Dermatology News

I don’t recommend ice baths. Perhaps I should. On my podcast-filled commute, I am reminded for miles of the mental and physical benefits of this revolutionary wellness routine: Cold exposure causes a spike in adrenaline and raises your baseline dopamine, thereby giving you superhuman focus and energy. Goodbye procrastination! Eliminate your ADHD in one icy step! I’m trying to be the fashionable mustached-columnist here so maybe I should get on board.

In fact, a heavyset, similarly-mustached 32-year-old patient just asked if I do ice baths. It was meant as a compliment, I believe. Displaying poise wearing my Chief of Dermatology embroidered white coat in my toddler-art-adorned office, I could hear him thinking: “This doc is legit. On fleek.” (Note, this is an approximation and the patient’s actual thoughts may have varied). We were talking podcasts and he was curious about my daily routine.

Kaiser Permanente

Now, ice baths probably do have the benefits that Andrew Huberman, Joe Rogan, and the others have described, I don’t argue. And the experience is oft described as invigorating with a runner’s high-like euphoria that follows a good dunk. I’ve tried it. I would describe it as “very uncomfortable.” To boot, following icy-cold morning showers, I wasn’t any better able to stave off opening my New York Times app on a newsy day. No, cold water isn’t my jams. But then again, I don’t journal like Marcus Aurelius or sleep on a mattress that keeps my body a chill 97 degrees like an inverse sous vide. If I were asked by Huberman in an interview what I do to be mentally strong, I’d answer, “I clean the pool.”

“Here’s how I do it, Dr. Huberman,” I’d say. “First, open the pool cover. Then with a cup with pool water from about 12 inches down, fill these little beakers with water and add a few drops of chemical reagents. Then calculate the ounces of calcium hypochlorite, muriatic acid, and other chemicals to make your pools sparkle. After skimming, take your pool brush and brush the bottom and sides of your pool. Rack your equipment when done and close the cover back up. This exercise takes about 15 minutes.” It’s a mundane task, but ah, there’s the point. Like folding the laundry, weeding the garden, emptying the dishwasher, they can be oh, so gratifying. Each of these has a crisp beginning and end and offer a lovely spot to be present. Let the thoughts flow with each stroke of the brush. Watch the water ripple the surface as you slowly pull the long pole out, dripping 7.4 pH water as you glide it in for the next pass. This is the Benabio secret to success.

Dr. Benabio

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

I don’t recommend ice baths. Perhaps I should. On my podcast-filled commute, I am reminded for miles of the mental and physical benefits of this revolutionary wellness routine: Cold exposure causes a spike in adrenaline and raises your baseline dopamine, thereby giving you superhuman focus and energy. Goodbye procrastination! Eliminate your ADHD in one icy step! I’m trying to be the fashionable mustached-columnist here so maybe I should get on board.

In fact, a heavyset, similarly-mustached 32-year-old patient just asked if I do ice baths. It was meant as a compliment, I believe. Displaying poise wearing my Chief of Dermatology embroidered white coat in my toddler-art-adorned office, I could hear him thinking: “This doc is legit. On fleek.” (Note, this is an approximation and the patient’s actual thoughts may have varied). We were talking podcasts and he was curious about my daily routine.

Kaiser Permanente

Now, ice baths probably do have the benefits that Andrew Huberman, Joe Rogan, and the others have described, I don’t argue. And the experience is oft described as invigorating with a runner’s high-like euphoria that follows a good dunk. I’ve tried it. I would describe it as “very uncomfortable.” To boot, following icy-cold morning showers, I wasn’t any better able to stave off opening my New York Times app on a newsy day. No, cold water isn’t my jams. But then again, I don’t journal like Marcus Aurelius or sleep on a mattress that keeps my body a chill 97 degrees like an inverse sous vide. If I were asked by Huberman in an interview what I do to be mentally strong, I’d answer, “I clean the pool.”

“Here’s how I do it, Dr. Huberman,” I’d say. “First, open the pool cover. Then with a cup with pool water from about 12 inches down, fill these little beakers with water and add a few drops of chemical reagents. Then calculate the ounces of calcium hypochlorite, muriatic acid, and other chemicals to make your pools sparkle. After skimming, take your pool brush and brush the bottom and sides of your pool. Rack your equipment when done and close the cover back up. This exercise takes about 15 minutes.” It’s a mundane task, but ah, there’s the point. Like folding the laundry, weeding the garden, emptying the dishwasher, they can be oh, so gratifying. Each of these has a crisp beginning and end and offer a lovely spot to be present. Let the thoughts flow with each stroke of the brush. Watch the water ripple the surface as you slowly pull the long pole out, dripping 7.4 pH water as you glide it in for the next pass. This is the Benabio secret to success.

Dr. Benabio

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

I don’t recommend ice baths. Perhaps I should. On my podcast-filled commute, I am reminded for miles of the mental and physical benefits of this revolutionary wellness routine: Cold exposure causes a spike in adrenaline and raises your baseline dopamine, thereby giving you superhuman focus and energy. Goodbye procrastination! Eliminate your ADHD in one icy step! I’m trying to be the fashionable mustached-columnist here so maybe I should get on board.

In fact, a heavyset, similarly-mustached 32-year-old patient just asked if I do ice baths. It was meant as a compliment, I believe. Displaying poise wearing my Chief of Dermatology embroidered white coat in my toddler-art-adorned office, I could hear him thinking: “This doc is legit. On fleek.” (Note, this is an approximation and the patient’s actual thoughts may have varied). We were talking podcasts and he was curious about my daily routine.

Kaiser Permanente

Now, ice baths probably do have the benefits that Andrew Huberman, Joe Rogan, and the others have described, I don’t argue. And the experience is oft described as invigorating with a runner’s high-like euphoria that follows a good dunk. I’ve tried it. I would describe it as “very uncomfortable.” To boot, following icy-cold morning showers, I wasn’t any better able to stave off opening my New York Times app on a newsy day. No, cold water isn’t my jams. But then again, I don’t journal like Marcus Aurelius or sleep on a mattress that keeps my body a chill 97 degrees like an inverse sous vide. If I were asked by Huberman in an interview what I do to be mentally strong, I’d answer, “I clean the pool.”

“Here’s how I do it, Dr. Huberman,” I’d say. “First, open the pool cover. Then with a cup with pool water from about 12 inches down, fill these little beakers with water and add a few drops of chemical reagents. Then calculate the ounces of calcium hypochlorite, muriatic acid, and other chemicals to make your pools sparkle. After skimming, take your pool brush and brush the bottom and sides of your pool. Rack your equipment when done and close the cover back up. This exercise takes about 15 minutes.” It’s a mundane task, but ah, there’s the point. Like folding the laundry, weeding the garden, emptying the dishwasher, they can be oh, so gratifying. Each of these has a crisp beginning and end and offer a lovely spot to be present. Let the thoughts flow with each stroke of the brush. Watch the water ripple the surface as you slowly pull the long pole out, dripping 7.4 pH water as you glide it in for the next pass. This is the Benabio secret to success.

Dr. Benabio

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on X. Write to him at dermnews@mdedge.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, 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.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, 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.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, 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.

The use of hair-straightening products containing glyoxylic acid is associated with a risk for acute kidney failure because of the accumulation of calcium oxalate crystals in the kidneys. The observation was made by a team of French researchers who tested the suspected straightening product on animals. The product is believed to be the cause of several episodes of renal damage in a young woman.

“The results on mice are striking,” said study author Emmanuel Letavernier, MD, a nephrologist at Tenon Hospital in Paris. “They develop extremely severe acute kidney failure within 24 hours of applying the straightening cream. Samples show the presence of calcium oxalate crystals in all renal tubules.”

Given the potential nephrotoxicity of glyoxylic acid through topical application, products containing this compound should be avoided and ideally withdrawn from the market, the researchers suggested in a letter published in The New England Journal of Medicine. The appropriate departments of the French Agency for Food, Environmental, and Occupational Health and Safety have been alerted, Dr. Letavernier added.
 

Replacing Formaldehyde

Glyoxylic acid has recently been introduced into certain cosmetic products (such as shampoo, styling lotion, and straightening products), often as a replacement for formaldehyde, which is irritating and possibly carcinogenic. Glyoxylic acid is praised for its smoothing qualities. However, it is recommended to avoid contact with the scalp.

Cases of renal complications could be underdiagnosed, according to the researchers, who are preparing a nationwide survey. Renal failure can be silent. Among the signs that should raise concern are “scalp irritation accompanied by nausea or vomiting after a hair salon visit,” said Dr. Letavernier.

Similar cases have already been reported in the literature. An Israeli team recently described 26 patients treated for acute renal injuries after hair straightening in hair salons. Biopsies revealed calcium oxalate crystals in the kidneys.

The Israeli researchers suspected an effect of glycolic acid, another substance found in many cosmetic products, including straightening products. However, they could not provide evidence.
 

Glycolic Acid Safe?

By conducting a second animal study, which should be published soon, Dr. Letavernier and his team were able to rule out this hypothesis. “Glycolic acid does not pose a problem. Unlike glyoxylic acid, the application of glycolic acid on the skin of mice does not induce the formation of oxalate crystals in the kidneys, nor acute kidney failure.”

The French clinical case reported in the correspondence concerns a 26-year-old woman with no prior health history who had three episodes of acute renal damage 1 year apart. It turned out that each episode occurred shortly after hair straightening at a hair salon in Marseille.

The patient reported feeling a burning sensation during the hair treatment. Scalp irritations appeared. She then experienced vomiting, diarrhea, fever, and back pain. Analyses revealed high levels of plasma creatinine during each episode, indicating renal failure.

A CT scan showed no signs of urinary tract obstruction. However, the patient had a small kidney stone. Further analysis revealed the presence of blood and leukocytes in the urine. But there was no proteinuria or urinary infection.
 

Chronic Renal Failure

After each episode, renal function rapidly improved. “The repetition of episodes of acute renal failure is, however, a major risk factor for developing chronic renal failure in the long term,” said Dr. Letavernier.

The cream used in the hair salon to straighten hair was retrieved by the researchers. It contained a significant amount of glyoxylic acid but no glycolic acid.

To explore its potential nephrotoxic effect, they conducted a study on 10 mice. The animals were divided into two groups to test on one side topical application of the product and a gel without active product (control group) on the other.

Mice exposed to the product had oxalate crystals in their urine, unlike mice in the control group. A scan confirmed calcium oxalate deposits in the kidneys. Plasma creatinine levels increased significantly after exposure to glyoxylic acid.

“After passing through the epidermis, glyoxylic acid is rapidly converted in the blood to glyoxylate. In the liver and probably in other organs, glyoxylate is metabolized to become oxalate, which upon contact with calcium in the urine forms calcium oxalate crystals,” explained the specialist.

Excess calcium oxalate crystals causing renal failure are observed in rare conditions such as primary hyperoxaluria, a genetic disease affecting liver metabolism, or enteric hyperoxaluria, which is linked to increased intestinal permeability to oxalate: an anion naturally found in certain plants.
 

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

The use of hair-straightening products containing glyoxylic acid is associated with a risk for acute kidney failure because of the accumulation of calcium oxalate crystals in the kidneys. The observation was made by a team of French researchers who tested the suspected straightening product on animals. The product is believed to be the cause of several episodes of renal damage in a young woman.

“The results on mice are striking,” said study author Emmanuel Letavernier, MD, a nephrologist at Tenon Hospital in Paris. “They develop extremely severe acute kidney failure within 24 hours of applying the straightening cream. Samples show the presence of calcium oxalate crystals in all renal tubules.”

Given the potential nephrotoxicity of glyoxylic acid through topical application, products containing this compound should be avoided and ideally withdrawn from the market, the researchers suggested in a letter published in The New England Journal of Medicine. The appropriate departments of the French Agency for Food, Environmental, and Occupational Health and Safety have been alerted, Dr. Letavernier added.
 

Replacing Formaldehyde

Glyoxylic acid has recently been introduced into certain cosmetic products (such as shampoo, styling lotion, and straightening products), often as a replacement for formaldehyde, which is irritating and possibly carcinogenic. Glyoxylic acid is praised for its smoothing qualities. However, it is recommended to avoid contact with the scalp.

