Dermatology News

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

Investigators have found a correlation between vitamin D deficiency and psoriasis severity, suggesting that some people who increase their intake of the vitamin could better control this skin condition that affects up to 8 million people in the United States alone. 

Brown University researchers studied almost 500 psoriasis cases taken from the National Health and Nutrition Examination Survey (NHANES), the scientists told attendees at the conference of the American Society for Nutrition. They compared the peoples’ reports on how much of their body surface was affected by psoriasis to vitamin D levels collected in blood samples.

“After adjusting for lifestyle factors such as smoking, the analysis showed that lower vitamin D levels and vitamin D deficiency were significantly associated with greater psoriasis severity,” the ASN said in a news release. “The researchers also found that patients with the least amount of body surface affected by psoriasis had the highest average vitamin D levels while those with the greatest affected area had the lowest average levels of vitamin D.”

The researchers said that people with psoriasis might improve their condition by getting more vitamin D in their diet and through supplements.

“Topical synthetic vitamin D creams are emerging as new therapies for psoriasis, but these usually require a doctor’s prescription,” said researcher Rachel K. Lim, an MD candidate at Brown University, Providence, R.I. “Our results suggest that a vitamin D–rich diet or oral vitamin D supplementation may also provide some benefit to psoriasis patients.”

The researchers said that vitamin D toxicity is rare but that people should consult with their medical caregivers before they start taking supplements.

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

ASHEVILLE, N.C. – TikTok, typical of several forms of social media, has been intentionally repositioned to rival Google as a primary source of information, meaning that health care professionals, including those who provide dermatologic care to children, should be thinking about how to get on board to counter myths, erroneous facts, and fake news, warned an expert at the annual meeting of the Society for Pediatric Dermatology.

“If we don’t get involved, we are basically letting misinformation win. We need to be there,” said Angelo Landriscina, MD, director of dermatology at a Mount Sinai Doctors Clinic in New York.

Most of the content currently available on medical topics, including dermatology and pediatric dermatology, is not created by health care professionals, Dr. Landriscina noted. Not surprisingly, given that much of the content is based on personal opinion from individuals who have no expertise in medical care, he described the information as being of “low quality” when not fully erroneous.

Dr. Landriscina has been active on social media, including TikTok, for several years. Most of his posts involve responses to misinformation. When he sets the record straight on the basis of existing evidence, he often supports his counterargument with references.

He acknowledged that when he became involved in social media he faced criticism from colleagues about participating on an entertainment platform that many considered unworthy of providing objective information. If that was ever true, he argued, it is no longer the case.

“TikTok has adopted a new strategy. The goal is to unseat Google as a search tool, and it’s working,” he said. He explained that many people now use TikTok and other social media sites as their primary source of information on essentially every topic, from where to eat to whether to be screened for cancer.

The particular problem with TikTok – one of the most popular social media outlets – is that there is no mechanism for vetting the source of information. YouTube, by contrast, now requires some sort of validation for anyone who claims to have a medical degree or any other verifiable qualification, according to Dr. Landriscina. TikTok, like many other platforms, has no such requirement.

“Anyone can buy a pair of scrubs [implying expertise] and then post a video,” Dr. Landriscina said.

Even if information from one content provider is more valid than information from others, the TikTok algorithm is specifically designed to emphasize content that has the potential for going viral, which means it favors videos that are provocative over those that are not.

“The algorithm favors any content that is more controversial, more surprising, and keeps viewers engaged,” Dr. Landriscina pointed out.

This does not mean that objective and factual information is ignored, but the algorithm is indifferent to the validity of information, meaning that it allows videos to be posted without regard to whether the content is true, untrue, purposefully misleading, or utter nonsense. For that reason, it is often easier to attract attention by responding to a post that has already gone viral. Information that is clear and digestible can attract viewers and therefore is distributed more widely with the TikTok algorithm.
 

Parents are on Tiktok too

There is a misperception that the TikTok audience is younger, according to Dr. Landriscina. While peak use in the United States fell among people between the ages of 25 and 34 years in 2022, he said the number of users falls off relatively slowly with subsequent 10-year increments in age. In 2022, there were nearly 20 million users in the peak 10-year age range, but 7.5 million users were 55 years of age or older.

“Pediatric dermatologists should recognize that it is not just kids who are looking for information about their skin diseases, but also their parents,” Dr. Landriscina said.

The top three dermatology topics searched on TikTok in a recent period were acne, alopecia, and cysts. But top searches are very fluid and are extremely hard to quantify, because the basis of the algorithm, which is a proprietary secret, is not only unknown but produces different results for every user.

“The second you touch the app, it changes,” Dr. Landriscina said. He explained that an inquiry about any subject, including those that are medically related, yields content that is different, or at least ordered differently, “depending on how you behaved on the app in the past.”

The phenomenon that drives social media predates this technology. Dr. Landriscina cited a study in 1956 that described the “parasocial interaction theory.” The theory was based on the observation that those who consume media, such as television, which was relatively new in 1956, believed that they had a personal relationship with media figures.

“The users begin to trust influencers as a source, like a friend providing them advice,” Dr. Landriscina said. As an example, he suggested that a fan of the television show Friends who follows actor Jennifer Aniston on social media platforms may begin to think of her as a trusted source of information on any topic, including those for which she may not have expertise.

The reason that he urges medical professionals to become active on TikTok and other social media platforms is that they have a potentially critical role in responding to information that is not just wrong but harmful.

On TikTok and other social media platforms, “there is a lot of interest in content about dermatologic conditions in children. There is a real need for accurate information,” he said,

In the question-and-answer session following his presentation, Dr. Landriscina’s message was not uniformly embraced. One risk, according to an audience member, is that medical professionals will begin to express their own personal opinions rather than rely on evidence, with the result that they will “just add to the sea of misinformation.”

However, this opinion appeared to be the minority view. Most of those who commented took a “that-ship-has-sailed” stance, recognizing the irreversible ascendancy of social media.

“Whether you like it or not, social media is here to stay. We cannot fight it. Rather, we need to embrace it in a responsible way,” said Dakara R. Wright, MD, a dermatologist at the Mid-Atlantic Kaiser Permanente Group, Halethorpe, Md. She, like others, reported that she has come to recognize that social media is a major source of medical information for her patients.

“We need to be a presence on these platforms for the benefit of our patients and their parents,” she said. She acknowledged that she has not been active in posting on social media in the past but said that she has been speaking with administrators in her organization about how to become involved in a responsible way that can be useful to patients.

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, has been active on social media for several years, posting content on her own account, which is not related to her academic affiliation. She posts for many reasons, not least of which is drawing attention to her expertise.

Like Dr. Landriscina, she recognizes that users of these platforms are guided by the content to make decisions about health care. She also agreed that physicians should not ignore this phenomenon.

Tips on providing content

Given the fact that the algorithm is intended to produce posts that go viral, Dr. Landriscina urged clinicians to make their content easy to watch. He said it is not necessary to overthink content beyond providing accurate information, but he advised that videos be made with attention to adequate lighting and other simple factors to promote visual quality. He said that accurate information is not necessarily dull.

“Some facts can actually be surprising to patients,” he said. He noted that a calm, coherent video can be particularly effective in attracting an audience when it is in reaction to information that has gone viral but is misleading or patently incorrect.

Dr. Landriscina has been an influencer associated with multiple social media platforms, including TikTok. He has in the past been paid for consulting work for TikTok. Dr. Wright and Dr. Heath reported no potential conflicts of interest.

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

ASHEVILLE, N.C. – TikTok, typical of several forms of social media, has been intentionally repositioned to rival Google as a primary source of information, meaning that health care professionals, including those who provide dermatologic care to children, should be thinking about how to get on board to counter myths, erroneous facts, and fake news, warned an expert at the annual meeting of the Society for Pediatric Dermatology.

“If we don’t get involved, we are basically letting misinformation win. We need to be there,” said Angelo Landriscina, MD, director of dermatology at a Mount Sinai Doctors Clinic in New York.

Most of the content currently available on medical topics, including dermatology and pediatric dermatology, is not created by health care professionals, Dr. Landriscina noted. Not surprisingly, given that much of the content is based on personal opinion from individuals who have no expertise in medical care, he described the information as being of “low quality” when not fully erroneous.

Dr. Landriscina has been active on social media, including TikTok, for several years. Most of his posts involve responses to misinformation. When he sets the record straight on the basis of existing evidence, he often supports his counterargument with references.

He acknowledged that when he became involved in social media he faced criticism from colleagues about participating on an entertainment platform that many considered unworthy of providing objective information. If that was ever true, he argued, it is no longer the case.

