. Still, positivity rates in the mid-Atlantic dropped from 44% to 33%. The states included in that group were New York, Pennsylvania, Delaware, and New Jersey. East North Central states (Ohio, Michigan, Wisconsin, Indiana, and Illinois) also experienced a decline in positive tests from 32% to 30%.

The South Atlantic states, which include Maryland, Virginia, West Virginia, North and South Carolina, Georgia, and Florida, had a 17% increase in positivity — from 22% to 26%.

From April 2023 to April 2024 state-level UDT positivity rates were 40% in Pennsylvania, 37% in New York, and 35% in Ohio. But rates vary by locality. In Clermont and Hamilton counties in Ohio — both in the Cincinnati area — about 70% of specimens were positive for xylazine.

About one third of specimens in Maryland and South Carolina contained xylazine.

“Because xylazine exposure remains a significant challenge in the East and is a growing concern in the West, clinicians across the US need to be prepared to recognize and address the consequences of xylazine use — like diminished responses to naloxone and severe skin wounds that may lead to amputation — among people who use fentanyl,” Millennium Health Chief Clinical Officer Angela Huskey, PharmD, said in a press release.

The Health Signals Alert analyzed more than 50,000 fentanyl-positive UDT specimens collected between April 12, 2023, and April 11, 2024. Millennium Health researchers analyzed xylazine positivity rates in fentanyl-positive UDT specimens by the US Census Division and state.

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

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Revamping Resident Schedules to Reduce Burnout

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Changed
Wed, 07/17/2024 - 12:34

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

 

 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

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It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

 

 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

It’s the difference between running a marathon and taking a leisurely stroll. That’s how recent pediatrics resident Joey Whelihan, MD, compared an 11-hour inpatient hospital day with an 8-hour outpatient shift where residents see patients in a clinic.

With inpatient training, “you are lucky if you have time to cook dinner, go to bed, and get ready for the next day,” said Dr. Whelihan, who recently started his adolescent medicine fellowship at Children’s Hospital of Philadelphia after 3 years of residency there. Some residents have call every fourth day during inpatient rotations, working 24-28 hours at a time. They come in one morning and go home the next, he told this news organization.

“Outpatient blocks give you more time to catch your breath and feel somewhat refreshed and ready to take care of patients.”

Longer stretches of inpatient rotations are not sustainable, Dr. Whelihan added, and residents are likely to become exhausted. Fatigue is a leading cause of burnout, a mental, physical, and emotional challenge that residency programs and national medical organizations have been struggling to address.

In recent years, there has been a movement to reduce the maximum consecutive duration of resident duty hours in residency programs across the country. Fueled by resident health and patient safety concerns, the movement is a shift from the previous 24- to 36-hour call duty schedules.
 

Improved Call Systems = Better Residents

The connection between burnout, well-being, and work schedules appears regularly in national program standards. “Residents and faculty members are at risk for burnout and depression,” according to the current Accreditation Council for Graduate Medical Education’s standard residency program requirements.

“Programs, in partnership with their sponsoring institutions, have the same responsibility to address well-being as other aspects of resident competence,” the guidelines state. That charge includes “attention to scheduling, work intensity, and work compression that impacts resident well-being.”

In Medscape’s Residents Lifestyle & Happiness Report 2023, a third of residents surveyed rarely or never paid attention to their well-being, which closely mirrors the 31% who rarely or never had time for a social life. Slightly more residents (37%) said their work-life balance was “somewhat worse” or “much worse” than they expected.

“I think everyone has burnout as a resident, regardless of the type of program they are in,” Dr. Whelihan said. He described the experience as when you lack fulfillment and empathy and feel exhausted, callous, and removed from interactions with colleagues and patients.

The American Medical Association’s recently released report on the state of residency well-being in 2023 also found that about 43% of residents and fellows had at least one symptom of burnout, about a 2% increase from 2022.
 

Efforts to Combat Burnout

One residency program found a way to reduce burnout by changing its block scheduling from 4 inpatient weeks followed by 1 outpatient week (4 + 1) to 4 inpatient call-based weeks and 4 outpatient ambulatory, non-call weeks (4 + 4), according to a survey study published recently in JAMA Network Open. The initiative drew praise from some residents and a med school professor who studies wellness issues.