Cases of renal complications could be underdiagnosed, according to the researchers, who are preparing a nationwide survey. Renal failure can be silent. Among the signs that should raise concern are “scalp irritation accompanied by nausea or vomiting after a hair salon visit,” said Dr. Letavernier.

Similar cases have already been reported in the literature. An Israeli team recently described 26 patients treated for acute renal injuries after hair straightening in hair salons. Biopsies revealed calcium oxalate crystals in the kidneys.

The Israeli researchers suspected an effect of glycolic acid, another substance found in many cosmetic products, including straightening products. However, they could not provide evidence.
 

Glycolic Acid Safe?

By conducting a second animal study, which should be published soon, Dr. Letavernier and his team were able to rule out this hypothesis. “Glycolic acid does not pose a problem. Unlike glyoxylic acid, the application of glycolic acid on the skin of mice does not induce the formation of oxalate crystals in the kidneys, nor acute kidney failure.”

The French clinical case reported in the correspondence concerns a 26-year-old woman with no prior health history who had three episodes of acute renal damage 1 year apart. It turned out that each episode occurred shortly after hair straightening at a hair salon in Marseille.

The patient reported feeling a burning sensation during the hair treatment. Scalp irritations appeared. She then experienced vomiting, diarrhea, fever, and back pain. Analyses revealed high levels of plasma creatinine during each episode, indicating renal failure.

A CT scan showed no signs of urinary tract obstruction. However, the patient had a small kidney stone. Further analysis revealed the presence of blood and leukocytes in the urine. But there was no proteinuria or urinary infection.
 

Chronic Renal Failure

After each episode, renal function rapidly improved. “The repetition of episodes of acute renal failure is, however, a major risk factor for developing chronic renal failure in the long term,” said Dr. Letavernier.

The cream used in the hair salon to straighten hair was retrieved by the researchers. It contained a significant amount of glyoxylic acid but no glycolic acid.

To explore its potential nephrotoxic effect, they conducted a study on 10 mice. The animals were divided into two groups to test on one side topical application of the product and a gel without active product (control group) on the other.

Mice exposed to the product had oxalate crystals in their urine, unlike mice in the control group. A scan confirmed calcium oxalate deposits in the kidneys. Plasma creatinine levels increased significantly after exposure to glyoxylic acid.

“After passing through the epidermis, glyoxylic acid is rapidly converted in the blood to glyoxylate. In the liver and probably in other organs, glyoxylate is metabolized to become oxalate, which upon contact with calcium in the urine forms calcium oxalate crystals,” explained the specialist.

Excess calcium oxalate crystals causing renal failure are observed in rare conditions such as primary hyperoxaluria, a genetic disease affecting liver metabolism, or enteric hyperoxaluria, which is linked to increased intestinal permeability to oxalate: an anion naturally found in certain plants.
 

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

The use of hair-straightening products containing glyoxylic acid is associated with a risk for acute kidney failure because of the accumulation of calcium oxalate crystals in the kidneys. The observation was made by a team of French researchers who tested the suspected straightening product on animals. The product is believed to be the cause of several episodes of renal damage in a young woman.

“The results on mice are striking,” said study author Emmanuel Letavernier, MD, a nephrologist at Tenon Hospital in Paris. “They develop extremely severe acute kidney failure within 24 hours of applying the straightening cream. Samples show the presence of calcium oxalate crystals in all renal tubules.”

Given the potential nephrotoxicity of glyoxylic acid through topical application, products containing this compound should be avoided and ideally withdrawn from the market, the researchers suggested in a letter published in The New England Journal of Medicine. The appropriate departments of the French Agency for Food, Environmental, and Occupational Health and Safety have been alerted, Dr. Letavernier added.
 

Replacing Formaldehyde

Glyoxylic acid has recently been introduced into certain cosmetic products (such as shampoo, styling lotion, and straightening products), often as a replacement for formaldehyde, which is irritating and possibly carcinogenic. Glyoxylic acid is praised for its smoothing qualities. However, it is recommended to avoid contact with the scalp.

Cases of renal complications could be underdiagnosed, according to the researchers, who are preparing a nationwide survey. Renal failure can be silent. Among the signs that should raise concern are “scalp irritation accompanied by nausea or vomiting after a hair salon visit,” said Dr. Letavernier.

Similar cases have already been reported in the literature. An Israeli team recently described 26 patients treated for acute renal injuries after hair straightening in hair salons. Biopsies revealed calcium oxalate crystals in the kidneys.

The Israeli researchers suspected an effect of glycolic acid, another substance found in many cosmetic products, including straightening products. However, they could not provide evidence.
 

Glycolic Acid Safe?

By conducting a second animal study, which should be published soon, Dr. Letavernier and his team were able to rule out this hypothesis. “Glycolic acid does not pose a problem. Unlike glyoxylic acid, the application of glycolic acid on the skin of mice does not induce the formation of oxalate crystals in the kidneys, nor acute kidney failure.”

The French clinical case reported in the correspondence concerns a 26-year-old woman with no prior health history who had three episodes of acute renal damage 1 year apart. It turned out that each episode occurred shortly after hair straightening at a hair salon in Marseille.

The patient reported feeling a burning sensation during the hair treatment. Scalp irritations appeared. She then experienced vomiting, diarrhea, fever, and back pain. Analyses revealed high levels of plasma creatinine during each episode, indicating renal failure.

A CT scan showed no signs of urinary tract obstruction. However, the patient had a small kidney stone. Further analysis revealed the presence of blood and leukocytes in the urine. But there was no proteinuria or urinary infection.
 

Chronic Renal Failure

After each episode, renal function rapidly improved. “The repetition of episodes of acute renal failure is, however, a major risk factor for developing chronic renal failure in the long term,” said Dr. Letavernier.

The cream used in the hair salon to straighten hair was retrieved by the researchers. It contained a significant amount of glyoxylic acid but no glycolic acid.

To explore its potential nephrotoxic effect, they conducted a study on 10 mice. The animals were divided into two groups to test on one side topical application of the product and a gel without active product (control group) on the other.

Mice exposed to the product had oxalate crystals in their urine, unlike mice in the control group. A scan confirmed calcium oxalate deposits in the kidneys. Plasma creatinine levels increased significantly after exposure to glyoxylic acid.

“After passing through the epidermis, glyoxylic acid is rapidly converted in the blood to glyoxylate. In the liver and probably in other organs, glyoxylate is metabolized to become oxalate, which upon contact with calcium in the urine forms calcium oxalate crystals,” explained the specialist.

Excess calcium oxalate crystals causing renal failure are observed in rare conditions such as primary hyperoxaluria, a genetic disease affecting liver metabolism, or enteric hyperoxaluria, which is linked to increased intestinal permeability to oxalate: an anion naturally found in certain plants.
 

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

An estimated 3% of the world’s population have psoriasis, with approximately 6.4 million people across Europe affected. Almost one third of people with psoriasis will develop psoriatic arthritis (PsA), a disease that can be severe and debilitating and lead to irreversible degeneration of bone and tissue, typically affecting the joints of hands and feet. 

As inflammatory autoimmune diseases, psoriasis and PsA also increase the risk for further comorbidities, such as cardiovascular diseases and obesity, with higher rates of depression among those affected. 

Although notable advances have been made in the range of treatment options for PsA, it remains difficult to diagnose. No specific diagnostic criteria or laboratory tests are available, and the disease course and response to treatment can be unpredictable.

“Another key unmet need relates to whether we can reliably identify risk factors for which a person with psoriasis will develop PsA. We know that 30% will develop PsA, but we cannot identify which person with psoriasis is at risk,” said Professor Oliver FitzGerald of University College Dublin (UCD), Dublin, Ireland, an international opinion leader in rheumatology. A clearer understanding of PsA could lead to development of tools for its early diagnosis and identification of disease prevention strategies, he explained.

Thus, HIPPOCRATES (Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States ) was created. This ambitious research consortium was conceived by Dr. FitzGerald and his colleague Stephen Pennington, professor of proteomics at UCD, together with a number of likeminded colleagues in the fields of rheumatology and dermatology and at organizations such as GRAPPA, HUPO, EULAR, and EUROPSO. 

The collaboration has brought together world-leading clinicians, researchers, and people living with psoriasis and PsA to address the main challenges in its early identification and management.

HIPPOCRATES received €23.5 million in funding from the EU Innovative Medicines Initiative public-private partnership in 2021 and is now half way through its 5-year plan. 

Key Goals 

HIPPOCRATES involves 27 partners, including from industry, in 11 countries. 

Its four key goals are:

• Identifying specific PsA disease markers to develop accurate diagnostic tools;
• Developing prediction strategies to identify which person with psoriasis will develop PsA;
• Monitoring and prevention of PsA disease progression to irreversible joint damage; and
• Identifying personalized treatment options, so that patients are treated with the right medicines for their specific disease.

“The pharmaceutical companies have come up with a veritable armory of potential treatments, but rheumatologists still don’t know which one to use for a particular patient at a particular time,” Dr. Pennington explained to this news organization. “So the reality is they tend to cycle through treatments until they find one that is effective.” This is not very efficient or desirable for patients, he added. 

Multidisciplinary Approach

A key advantage of HIPPOCRATES is that it brings several medical disciplines together. The current approach of clinicians working in silos is a key barrier to earlier diagnosis of PsA.

“The reality is that a patient with psoriasis will see a dermatologist, and dermatologists don’t necessarily have the skills or training to identify the very early stages of psoriatic arthritis, so they will only refer a patient of theirs to a rheumatologist at a very late stage,” said Dr. Pennington.

Dermatologists need better tools to be able to recognize when they should refer their psoriasis patients to rheumatologists, so that patients developing PsA are diagnosed and treated earlier, he explained. 

GPs will also be an important component of the project because they are the first point of healthcare contact for people with PsA or psoriasis.

“[I]t is about helping GPs diagnose earlier and raise awareness among patients. Historically, there has been a bit of a lag between people having their first symptoms and getting a diagnosis,” explained HIPPOCRATES collaborator Frances Mair, the Norie Miller Professor of General Practice and head of general practice and primary care at the University of Glasgow, Glasgow, Scotland. 

Dr. Mair said that diagnosis isn't always straightforward, and the hope is that the study will identify more specific risk factors that will help GPs flag PsA earlier. 

Patient Involvement and Data Sharing

The HIPPOCRATES consortium involves patients in all stages of the project.

“In HIPPOCRATES, patient and public involvement is really a central feature, which is quite unusual at the more experimental side of healthcare and research. In HIPPOCRATES, the patient research partners have a leading role, making a real difference…” said Dr. Mair.

To facilitate its goals, the consortium partners are sharing data and samples from previously conducted studies on psoriasis and PsA populations. This will facilitate extensive omics-based analyses to establish and validate robust biomarkers across datasets, using the latest cutting-edge techniques, including machine learning and artificial intelligence. 

In addition, the HIPPOCRATES Prospective Observational Study (HPOS) was launched last year. This web-based study aims to recruit 25,000 adults (≥ 18 years of age) with skin psoriasis across Europe. They will collect their clinical data every 6 months, including emerging musculoskeletal symptoms. Blood samples will also be collected remotely from a subset of 3000 participants using a finger-prick kit that will be posted to their homes. 

HPOS has already commenced recruitment in the UK, Ireland and, most recently, Greece and Portugal, with nearly 2300 participants enrolled to date. HPOS also plans to launch in France, Italy, Spain, Denmark, Germany, Belgium, the Netherlands, and Sweden. 

“This ambitious study will give us the statistical power to identify clinical/molecular risk factors for progression from psoriasis to PsA. We anticipate that 675 participants per year will develop PsA in our studied population. Participants will receive regular feedback to help monitor their condition, and we will help them to get the medical care that they need,” said Dr. FitzGerald.

Dr. Pennington added that the consortium believes it is a “realistic goal” that the resulting molecular risk prediction tools could eventually enable clinicians to intervene to prevent PsA. 

From Research to Practice

The HIPPOCRATES projects are making good progress, with several early publications, and further publications being drafted. 