“TikTok has adopted a new strategy. The goal is to unseat Google as a search tool, and it’s working,” he said. He explained that many people now use TikTok and other social media sites as their primary source of information on essentially every topic, from where to eat to whether to be screened for cancer.

The particular problem with TikTok – one of the most popular social media outlets – is that there is no mechanism for vetting the source of information. YouTube, by contrast, now requires some sort of validation for anyone who claims to have a medical degree or any other verifiable qualification, according to Dr. Landriscina. TikTok, like many other platforms, has no such requirement.

“Anyone can buy a pair of scrubs [implying expertise] and then post a video,” Dr. Landriscina said.

Even if information from one content provider is more valid than information from others, the TikTok algorithm is specifically designed to emphasize content that has the potential for going viral, which means it favors videos that are provocative over those that are not.

“The algorithm favors any content that is more controversial, more surprising, and keeps viewers engaged,” Dr. Landriscina pointed out.

This does not mean that objective and factual information is ignored, but the algorithm is indifferent to the validity of information, meaning that it allows videos to be posted without regard to whether the content is true, untrue, purposefully misleading, or utter nonsense. For that reason, it is often easier to attract attention by responding to a post that has already gone viral. Information that is clear and digestible can attract viewers and therefore is distributed more widely with the TikTok algorithm.
 

Parents are on Tiktok too

There is a misperception that the TikTok audience is younger, according to Dr. Landriscina. While peak use in the United States fell among people between the ages of 25 and 34 years in 2022, he said the number of users falls off relatively slowly with subsequent 10-year increments in age. In 2022, there were nearly 20 million users in the peak 10-year age range, but 7.5 million users were 55 years of age or older.

“Pediatric dermatologists should recognize that it is not just kids who are looking for information about their skin diseases, but also their parents,” Dr. Landriscina said.

The top three dermatology topics searched on TikTok in a recent period were acne, alopecia, and cysts. But top searches are very fluid and are extremely hard to quantify, because the basis of the algorithm, which is a proprietary secret, is not only unknown but produces different results for every user.

“The second you touch the app, it changes,” Dr. Landriscina said. He explained that an inquiry about any subject, including those that are medically related, yields content that is different, or at least ordered differently, “depending on how you behaved on the app in the past.”

The phenomenon that drives social media predates this technology. Dr. Landriscina cited a study in 1956 that described the “parasocial interaction theory.” The theory was based on the observation that those who consume media, such as television, which was relatively new in 1956, believed that they had a personal relationship with media figures.

“The users begin to trust influencers as a source, like a friend providing them advice,” Dr. Landriscina said. As an example, he suggested that a fan of the television show Friends who follows actor Jennifer Aniston on social media platforms may begin to think of her as a trusted source of information on any topic, including those for which she may not have expertise.

The reason that he urges medical professionals to become active on TikTok and other social media platforms is that they have a potentially critical role in responding to information that is not just wrong but harmful.

On TikTok and other social media platforms, “there is a lot of interest in content about dermatologic conditions in children. There is a real need for accurate information,” he said,

In the question-and-answer session following his presentation, Dr. Landriscina’s message was not uniformly embraced. One risk, according to an audience member, is that medical professionals will begin to express their own personal opinions rather than rely on evidence, with the result that they will “just add to the sea of misinformation.”

However, this opinion appeared to be the minority view. Most of those who commented took a “that-ship-has-sailed” stance, recognizing the irreversible ascendancy of social media.

“Whether you like it or not, social media is here to stay. We cannot fight it. Rather, we need to embrace it in a responsible way,” said Dakara R. Wright, MD, a dermatologist at the Mid-Atlantic Kaiser Permanente Group, Halethorpe, Md. She, like others, reported that she has come to recognize that social media is a major source of medical information for her patients.

“We need to be a presence on these platforms for the benefit of our patients and their parents,” she said. She acknowledged that she has not been active in posting on social media in the past but said that she has been speaking with administrators in her organization about how to become involved in a responsible way that can be useful to patients.

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, has been active on social media for several years, posting content on her own account, which is not related to her academic affiliation. She posts for many reasons, not least of which is drawing attention to her expertise.

Like Dr. Landriscina, she recognizes that users of these platforms are guided by the content to make decisions about health care. She also agreed that physicians should not ignore this phenomenon.

Tips on providing content

Given the fact that the algorithm is intended to produce posts that go viral, Dr. Landriscina urged clinicians to make their content easy to watch. He said it is not necessary to overthink content beyond providing accurate information, but he advised that videos be made with attention to adequate lighting and other simple factors to promote visual quality. He said that accurate information is not necessarily dull.

“Some facts can actually be surprising to patients,” he said. He noted that a calm, coherent video can be particularly effective in attracting an audience when it is in reaction to information that has gone viral but is misleading or patently incorrect.

Dr. Landriscina has been an influencer associated with multiple social media platforms, including TikTok. He has in the past been paid for consulting work for TikTok. Dr. Wright and Dr. Heath reported no potential conflicts of interest.

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

ASHEVILLE, N.C. – TikTok, typical of several forms of social media, has been intentionally repositioned to rival Google as a primary source of information, meaning that health care professionals, including those who provide dermatologic care to children, should be thinking about how to get on board to counter myths, erroneous facts, and fake news, warned an expert at the annual meeting of the Society for Pediatric Dermatology.

“If we don’t get involved, we are basically letting misinformation win. We need to be there,” said Angelo Landriscina, MD, director of dermatology at a Mount Sinai Doctors Clinic in New York.

Most of the content currently available on medical topics, including dermatology and pediatric dermatology, is not created by health care professionals, Dr. Landriscina noted. Not surprisingly, given that much of the content is based on personal opinion from individuals who have no expertise in medical care, he described the information as being of “low quality” when not fully erroneous.

Dr. Landriscina has been active on social media, including TikTok, for several years. Most of his posts involve responses to misinformation. When he sets the record straight on the basis of existing evidence, he often supports his counterargument with references.

He acknowledged that when he became involved in social media he faced criticism from colleagues about participating on an entertainment platform that many considered unworthy of providing objective information. If that was ever true, he argued, it is no longer the case.

“TikTok has adopted a new strategy. The goal is to unseat Google as a search tool, and it’s working,” he said. He explained that many people now use TikTok and other social media sites as their primary source of information on essentially every topic, from where to eat to whether to be screened for cancer.

The particular problem with TikTok – one of the most popular social media outlets – is that there is no mechanism for vetting the source of information. YouTube, by contrast, now requires some sort of validation for anyone who claims to have a medical degree or any other verifiable qualification, according to Dr. Landriscina. TikTok, like many other platforms, has no such requirement.

“Anyone can buy a pair of scrubs [implying expertise] and then post a video,” Dr. Landriscina said.

Even if information from one content provider is more valid than information from others, the TikTok algorithm is specifically designed to emphasize content that has the potential for going viral, which means it favors videos that are provocative over those that are not.

“The algorithm favors any content that is more controversial, more surprising, and keeps viewers engaged,” Dr. Landriscina pointed out.

This does not mean that objective and factual information is ignored, but the algorithm is indifferent to the validity of information, meaning that it allows videos to be posted without regard to whether the content is true, untrue, purposefully misleading, or utter nonsense. For that reason, it is often easier to attract attention by responding to a post that has already gone viral. Information that is clear and digestible can attract viewers and therefore is distributed more widely with the TikTok algorithm.
 

Parents are on Tiktok too

There is a misperception that the TikTok audience is younger, according to Dr. Landriscina. While peak use in the United States fell among people between the ages of 25 and 34 years in 2022, he said the number of users falls off relatively slowly with subsequent 10-year increments in age. In 2022, there were nearly 20 million users in the peak 10-year age range, but 7.5 million users were 55 years of age or older.

“Pediatric dermatologists should recognize that it is not just kids who are looking for information about their skin diseases, but also their parents,” Dr. Landriscina said.

The top three dermatology topics searched on TikTok in a recent period were acne, alopecia, and cysts. But top searches are very fluid and are extremely hard to quantify, because the basis of the algorithm, which is a proprietary secret, is not only unknown but produces different results for every user.

“The second you touch the app, it changes,” Dr. Landriscina said. He explained that an inquiry about any subject, including those that are medically related, yields content that is different, or at least ordered differently, “depending on how you behaved on the app in the past.”

The phenomenon that drives social media predates this technology. Dr. Landriscina cited a study in 1956 that described the “parasocial interaction theory.” The theory was based on the observation that those who consume media, such as television, which was relatively new in 1956, believed that they had a personal relationship with media figures.