In the survey of postgraduate year (PGY) 1 and PGY-2 hospitalist and primary care residents from the University of Colorado’s Internal Medicine Residency Program, Aurora, between June 2019 and June 2021, the schedule change resulted in improved burnout scores and self-reported professional, educational, and health benefits.

As part of the survey, residents rated symptoms on a 7-point scale on the basis of how frequently they experienced emotional exhaustion, depersonalization, and personal accomplishment.

Investigators also used a questionnaire to evaluate how participants perceived the rotation structure with various outcomes, including the ability to acquire clinical skills, access educational and scholarly opportunities, job satisfaction, and health.

The study concluded that the schedule change improved burnout, health, wellness, and professional development without weakening residents perceived clinical skills or standardized exam scores.

Still, the study authors acknowledged that several factors, including the pandemic, may have limited the findings. During that time, the study transitioned from in-person to electronic submissions, resulting in reduced response rates because of changes in staffing needs and fewer research and scholarly activities.

“One of the things we worried about was that the pandemic would make [burnout findings] look worse,” said lead author Dan Heppe, MD, a hospitalist and associate director of the CU Internal Medicine Residency Program. “Anecdotally, residents may have had more support in our program than perhaps some other programs. Though they had long hours with very sick patients, we tried to keep going in a positive direction.”

Dr. Heppe said in an interview that the purpose of the schedule change was to space out more intense rotations and build in more time for research, leadership, teaching, and professional development. He suggested the new schedule could help with other aspects of residents’ careers, exposing them to alternate avenues earlier in their training and in a more structured way.

Like most of the study authors, Dr. Heppe is a graduate of the residency program. He recalled how the program changed from multiple inpatient months in a row with clinic half days during those rotations to a 4 + 1 schedule. But the 1 week between inpatient rotations wasn’t enough time to recover or catch up on clinical work, said Dr. Heppe, who is also an associate professor of medicine at CU.

“It was too erratic,” he said of his former residency schedule. “There was a month of research here or there and clinic and then right back to the ICU for a couple of months without a break, and it was less predictable.”

Dr. Heppe said other residency programs have expressed interest in duplicating CU’s schedule change. He admits it may be difficult because of intensive schedule coordination, and some hospitals may not want to reduce clinical services.

The Yale Internal Medicine Traditional Residency Program also recently ended its 28-hour call, during which residents worked 24 hours with an additional 4 hours to transfer the patient to the incoming team. The move was made in response to residents’ requests, saying that the grueling call rotation’s time had come. The reaction has been overwhelmingly positive.

Proponents of alternate scheduling blocks [4 + 4 or 6 + 2] say that they improve residents’ educational experience, patient care, and continuity of care, reduce burnout, and guarantee residents time off.
 

 

 

Advancing Resident Well-Being

“The premise of looking at scheduling in a more intentional way is a sound one in the process of trying to support and advance resident well-being,” said Mark Greenawald, MD, vice chair of academic affairs, well-being, and professional development for the Virginia Tech Carilion School of Medicine’s Department of Family and Community Medicine in Roanoke.

He said it’s up to residency program directors or graduate medical education departments within a specialty to determine whether such scheduling changes fit their requirements for inpatient and outpatient care and training electives. Requirements may limit some scheduling changes, but within the specialty, there’s some flexibility to be creative with rotations. The CU study considered how to create a residency rhythm without stacking inpatient rotations so there’s recovery time.

“Human beings need a break. If residents work 80 hours continually, they will start to experience greater distress, which for many leads to burnout,” he said

Still, the study includes design flaws because it doesn’t explain how call times and hours differ between inpatient and outpatient rotations. “My own [family medicine] program also does outpatient clinics when we have inpatient service. We have half days in the clinic, which ensures better continuity care with the patient.”

Dr. Greenawald has yet to see much research published about the impact of resident schedule changes. By taking an experimental approach, the CU study showed that their particular change positively affected burnout. If the study leads to improvements in rotation schedules or encourages other programs to experiment with their schedules, it will be a step in the right direction.
 