“One of the biggest achievements so far has been to assemble this massive resource of patient samples — tens of thousands in total in a single integrated database, which is the foundation of the project,” said Dr. Pennington. He explained that it took a significant amount of work to secure the necessary agreements from all 27 partners to share the patient data securely, appropriately, and anonymously within the consortium.

Creating successful biomarkers, algorithms, and other tools is one thing, but disseminating the knowledge learned and rolling out the final agreed guidelines will be just as important as the research work, said Dr. Pennington.

Dr. Mair, who is responsible for promoting communication, dissemination, and maximizing the impact of the research undertaken by the HIPPOCRATES consortium, said: “We see so often in healthcare that people come with great ideas or tools, yet they don’t become part of everyday practice. Hence, I am working on the implementation side of HIPPOCRATES, to make sure its findings will be embedded and routinely used in practice,” she said.

A version of this article appeared on Medscape.com.

An estimated 3% of the world’s population have psoriasis, with approximately 6.4 million people across Europe affected. Almost one third of people with psoriasis will develop psoriatic arthritis (PsA), a disease that can be severe and debilitating and lead to irreversible degeneration of bone and tissue, typically affecting the joints of hands and feet. 

As inflammatory autoimmune diseases, psoriasis and PsA also increase the risk for further comorbidities, such as cardiovascular diseases and obesity, with higher rates of depression among those affected. 

Although notable advances have been made in the range of treatment options for PsA, it remains difficult to diagnose. No specific diagnostic criteria or laboratory tests are available, and the disease course and response to treatment can be unpredictable.

“Another key unmet need relates to whether we can reliably identify risk factors for which a person with psoriasis will develop PsA. We know that 30% will develop PsA, but we cannot identify which person with psoriasis is at risk,” said Professor Oliver FitzGerald of University College Dublin (UCD), Dublin, Ireland, an international opinion leader in rheumatology. A clearer understanding of PsA could lead to development of tools for its early diagnosis and identification of disease prevention strategies, he explained.

Thus, HIPPOCRATES (Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States ) was created. This ambitious research consortium was conceived by Dr. FitzGerald and his colleague Stephen Pennington, professor of proteomics at UCD, together with a number of likeminded colleagues in the fields of rheumatology and dermatology and at organizations such as GRAPPA, HUPO, EULAR, and EUROPSO. 

The collaboration has brought together world-leading clinicians, researchers, and people living with psoriasis and PsA to address the main challenges in its early identification and management.

HIPPOCRATES received €23.5 million in funding from the EU Innovative Medicines Initiative public-private partnership in 2021 and is now half way through its 5-year plan. 

Key Goals 

HIPPOCRATES involves 27 partners, including from industry, in 11 countries. 

Its four key goals are:

• Identifying specific PsA disease markers to develop accurate diagnostic tools;
• Developing prediction strategies to identify which person with psoriasis will develop PsA;
• Monitoring and prevention of PsA disease progression to irreversible joint damage; and
• Identifying personalized treatment options, so that patients are treated with the right medicines for their specific disease.

“The pharmaceutical companies have come up with a veritable armory of potential treatments, but rheumatologists still don’t know which one to use for a particular patient at a particular time,” Dr. Pennington explained to this news organization. “So the reality is they tend to cycle through treatments until they find one that is effective.” This is not very efficient or desirable for patients, he added. 

Multidisciplinary Approach

A key advantage of HIPPOCRATES is that it brings several medical disciplines together. The current approach of clinicians working in silos is a key barrier to earlier diagnosis of PsA.

“The reality is that a patient with psoriasis will see a dermatologist, and dermatologists don’t necessarily have the skills or training to identify the very early stages of psoriatic arthritis, so they will only refer a patient of theirs to a rheumatologist at a very late stage,” said Dr. Pennington.

Dermatologists need better tools to be able to recognize when they should refer their psoriasis patients to rheumatologists, so that patients developing PsA are diagnosed and treated earlier, he explained. 

GPs will also be an important component of the project because they are the first point of healthcare contact for people with PsA or psoriasis.

“[I]t is about helping GPs diagnose earlier and raise awareness among patients. Historically, there has been a bit of a lag between people having their first symptoms and getting a diagnosis,” explained HIPPOCRATES collaborator Frances Mair, the Norie Miller Professor of General Practice and head of general practice and primary care at the University of Glasgow, Glasgow, Scotland. 

Dr. Mair said that diagnosis isn't always straightforward, and the hope is that the study will identify more specific risk factors that will help GPs flag PsA earlier. 

Patient Involvement and Data Sharing

The HIPPOCRATES consortium involves patients in all stages of the project.

“In HIPPOCRATES, patient and public involvement is really a central feature, which is quite unusual at the more experimental side of healthcare and research. In HIPPOCRATES, the patient research partners have a leading role, making a real difference…” said Dr. Mair.

To facilitate its goals, the consortium partners are sharing data and samples from previously conducted studies on psoriasis and PsA populations. This will facilitate extensive omics-based analyses to establish and validate robust biomarkers across datasets, using the latest cutting-edge techniques, including machine learning and artificial intelligence. 

In addition, the HIPPOCRATES Prospective Observational Study (HPOS) was launched last year. This web-based study aims to recruit 25,000 adults (≥ 18 years of age) with skin psoriasis across Europe. They will collect their clinical data every 6 months, including emerging musculoskeletal symptoms. Blood samples will also be collected remotely from a subset of 3000 participants using a finger-prick kit that will be posted to their homes. 

HPOS has already commenced recruitment in the UK, Ireland and, most recently, Greece and Portugal, with nearly 2300 participants enrolled to date. HPOS also plans to launch in France, Italy, Spain, Denmark, Germany, Belgium, the Netherlands, and Sweden. 

“This ambitious study will give us the statistical power to identify clinical/molecular risk factors for progression from psoriasis to PsA. We anticipate that 675 participants per year will develop PsA in our studied population. Participants will receive regular feedback to help monitor their condition, and we will help them to get the medical care that they need,” said Dr. FitzGerald.

Dr. Pennington added that the consortium believes it is a “realistic goal” that the resulting molecular risk prediction tools could eventually enable clinicians to intervene to prevent PsA. 

From Research to Practice

The HIPPOCRATES projects are making good progress, with several early publications, and further publications being drafted. 

“One of the biggest achievements so far has been to assemble this massive resource of patient samples — tens of thousands in total in a single integrated database, which is the foundation of the project,” said Dr. Pennington. He explained that it took a significant amount of work to secure the necessary agreements from all 27 partners to share the patient data securely, appropriately, and anonymously within the consortium.

Creating successful biomarkers, algorithms, and other tools is one thing, but disseminating the knowledge learned and rolling out the final agreed guidelines will be just as important as the research work, said Dr. Pennington.

Dr. Mair, who is responsible for promoting communication, dissemination, and maximizing the impact of the research undertaken by the HIPPOCRATES consortium, said: “We see so often in healthcare that people come with great ideas or tools, yet they don’t become part of everyday practice. Hence, I am working on the implementation side of HIPPOCRATES, to make sure its findings will be embedded and routinely used in practice,” she said.

A version of this article appeared on Medscape.com.

An estimated 3% of the world’s population have psoriasis, with approximately 6.4 million people across Europe affected. Almost one third of people with psoriasis will develop psoriatic arthritis (PsA), a disease that can be severe and debilitating and lead to irreversible degeneration of bone and tissue, typically affecting the joints of hands and feet. 

As inflammatory autoimmune diseases, psoriasis and PsA also increase the risk for further comorbidities, such as cardiovascular diseases and obesity, with higher rates of depression among those affected. 

Although notable advances have been made in the range of treatment options for PsA, it remains difficult to diagnose. No specific diagnostic criteria or laboratory tests are available, and the disease course and response to treatment can be unpredictable.

“Another key unmet need relates to whether we can reliably identify risk factors for which a person with psoriasis will develop PsA. We know that 30% will develop PsA, but we cannot identify which person with psoriasis is at risk,” said Professor Oliver FitzGerald of University College Dublin (UCD), Dublin, Ireland, an international opinion leader in rheumatology. A clearer understanding of PsA could lead to development of tools for its early diagnosis and identification of disease prevention strategies, he explained.

Thus, HIPPOCRATES (Health Initiatives in Psoriasis and Psoriatic Arthritis Consortium European States ) was created. This ambitious research consortium was conceived by Dr. FitzGerald and his colleague Stephen Pennington, professor of proteomics at UCD, together with a number of likeminded colleagues in the fields of rheumatology and dermatology and at organizations such as GRAPPA, HUPO, EULAR, and EUROPSO. 

The collaboration has brought together world-leading clinicians, researchers, and people living with psoriasis and PsA to address the main challenges in its early identification and management.

HIPPOCRATES received €23.5 million in funding from the EU Innovative Medicines Initiative public-private partnership in 2021 and is now half way through its 5-year plan. 

Key Goals 

HIPPOCRATES involves 27 partners, including from industry, in 11 countries. 

Its four key goals are:

• Identifying specific PsA disease markers to develop accurate diagnostic tools;
• Developing prediction strategies to identify which person with psoriasis will develop PsA;
• Monitoring and prevention of PsA disease progression to irreversible joint damage; and
• Identifying personalized treatment options, so that patients are treated with the right medicines for their specific disease.

“The pharmaceutical companies have come up with a veritable armory of potential treatments, but rheumatologists still don’t know which one to use for a particular patient at a particular time,” Dr. Pennington explained to this news organization. “So the reality is they tend to cycle through treatments until they find one that is effective.” This is not very efficient or desirable for patients, he added. 

Multidisciplinary Approach

A key advantage of HIPPOCRATES is that it brings several medical disciplines together. The current approach of clinicians working in silos is a key barrier to earlier diagnosis of PsA.

“The reality is that a patient with psoriasis will see a dermatologist, and dermatologists don’t necessarily have the skills or training to identify the very early stages of psoriatic arthritis, so they will only refer a patient of theirs to a rheumatologist at a very late stage,” said Dr. Pennington.

Dermatologists need better tools to be able to recognize when they should refer their psoriasis patients to rheumatologists, so that patients developing PsA are diagnosed and treated earlier, he explained. 

GPs will also be an important component of the project because they are the first point of healthcare contact for people with PsA or psoriasis.

“[I]t is about helping GPs diagnose earlier and raise awareness among patients. Historically, there has been a bit of a lag between people having their first symptoms and getting a diagnosis,” explained HIPPOCRATES collaborator Frances Mair, the Norie Miller Professor of General Practice and head of general practice and primary care at the University of Glasgow, Glasgow, Scotland. 

Dr. Mair said that diagnosis isn't always straightforward, and the hope is that the study will identify more specific risk factors that will help GPs flag PsA earlier. 

Patient Involvement and Data Sharing

The HIPPOCRATES consortium involves patients in all stages of the project.

“In HIPPOCRATES, patient and public involvement is really a central feature, which is quite unusual at the more experimental side of healthcare and research. In HIPPOCRATES, the patient research partners have a leading role, making a real difference…” said Dr. Mair.

To facilitate its goals, the consortium partners are sharing data and samples from previously conducted studies on psoriasis and PsA populations. This will facilitate extensive omics-based analyses to establish and validate robust biomarkers across datasets, using the latest cutting-edge techniques, including machine learning and artificial intelligence. 

In addition, the HIPPOCRATES Prospective Observational Study (HPOS) was launched last year. This web-based study aims to recruit 25,000 adults (≥ 18 years of age) with skin psoriasis across Europe. They will collect their clinical data every 6 months, including emerging musculoskeletal symptoms. Blood samples will also be collected remotely from a subset of 3000 participants using a finger-prick kit that will be posted to their homes. 

HPOS has already commenced recruitment in the UK, Ireland and, most recently, Greece and Portugal, with nearly 2300 participants enrolled to date. HPOS also plans to launch in France, Italy, Spain, Denmark, Germany, Belgium, the Netherlands, and Sweden. 

“This ambitious study will give us the statistical power to identify clinical/molecular risk factors for progression from psoriasis to PsA. We anticipate that 675 participants per year will develop PsA in our studied population. Participants will receive regular feedback to help monitor their condition, and we will help them to get the medical care that they need,” said Dr. FitzGerald.