“The users begin to trust influencers as a source, like a friend providing them advice,” Dr. Landriscina said. As an example, he suggested that a fan of the television show Friends who follows actor Jennifer Aniston on social media platforms may begin to think of her as a trusted source of information on any topic, including those for which she may not have expertise.

The reason that he urges medical professionals to become active on TikTok and other social media platforms is that they have a potentially critical role in responding to information that is not just wrong but harmful.

On TikTok and other social media platforms, “there is a lot of interest in content about dermatologic conditions in children. There is a real need for accurate information,” he said,

In the question-and-answer session following his presentation, Dr. Landriscina’s message was not uniformly embraced. One risk, according to an audience member, is that medical professionals will begin to express their own personal opinions rather than rely on evidence, with the result that they will “just add to the sea of misinformation.”

However, this opinion appeared to be the minority view. Most of those who commented took a “that-ship-has-sailed” stance, recognizing the irreversible ascendancy of social media.

“Whether you like it or not, social media is here to stay. We cannot fight it. Rather, we need to embrace it in a responsible way,” said Dakara R. Wright, MD, a dermatologist at the Mid-Atlantic Kaiser Permanente Group, Halethorpe, Md. She, like others, reported that she has come to recognize that social media is a major source of medical information for her patients.

“We need to be a presence on these platforms for the benefit of our patients and their parents,” she said. She acknowledged that she has not been active in posting on social media in the past but said that she has been speaking with administrators in her organization about how to become involved in a responsible way that can be useful to patients.

Candrice R. Heath, MD, assistant professor of dermatology at Temple University, Philadelphia, has been active on social media for several years, posting content on her own account, which is not related to her academic affiliation. She posts for many reasons, not least of which is drawing attention to her expertise.

Like Dr. Landriscina, she recognizes that users of these platforms are guided by the content to make decisions about health care. She also agreed that physicians should not ignore this phenomenon.

Tips on providing content

Given the fact that the algorithm is intended to produce posts that go viral, Dr. Landriscina urged clinicians to make their content easy to watch. He said it is not necessary to overthink content beyond providing accurate information, but he advised that videos be made with attention to adequate lighting and other simple factors to promote visual quality. He said that accurate information is not necessarily dull.

“Some facts can actually be surprising to patients,” he said. He noted that a calm, coherent video can be particularly effective in attracting an audience when it is in reaction to information that has gone viral but is misleading or patently incorrect.

Dr. Landriscina has been an influencer associated with multiple social media platforms, including TikTok. He has in the past been paid for consulting work for TikTok. Dr. Wright and Dr. Heath reported no potential conflicts of interest.

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

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

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

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

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

One has to be living off the grid to not be bombarded with direct-to-consumer (DTC) pharmaceutical advertising. Since 1997, when the Food and Drug Administration eased restrictions on this prohibition and allowed pharmaceutical companies to promote prescription-only medications to the public, there has been a deluge of ads in magazines, on the Internet, and, most annoying, on commercial television.

These television ads are quite formulaic:

We are initially introduced to a number of highly functioning patients (typically actors) who are engaged in rewarding pursuits. A voiceover narration then presents the pharmaceutical to be promoted, suggesting (not so subtly) to consumers that taking the advertised drug will improve one’s disease outlook or quality of life such that they too, just like the actors in the minidrama, can lead such highly productive lives.

The potential best-case scenarios of these new treatments may be stated. There then follows a litany of side effects – some of them life threatening – warnings, and contraindications. We’re again treated to another 5 or 10 seconds of patients leading “the good life,” and almost all of the ads end with the narrator concluding: “Ask your doctor (sometimes ‘provider’) if _____ is right for you.”

Big pharma spends nearly $10 billion on DTC advertising, with television ads accounting for the vast majority of these dollars. Is this type of advertising appropriate? Or even ethical?

Americans spend more money on their prescriptions than do citizens of any other highly developed nation. I have personally heard from patients who get their prescriptions from other countries, where they are more affordable. These patients will also cut their pills in half or take a medication every other day instead of every day, to economize on drug costs.

Another “trick” they use to save money – and I have heard pharmacists and pharmaceutical reps themselves recommend this – is to ask for a higher dose of a medication, usually double, and then use a pill cutter to divide a tablet in half, thus making their prescription last twice as long. Why do Americans have to resort to such “workarounds”?

Many of the medications advertised are for relatively rare conditions, such as thyroid eye disease or myasthenia gravis (which affects up to about 60,000 patients in the United States). Why not spend these advertising dollars on programs to make drugs taken by the millions of Americans with common conditions (for example, hypertension, diabetes, heart failure) more affordable?

Very often the television ads contain medical jargon, such as: “If you have the EGFR mutation, or if your cancer is HER2 negative ...”

Do most patients truly understand what these terms mean? And what happens when a patient’s physician doesn’t prescribe a medication that a patient has seen on TV and asks for, or when the physician believes that a generic (nonadvertised) medication might work just as well? This creates conflict and potential discord, adversely affecting the doctor-patient relationship.

An oncologist colleague related to me that he often has to spend time correcting patients’ misperceptions of potential miracle cures offered by these ads, and that several patients have left his practice because he would not prescribe a drug they saw advertised.

Further, while these ads urge patients to try expensive “newest and latest” treatments, pharmacy benefit plans are working with health care insurance conglomerates to reduce costs of pharmaceuticals.

How does this juxtaposition of opposing forces make any sense?

It is time for us to put an end to DTC advertising, at least on television. It will require legislative action by our federal government to end this practice (legal, by the way, only in the United States and New Zealand), and hence the willingness of our politicians to get behind legislation to do so.

Just as a law was passed to prohibit tobacco advertising on television, so should a law be passed to regulate DTC pharmaceutical advertising.

The time to end DTC advertising has come!
 

Lloyd Alterman, MD, is a retired physician and chairman of the New Jersey Universal Healthcare Coalition. He disclosed having no relevant financial relationships.

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

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

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

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

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

Asian American, Hispanic/Latino, and older individuals appear to have the greatest burden of vitiligo in the United States, according to the results of a cross sectional study.

To investigate the incidence and prevalence of diagnosed vitiligo in the United States, researchers used a 15% random sample of electronic medical records from the IBM Explorys database. Two cohorts were included: 2,980,778 patients diagnosed with vitiligo between Jan. 1, 2015, and Dec. 31, 2019 (incidence analysis), and 1,057,534 patients diagnosed with vitiligo between Jan. 1 and Dec. 31, 2019 (prevalence analysis).The main outcomes were incidence (per 100,000 person-years) and prevalence of diagnosed vitiligo overall and by age, race/ethnicity, and sex. Amit Garg, MD, a dermatologist with Northwell Health, New Hyde Park, N.Y., led the study, which was published in JAMA Dermatology.

The age- and sex-adjusted overall incidence rate of diagnosed vitiligo was 22.6 per 100,000 person-years, and the prevalence was 0.16%, the authors reported. The sex-adjusted IR was highest among patients aged 60-69 years (25.3 per 100,000 person-years); prevalence was highest among patients aged 70 years or older (0.21%).

The highest age-adjusted IR was among Asian American patients (41.2 per 100,000 person-years), followed by Hispanic/Latino patients (37.3 per 100,000 PY), those reporting other or multiple races (31.1 per 100,000), Black patients (29.6 per 100,000 person-years), and White patients (18.7 per 100,000 person-years). The highest age-adjusted prevalence was among Hispanic/Latino patients (0.29%), followed by Asian American patients (0.27%), those reporting other or multiple races (0.24%), Black patients (0.22%), and White patients (0.13%).

The burden of vitiligo in the United States is poorly understood, and the findings “may support improving awareness of vitiligo disease burden in medical and public sectors, informing research agendas, improving enrollment of racial and ethnic minority populations in trials, and developing health policies,” the authors wrote.

Limitations of the study included that the analysis only captured patients who sought care in health systems included in the database, and there was the potential for underreporting, “since not all patients with vitiligo seek care,” the authors noted.

Dr. Garg reported being an adviser for and receiving honoraria from many pharmaceutical companies. He has also received research grants from AbbVie, UCB, the National Psoriasis Foundation, and the CHORD COUSIN Collaboration. No other disclosures were reported.

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

Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.

Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.

So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).

As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.

In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”

Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”

Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”

It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”

In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.

Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.

“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”

Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.

Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.

Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”

Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”

The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.

A version of this article appeared on Medscape.com.

Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.

Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.

So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).

As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.

In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”

Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”

Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”

It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”

In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.

Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.

“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”

Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.

Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.

Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”

Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”

The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.

A version of this article appeared on Medscape.com.

Clinical research in lupus has a mammoth diversity problem: Black individuals are most likely to develop the disease, but they’re the least likely to take part in studies. By the numbers, a 2018 analysis of randomized controlled trials in systemic lupus erythematosus from the years 1997 to 2017 found that 51% of trial participants were White and 14% were Black, even though an estimated 33% of patients with lupus were White and 43% were Black.