How Residents Respond

Haidn Foster, MD, a third-year internal medicine resident at Penn State Health Milton S. Hershey Medical Center, Hershey, remembered experiencing burnout as an intern. At that time, he occasionally dealt with poor patient outcomes and sick patients while working long hours with only 1 day off each week. During a particularly challenging rotation, he felt overwhelmed and numb, which was exacerbated if a patient’s condition worsened or they passed away, he said.

His program follows a schedule of 6 weeks of inpatient training and 2 weeks of outpatient rotations (6 + 2). He said that restructuring residents’ schedules may be more effective than commonly used individual wellness modules, referring to the CU study. “The authors tried out a novel systematic way to tackle the epidemic of physician burnout overwhelming people in the medical community.”

Although the study found that schedule changes don’t affect standardized exam scores, Dr. Foster wondered about preceptor ratings, another marker for clinical competency.

He said future studies should attempt to change the structure of medical training delivery by evaluating models that best reduce burnout, are consistent with residents’ career goals, and produce competent physicians. “Burnout plagues our medical system and leads to too many physicians and physicians-in-training leaving the field or taking their lives. I’m not sure this particular mechanism gets us there, but it’s a step, and so that’s very important.”

Like Dr. Foster, Dr. Whelihan follows a 6 + 2 schedule. He said he would have welcomed a schedule that included more outpatient and less inpatient training and can see how changes in scheduling could reduce burnout. “More outpatient time gives you an opportunity to breathe. You get a little more time off working in clinic with less sick people at a slower pace.”

Ally Fuher, MD, said she chose CU’s Internal Medicine Residency Program 4 years ago largely because of its innovative schedule. Now the program’s chief medical resident, she knew the structure would give her more time to pursue other nonclinical interests including research and medical education, meet regularly with mentors, visit family in another state, and attend important life events.

She acknowledged that the alternative would have meant a more irregular schedule with the possibility of working as many as 80 hours a week on back-to-back inpatient rotations with only 1 day off a week, leaving minimal time to plan other activities, let alone rest and recover.

Dr. Fuher said a balanced schedule made her a more well-rounded person excited to engage in her profession. While she hasn’t personally experienced burnout, she realizes a schedule change may not completely solve the issue for others. However, it shows what progress programs can make when they create systemic structural change.

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

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Study Finds Potential benefits of Spironolactone for Women with HS

Article Type
Changed
Wed, 07/17/2024 - 09:56

 

TOPLINE: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

  • This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
  • The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
  • Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

  • Overall, 31 patients (20%) showed improvements with spironolactone treatment.
  • A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
  • Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
  • Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

  • This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
  • The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
  • Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

  • Overall, 31 patients (20%) showed improvements with spironolactone treatment.
  • A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
  • Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
  • Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE: 

Spironolactone may benefit women of childbearing age with mild hidradenitis suppurativa (HS), especially if initiated early, according to the results of a single-center retrospective study.

METHODOLOGY:

  • This retrospective study included 157 women (median age, 36.5 years) with HS who received spironolactone for at least 3 months between 2000 and 2021 at Michigan Medicine outpatient dermatology clinics. The majority of patients were White (59%) or Black (37%) individuals.
  • The median prescribed dose was 100 mg/d, the most common dose was 50-100 mg/d, and the median time spironolactone was initiated was 8.8 years after HS was diagnosed.
  • Improvement status was classified on the basis of objective clinician assessments, including documented reductions in the lesion count, pain, and symptoms.

TAKEAWAY:

  • Overall, 31 patients (20%) showed improvements with spironolactone treatment.
  • A shorter duration between the diagnosis of HS and the initiation of spironolactone was associated with improvement (P = .047).
  • Axillary involvement (P = .003), the use of intralesional steroids (P = .015), previous treatments (P = .023), and previous treatment failures (P = .030) were linked to a lack of improvement with spironolactone.
  • Patients with Hurley stage III were 85% less likely to experience improvement with spironolactone (P = .036).

IN PRACTICE:

Spironolactone, which has antiandrogenic properties, “may be beneficial for patients with mild HS, notably those at Hurley stage I if implemented early as a primary or ancillary treatment,” the authors concluded, adding that prospective, multicenter studies are needed to “elucidate further the safety and efficacy of spironolactone for treating HS.”