Dr. Pennington added that the consortium believes it is a “realistic goal” that the resulting molecular risk prediction tools could eventually enable clinicians to intervene to prevent PsA. 

From Research to Practice

The HIPPOCRATES projects are making good progress, with several early publications, and further publications being drafted. 

“One of the biggest achievements so far has been to assemble this massive resource of patient samples — tens of thousands in total in a single integrated database, which is the foundation of the project,” said Dr. Pennington. He explained that it took a significant amount of work to secure the necessary agreements from all 27 partners to share the patient data securely, appropriately, and anonymously within the consortium.

Creating successful biomarkers, algorithms, and other tools is one thing, but disseminating the knowledge learned and rolling out the final agreed guidelines will be just as important as the research work, said Dr. Pennington.

Dr. Mair, who is responsible for promoting communication, dissemination, and maximizing the impact of the research undertaken by the HIPPOCRATES consortium, said: “We see so often in healthcare that people come with great ideas or tools, yet they don’t become part of everyday practice. Hence, I am working on the implementation side of HIPPOCRATES, to make sure its findings will be embedded and routinely used in practice,” she said.

A version of this article appeared on Medscape.com.

Most survivors of childhood cancer don’t meet surveillance guidelines that recommend screening for adult cancers or other long-term adverse effects of treatment, according to a new study.

Among childhood cancer survivors in Ontario, Canada, who faced an elevated risk due to chemotherapy or radiation treatments, 53% followed screening recommendations for cardiomyopathy, 13% met colorectal cancer screening guidelines, and 6% adhered to breast cancer screening guidelines.

“Although over 80% of children newly diagnosed with cancer will become long-term survivors, as many as four out of five of these survivors will develop a serious or life-threatening late effect of their cancer therapy by age 45,” lead author Jennifer Shuldiner, PhD, MPH, a scientist at Women’s College Hospital Institute for Health Systems Solutions and Virtual Care in Toronto, told this news organization.

For instance, the risk for colorectal cancer in childhood cancer survivors is two to three times higher than it is among the general population, and the risk for breast cancer is similar between those who underwent chest radiation and those with a BRCA mutation. As many as 50% of those who received anthracycline chemotherapy or radiation involving the heart later develop cardiotoxicity.

The North American Children’s Oncology Group has published long-term follow-up guidelines for survivors of childhood cancer, yet many survivors don’t follow them because of lack of awareness or other barriers, said Dr. Shuldiner.

“Prior research has shown that many survivors do not complete these recommended tests,” she said. “With better knowledge of this at-risk population, we can design, test, and implement appropriate interventions and supports to tackle the issues.”

The study was published online on March 11 in CMAJ. 
 

Changes in Adherence 

The researchers conducted a retrospective population-based cohort study analyzing Ontario healthcare administrative data for adult survivors of childhood cancer diagnosed between 1986 and 2014 who faced an elevated risk for therapy-related colorectal cancer, breast cancer, or cardiomyopathy. The research team then assessed long-term adherence to the North American Children’s Oncology Group guidelines and predictors of adherence.

Among 3241 survivors, 3205 (99%) were at elevated risk for cardiomyopathy, 327 (10%) were at elevated risk for colorectal cancer, and 234 (7%) were at elevated risk for breast cancer. In addition, 2806 (87%) were at risk for one late effect, 345 (11%) were at risk for two late effects, and 90 (3%) were at risk for three late effects.

Overall, 53%, 13%, and 6% were adherent to their recommended surveillance for cardiomyopathy, colorectal cancer, and breast cancer, respectively. Over time, adherence increased for colorectal cancer and cardiomyopathy but decreased for breast cancer.

In addition, patients who were older at diagnosis were more likely to follow screening guidelines for colorectal and breast cancers, whereas those who were younger at diagnosis were more likely to follow screening guidelines for cardiomyopathy.

During a median follow-up of 7.8 years, the proportion of time spent adherent was 43% for cardiomyopathy, 14% for colorectal cancer, and 10% for breast cancer.

Survivors who attended a long-term follow-up clinic in the previous year had low adherence rates as well, though they were higher than in the rest of the cohort. In this group, the proportion of time that was spent adherent was 71% for cardiomyopathy, 27% for colorectal cancer, and 15% for breast cancer.

Shuldiner and colleagues are launching a research trial to determine whether a provincial support system can help childhood cancer survivors receive the recommended surveillance. The support system provides information about screening recommendations to survivors as well as reminders and sends key information to their family doctors.

“We now understand that childhood cancer survivors need help to complete the recommended tests,” said Dr. Shuldiner. “If the trial is successful, we hope it will be implemented in Ontario.” 
 

Survivorship Care Plans 

Low screening rates may result from a lack of awareness about screening recommendations and the negative long-term effects of cancer treatments, the study authors wrote. Cancer survivors, caregivers, family physicians, specialists, and survivor support groups can share the responsibility of spreading awareness and adhering to guidelines, they noted. In some cases, a survivorship care plan (SCP) may help.

“SCPs are intended to improve adherence by providing follow-up information and facilitating the transition from cancer treatment to survivorship and from pediatric to adult care,” Adam Yan, MD, a staff oncologist and oncology informatics lead at the Hospital for Sick Children in Toronto, told this news organization.

Dr. Yan, who wasn’t involved with this study, has researched surveillance adherence for secondary cancers and cardiac dysfunction among childhood cancer survivors. He and his colleagues found that screening rates were typically low among survivors who faced high risks for cardiac dysfunction and breast, colorectal, or skin cancers.

However, having a survivorship care plan seemed to help, and survivors treated after 1990 were more likely to have an SCP.

“SCP possession by high-risk survivors was associated with increased breast, skin, and cardiac surveillance,” he said. “It is uncertain whether SCP possession leads to adherence or whether SCP possession is a marker of survivors who are focused on their health and thus likely to adhere to preventive health practices, including surveillance.”

The study was funded by the Canadian Institutes of Health Research and ICES, which receives support from the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Shuldiner received a Canadian Institutes of Health Research Health System Impact Postdoctoral Fellowship in support of the work. Dr. Yan disclosed no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

Most survivors of childhood cancer don’t meet surveillance guidelines that recommend screening for adult cancers or other long-term adverse effects of treatment, according to a new study.

Among childhood cancer survivors in Ontario, Canada, who faced an elevated risk due to chemotherapy or radiation treatments, 53% followed screening recommendations for cardiomyopathy, 13% met colorectal cancer screening guidelines, and 6% adhered to breast cancer screening guidelines.

“Although over 80% of children newly diagnosed with cancer will become long-term survivors, as many as four out of five of these survivors will develop a serious or life-threatening late effect of their cancer therapy by age 45,” lead author Jennifer Shuldiner, PhD, MPH, a scientist at Women’s College Hospital Institute for Health Systems Solutions and Virtual Care in Toronto, told this news organization.

For instance, the risk for colorectal cancer in childhood cancer survivors is two to three times higher than it is among the general population, and the risk for breast cancer is similar between those who underwent chest radiation and those with a BRCA mutation. As many as 50% of those who received anthracycline chemotherapy or radiation involving the heart later develop cardiotoxicity.

The North American Children’s Oncology Group has published long-term follow-up guidelines for survivors of childhood cancer, yet many survivors don’t follow them because of lack of awareness or other barriers, said Dr. Shuldiner.

“Prior research has shown that many survivors do not complete these recommended tests,” she said. “With better knowledge of this at-risk population, we can design, test, and implement appropriate interventions and supports to tackle the issues.”

The study was published online on March 11 in CMAJ. 
 

Changes in Adherence 

The researchers conducted a retrospective population-based cohort study analyzing Ontario healthcare administrative data for adult survivors of childhood cancer diagnosed between 1986 and 2014 who faced an elevated risk for therapy-related colorectal cancer, breast cancer, or cardiomyopathy. The research team then assessed long-term adherence to the North American Children’s Oncology Group guidelines and predictors of adherence.

Among 3241 survivors, 3205 (99%) were at elevated risk for cardiomyopathy, 327 (10%) were at elevated risk for colorectal cancer, and 234 (7%) were at elevated risk for breast cancer. In addition, 2806 (87%) were at risk for one late effect, 345 (11%) were at risk for two late effects, and 90 (3%) were at risk for three late effects.

Overall, 53%, 13%, and 6% were adherent to their recommended surveillance for cardiomyopathy, colorectal cancer, and breast cancer, respectively. Over time, adherence increased for colorectal cancer and cardiomyopathy but decreased for breast cancer.

In addition, patients who were older at diagnosis were more likely to follow screening guidelines for colorectal and breast cancers, whereas those who were younger at diagnosis were more likely to follow screening guidelines for cardiomyopathy.

During a median follow-up of 7.8 years, the proportion of time spent adherent was 43% for cardiomyopathy, 14% for colorectal cancer, and 10% for breast cancer.

Survivors who attended a long-term follow-up clinic in the previous year had low adherence rates as well, though they were higher than in the rest of the cohort. In this group, the proportion of time that was spent adherent was 71% for cardiomyopathy, 27% for colorectal cancer, and 15% for breast cancer.

Shuldiner and colleagues are launching a research trial to determine whether a provincial support system can help childhood cancer survivors receive the recommended surveillance. The support system provides information about screening recommendations to survivors as well as reminders and sends key information to their family doctors.

“We now understand that childhood cancer survivors need help to complete the recommended tests,” said Dr. Shuldiner. “If the trial is successful, we hope it will be implemented in Ontario.” 
 

Survivorship Care Plans 

Low screening rates may result from a lack of awareness about screening recommendations and the negative long-term effects of cancer treatments, the study authors wrote. Cancer survivors, caregivers, family physicians, specialists, and survivor support groups can share the responsibility of spreading awareness and adhering to guidelines, they noted. In some cases, a survivorship care plan (SCP) may help.

“SCPs are intended to improve adherence by providing follow-up information and facilitating the transition from cancer treatment to survivorship and from pediatric to adult care,” Adam Yan, MD, a staff oncologist and oncology informatics lead at the Hospital for Sick Children in Toronto, told this news organization.

Dr. Yan, who wasn’t involved with this study, has researched surveillance adherence for secondary cancers and cardiac dysfunction among childhood cancer survivors. He and his colleagues found that screening rates were typically low among survivors who faced high risks for cardiac dysfunction and breast, colorectal, or skin cancers.

However, having a survivorship care plan seemed to help, and survivors treated after 1990 were more likely to have an SCP.

“SCP possession by high-risk survivors was associated with increased breast, skin, and cardiac surveillance,” he said. “It is uncertain whether SCP possession leads to adherence or whether SCP possession is a marker of survivors who are focused on their health and thus likely to adhere to preventive health practices, including surveillance.”

The study was funded by the Canadian Institutes of Health Research and ICES, which receives support from the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Shuldiner received a Canadian Institutes of Health Research Health System Impact Postdoctoral Fellowship in support of the work. Dr. Yan disclosed no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

Most survivors of childhood cancer don’t meet surveillance guidelines that recommend screening for adult cancers or other long-term adverse effects of treatment, according to a new study.

Among childhood cancer survivors in Ontario, Canada, who faced an elevated risk due to chemotherapy or radiation treatments, 53% followed screening recommendations for cardiomyopathy, 13% met colorectal cancer screening guidelines, and 6% adhered to breast cancer screening guidelines.

“Although over 80% of children newly diagnosed with cancer will become long-term survivors, as many as four out of five of these survivors will develop a serious or life-threatening late effect of their cancer therapy by age 45,” lead author Jennifer Shuldiner, PhD, MPH, a scientist at Women’s College Hospital Institute for Health Systems Solutions and Virtual Care in Toronto, told this news organization.

For instance, the risk for colorectal cancer in childhood cancer survivors is two to three times higher than it is among the general population, and the risk for breast cancer is similar between those who underwent chest radiation and those with a BRCA mutation. As many as 50% of those who received anthracycline chemotherapy or radiation involving the heart later develop cardiotoxicity.

The North American Children’s Oncology Group has published long-term follow-up guidelines for survivors of childhood cancer, yet many survivors don’t follow them because of lack of awareness or other barriers, said Dr. Shuldiner.