Are there ways to fix this disparity? The topic is getting plenty of attention, and speakers at a July 21 online conference touted research projects that aim to boost the numbers of non-White participants in lupus trials.

So far there doesn’t seem to be anything like a magic bullet. Still, the stakes are high. “While race is a social construct, genetic polymorphisms as well as environmental and social differences may influence drugs, safety, and efficacy,” Joy Buie, PhD, MSCR, research director for the Lupus Foundation of America, said at the “Engaging Diverse Participants in Lupus Clinical Trials: The Path Forward” summit held by the American College of Rheumatology (ACR).

As African American patients explained, minority populations often don’t trust the medical system and feel burned by their lengthy struggles to get diagnosed. In some cases, they don’t have full faith in their clinicians and feel unheard.

In a video presentation developed as part of a federal education campaign, Shanelle Gabriel, a poet and musician diagnosed with lupus, described her first reaction when her physician suggested she join a clinical trial. “My first reaction was no. I know my history,” she said, apparently referring to the infamous Tuskegee study that withheld proper treatment from Black men with syphilis for decades. “As an African American woman, I was scared. I didn’t want to be a guinea pig.”

Stacey Kennedy-Conner, a Chicago-area patient and advocate, told the summit audience about how patients can feel that clinical trial information can add “an extra layer of confusion” to their experience. “There’s also the mentality of, ‘If it’s not broke, don’t fix it’: If this medication regimen is working, I don’t want anybody to touch me.”

Monique Gore-Massy, a New York City patient and advocate, added that there can be a perception that patients with lupus “are stuck at home in bed.” In reality, she said, “we have jobs, we have families. Think about that, and consider everything that you’re asking from us: Is this taking me away from my family? Am I going to have to take off work? There may be incentives, but is that worth me taking time off work that I may not get paid for? These are some of the realities that we have to look at in terms of the whole entire clinical trial process.”

It’s also important to keep patients informed of progress being made in trials, she said. “You don’t want to say you just felt like a number and then not get any kind of follow-up.”

In the big picture, “there has to be something that builds up the confidence of individuals so that they are more mindful to participate in these clinical trials,” said Aleta McLean, an Atlanta patient who was diagnosed with lupus 14 years ago.

Several researchers highlighted ongoing projects at the summit. The ACR, for example, has launched a $500,000 initiative called Training to Increase Minority Enrollment in Lupus Clinical Trials with Community Engagement (TIMELY). The federally funded project aims to evaluate whether training of health care professionals can boost clinical trial participation among Black and Hispanic patients.

“We hope to disseminate the results of our project to the scientific community through abstracts, manuscripts, presentations at national meetings,” said rheumatologist Saira Z. Sheikh, MD, of the University of North Carolina at Chapel Hill. “Overall, our goal is to establish new partnerships to support the TIMELY model and advance the education and engagement of providers and community health workers.”

Pamela Payne-Foster, MD, MPH, preventive medicine/public health physician at the University of Alabama College of Community Health Sciences, Tuscaloosa, spoke about the federally funded Deep South Health Equity Project, which is paying patients to take part in an online education program and attend an online regional conference.

Other efforts are underway. The Lupus Research Alliance and its clinical affiliate Lupus Therapeutics have launched two initiatives. One is a program called Project Change (Community-based Health Action Network to Generate Trial Participation and Eliminate Disparities), and the Diversity in Lupus Research Program aims to fund scientists’ work.

Will any of this work boost diversity in clinical trials? As one audience member noted in a Q&A session, health care disparities – and knowledge about them – are nothing new: “Why are we not able to narrow the gap?”

Rear Admiral Richardae Araojo, PharmD, MS, director of the FDA’s Office of Minority Health and Health Equity and associate commissioner for minority health, replied that waves of interest in disparities come and go. “That contributes to why we may not see solutions. But ultimately, there are a lot of people doing a lot of work trying to solve the issues.”

The summit was sponsored by Bristol-Myers Squibb, Genentech, and RemeGen.

A version of this article appeared on Medscape.com.

In March 2023, four “medical tourists” from South Carolina who were seeking health care in Mexico were kidnapped by a drug cartel. Two were killed when they were trapped in a shootout. One of them was scheduled for tummy-tuck surgery, and others were seeking cheaper prescription drugs.

The news reached Bruce Hermann, MD, a plastic surgeon in Denton, Tex., who brought up the incident in a segment of his podcast, “Nip Talk,” in which he talked about the risks of medical tourism. But violence in foreign countries isn’t Dr. Hermann’s primary concern.

“Being the victim of a crime is lower down the risk strata,” Dr. Hermann said in an interview. “A bigger concern is the lack of regulations of doctors and facilities in countries like Mexico.”

The savings from medical tourism may be tempting, but the unpredictable clinical risks are daunting. Some employers pay for treatment at certain foreign clinics, and Blue Shield of California’s HMO plan, Access Baja, covers care in certain clinics in Mexico’s Baja peninsula. But U.S. health insurance generally does not cover medical tourism.

Despite its popularity, medical tourism is not siphoning off a significant number of patients from U.S. doctors, with the possible exception of plastic surgery. One study found that medical tourism accounts for less than 2% of U.S. spending on noncosmetic health care.

Still, as many as 1.2 million Americans travel to Mexico each year seeking health care at lower costs, particularly dental care, bariatric surgery, and cosmetic procedures.

Physicians such as Dr. Hermann see the results when things go awry. Dr. Hermann said when he takes calls at a nearby level II trauma center, he sees, on average, one patient a month with complications from plastic surgeries performed abroad.

Patients tell Dr. Hermann they often had little preoperative time with the surgeons, and some may not even see their surgeon. They have to fly back home just days after their procedures, so complications that typically arise later are missed, he said.
 

Who opts for medical tourism?

There are few statistics on the number of medical tourists or the clinical problems they have. Josef Woodman, CEO of Patients Beyond Borders, a medical tourism consultancy in Chapel Hill, N.C., has developed a profile of medical tourism that is based on his close contacts within the industry.

Mr. Woodman said the vast majority of U.S. medical tourists go to Mexico, which accounts for an estimated 1 million to 1.2 million medical visitors a year. He said Costa Rica is another popular destination, followed by other Latin American countries and some in the Far East, the Middle East, and Eastern Europe.

Mr. Woodman estimates that dental treatments make up 65% of all medical tourism. Cosmetic procedures come in a distant second, at 15%. Cosmetic procedures can be expensive and are rarely covered by insurance. They can be performed at half the price abroad, he said.

According to Mr. Woodman, other significant fields for medical tourism are orthopedics, which accounts for 5% of all visits, and bariatrics, with 3%-5%. Hip and knee replacements are expensive, and in the case of bariatrics, U.S. insurers often deny coverage, he said.

People also go abroad for fertility care and organ transplants, and one Jamaica company even offered dialysis vacations for U.S. tourists.

On the other hand, medical tourism does not work well for cancer treatments, because cancer care involves long periods of treatment and cannot be completed in a trip or two, Mr. Woodman said. “The media also plays up major procedures like open heart surgery, but they are in fact very rare,” he added.
 

What patients are looking for

Medical tourists typically pay 50%-70% of what they would pay in the United States for the same procedure, Mr. Woodman said. Prices are lower because patients pay in cash, foreign wages are lower, and expenses such as malpractice insurance are much lower.

“Many medical tourists don’t have a choice,” Mr. Woodman said. “They cannot afford the U.S. price for the procedure, even if they have health insurance, because they often have a high deductible.” In one study, the majority of medical tourists to Mexico reported an income of $25,000-$50,000 a year.

That same study also found that the average age of medical tourists was just under 65. These older patients often come for a vacation. “A sizable number of medical tourists are looking for surgery plus a vacation, a tummy-tuck and a stay at an all-inclusive resort,” said Steven P. Davison, MD, DDS, a plastic surgeon in Washington, who has written on the phenomenon.

Another large group of medical tourists are immigrants to the United States who want surgery in their country of origin, such as Brazil or Iran, Dr. Davison said, perhaps because they feel more comfortable or have family members who can act as caregivers. He said some go to places that have expertise in a certain procedure.

“For instance, they get their hair transplantation done in Turkey because surgeons there have the expertise and it’s cheaper than in the United States,” Dr. Davison said.
 

Arranging the trip

Patients often find foreign providers through online brokers who can arrange the flight, hotel, clinic, and physician. Brokers are not unbiased because they are usually paid by the clinic. Mr. Woodman said this arrangement works when the broker can offer a wide variety of options but not when the broker represents just a few clinics.