SOURCE:

The study was led by Suma V. Gangidi, BS, Carle Illinois College of Medicine, University of Illinois Urbana-Champaign, and was published online in the International Journal of Women’s Dermatology.

LIMITATIONS:

Retrospective design can introduce inherent biases, including the potential for missing or misclassified data. Additionally, the study was conducted at a single center, which may limit the generalizability, and findings were also limited by lack of standardized objective measures for assessing treatment improvement, presence of confounding variables from concomitant treatments, small sample size, and potential multicollinearity.

DISCLOSURES:

This study did not receive any funding. One author declared ties with various pharmaceutical companies. The other authors declared no conflicts of interest. 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Studies Show Dupilumab Effects In Children with Both Atopic Dermatitis and Alopecia

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Wed, 07/17/2024 - 09:57

 

TOPLINE:

Dupilumab treatment significantly improved both hair regrowth and the severity of atopic dermatitis (AD) in pediatric patients who also had alopecia areata (AA) in a review. 

METHODOLOGY:

  • Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
  • The review included four case reports, two case series, and one retrospective chart review.
  • Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
  • The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).

TAKEAWAY:

  • Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
  • Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
  • There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
  • Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.

IN PRACTICE:

“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.” 

SOURCE:

The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology

LIMITATIONS:

Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.

DISCLOSURES:

The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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TOPLINE:

Dupilumab treatment significantly improved both hair regrowth and the severity of atopic dermatitis (AD) in pediatric patients who also had alopecia areata (AA) in a review. 

METHODOLOGY:

  • Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
  • The review included four case reports, two case series, and one retrospective chart review.
  • Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
  • The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).

TAKEAWAY:

  • Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
  • Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
  • There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
  • Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.

IN PRACTICE:

“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.” 

SOURCE:

The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology

LIMITATIONS:

Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.

DISCLOSURES:

The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

 

TOPLINE:

Dupilumab treatment significantly improved both hair regrowth and the severity of atopic dermatitis (AD) in pediatric patients who also had alopecia areata (AA) in a review. 

METHODOLOGY:

  • Researchers conducted a scoping review of seven studies, a result of a MEDLINE and Embase search on March 1, 2024, which included 31 patients aged 4-17 years with both AD and AA (average age, 11.4 years; 64.5% women).
  • The review included four case reports, two case series, and one retrospective chart review.
  • Patients had an average duration of AA and AD of 3.31 years and 5.33 years, respectively, before starting dupilumab.
  • The type of AA was listed in 22 patients; among these patients, alopecia universalis was the most common (50%), followed by alopecia ophiasis (22.7%), patchy alopecia (18.2%), and alopecia totalis (9.09%).

TAKEAWAY:

  • Overall, 77.4% of patients in the trials achieved hair regrowth with dupilumab treatment with a mean 42.6 reduction in SALT score (measuring scalp hair loss on a scale of 0-100) over an average of 3.21 months (P < .01).
  • Severity of AD was reduced by an average of 2.14 units to an average of 0.857 (clear or almost clear AD; P < .01) on the AD Investigator Global Assessment dropping from an average of 3 (severe disease) before treatment.
  • There were no characteristics that significantly distinguished patients with AA who responded to treatment from those who did not.
  • Four patients reported worsening of preexisting AA after starting dupilumab; two of these continued dupilumab and showed improvement at subsequent follow-ups.

IN PRACTICE:

“Our review highlights the efficacy of dupilumab in pediatric AA with concurrent AD,” wrote the authors, noting that “the exact mechanism for this efficacy remains speculative.” Although there have been reports of new or worsening AA with dupilumab, they added, its “favorable safety profile in pediatrics enhances its appeal for AA treatment, as monotherapy or in combination with other AA medications.” 

SOURCE:

The study was led by Dea Metko, Michael G. DeGroote School of Medicine in Hamilton, Ontario, Canada. It was published online on July 4, 2024, in Pediatric Dermatology

LIMITATIONS:

Potential publication bias, inconsistent data reporting, the small number of patients, and short follow-up duration were the main limitations of this study.

DISCLOSURES:

The study funding source was not disclosed. One author received honoraria outside this work. Other authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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