“Prior research has shown that many survivors do not complete these recommended tests,” she said. “With better knowledge of this at-risk population, we can design, test, and implement appropriate interventions and supports to tackle the issues.”

The study was published online on March 11 in CMAJ. 
 

Changes in Adherence 

The researchers conducted a retrospective population-based cohort study analyzing Ontario healthcare administrative data for adult survivors of childhood cancer diagnosed between 1986 and 2014 who faced an elevated risk for therapy-related colorectal cancer, breast cancer, or cardiomyopathy. The research team then assessed long-term adherence to the North American Children’s Oncology Group guidelines and predictors of adherence.

Among 3241 survivors, 3205 (99%) were at elevated risk for cardiomyopathy, 327 (10%) were at elevated risk for colorectal cancer, and 234 (7%) were at elevated risk for breast cancer. In addition, 2806 (87%) were at risk for one late effect, 345 (11%) were at risk for two late effects, and 90 (3%) were at risk for three late effects.

Overall, 53%, 13%, and 6% were adherent to their recommended surveillance for cardiomyopathy, colorectal cancer, and breast cancer, respectively. Over time, adherence increased for colorectal cancer and cardiomyopathy but decreased for breast cancer.

In addition, patients who were older at diagnosis were more likely to follow screening guidelines for colorectal and breast cancers, whereas those who were younger at diagnosis were more likely to follow screening guidelines for cardiomyopathy.

During a median follow-up of 7.8 years, the proportion of time spent adherent was 43% for cardiomyopathy, 14% for colorectal cancer, and 10% for breast cancer.

Survivors who attended a long-term follow-up clinic in the previous year had low adherence rates as well, though they were higher than in the rest of the cohort. In this group, the proportion of time that was spent adherent was 71% for cardiomyopathy, 27% for colorectal cancer, and 15% for breast cancer.

Shuldiner and colleagues are launching a research trial to determine whether a provincial support system can help childhood cancer survivors receive the recommended surveillance. The support system provides information about screening recommendations to survivors as well as reminders and sends key information to their family doctors.

“We now understand that childhood cancer survivors need help to complete the recommended tests,” said Dr. Shuldiner. “If the trial is successful, we hope it will be implemented in Ontario.” 
 

Survivorship Care Plans 

Low screening rates may result from a lack of awareness about screening recommendations and the negative long-term effects of cancer treatments, the study authors wrote. Cancer survivors, caregivers, family physicians, specialists, and survivor support groups can share the responsibility of spreading awareness and adhering to guidelines, they noted. In some cases, a survivorship care plan (SCP) may help.

“SCPs are intended to improve adherence by providing follow-up information and facilitating the transition from cancer treatment to survivorship and from pediatric to adult care,” Adam Yan, MD, a staff oncologist and oncology informatics lead at the Hospital for Sick Children in Toronto, told this news organization.

Dr. Yan, who wasn’t involved with this study, has researched surveillance adherence for secondary cancers and cardiac dysfunction among childhood cancer survivors. He and his colleagues found that screening rates were typically low among survivors who faced high risks for cardiac dysfunction and breast, colorectal, or skin cancers.

However, having a survivorship care plan seemed to help, and survivors treated after 1990 were more likely to have an SCP.

“SCP possession by high-risk survivors was associated with increased breast, skin, and cardiac surveillance,” he said. “It is uncertain whether SCP possession leads to adherence or whether SCP possession is a marker of survivors who are focused on their health and thus likely to adhere to preventive health practices, including surveillance.”

The study was funded by the Canadian Institutes of Health Research and ICES, which receives support from the Ontario Ministry of Health and the Ministry of Long-Term Care. Dr. Shuldiner received a Canadian Institutes of Health Research Health System Impact Postdoctoral Fellowship in support of the work. Dr. Yan disclosed no relevant financial relationships. 
 

A version of this article appeared on Medscape.com.

Just over 2 months into 2024, measles cases in the United States aren’t looking great. 

The recent rise in cases across the U.S. is linked to unvaccinated travelers, lower than ideal vaccination rates, and misinformation, experts said. 

The Centers for Disease Control and Prevention has identified 45 cases of measles in 17 jurisdictions across the U.S. As of March 7, the federal health agency reported measles cases in Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

As for the 45 cases, “that’s almost as many as we had for the entire calendar year of 2023,” said Sarah Lim, MD, a medical specialist at the Minnesota Department of Health. “So we’re really not off to a great start.” (For context, there were 58 officially reported measles cases last year.) 

Chicago is having a measles outbreak — with eight cases reported so far. All but one case has been linked to a migrant child at a city shelter. Given the potential for rapid spread — measles is relatively rare here but potentially very serious — the CDC sent a team of experts to investigate and to help keep this outbreak from growing further.


 

Sometimes Deadly

About 30% of children have measles symptoms and about 25% end up hospitalized. Complications include diarrhea, a whole-body rash, ear infections that can lead to permanent deafness, and pneumonia. Pneumonia with measles can be so serious that 1 in 20 affected children die. Measles can also cause inflammation of the brain called encephalitis in about 1 in 1,000 children, sometimes causing epilepsy or permanent brain damage.

As with long COVID, some effects can last beyond the early infection. For example, measles “can wipe out immune memory that protects you against other bacterial and viral pathogens,” Dr. Lim said at a media briefing sponsored by the Infectious Diseases Society of America. This vulnerability to other infections can last up to 3 years after the early infection, she noted. 

Overall, measles kills between 1 and 3 people infected per thousand, mostly children.
 

Vaccine Misinformation Playing a Role

Vaccine misinformation is partly behind the uptick, and while many cases are mild, “this can be a devastating disease,” said Joshua Barocas, MD, associate professor of medicine in the divisions of General Internal Medicine and Infectious Diseases at the University of Colorado School of Medicine.

“I’m a parent myself. Parents are flooded with tons of information, some of that time being misinformation,” he said at the media briefing. “If you are a parent who’s been on the fence [about vaccination], now is the time, given the outbreak potential and the outbreaks that we’re seeing.” 

Vaccine misinformation “is about as old as vaccines themselves,” Dr. Lim said. Concerns about the MMR vaccine, which includes measles protection, are not new.

“It does seem to change periodically — new things bubble up, new ideas bubble up, and the problem is that it is like the old saying that ‘a lie can get halfway around the world before the truth can get its boots on.’ ” Social media helps to amplify vaccine misinformation, she said. 

“You don’t want to scare people unnecessarily — but reminding people what these childhood diseases really look like and what they do is incredibly important,” Dr. Lim said. “It’s so much easier to see stories about potential side effects of vaccines than it is to see stories about parents whose children were in intensive care for 2 weeks with pneumonia because of a severe case of measles.”

Dr. Barocas said misinformation is sometimes deliberate, sometimes not. Regardless, “our job as infectious disease physicians and public health professionals is not necessarily to put the counternarrative out there, but to continue to advocate for what we know works based on the best science and the best evidence.”

“And there is no reason to believe that vaccines are anything but helpful when it comes to preventing measles,” he noted. 
 

Lifelong Protection in Most Cases

The MMR vaccine, typically given as two doses in childhood, offers 93% and then 97% protection against the highly contagious virus. During the 2022-to-2023 school year, the measles vaccination rate among kindergarten children nationwide was 92%. That sounds like a high rate, Dr. Lim said, “but because measles is so contagious, vaccination rates need to be 95% or higher to contain transmission.”

One person with measles can infect anywhere from 12 to 18 other people, she said. When an infected person coughs or sneezes, tiny droplets spread through the air. “And if someone is unvaccinated and exposed, 9 times out of 10, that person will go on to develop the disease.” She said given the high transmission rate, measles often spreads within families to infect multiple children. 

If you know you’re not vaccinated but exposed, the advice is to get the measles shot as quickly as possible. “There is a recommendation to receive the MMR vaccine within 72 hours as post-exposure prophylaxis,” Dr. Lim said. “That’s a tight time window, but if you can do that, it reduces the risk of developing measles significantly.”

If you’re unsure or do not remember getting vaccinated against measles as a young child, your health care provider may be able to search state registries for an answer. If that doesn’t work, getting revaccinated with the MMR vaccine as an adult is an option. “There is no shame in getting caught up now,” Dr. Barocas said.

Dr. Lim agreed. “There is really no downside to getting additional doses.”
 

A version of this article appeared on WebMD.com.

Just over 2 months into 2024, measles cases in the United States aren’t looking great. 

The recent rise in cases across the U.S. is linked to unvaccinated travelers, lower than ideal vaccination rates, and misinformation, experts said. 

The Centers for Disease Control and Prevention has identified 45 cases of measles in 17 jurisdictions across the U.S. As of March 7, the federal health agency reported measles cases in Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

As for the 45 cases, “that’s almost as many as we had for the entire calendar year of 2023,” said Sarah Lim, MD, a medical specialist at the Minnesota Department of Health. “So we’re really not off to a great start.” (For context, there were 58 officially reported measles cases last year.) 

Chicago is having a measles outbreak — with eight cases reported so far. All but one case has been linked to a migrant child at a city shelter. Given the potential for rapid spread — measles is relatively rare here but potentially very serious — the CDC sent a team of experts to investigate and to help keep this outbreak from growing further.


 

Sometimes Deadly

About 30% of children have measles symptoms and about 25% end up hospitalized. Complications include diarrhea, a whole-body rash, ear infections that can lead to permanent deafness, and pneumonia. Pneumonia with measles can be so serious that 1 in 20 affected children die. Measles can also cause inflammation of the brain called encephalitis in about 1 in 1,000 children, sometimes causing epilepsy or permanent brain damage.

As with long COVID, some effects can last beyond the early infection. For example, measles “can wipe out immune memory that protects you against other bacterial and viral pathogens,” Dr. Lim said at a media briefing sponsored by the Infectious Diseases Society of America. This vulnerability to other infections can last up to 3 years after the early infection, she noted. 

Overall, measles kills between 1 and 3 people infected per thousand, mostly children.
 

Vaccine Misinformation Playing a Role

Vaccine misinformation is partly behind the uptick, and while many cases are mild, “this can be a devastating disease,” said Joshua Barocas, MD, associate professor of medicine in the divisions of General Internal Medicine and Infectious Diseases at the University of Colorado School of Medicine.

“I’m a parent myself. Parents are flooded with tons of information, some of that time being misinformation,” he said at the media briefing. “If you are a parent who’s been on the fence [about vaccination], now is the time, given the outbreak potential and the outbreaks that we’re seeing.” 

Vaccine misinformation “is about as old as vaccines themselves,” Dr. Lim said. Concerns about the MMR vaccine, which includes measles protection, are not new.

“It does seem to change periodically — new things bubble up, new ideas bubble up, and the problem is that it is like the old saying that ‘a lie can get halfway around the world before the truth can get its boots on.’ ” Social media helps to amplify vaccine misinformation, she said. 

“You don’t want to scare people unnecessarily — but reminding people what these childhood diseases really look like and what they do is incredibly important,” Dr. Lim said. “It’s so much easier to see stories about potential side effects of vaccines than it is to see stories about parents whose children were in intensive care for 2 weeks with pneumonia because of a severe case of measles.”

Dr. Barocas said misinformation is sometimes deliberate, sometimes not. Regardless, “our job as infectious disease physicians and public health professionals is not necessarily to put the counternarrative out there, but to continue to advocate for what we know works based on the best science and the best evidence.”

“And there is no reason to believe that vaccines are anything but helpful when it comes to preventing measles,” he noted. 
 

Lifelong Protection in Most Cases

The MMR vaccine, typically given as two doses in childhood, offers 93% and then 97% protection against the highly contagious virus. During the 2022-to-2023 school year, the measles vaccination rate among kindergarten children nationwide was 92%. That sounds like a high rate, Dr. Lim said, “but because measles is so contagious, vaccination rates need to be 95% or higher to contain transmission.”

One person with measles can infect anywhere from 12 to 18 other people, she said. When an infected person coughs or sneezes, tiny droplets spread through the air. “And if someone is unvaccinated and exposed, 9 times out of 10, that person will go on to develop the disease.” She said given the high transmission rate, measles often spreads within families to infect multiple children. 