Mr. Woodman said patients could conceivably make their own arrangements without a broker, and some do so. “All the tools are on the Internet,” he said. “However, many people don’t trust themselves to do this work.”

Even for patients who depend on brokers, Mr. Woodman advises verifying the quality of the clinic and its doctors before signing on. Most countries have online lists of registered doctors, and patients seeking health care can research complaints against a doctor.

There is no insurance that patients can have to guard against the risks of medical tourism, Mr. Woodman said. “When you could get it, it was prohibitively expensive,” he said. “You can get travel insurance, but that just covers peripheral problems, such as flight cancellations, accidental injury, and emergency care. It has nothing to do with problems stemming from planned procedures.

“Some clinics and hospitals serving medical tourists provide warranties on their work,” he added. “However, plastic surgery clinics are less likely to offer warranties, because patients are so frequently dissatisfied.”
 

How things can go wrong

Mr. Woodman said medical tourists may often receive substandard care when they select a provider who offers unusually large savings, such as 80% off the U.S. price. “Those providers are likely cutting corners to get that kind of savings, and you should stay away from them,” he said.

Even when receiving care at an excellent clinic, patients can get infections if postoperative requirements are not followed, according to Darrick E. Antell, MD, a plastic surgeon in New York, who has treated medical tourists upon their return to the United States.

Typically, patients are told to stay in their rooms for several days after the operation, but friends may push them to go out and have fun, he said. Sometimes patients choose exotic arrangements that place them at risk for infection. As an example, Dr. Antell mentioned a broker who offered a safari in combination with plastic surgery.

Dr. Hermann said tummy tucks are riskier because they involve large incisions, and many such patients are overweight, which impairs healing. “Tummy-tuck patients need a longer recovery, and they often have more discomfort than other plastic surgery,” he said.

When things go wrong, medical tourists have few legal protections. “They usually don’t go to an accredited facility, there is no credentialing of physicians, and their ability to sue is extremely limited,” Dr. Davison said. Patients would have to return to the foreign country and hire a lawyer there, and even then, it is harder to win a case and to receive an award as high as in the United States, he added.
 

Dealing with follow-ups

An inherent flaw with medical tourism, Dr. Antell said, is that patients typically go back home before postoperative care is fully completed. “They may stay just a few days after surgery, and then fly back home,” he said.

“Patients who have complex operations abroad should stay for 8-10 days to have a proper follow-up,” he said. “But they fly back early, which can also lead to getting pulmonary embolisms on the flight.

“A checkup right after surgery doesn’t uncover many complications, because these tend to occur 7-12 days after surgery,” Dr. Hermann said.

“If they come to me within 3 months after surgery, I charge an upfront fee just to see them, because it takes an hour of my time,” Dr. Davison said. “Then I will take care of acute emergency, such as taking out an infected implant.”

Hermann said many patients wait too long to have their complications treated in the United States. “They may first try calling their doctor in Mexico, who tells them to take some antibiotics or something,” he said. “So when they finally do seek care, the infection is pretty far along.”
 

What U.S. doctors can do

Patients rarely tell their U.S. doctors that they are planning a trip to a foreign country to undergo medical treatment, even though they have to request a copy of their medical records for the foreign doctor, Mr. Woodman said.

Dr. Hermann said only one of his patients told him she was planning to go aboard for plastic surgery. “She was a young mom, and I tried to talk her out of it,” he said. “I don’t know what happened because she didn’t come back.”

Dr. Hermann said doctors should assume that they won’t be able to change their patients’ minds, and they should try to help their patients make the best of it.

“They should insist on seeing the doctor ahead of time and make sure they get along with them,” he said. “Ask for credentialing of the doctor and the facility, and stay there several weeks post op. But they’re probably not going to do all of this.”

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

In March 2023, four “medical tourists” from South Carolina who were seeking health care in Mexico were kidnapped by a drug cartel. Two were killed when they were trapped in a shootout. One of them was scheduled for tummy-tuck surgery, and others were seeking cheaper prescription drugs.

The news reached Bruce Hermann, MD, a plastic surgeon in Denton, Tex., who brought up the incident in a segment of his podcast, “Nip Talk,” in which he talked about the risks of medical tourism. But violence in foreign countries isn’t Dr. Hermann’s primary concern.

“Being the victim of a crime is lower down the risk strata,” Dr. Hermann said in an interview. “A bigger concern is the lack of regulations of doctors and facilities in countries like Mexico.”

The savings from medical tourism may be tempting, but the unpredictable clinical risks are daunting. Some employers pay for treatment at certain foreign clinics, and Blue Shield of California’s HMO plan, Access Baja, covers care in certain clinics in Mexico’s Baja peninsula. But U.S. health insurance generally does not cover medical tourism.

Despite its popularity, medical tourism is not siphoning off a significant number of patients from U.S. doctors, with the possible exception of plastic surgery. One study found that medical tourism accounts for less than 2% of U.S. spending on noncosmetic health care.

Still, as many as 1.2 million Americans travel to Mexico each year seeking health care at lower costs, particularly dental care, bariatric surgery, and cosmetic procedures.

Physicians such as Dr. Hermann see the results when things go awry. Dr. Hermann said when he takes calls at a nearby level II trauma center, he sees, on average, one patient a month with complications from plastic surgeries performed abroad.

Patients tell Dr. Hermann they often had little preoperative time with the surgeons, and some may not even see their surgeon. They have to fly back home just days after their procedures, so complications that typically arise later are missed, he said.
 

Who opts for medical tourism?

There are few statistics on the number of medical tourists or the clinical problems they have. Josef Woodman, CEO of Patients Beyond Borders, a medical tourism consultancy in Chapel Hill, N.C., has developed a profile of medical tourism that is based on his close contacts within the industry.

Mr. Woodman said the vast majority of U.S. medical tourists go to Mexico, which accounts for an estimated 1 million to 1.2 million medical visitors a year. He said Costa Rica is another popular destination, followed by other Latin American countries and some in the Far East, the Middle East, and Eastern Europe.

Mr. Woodman estimates that dental treatments make up 65% of all medical tourism. Cosmetic procedures come in a distant second, at 15%. Cosmetic procedures can be expensive and are rarely covered by insurance. They can be performed at half the price abroad, he said.

According to Mr. Woodman, other significant fields for medical tourism are orthopedics, which accounts for 5% of all visits, and bariatrics, with 3%-5%. Hip and knee replacements are expensive, and in the case of bariatrics, U.S. insurers often deny coverage, he said.

People also go abroad for fertility care and organ transplants, and one Jamaica company even offered dialysis vacations for U.S. tourists.

On the other hand, medical tourism does not work well for cancer treatments, because cancer care involves long periods of treatment and cannot be completed in a trip or two, Mr. Woodman said. “The media also plays up major procedures like open heart surgery, but they are in fact very rare,” he added.
 

What patients are looking for

Medical tourists typically pay 50%-70% of what they would pay in the United States for the same procedure, Mr. Woodman said. Prices are lower because patients pay in cash, foreign wages are lower, and expenses such as malpractice insurance are much lower.

“Many medical tourists don’t have a choice,” Mr. Woodman said. “They cannot afford the U.S. price for the procedure, even if they have health insurance, because they often have a high deductible.” In one study, the majority of medical tourists to Mexico reported an income of $25,000-$50,000 a year.

That same study also found that the average age of medical tourists was just under 65. These older patients often come for a vacation. “A sizable number of medical tourists are looking for surgery plus a vacation, a tummy-tuck and a stay at an all-inclusive resort,” said Steven P. Davison, MD, DDS, a plastic surgeon in Washington, who has written on the phenomenon.

Another large group of medical tourists are immigrants to the United States who want surgery in their country of origin, such as Brazil or Iran, Dr. Davison said, perhaps because they feel more comfortable or have family members who can act as caregivers. He said some go to places that have expertise in a certain procedure.

“For instance, they get their hair transplantation done in Turkey because surgeons there have the expertise and it’s cheaper than in the United States,” Dr. Davison said.
 

Arranging the trip

Patients often find foreign providers through online brokers who can arrange the flight, hotel, clinic, and physician. Brokers are not unbiased because they are usually paid by the clinic. Mr. Woodman said this arrangement works when the broker can offer a wide variety of options but not when the broker represents just a few clinics.

Mr. Woodman said patients could conceivably make their own arrangements without a broker, and some do so. “All the tools are on the Internet,” he said. “However, many people don’t trust themselves to do this work.”

Even for patients who depend on brokers, Mr. Woodman advises verifying the quality of the clinic and its doctors before signing on. Most countries have online lists of registered doctors, and patients seeking health care can research complaints against a doctor.