If you know you’re not vaccinated but exposed, the advice is to get the measles shot as quickly as possible. “There is a recommendation to receive the MMR vaccine within 72 hours as post-exposure prophylaxis,” Dr. Lim said. “That’s a tight time window, but if you can do that, it reduces the risk of developing measles significantly.”

If you’re unsure or do not remember getting vaccinated against measles as a young child, your health care provider may be able to search state registries for an answer. If that doesn’t work, getting revaccinated with the MMR vaccine as an adult is an option. “There is no shame in getting caught up now,” Dr. Barocas said.

Dr. Lim agreed. “There is really no downside to getting additional doses.”
 

A version of this article appeared on WebMD.com.

Just over 2 months into 2024, measles cases in the United States aren’t looking great. 

The recent rise in cases across the U.S. is linked to unvaccinated travelers, lower than ideal vaccination rates, and misinformation, experts said. 

The Centers for Disease Control and Prevention has identified 45 cases of measles in 17 jurisdictions across the U.S. As of March 7, the federal health agency reported measles cases in Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York City, Ohio, Pennsylvania, Virginia, and Washington.

As for the 45 cases, “that’s almost as many as we had for the entire calendar year of 2023,” said Sarah Lim, MD, a medical specialist at the Minnesota Department of Health. “So we’re really not off to a great start.” (For context, there were 58 officially reported measles cases last year.) 

Chicago is having a measles outbreak — with eight cases reported so far. All but one case has been linked to a migrant child at a city shelter. Given the potential for rapid spread — measles is relatively rare here but potentially very serious — the CDC sent a team of experts to investigate and to help keep this outbreak from growing further.


 

Sometimes Deadly

About 30% of children have measles symptoms and about 25% end up hospitalized. Complications include diarrhea, a whole-body rash, ear infections that can lead to permanent deafness, and pneumonia. Pneumonia with measles can be so serious that 1 in 20 affected children die. Measles can also cause inflammation of the brain called encephalitis in about 1 in 1,000 children, sometimes causing epilepsy or permanent brain damage.

As with long COVID, some effects can last beyond the early infection. For example, measles “can wipe out immune memory that protects you against other bacterial and viral pathogens,” Dr. Lim said at a media briefing sponsored by the Infectious Diseases Society of America. This vulnerability to other infections can last up to 3 years after the early infection, she noted. 

Overall, measles kills between 1 and 3 people infected per thousand, mostly children.
 

Vaccine Misinformation Playing a Role

Vaccine misinformation is partly behind the uptick, and while many cases are mild, “this can be a devastating disease,” said Joshua Barocas, MD, associate professor of medicine in the divisions of General Internal Medicine and Infectious Diseases at the University of Colorado School of Medicine.

“I’m a parent myself. Parents are flooded with tons of information, some of that time being misinformation,” he said at the media briefing. “If you are a parent who’s been on the fence [about vaccination], now is the time, given the outbreak potential and the outbreaks that we’re seeing.” 

Vaccine misinformation “is about as old as vaccines themselves,” Dr. Lim said. Concerns about the MMR vaccine, which includes measles protection, are not new.

“It does seem to change periodically — new things bubble up, new ideas bubble up, and the problem is that it is like the old saying that ‘a lie can get halfway around the world before the truth can get its boots on.’ ” Social media helps to amplify vaccine misinformation, she said. 

“You don’t want to scare people unnecessarily — but reminding people what these childhood diseases really look like and what they do is incredibly important,” Dr. Lim said. “It’s so much easier to see stories about potential side effects of vaccines than it is to see stories about parents whose children were in intensive care for 2 weeks with pneumonia because of a severe case of measles.”

Dr. Barocas said misinformation is sometimes deliberate, sometimes not. Regardless, “our job as infectious disease physicians and public health professionals is not necessarily to put the counternarrative out there, but to continue to advocate for what we know works based on the best science and the best evidence.”

“And there is no reason to believe that vaccines are anything but helpful when it comes to preventing measles,” he noted. 
 

Lifelong Protection in Most Cases

The MMR vaccine, typically given as two doses in childhood, offers 93% and then 97% protection against the highly contagious virus. During the 2022-to-2023 school year, the measles vaccination rate among kindergarten children nationwide was 92%. That sounds like a high rate, Dr. Lim said, “but because measles is so contagious, vaccination rates need to be 95% or higher to contain transmission.”

One person with measles can infect anywhere from 12 to 18 other people, she said. When an infected person coughs or sneezes, tiny droplets spread through the air. “And if someone is unvaccinated and exposed, 9 times out of 10, that person will go on to develop the disease.” She said given the high transmission rate, measles often spreads within families to infect multiple children. 

If you know you’re not vaccinated but exposed, the advice is to get the measles shot as quickly as possible. “There is a recommendation to receive the MMR vaccine within 72 hours as post-exposure prophylaxis,” Dr. Lim said. “That’s a tight time window, but if you can do that, it reduces the risk of developing measles significantly.”

If you’re unsure or do not remember getting vaccinated against measles as a young child, your health care provider may be able to search state registries for an answer. If that doesn’t work, getting revaccinated with the MMR vaccine as an adult is an option. “There is no shame in getting caught up now,” Dr. Barocas said.

Dr. Lim agreed. “There is really no downside to getting additional doses.”
 

A version of this article appeared on WebMD.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women's Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women's Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

Nine days after the independent laboratory Valisure petitioned the Food and Drug Administration (FDA) to recall acne products with benzoyl peroxide (BP) because of the lab’s findings of extremely high levels of the carcinogen benzene, it published another report in Environmental Health Perspectives (EHP), on March 14, also warning about BP acne products.

The bottom line was the same: The laboratory, based in New Haven, Connecticut, said its analyses raise substantial concerns about the safety of BP-containing acne products currently on the market.

The lab’s results showed that the products can form over 800 times the conditionally restricted FDA concentration limit of 2 parts per million (ppm) of benzene, with both prescription and over-the-counter products affected.

“This is a problem of degradation, not contamination,” David Light, CEO and founder of Valisure, said in a telephone interview. BP can decompose into benzene, and exposure to benzene has been linked with a higher risk for leukemia and other blood cancers, according to the American Cancer Society.

In the wake of the findings, however, debate has erupted over the method and approach used by Valisure to test these products, with critics and companies contending that more “real-world” use data are needed. And the US Pharmacopeia (USP) is asking for full transparency about the testing methods.

In a March 8 statement, USP said the petition indicated that modified USP methods were used in the study, noting that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

However, Valisure contended that drug products need to demonstrate stability over the entire life cycle, from shipment to continued use, emphasizing that constitutes the best “real-world” approach. It also defended the methodology it used.

The reports have led to a state of uncertainty about the use of BP products.

“Right now, we have more unknowns than anything else,” John Barbieri, MD, MBA, assistant professor of dermatology at Harvard Medical School and director of the Advanced Acne Therapeutics Clinic at Brigham and Women’s Hospital, Boston, said in a video posted on X and YouTube, summarizing the findings released by Valisure on March 6 and 14. He was not involved in the Valisure research.

Brigham and Women's Hospital

In a telephone interview, Dr. Barbieri said the report “needs to be taken seriously,” but he also believed the Valisure report is lacking information about testing under “real-world” conditions. He is calling for more information and more transparency about the data. What’s clear, Dr. Barbieri told this news organization, is that the findings about high benzene levels are not a manufacturing error. “It’s something to do with the molecule itself.”
 

Valisure’s Analyses

Valisure performed an initial analysis, using a method called gas chromatography-mass spectrometry, which is the FDA-preferred method for detecting benzene, Mr. Light said. It tested 175 acne products, 99 containing BP and 76 with other ingredients, such as salicylic acid. All the products without BP had no detectable benzene or values below 2 ppm, the FDA concentration limit for benzene.

Of the 99 BP products, 94 contained benzene without any elevated temperature incubation, according to Valisure. Using 50 °C (122 °F, the accepted pharmaceutical stability testing temperature) on 66 products, Valisure detected over 1500 ppm of benzene in two products, over 100 ppm in 17 products, and over 10 ppm in 42 products over an 18-day period.

The analysis confirmed, Valisure said in a press release and the petition, that a substantial amount of benzene can form in a BP product and leak outside the packaging into surrounding air.

The EHP paper, which includes authors from Valisure, reported that researchers took single lots of seven branded BP products, namely, Equate Beauty 2.5% BP cleansers, Neutrogena 10% BP cleanser, CVS Health 10% BP face wash, Walgreens 10% BP cream, Clean & Clear 10% cleanser, Equate Beauty 10% BP acne wash, and Proactiv 2.5% BP cleanser.

Using testing that involved gas chromatography-mass spectrometry, benzene was detected in all the BP products samples tested, and levels increased during incubation at body and shelf-life performance temperatures to more than 2 ppm. The authors concluded that the study “raises substantial concerns” about the safety of BP products currently on the market.
 

Methodology Debates

Two days after Valisure released its analysis on March 6, the USP reviewed the citizen’s petition filed by Valisure and called for more transparency around the testing methods.

“The petition referenced USP and indicated that modified USP methods and procedures were used in the study. The presence of unsafe levels of benzene should be taken seriously,” the statement said. The USP statement also noted that the Valisure analysis used modified USP methods and said that “if changes are made to a USP method, complete validation data is necessary to demonstrate that a product meets USP standards.”

In its statement, USP took issue with a practice known as accelerated thermal degradation, which it said Valisure used. USP said the approach involves raising the storage temperature of a product to higher than the temperature indicated on the label for the purpose of simulating degradation over a longer period. While the approach may be acceptable, USP said, the temperatures chosen may not be what is expected to happen to the products.

In response, Mr. Light of Valisure referenced guidance issued in August, 2020, from the FDA, stating that the method it used in the BP analysis can be used to detect impurities in hand sanitizers, including benzene. (In 2021, Valisure detected high levels of benzene in some hand sanitizers and asked the FDA to take action.)
 

Company Response

Among the companies that took issue with the report was Reckitt, which makes Clearasil, which contains BP. In a statement, the company said, in part: “The products and their ingredients are stable over the storage conditions described on their packaging which represent all reasonable and foreseeable conditions.” It said the findings presented by Valisure reflect “unrealistic scenarios rather than real-world conditions.”

The Personal Care Products Council, a national trade association that represents cosmetic and personal care product manufacturers, also took issue with the findings and the approach used to evaluate the products.
 

FDA and the Citizen’s Petition

The FDA accepted the petition, Mr. Light said, and gave it a docket number. “We’ll hopefully hear more soon” because the FDA is required to respond to a citizen’s petition within 180 days, he said.

“We generally don’t comment on pending citizens’ petitions,” an FDA spokesperson said in an email. “When we respond, we will respond directly to the petitioner and post the response in the designated agency public docket.”
 

Valisure’s Patent Application

Mr. Light and others have applied for a patent on methods of producing shelf-stable formulations to prevent degradation of BP to benzene.

“We saw the problem long before we had any sort of application,” Mr. Light said. The issue has been “known for decades.”
 

Role of BP Products for Acne

In the midst of uncertainty, “the first discussion is, do we want to use it?” Dr. Barbieri said in the interview. Some patients may want to avoid it altogether, until more data are available, including more verification of the findings, while others may be comfortable accepting the potential risk, he said.

“Benzoyl peroxide is one of our foundational acne treatments,” Dr. Barbieri said. In the American Academy of Dermatology updated guidelines on acne, published in January, 2024, strong recommendations were made for BP products, as well as topical retinoids, topical antibiotics, and oral doxycycline.

“When you take away BP, there’s no substitute for it,” Dr. Barbieri said. And if patients don’t get improvement with topicals, oral medications might be needed, and “these all have their own risks.”
 

In the Interim

Until more information is available, Dr. Barbieri is advising patients not to store the products at high temperatures or for a long time. Don’t keep the products past their expiration date, and perhaps keep products for a shorter time, “something like a month,” he said.

Those living in a hot climate might consider storing the products in the refrigerator, he said.

“We need more data from Valisure, from other groups that confirm their findings, and we need to hear from the FDA,” Dr. Barbieri said. “There’s a lot of uncertainty right now. But it’s important not to overreact.”

Dr. Barbieri had no relevant disclosures.


 

A version of this article appeared on Medscape.com.

SAN DIEGO — Just a day before the annual meeting of the American Academy of Dermatology (AAD) began, a study was published online in JAMA Dermatology, cautioning that most downloadable mobile apps driven by artificial intelligence (AI) for use in monitoring dermatologic conditions lack validation.

Not least of the problems among the 41 apps evaluated, the majority offered no supporting evidence, no information about whether the app performance had been validated, and no information about how user privacy would be managed, reported Shannon Wongvibulsin, MD, PhD, a resident in the dermatology program at the University of California, Los Angeles, and her coauthors.

The findings from this report were also summarized in a poster at the AAD meeting, and the major themes were reiterated in several AAD symposia devoted to AI at the meeting. Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York City, was one of those who weighed in on the future of AI. Although she was the senior author of the report, she did not address the report or poster directly, but her presentation on the practical aspects of incorporating AI into dermatology practice revisited several of its themes. 

Of the different themes, perhaps the most important were the concept that the source of AI data matters and the point that practicing clinicians should be familiar with the data source.

To date, “there is not much transparency in what data AI models are using,” Dr. Rotemberg said at the meeting. Based on the expectation that dermatologists will be purchasing rather than developing their own AI-based systems, she reiterated more than once that “transparency of data is critical,” even if vendors are often reluctant to reveal how their proprietary systems have been developed.

Few Dermatology Apps Are Vetted for Accuracy

In the poster and in the more detailed JAMA Dermatology paper, Dr. Wongvibulsin and her coinvestigators evaluated direct-to-consumer downloadable apps that claim to help with the assessment and management of skin conditions. Very few provided any supporting evidence of accuracy or even information about how they functioned.

The 41 apps were drawn from more than 300 apps; the others were excluded for failing to meet such criteria as failing to employ AI, not being available in English, or not addressing clinical management of dermatologic diseases. Dr. Wongvibulsin pointed out that none of the apps had been granted regulatory approval even though only two provided a disclaimer to that effect.

In all, just 5 of the 41 provided supporting evidence from a peer-reviewed journal, and less than 40% were created with any input from a dermatologist, Dr. Wongvibulsin reported. The result is that the utility and accuracy of these apps were, for the most part, difficult to judge.

“At a minimum, app developers should provide details on what AI algorithms are used, what data sets were used for training, testing, and validation, whether there was any clinician input, whether there are any supporting publications, how user-submitted images are used, and if there are any measures used to ensure data privacy,” Dr. Wongvibulsin wrote in the poster.

For AI-based apps or systems designed for use by dermatologists, Dr. Rotemberg made similar assertions in her overview of what clinicians should be considering for proprietary AI systems, whether to help with diagnosis or improve office efficiency.
 

Only One Dermatology App Cleared By the FDA

Currently, the only FDA-cleared app for dermatologic use is the DermaSensor, an AI-driven device. It was cleared for use in January 2024 for the evaluation of skin lesions “suggestive” of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged ≥ 40 years “to assist health care providers in determining whether to refer a patient to a dermatologist,” according to an FDA announcement.

Using elastic scattering spectroscopy to analyze light reflecting off the skin to detect malignancy, the manufacturer’s promotional material claims a 96% sensitivity and a 97% specificity. 

While Dr. Rotemberg did not comment on these claims, she cautioned that AI models differ with regards to how they were trained and the relative heterogeneity of the training dataset defined by types of patients, types of skin, and types of AI learning processes. All of these variables are relevant in whether the AI will perform in a given clinical setting at the level it performed during development.

“The most accurate models employ narrow datasets, but these do not necessarily mimic what we see in practice,” she said.

In addition, even when an AI-based system is working for a given task, it must be monitored over time. Dr. Rotemberg warned about the potential for “data drift,” which describes the slow evolution in how diseases present, their prevalence by age, or other factors that might affect AI performance. She explained that repeated validation is needed to ensure that the AI-based models remain as accurate over time as they were when first used.

Many of these concepts were explored in a consensus statement from the International Skin Imaging Collaboration AI Working Group, published in JAMA Dermatology in December 2021. The statement, of which Dr. Rotemberg was a coauthor, provided recommendations for the principles of AI algorithm development specific to dermatologic considerations.

At the AAD symposium, Dr. Rotemberg asked the audience for suggestions about the needs they hoped AI might address for in office care or efficiency. Their responses included generating prior authorizations for prescriptions, triaging email for importance, and helping to improve efficiency for common front desk tasks. She liked all of these suggestions, but she warned that as powerful as it can be, AI is not likely to provide technology that will fit seamlessly into workflows without adjustment.

“Our current systems do not allow human integration of AI models,” Dr. Rotemberg said. Rather than counting on AI to adapt to current practices, she cautioned that “we may have to redesign our entire structure to actually be able to accommodate AI-based” systems. The risk for users is tasks that become more challenging before they become easier. 

AI Should Not Be a Black Box

AI is promising, but it is not magic, according to other investigators, including Tofunmi A. Omiye, PhD, a postdoctoral scholar in dermatology at Stanford University, California. First author of a recent review of AI in dermatology published in Frontiers in Medicine, Dr. Omiye agreed that clinicians who want to employ AI should be able to understand basic principles if they want the technology to perform as expected.

“I totally agree that physicians should at least have a basic understanding of the data sources for training AI models as we have found that to be important to the performance of these models in the clinical setting,” he told this news organization.

“Beyond understanding the data sources, I believe physicians can also try to have a comprehensive understanding of what AI means, its training process, and evaluation as this will help them to evaluate its utility in their practice,” he added. He also reinforced the relevance of data drift.

“Concepts like distribution shift — where models perform less well over time due to changes in the patient population — are also important to keep in mind,” Dr. Omiye said.

Dr. Wongvibulsin, Dr. Rotemberg, and Dr. Omiye reported no potential financial conflicts of interest relevant to this topic. 

A version of this article appeared on Medscape.com .

SAN DIEGO — Just a day before the annual meeting of the American Academy of Dermatology (AAD) began, a study was published online in JAMA Dermatology, cautioning that most downloadable mobile apps driven by artificial intelligence (AI) for use in monitoring dermatologic conditions lack validation.

Not least of the problems among the 41 apps evaluated, the majority offered no supporting evidence, no information about whether the app performance had been validated, and no information about how user privacy would be managed, reported Shannon Wongvibulsin, MD, PhD, a resident in the dermatology program at the University of California, Los Angeles, and her coauthors.

The findings from this report were also summarized in a poster at the AAD meeting, and the major themes were reiterated in several AAD symposia devoted to AI at the meeting. Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York City, was one of those who weighed in on the future of AI. Although she was the senior author of the report, she did not address the report or poster directly, but her presentation on the practical aspects of incorporating AI into dermatology practice revisited several of its themes. 

Of the different themes, perhaps the most important were the concept that the source of AI data matters and the point that practicing clinicians should be familiar with the data source.

To date, “there is not much transparency in what data AI models are using,” Dr. Rotemberg said at the meeting. Based on the expectation that dermatologists will be purchasing rather than developing their own AI-based systems, she reiterated more than once that “transparency of data is critical,” even if vendors are often reluctant to reveal how their proprietary systems have been developed.

Few Dermatology Apps Are Vetted for Accuracy

In the poster and in the more detailed JAMA Dermatology paper, Dr. Wongvibulsin and her coinvestigators evaluated direct-to-consumer downloadable apps that claim to help with the assessment and management of skin conditions. Very few provided any supporting evidence of accuracy or even information about how they functioned.

The 41 apps were drawn from more than 300 apps; the others were excluded for failing to meet such criteria as failing to employ AI, not being available in English, or not addressing clinical management of dermatologic diseases. Dr. Wongvibulsin pointed out that none of the apps had been granted regulatory approval even though only two provided a disclaimer to that effect.

In all, just 5 of the 41 provided supporting evidence from a peer-reviewed journal, and less than 40% were created with any input from a dermatologist, Dr. Wongvibulsin reported. The result is that the utility and accuracy of these apps were, for the most part, difficult to judge.

“At a minimum, app developers should provide details on what AI algorithms are used, what data sets were used for training, testing, and validation, whether there was any clinician input, whether there are any supporting publications, how user-submitted images are used, and if there are any measures used to ensure data privacy,” Dr. Wongvibulsin wrote in the poster.

For AI-based apps or systems designed for use by dermatologists, Dr. Rotemberg made similar assertions in her overview of what clinicians should be considering for proprietary AI systems, whether to help with diagnosis or improve office efficiency.
 

Only One Dermatology App Cleared By the FDA

Currently, the only FDA-cleared app for dermatologic use is the DermaSensor, an AI-driven device. It was cleared for use in January 2024 for the evaluation of skin lesions “suggestive” of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged ≥ 40 years “to assist health care providers in determining whether to refer a patient to a dermatologist,” according to an FDA announcement.

Using elastic scattering spectroscopy to analyze light reflecting off the skin to detect malignancy, the manufacturer’s promotional material claims a 96% sensitivity and a 97% specificity. 

While Dr. Rotemberg did not comment on these claims, she cautioned that AI models differ with regards to how they were trained and the relative heterogeneity of the training dataset defined by types of patients, types of skin, and types of AI learning processes. All of these variables are relevant in whether the AI will perform in a given clinical setting at the level it performed during development.

“The most accurate models employ narrow datasets, but these do not necessarily mimic what we see in practice,” she said.

In addition, even when an AI-based system is working for a given task, it must be monitored over time. Dr. Rotemberg warned about the potential for “data drift,” which describes the slow evolution in how diseases present, their prevalence by age, or other factors that might affect AI performance. She explained that repeated validation is needed to ensure that the AI-based models remain as accurate over time as they were when first used.

Many of these concepts were explored in a consensus statement from the International Skin Imaging Collaboration AI Working Group, published in JAMA Dermatology in December 2021. The statement, of which Dr. Rotemberg was a coauthor, provided recommendations for the principles of AI algorithm development specific to dermatologic considerations.

At the AAD symposium, Dr. Rotemberg asked the audience for suggestions about the needs they hoped AI might address for in office care or efficiency. Their responses included generating prior authorizations for prescriptions, triaging email for importance, and helping to improve efficiency for common front desk tasks. She liked all of these suggestions, but she warned that as powerful as it can be, AI is not likely to provide technology that will fit seamlessly into workflows without adjustment.

“Our current systems do not allow human integration of AI models,” Dr. Rotemberg said. Rather than counting on AI to adapt to current practices, she cautioned that “we may have to redesign our entire structure to actually be able to accommodate AI-based” systems. The risk for users is tasks that become more challenging before they become easier. 

AI Should Not Be a Black Box

AI is promising, but it is not magic, according to other investigators, including Tofunmi A. Omiye, PhD, a postdoctoral scholar in dermatology at Stanford University, California. First author of a recent review of AI in dermatology published in Frontiers in Medicine, Dr. Omiye agreed that clinicians who want to employ AI should be able to understand basic principles if they want the technology to perform as expected.

“I totally agree that physicians should at least have a basic understanding of the data sources for training AI models as we have found that to be important to the performance of these models in the clinical setting,” he told this news organization.

“Beyond understanding the data sources, I believe physicians can also try to have a comprehensive understanding of what AI means, its training process, and evaluation as this will help them to evaluate its utility in their practice,” he added. He also reinforced the relevance of data drift.

“Concepts like distribution shift — where models perform less well over time due to changes in the patient population — are also important to keep in mind,” Dr. Omiye said.

Dr. Wongvibulsin, Dr. Rotemberg, and Dr. Omiye reported no potential financial conflicts of interest relevant to this topic. 

A version of this article appeared on Medscape.com .

SAN DIEGO — Just a day before the annual meeting of the American Academy of Dermatology (AAD) began, a study was published online in JAMA Dermatology, cautioning that most downloadable mobile apps driven by artificial intelligence (AI) for use in monitoring dermatologic conditions lack validation.

Not least of the problems among the 41 apps evaluated, the majority offered no supporting evidence, no information about whether the app performance had been validated, and no information about how user privacy would be managed, reported Shannon Wongvibulsin, MD, PhD, a resident in the dermatology program at the University of California, Los Angeles, and her coauthors.