There is no insurance that patients can have to guard against the risks of medical tourism, Mr. Woodman said. “When you could get it, it was prohibitively expensive,” he said. “You can get travel insurance, but that just covers peripheral problems, such as flight cancellations, accidental injury, and emergency care. It has nothing to do with problems stemming from planned procedures.

“Some clinics and hospitals serving medical tourists provide warranties on their work,” he added. “However, plastic surgery clinics are less likely to offer warranties, because patients are so frequently dissatisfied.”
 

How things can go wrong

Mr. Woodman said medical tourists may often receive substandard care when they select a provider who offers unusually large savings, such as 80% off the U.S. price. “Those providers are likely cutting corners to get that kind of savings, and you should stay away from them,” he said.

Even when receiving care at an excellent clinic, patients can get infections if postoperative requirements are not followed, according to Darrick E. Antell, MD, a plastic surgeon in New York, who has treated medical tourists upon their return to the United States.

Typically, patients are told to stay in their rooms for several days after the operation, but friends may push them to go out and have fun, he said. Sometimes patients choose exotic arrangements that place them at risk for infection. As an example, Dr. Antell mentioned a broker who offered a safari in combination with plastic surgery.

Dr. Hermann said tummy tucks are riskier because they involve large incisions, and many such patients are overweight, which impairs healing. “Tummy-tuck patients need a longer recovery, and they often have more discomfort than other plastic surgery,” he said.

When things go wrong, medical tourists have few legal protections. “They usually don’t go to an accredited facility, there is no credentialing of physicians, and their ability to sue is extremely limited,” Dr. Davison said. Patients would have to return to the foreign country and hire a lawyer there, and even then, it is harder to win a case and to receive an award as high as in the United States, he added.
 

Dealing with follow-ups

An inherent flaw with medical tourism, Dr. Antell said, is that patients typically go back home before postoperative care is fully completed. “They may stay just a few days after surgery, and then fly back home,” he said.

“Patients who have complex operations abroad should stay for 8-10 days to have a proper follow-up,” he said. “But they fly back early, which can also lead to getting pulmonary embolisms on the flight.

“A checkup right after surgery doesn’t uncover many complications, because these tend to occur 7-12 days after surgery,” Dr. Hermann said.

“If they come to me within 3 months after surgery, I charge an upfront fee just to see them, because it takes an hour of my time,” Dr. Davison said. “Then I will take care of acute emergency, such as taking out an infected implant.”

Hermann said many patients wait too long to have their complications treated in the United States. “They may first try calling their doctor in Mexico, who tells them to take some antibiotics or something,” he said. “So when they finally do seek care, the infection is pretty far along.”
 

What U.S. doctors can do

Patients rarely tell their U.S. doctors that they are planning a trip to a foreign country to undergo medical treatment, even though they have to request a copy of their medical records for the foreign doctor, Mr. Woodman said.

Dr. Hermann said only one of his patients told him she was planning to go aboard for plastic surgery. “She was a young mom, and I tried to talk her out of it,” he said. “I don’t know what happened because she didn’t come back.”

Dr. Hermann said doctors should assume that they won’t be able to change their patients’ minds, and they should try to help their patients make the best of it.

“They should insist on seeing the doctor ahead of time and make sure they get along with them,” he said. “Ask for credentialing of the doctor and the facility, and stay there several weeks post op. But they’re probably not going to do all of this.”

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

In March 2023, four “medical tourists” from South Carolina who were seeking health care in Mexico were kidnapped by a drug cartel. Two were killed when they were trapped in a shootout. One of them was scheduled for tummy-tuck surgery, and others were seeking cheaper prescription drugs.

The news reached Bruce Hermann, MD, a plastic surgeon in Denton, Tex., who brought up the incident in a segment of his podcast, “Nip Talk,” in which he talked about the risks of medical tourism. But violence in foreign countries isn’t Dr. Hermann’s primary concern.

“Being the victim of a crime is lower down the risk strata,” Dr. Hermann said in an interview. “A bigger concern is the lack of regulations of doctors and facilities in countries like Mexico.”

The savings from medical tourism may be tempting, but the unpredictable clinical risks are daunting. Some employers pay for treatment at certain foreign clinics, and Blue Shield of California’s HMO plan, Access Baja, covers care in certain clinics in Mexico’s Baja peninsula. But U.S. health insurance generally does not cover medical tourism.

Despite its popularity, medical tourism is not siphoning off a significant number of patients from U.S. doctors, with the possible exception of plastic surgery. One study found that medical tourism accounts for less than 2% of U.S. spending on noncosmetic health care.

Still, as many as 1.2 million Americans travel to Mexico each year seeking health care at lower costs, particularly dental care, bariatric surgery, and cosmetic procedures.

Physicians such as Dr. Hermann see the results when things go awry. Dr. Hermann said when he takes calls at a nearby level II trauma center, he sees, on average, one patient a month with complications from plastic surgeries performed abroad.

Patients tell Dr. Hermann they often had little preoperative time with the surgeons, and some may not even see their surgeon. They have to fly back home just days after their procedures, so complications that typically arise later are missed, he said.
 

Who opts for medical tourism?

There are few statistics on the number of medical tourists or the clinical problems they have. Josef Woodman, CEO of Patients Beyond Borders, a medical tourism consultancy in Chapel Hill, N.C., has developed a profile of medical tourism that is based on his close contacts within the industry.

Mr. Woodman said the vast majority of U.S. medical tourists go to Mexico, which accounts for an estimated 1 million to 1.2 million medical visitors a year. He said Costa Rica is another popular destination, followed by other Latin American countries and some in the Far East, the Middle East, and Eastern Europe.

Mr. Woodman estimates that dental treatments make up 65% of all medical tourism. Cosmetic procedures come in a distant second, at 15%. Cosmetic procedures can be expensive and are rarely covered by insurance. They can be performed at half the price abroad, he said.

According to Mr. Woodman, other significant fields for medical tourism are orthopedics, which accounts for 5% of all visits, and bariatrics, with 3%-5%. Hip and knee replacements are expensive, and in the case of bariatrics, U.S. insurers often deny coverage, he said.

People also go abroad for fertility care and organ transplants, and one Jamaica company even offered dialysis vacations for U.S. tourists.

On the other hand, medical tourism does not work well for cancer treatments, because cancer care involves long periods of treatment and cannot be completed in a trip or two, Mr. Woodman said. “The media also plays up major procedures like open heart surgery, but they are in fact very rare,” he added.
 

What patients are looking for

Medical tourists typically pay 50%-70% of what they would pay in the United States for the same procedure, Mr. Woodman said. Prices are lower because patients pay in cash, foreign wages are lower, and expenses such as malpractice insurance are much lower.

“Many medical tourists don’t have a choice,” Mr. Woodman said. “They cannot afford the U.S. price for the procedure, even if they have health insurance, because they often have a high deductible.” In one study, the majority of medical tourists to Mexico reported an income of $25,000-$50,000 a year.

That same study also found that the average age of medical tourists was just under 65. These older patients often come for a vacation. “A sizable number of medical tourists are looking for surgery plus a vacation, a tummy-tuck and a stay at an all-inclusive resort,” said Steven P. Davison, MD, DDS, a plastic surgeon in Washington, who has written on the phenomenon.

Another large group of medical tourists are immigrants to the United States who want surgery in their country of origin, such as Brazil or Iran, Dr. Davison said, perhaps because they feel more comfortable or have family members who can act as caregivers. He said some go to places that have expertise in a certain procedure.

“For instance, they get their hair transplantation done in Turkey because surgeons there have the expertise and it’s cheaper than in the United States,” Dr. Davison said.
 

Arranging the trip

Patients often find foreign providers through online brokers who can arrange the flight, hotel, clinic, and physician. Brokers are not unbiased because they are usually paid by the clinic. Mr. Woodman said this arrangement works when the broker can offer a wide variety of options but not when the broker represents just a few clinics.

Mr. Woodman said patients could conceivably make their own arrangements without a broker, and some do so. “All the tools are on the Internet,” he said. “However, many people don’t trust themselves to do this work.”

Even for patients who depend on brokers, Mr. Woodman advises verifying the quality of the clinic and its doctors before signing on. Most countries have online lists of registered doctors, and patients seeking health care can research complaints against a doctor.

There is no insurance that patients can have to guard against the risks of medical tourism, Mr. Woodman said. “When you could get it, it was prohibitively expensive,” he said. “You can get travel insurance, but that just covers peripheral problems, such as flight cancellations, accidental injury, and emergency care. It has nothing to do with problems stemming from planned procedures.

“Some clinics and hospitals serving medical tourists provide warranties on their work,” he added. “However, plastic surgery clinics are less likely to offer warranties, because patients are so frequently dissatisfied.”
 

How things can go wrong

Mr. Woodman said medical tourists may often receive substandard care when they select a provider who offers unusually large savings, such as 80% off the U.S. price. “Those providers are likely cutting corners to get that kind of savings, and you should stay away from them,” he said.

Even when receiving care at an excellent clinic, patients can get infections if postoperative requirements are not followed, according to Darrick E. Antell, MD, a plastic surgeon in New York, who has treated medical tourists upon their return to the United States.

Typically, patients are told to stay in their rooms for several days after the operation, but friends may push them to go out and have fun, he said. Sometimes patients choose exotic arrangements that place them at risk for infection. As an example, Dr. Antell mentioned a broker who offered a safari in combination with plastic surgery.

Dr. Hermann said tummy tucks are riskier because they involve large incisions, and many such patients are overweight, which impairs healing. “Tummy-tuck patients need a longer recovery, and they often have more discomfort than other plastic surgery,” he said.

When things go wrong, medical tourists have few legal protections. “They usually don’t go to an accredited facility, there is no credentialing of physicians, and their ability to sue is extremely limited,” Dr. Davison said. Patients would have to return to the foreign country and hire a lawyer there, and even then, it is harder to win a case and to receive an award as high as in the United States, he added.
 

Dealing with follow-ups

An inherent flaw with medical tourism, Dr. Antell said, is that patients typically go back home before postoperative care is fully completed. “They may stay just a few days after surgery, and then fly back home,” he said.

“Patients who have complex operations abroad should stay for 8-10 days to have a proper follow-up,” he said. “But they fly back early, which can also lead to getting pulmonary embolisms on the flight.

“A checkup right after surgery doesn’t uncover many complications, because these tend to occur 7-12 days after surgery,” Dr. Hermann said.

“If they come to me within 3 months after surgery, I charge an upfront fee just to see them, because it takes an hour of my time,” Dr. Davison said. “Then I will take care of acute emergency, such as taking out an infected implant.”

Hermann said many patients wait too long to have their complications treated in the United States. “They may first try calling their doctor in Mexico, who tells them to take some antibiotics or something,” he said. “So when they finally do seek care, the infection is pretty far along.”
 

What U.S. doctors can do

Patients rarely tell their U.S. doctors that they are planning a trip to a foreign country to undergo medical treatment, even though they have to request a copy of their medical records for the foreign doctor, Mr. Woodman said.

Dr. Hermann said only one of his patients told him she was planning to go aboard for plastic surgery. “She was a young mom, and I tried to talk her out of it,” he said. “I don’t know what happened because she didn’t come back.”

Dr. Hermann said doctors should assume that they won’t be able to change their patients’ minds, and they should try to help their patients make the best of it.

“They should insist on seeing the doctor ahead of time and make sure they get along with them,” he said. “Ask for credentialing of the doctor and the facility, and stay there several weeks post op. But they’re probably not going to do all of this.”

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

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

• Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
• Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
• The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
• Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
• Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

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

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

• Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
• Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
• The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
• Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
• Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

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

News of physicians accused or convicted of sexually inappropriate behavior toward patients during medical exams has been frequent recently. And patient advocates have brought up the fact that many patients are uncomfortable during sensitive exams.

As a result, more doctors and medical organizations are using chaperones to protect the patient and the physician.

For some institutions, the movement has been toward mandating chaperones. Chaperones can be present for any examination of what are often referred to as sensitive areas, such as breasts, genitalia, and the perianal area. For example, Yale University Health requires patients to use a medical staff member as a chaperone for all sensitive exams except in emergency situations. UCLA Health, on the other hand, allows any adult or child aged 12 years or older to decline a chaperone if they wish to do so. Michigan Medicine provides a chaperone on request, although a patient can opt out.

Many physicians fully support the concept. “If a patient requests a chaperone I think we all, as practitioners, should honor that request respectfully,” said Shieva Ghofrany, MD, an ob.gyn. practicing in Stamford, Conn., and cofounder of tribecalledv, a women’s health knowledge platform. “It’s a clear sign a patient wants to ensure that they feel safe and comfortable.”

However, using a chaperone can be challenging for many primary care physicians and specialists in terms of logistics. Should a chaperone’s job be purely observational? Or should the chaperone also be a medical professional who assists during the procedure? How, specifically, should a chaperone perform their duty during an exam? Where should the chaperone stand? What about legal and ethical ramifications?
 

Who should be a chaperone?

The role of a chaperone is sometimes vaguely defined. It’s logical that a chaperone should have sufficient medical knowledge. Could it be a medical student? Should it be a nurse or another doctor? Would a patient representative suffice even if they aren’t a direct-care clinician?

There are no set standards about who can assume the role. However, the American Medical Association recommends that a patient chaperone be an authorized member of a health care team. For many patients, this is vital.

“As a survivor of sexual assault by an ob.gyn. while I was pregnant, I can assure you that the heinous crime committed against me and hundreds of other women would have been prevented had there been another medical professional in the room,” said Laurie Kanyok, founder of a dance company in New York City, whose former doctor was recently convicted of federal sex abuse charges and is scheduled to be sentenced in July 2023. “The chaperone should be a physician assistant, nurse or medical professional. Qualified professionals better understand the nature and protocols of an exam.”

For children and adolescents, allowing a parent to be a chaperone might be a logical and comforting choice. However, a new British study found that it’s not appropriate.

Study authors Rebecca Jane Moon and Justin Huw Davies looked at pubertal staging–related exams and contend that a chaperone should always be impartial, and a parent’s presence could conceivably open up a physician to false charges of misconduct.

The solution: A parent should have the option be present during any physical exam of their child, with a medical professional additionally acting as chaperone. This can also work for any patient who wishes to bring a trusted friend or family member to their medical appointments.
 

How does a chaperoned exam work?

A research team from the Medical College of Wisconsin and Louisiana State University Health conducted a recent systematic review of patient and clinician perspectives on carrying out a chaperoned urology exam. The review found that the protocol could use improvement. For example, it was reported that over one-quarter of patients didn’t feel comfortable asking for a chaperone if they were not offered one. “Patients should not have to request this,” said Diana Londoño, MD, a board-certified urologist and assistant clinical professor at City of Hope National Medical Center in Duarte, Calif.

The researchers also found that 93% of female patients preferred a chaperone of the same gender, whereas male patients were split on this issue. Key duties of a chaperone should be to ensure privacy, help interpret instructions from doctor to patient, and continually clarify that consent is being requested as a sensitive exam proceeds, the researchers report. Although clinical practice standards for chaperones aren’t uniform, keeping these important points in mind can easily be adopted by any health care provider.

Many doctors do follow their own set guidelines. “Often, we have our medical assistants be our chaperones,” explained Dr. Ghofrany. “Ideally they ‘room’ the patient – take vitals and ask the patient what specific concerns they would like to address. This helps with exam set-up.

“For example, if a patient has a breast concern versus a concern about their genital area, this would change what drapes are used. The medical assistant would then stand near me if they are helping with a Pap smear or cultures, or they may stand by the patient’s head at the bedside and offer support if needed. Some patients want to hold someone’s hand during an uncomfortable exam.”

The issue of positioning is important. A patient may feel very uneasy if it appears that the chaperone is looking at their body from the doctor’s angle, negating the point of reassurance. The key is to explain before an exam exactly how a chaperone is needed during the exam itself and whether the chaperone is a medical assistant or nurse.

“Chaperones usually stand next to me on either side or on the side of the patient facing me, depending on if they are immediately assisting me or helping the patient,” said Dr. Londoño. If a chaperone will be moving back and forth during the exam, that should be conveyed as well. For virtual visits, a chaperone can act as a third party and be present on a split screen, a process Michigan Medicine uses.

It’s also important to inform patients that a chaperone can step in and stop an exam at any point, both at the patient’s request or because of any observation of inappropriate physician behavior. Understanding this can help reluctant patients feel less worry.

When Christian Miller was diagnosed with a sleep disorder, his doctor suggested having a chaperone present during his physical exams. At first, he was apprehensive but then found the experience to be very positive. “Having someone there with me gave me an extra measure of assurance that nothing untoward would happen,” he said. “I found that having a chaperone was reassuring. The chaperone was not intrusive but stood close enough to ensure everything went smoothly and respectfully.”
 

Do chaperones help protect physicians legally?

Some states mandate that chaperones be present by patient request during sensitive exams, such as Texas and Oregon. For the most part, though, physicians have no legal obligation to offer chaperones, although it could be in their best interest to do so.