The findings from this report were also summarized in a poster at the AAD meeting, and the major themes were reiterated in several AAD symposia devoted to AI at the meeting. Veronica Rotemberg, MD, PhD, a dermatologist at Memorial Sloan Kettering Cancer Center, New York City, was one of those who weighed in on the future of AI. Although she was the senior author of the report, she did not address the report or poster directly, but her presentation on the practical aspects of incorporating AI into dermatology practice revisited several of its themes. 

Of the different themes, perhaps the most important were the concept that the source of AI data matters and the point that practicing clinicians should be familiar with the data source.

To date, “there is not much transparency in what data AI models are using,” Dr. Rotemberg said at the meeting. Based on the expectation that dermatologists will be purchasing rather than developing their own AI-based systems, she reiterated more than once that “transparency of data is critical,” even if vendors are often reluctant to reveal how their proprietary systems have been developed.

Few Dermatology Apps Are Vetted for Accuracy

In the poster and in the more detailed JAMA Dermatology paper, Dr. Wongvibulsin and her coinvestigators evaluated direct-to-consumer downloadable apps that claim to help with the assessment and management of skin conditions. Very few provided any supporting evidence of accuracy or even information about how they functioned.

The 41 apps were drawn from more than 300 apps; the others were excluded for failing to meet such criteria as failing to employ AI, not being available in English, or not addressing clinical management of dermatologic diseases. Dr. Wongvibulsin pointed out that none of the apps had been granted regulatory approval even though only two provided a disclaimer to that effect.

In all, just 5 of the 41 provided supporting evidence from a peer-reviewed journal, and less than 40% were created with any input from a dermatologist, Dr. Wongvibulsin reported. The result is that the utility and accuracy of these apps were, for the most part, difficult to judge.

“At a minimum, app developers should provide details on what AI algorithms are used, what data sets were used for training, testing, and validation, whether there was any clinician input, whether there are any supporting publications, how user-submitted images are used, and if there are any measures used to ensure data privacy,” Dr. Wongvibulsin wrote in the poster.

For AI-based apps or systems designed for use by dermatologists, Dr. Rotemberg made similar assertions in her overview of what clinicians should be considering for proprietary AI systems, whether to help with diagnosis or improve office efficiency.
 

Only One Dermatology App Cleared By the FDA

Currently, the only FDA-cleared app for dermatologic use is the DermaSensor, an AI-driven device. It was cleared for use in January 2024 for the evaluation of skin lesions “suggestive” of melanoma, basal cell carcinoma, and/or squamous cell carcinoma in patients aged ≥ 40 years “to assist health care providers in determining whether to refer a patient to a dermatologist,” according to an FDA announcement.

Using elastic scattering spectroscopy to analyze light reflecting off the skin to detect malignancy, the manufacturer’s promotional material claims a 96% sensitivity and a 97% specificity. 

While Dr. Rotemberg did not comment on these claims, she cautioned that AI models differ with regards to how they were trained and the relative heterogeneity of the training dataset defined by types of patients, types of skin, and types of AI learning processes. All of these variables are relevant in whether the AI will perform in a given clinical setting at the level it performed during development.

“The most accurate models employ narrow datasets, but these do not necessarily mimic what we see in practice,” she said.

In addition, even when an AI-based system is working for a given task, it must be monitored over time. Dr. Rotemberg warned about the potential for “data drift,” which describes the slow evolution in how diseases present, their prevalence by age, or other factors that might affect AI performance. She explained that repeated validation is needed to ensure that the AI-based models remain as accurate over time as they were when first used.

Many of these concepts were explored in a consensus statement from the International Skin Imaging Collaboration AI Working Group, published in JAMA Dermatology in December 2021. The statement, of which Dr. Rotemberg was a coauthor, provided recommendations for the principles of AI algorithm development specific to dermatologic considerations.

At the AAD symposium, Dr. Rotemberg asked the audience for suggestions about the needs they hoped AI might address for in office care or efficiency. Their responses included generating prior authorizations for prescriptions, triaging email for importance, and helping to improve efficiency for common front desk tasks. She liked all of these suggestions, but she warned that as powerful as it can be, AI is not likely to provide technology that will fit seamlessly into workflows without adjustment.

“Our current systems do not allow human integration of AI models,” Dr. Rotemberg said. Rather than counting on AI to adapt to current practices, she cautioned that “we may have to redesign our entire structure to actually be able to accommodate AI-based” systems. The risk for users is tasks that become more challenging before they become easier. 

AI Should Not Be a Black Box

AI is promising, but it is not magic, according to other investigators, including Tofunmi A. Omiye, PhD, a postdoctoral scholar in dermatology at Stanford University, California. First author of a recent review of AI in dermatology published in Frontiers in Medicine, Dr. Omiye agreed that clinicians who want to employ AI should be able to understand basic principles if they want the technology to perform as expected.

“I totally agree that physicians should at least have a basic understanding of the data sources for training AI models as we have found that to be important to the performance of these models in the clinical setting,” he told this news organization.

“Beyond understanding the data sources, I believe physicians can also try to have a comprehensive understanding of what AI means, its training process, and evaluation as this will help them to evaluate its utility in their practice,” he added. He also reinforced the relevance of data drift.

“Concepts like distribution shift — where models perform less well over time due to changes in the patient population — are also important to keep in mind,” Dr. Omiye said.

Dr. Wongvibulsin, Dr. Rotemberg, and Dr. Omiye reported no potential financial conflicts of interest relevant to this topic. 

A version of this article appeared on Medscape.com .

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.

SAN DIEGO — Nemolizumab, the first-in-class inhibitor of interleukin-31 (IL-31), a neuroimmune cytokine linked to the promotion of pruritus and inflammation, continues to show good efficacy and safety for prurigo nodularis in an open-label follow-up pivotal trial following patients out to 52 weeks.

The OLYMPIA 2 trial, published just a few months ago, was positive for the primary endpoint of itch, and the 52-week data show “on-going improvement” not just in this key symptom but in the resolution of skin lesions, according to Shawn Kwatra, MD, director of the itch center and associate professor of dermatology, Johns Hopkins School of Medicine, Baltimore, Maryland.

The drug, which was found well tolerated in the double-blind OLYMPIA 2 study at 16 weeks, has not been associated with any new adverse events (AEs) in follow-up so far, according to Dr. Kwatra, who presented these findings in a late-breaker session at the annual meeting of the American Academy of Dermatology (AAD).

The promise of an anti-IL-31 drug for sustained control of itch and inflammation was further supported by a separate late breaker on long-term maintenance data on nemolizumab for moderate to severe atopic dermatitis (AD).
 

New Prurigo Nodularis Therapies Needed

For prurigo nodularis, excitement about a new therapy is particularly warranted, according to Dr. Kwatra. Current treatment options, such as steroids and antihistamines, are neither well-tolerated nor particularly effective in most patients. He indicated that the very positive interim 52-week data from the ongoing open-label extension suggests that nemolizumab might be an important step forward for patients with this disease.

The interim 52-week analysis included 307 patients on continuous nemolizumab and 174 patients randomized previously to placebo and were nemolizumab-naive when they entered the open-label extension. Participants were drawn from the phase 3 trial as well as an earlier phase 2 study. Nemolizumab in all patients was delivered at a subcutaneous dose of 45 mg every 4 weeks.

Pointing out that the 2024 AAD annual meeting, with more than 19,000 attendees, “was the largest dermatology conference in the history of the world,” he added that his late-breaker results represent “the largest prurigo nodularis clinical study in the history of the world.”

At 52 weeks, 89.9% and 83.3% of those on continuous nemolizumab and those switched to nemolizumab, respectively, had achieved at least a 4-point reduction from baseline on the Peak Pruritus Numerical Rating Scale (NRS), which has a range from 0 to 10.

Approximately two thirds of patients (67.8% and 64.4%, respectively) had a weekly average peak NRS of ≤ 2, meaning they were free or almost free of itch. The improvement in a sleep index and in quality of life as measured with the Dermatology Life Quality Index closely followed the relief of itch with the large gains achieved within weeks of initiating treatment continuing on an upward slope at 52 weeks.

Over this time, lesions were also resolving. By week 52, healing of more than 75% of lesions had been achieved by 79.1% in both those on continuous nemolizumab and those who had been switched to nemolizumab. The rate of response was again about two thirds for those with lesion resolution considered clear or almost clear by the Investigator’s Global Assessment (IGA) response.
 

No Serious AEs Over Extended Follow-Up

With a mean duration of 388 days follow-up, there were no serious AEs that were clearly treatment related, but Dr. Kwatra did report that some patients developed mild eczematous lesions that typically responded to topical therapy. He also reported that asthma, particularly worsening asthma in patients already diagnosed with this disease, was seen in a small proportion of patients. Both were considered manageable, and no patients discontinued therapy because of these events, Dr. Kwatra said.

While further follow-up is planned, “we have never seen data in a prurigo nodularis [treatment trial] past 6 months,” he pointed out. For a challenging disease with a major adverse effect on quality of life, nemolizumab, if approved, will offer an important option for a difficult disease, he added.

Itch Improves in Patients with AD

Further support for the long-term safety of nemolizumab and its efficacy against itch was provided by another phase 3 extension study conducted in the treatment of AD. These long-term extension results were also presented in a late breaker session at the AAD meeting.

Evaluating maintenance data from responders, defined as a 75% reduction lesions on the Eczema Area and Severity Index (EASI-75) or as clear or almost clear skin on IGA at the end of the randomized ARCADIA 1 and 2 trials, there were 169 patients on every 4-week nemolizumab, 169 patients on every 8-week nemolizumab, and 169 patients on every 4-week placebo.

For pruritus, a ≥ 4 point NRS reduction was achieved at week 48 in 76.2% of those on the every 4-week dose, 59.7% of those on the every 8-week dose, and 41% on those on placebo, reported Jonathan Silverberg, MD, PhD, director of clinical research, Department of Dermatology, George Washington School of Medicine, Washington.

These not only represented sustained responses over the course of 48 weeks, but there was a gradual rise in this rate of success from baseline in the higher dose group. For a NRS score of ≤ 2, meaning no itch or almost no itch, the proportions were 64.9%, 52.9%, and 31.3%, respectively. These were accompanied by sustained responses in IGA and EASI-75 scores.

Overall, there was a “nice durability of response” over the maintenance period, with no new or dose-related safety signals, according to Dr. Silverberg. He pointed out that the every 8-week dose response was lower than every 4-week dose response, but “it looks very good” in regard to response and duration of response, “suggesting that this might be an option for a large subset of patients.”

Andrew Blauvelt, MD, an investigator with Oregon Medical Research Center, Portland, Oregon, cautioned that despite the promise, dermatologists “might need help” in understanding this new agent and using it appropriately. He pointed out that it employs a new mechanism of action, and it has “a couple of new twists that we have not seen with other drugs,” including its association with worsening asthma.

Noting that asthma exacerbation has been reported in a proportion of treated patients approaching 4%, he expressed concern “that this is not rare.” He also expressed concern about reports of peripheral edema and asked Dr. Kwatra specifically how this should be handled in the routine clinical setting.

Pointing out that the 1% of new cases of asthma in the nemolizumab arm was, in fact, lower than the rate of new cases in the placebo arm, Dr. Kwatra said that there have been cases of increased asthma symptoms in patients with existing disease. However, he added that this and the reports of peripheral edema, some of which appear to be simply associated with prurigo nodularis, typically resolve with routine interventions. He said, however, that these side effects represent legitimate concerns that clinicians should consider, but he indicated that they do not appear to be a threat to the benefit-to-risk ratio of this agent.

In February 2024, the Food and Drug Administration and the European Medicines Agency accepted submissions for nemolizumab for the treatment of prurigo nodularis and AD, according to Galderma, the company developing nemolizumab.

Dr. Kwatra reported a financial relationship with more than 15 pharmaceutical companies, including Galderma, which sponsored the nemolizumab trials. Dr. Silverberg reported financial relationships with more than 35 pharmaceutical companies, including Galderma. Dr. Blauvelt reported financial relationships with more than 20 pharmaceutical companies, including Galderma.

A version of this article appeared on Medscape.com.