Ob.gyn. is one of the most litigated specialties, for example, so these physicians may find chaperones can play a key role in averting lawsuits. According to data from Physicians’ Insurance, having a reliable witness in an exam room can mitigate claims, and doctors should follow a clear practice policy regarding chaperones for all patients to further reduce liability.

Another advantage to having a chaperone present: protection for a doctor against a problematic patient. The risk for assault or aggression during an exam can of course go both ways. It’s important to be able to prove any patient misconduct through a witness, and a chaperone can lessen the prospect of violence in any form. “Having a chaperone in an exam room is about protecting the doctors as well as the patient,” said Ms. Kanyok.

A chaperone can also defuse ethical dilemmas. Consider a patient who refuses to allow a chaperone in an exam, but a chaperone is required by the physician’s health care organization. Asking a patient to state their reasons for wanting privacy with the chaperone present before the actual exam can help document the patient’s wish respectfully as well as protect a physician and organization from any potential liability if the patient refuses the exam altogether or if an exception for the patient is made.
 

Making a chaperone policy work best

• Have your staff inform patients of a medical chaperone policy at the time an appointment is made. Have fact sheets available for the patient before appointments fully outlining your policy.
• Inform the chaperone fully about the details of the exam and the patient’s case prior to the exam, in accordance with HIPAA.
• The chaperone can introduce themselves to the patient in the waiting room or exam room before you enter the room. The chaperone can go over the policy again verbally and answer any questions the patient may have initially. You can then clarify whether the patient understands your chaperone policy when you come in.
• Document, document, document. Write down who the chaperone was for each exam in patient notes and note the details of any interactions that are significant, such as patient questions or conflicts.
• Practice respect, above all. “A patient’s safety and level of comfort should be prioritized,” said Ms. Kanyok.

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

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

On July 21, 2023, topical cantharidin became the first Food and Drug Administration–approved treatment of molluscum contagiosum (molluscum), for adults and pediatric patients 2 years of age and older.

The product is a drug-device combination that contains a formulation of cantharidin solution (0.7%), delivered topically via a single-use applicator, which allows for precise dosing and targeted administration. According to a press release from Verrica Pharmaceuticals, cantharidin is expected to be available by September 2023 and should be administered only by a trained health care professional; it is not for use in the home.

The approval of the product, also known as VP-102, is based on results from two identical multicenter phase 3 randomized, double-blind, placebo-controlled trials that evaluated the drug’s safety and efficacy in patients 2 years of age and older diagnosed with molluscum: Cantharidin Application in Molluscum Patients-1 (CAMP-1) and CAMP-2. Patients in both trials met the primary endpoint of complete clearance of all treatable molluscum lesions. Specifically, 46% of CAMP-1 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 18% of participants in the vehicle group (P < .0001), while 54% of CAMP-2 participants treated with VP-102 achieved complete clearance of molluscum lesions compared with 13% of participants in the vehicle group (P < .0001).

A post hoc analysis of both trials found that complete clearance of all lesions was significantly higher in the VP-102 group than vehicle across all body regions. It also found that there were no serious adverse reactions reported in the trials. Adverse reactions were mostly mild to moderate and included application site vesicles, erythema, pain, dryness, scab, discoloration, pruritus, and edema.

The product will be marketed as Ycanth.

In March of 2023, the FDA accepted a new drug application for another treatment for molluscum contagiosum, berdazimer gel 10.3%. That product is being developed by Novan.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.

These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.

“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.

“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.

For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.

The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).

The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).

There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).

“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.

In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context. 

“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”

Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”

Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic. 

UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.

These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.

“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.

“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.

For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.

The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).

The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).

There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).

“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.

In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context. 

“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”

Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”

Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic. 

UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.

Among more than 1,000 skin biopsies performed over the last 6 years by pediatric dermatologists at the University of California, San Francisco (UCSF), the three most common biopsy results were compound nevus, pyogenic granuloma, and spongiotic dermatitis.

In addition, fewer biopsies were performed in the first 3 years of the global COVID-19 pandemic than in the previous 3 years.

These findings from a retrospective analysis were presented during a poster session at the annual meeting of the Society for Pediatric Dermatology. The analysis set out to evaluate which patients required biopsy, which skin conditions were sampled, and if practice patterns changed following the start of the COVID-19 pandemic.

“The work is important because very few pediatric patients, relative to adult patients seen in dermatology clinics, have a biopsy done,” Kelly M. Cordoro, MD, one of the study authors, told this news organization.

“Approximately 1%-4% of pediatric patients visiting a dermatology clinic will have a biopsy done as compared to 30%-50% of adult patients. Understanding what is being biopsied in children sheds light on the medical decision-making required to decide when a biopsy is necessary,” said Dr. Cordoro, chief of pediatric dermatology at UCSF.

For the study, the researchers retrospectively reviewed 1,196 biopsy specimens from 1,080 unique patients that were performed by pediatric dermatologists at UCSF from 2017 to 2022. Half of the patients were female, their mean age was 11.5 years, and they ranged in age from 1 day to 61 years. Nearly half of biopsies (47%) were performed in patients aged 12-18 years and one-quarter (25.6%) were performed in those aged 6-11 years. In the remaining biopsies, 6.6% came from patients younger than 1 year, 5.8% of those aged 1-2 years, 7.3% from those aged 3-5 years, and 3.9% each in those aged 19-21 years and in those older than 21 years.

The five most common biopsy results were compound nevus (99 biopsies), pyogenic granuloma (96), spongiotic dermatitis (57), intradermal nevus (53), and pilomatricoma (40).

The researchers identified 30 malignant diagnoses in 28 unique patients, most commonly mycosis fungoides (in 16 patients with a median age of 12.5 years), basal cell carcinoma (in 5 patients with a median age of 9 years), and dermatofibrosarcoma protuberans (in 4 patients with a median age of 2 years).

There was no significant sex-based difference in the number of biopsies performed at a given age (P = .47), but Dr. Cordoro and colleagues noted a statistically significant decrease in the number of biopsies during the pandemic compared with the 3 years prior to the pandemic (P = .04).

“There was a slight uptick in 2022, although it remains to be seen whether this trend will continue,” they wrote in their abstract. “While the most common diagnoses in the years leading up to – versus following the start of the pandemic – were similar, there was one clear outlier. The histopathologic diagnosis of pernio spiked in 2020, reflecting the ‘COVID toes’ phenomenon”.

In an interview, Dr. Cordoro said that growths and rashes in children of all ages can, and should, be biopsied, but special considerations are necessary depending on the patient’s age and context. 

“Our data showed that neoplastic conditions were biopsied more often than inflammatory conditions, with an emphasis on lesions that required removal (such as pyogenic granuloma), raised concerns for atypia (nevi), or had implications for systemic management (such as Langerhans cell histiocytosis and graft-versus-host disease). Importantly, cutaneous malignancies in children are rare but do occur, and a high index of suspicion is required when approaching any child with a complex neoplasm or rash.”

Dr. Cordoro characterized the medical decision making and rationale for biopsying skin lesions and rashes in children as “a complex process that involves weighing the risks of the biopsy itself against the benefit of the information it will provide; shared decision-making with the caregivers, the patient (if age-appropriate), and other members of the health care team; age of the child and clinical context; and whether the biopsy can be done at the bedside or requires sedation.”

Based on the study results, Dr. Cordoro said, the rationale to proceed with a biopsy boils down to three main goals: To make or confirm a diagnosis, to make decisions about management, and/or the biopsy itself is therapeutic. 

UCSF dermatopathology fellow Suzanne W. Birmingham, MD, performed the study in collaboration with Dr. Cordoro and UCSF dermatopathologist Thaddeus W. Mully, MD. Additional analyses of this data set are in progress. The researchers reported having no relevant financial disclosures.

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.

The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.

The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.






 

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.

The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.

The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.






 

The Committee for Medicinal Products for Human Use of the European Medicines Agency has granted a positive opinion for ritlecitinib, a once-daily 50-mg oral treatment for severe alopecia areata, paving the way for possible marketing authorization of the drug in the European Union for individuals 12 years of age and older. A final decision is expected in the coming months.

The development, which was announced by the manufacturer, Pfizer, on July 21, 2023, follows approval of ritlecitinib (Litfulo) for the treatment of severe alopecia areata in adults and adolescents 12 years and older by the Food and Drug Administration and the Japanese Ministry of Health, Labour, and Welfare in June 2023. According to a press release from Pfizer, submissions to other regulatory agencies for the use of ritlecitinib in alopecia areata are ongoing.

The Marketing Authorization Application for ritlecitinib was based on results from a randomized, placebo-controlled, double-blind ALLEGRO Phase 2b/3 study.