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New treatment reduces risk of anal cancer in people with HIV
It all began with the question, “Has your butt been getting enough attention?”
Though that may seem unorthodox, it led researchers to discovering a treatment that may help prevent anal cancer in people with HIV/AIDS. It’s still featured on their study’s website, with this further explanation: “You get your viral load checked, your T-cell count checked, but what about your anus? Did you know that half of HIV+ men have cell changes in their anus caused by HPV?”
The Anal Cancer/HSIL Outcomes Research (ANCHOR) study, led by Joel Palefsky, MD, was published in The New England Journal of Medicine. Dr. Palefsky, an infectious disease expert at the University of California, San Francisco, and his team set out to determine whether a treatment that prevents cervical cancer in people with human papillomavirus (HPV) would benefit people with HIV/AIDS. The new treatment reduced the likelihood of anal cancer by more than 50%.
The team worked over 7 years, during which time they tested 4,459 men, women, transgender, and nonbinary individuals at 25 sites across the United States. The participants were sorted into two groups: Some received treatment for high-grade squamous intraepithelial lesions (HSILs), and some did not but were monitored for signs of disease. These included individuals over 35 who were living with HIV/AIDS and who were found to have patches of abnormal cells in their rectal lining.
HSILs are the cells gynecologists look for in performing a pap smear. They are precancerous cells commonly found in the cervix of persons with HPV. Finding HSILs during a gynecologic examination alerts clinicians to potential problems.
HSILs can also be found in the anal tract of men and women with HIV. Dr. Palefsky therefore hypothesized that, as with HPV and cervical cancer, these anal HSILs may be a precursor of anal cancer.
The scientists decided to treat these cells the same way they would treat them if found in the cervix and to see whether that reduced the risk of cancer. Doctors used lidocaine to numb the area, then removed the HSILs with an electric probe. The team then assessed whether the treatment prevented people from getting cancer.
It turns out that in many cases, it did. The study concluded after 30 of the participants developed anal cancer. Of those, 21 patients had not received HSIL treatment, compared with nine who did receive the treatment. The treatment resulted in a 57% reduction in the rate of anal cancer among patients who received treatment for their HSILs.
These results are encouraging, said Aasma Shaukat, MD, director of outcomes research in the Division of Gastroenterology and Hepatology at NYU Langone Health. Dr. Shaukat was not involved with the study. She believes it’s going to cause ripples across the field.
“The study is likely to change guidelines in favor of active and early treatment for HSIL and away from watchful waiting in individuals living with HIV to reduce the risk of developing anal squamous cell carcinoma, akin to removing polyps during colonoscopy to progression to and incidence of colorectal cancer,” she said in an email interview.
Treatments for this group of patients are more important now than ever. Since the beginning of the AIDS epidemic in the 1980s, the number of people with HIV has increased, Dr. Palefsky detailed in a press conference announcing the ANCHOR results. That’s partially because of new transmissions and partially owing to the fact that new treatments make it possible for people with HIV to live long, healthy lives. So as more people with HIV move into their sunset years, there are more people at risk for developing cancer, which is a disease associated with aging. Anal cancer sits at the intersection of risk for aging people who have HIV.
Any defense we have against the risk of cancer in this growing demographic is a good thing, says Hanna K. Sanoff, MD, a gastrointestinal oncologist at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, who was also not involved in the study. Although it’s not ready to be applied in doctors’ offices now, it could be a tool in the future. “Anything we can do to try and decrease the chance of precancerous lesions progressing to a real invasive cancer is of great importance. This kind of prevention work is critical to helping minimize the burden of cancer on our communities,” Dr. Sanoff said in an interview.
The study was funded by the National Cancer Institute of the National Institutes of Health and was conducted through the NCI-supported AIDS Malignancy Consortium. Dr. Shaukat and Dr. Sanoff report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
It all began with the question, “Has your butt been getting enough attention?”
Though that may seem unorthodox, it led researchers to discovering a treatment that may help prevent anal cancer in people with HIV/AIDS. It’s still featured on their study’s website, with this further explanation: “You get your viral load checked, your T-cell count checked, but what about your anus? Did you know that half of HIV+ men have cell changes in their anus caused by HPV?”
The Anal Cancer/HSIL Outcomes Research (ANCHOR) study, led by Joel Palefsky, MD, was published in The New England Journal of Medicine. Dr. Palefsky, an infectious disease expert at the University of California, San Francisco, and his team set out to determine whether a treatment that prevents cervical cancer in people with human papillomavirus (HPV) would benefit people with HIV/AIDS. The new treatment reduced the likelihood of anal cancer by more than 50%.
The team worked over 7 years, during which time they tested 4,459 men, women, transgender, and nonbinary individuals at 25 sites across the United States. The participants were sorted into two groups: Some received treatment for high-grade squamous intraepithelial lesions (HSILs), and some did not but were monitored for signs of disease. These included individuals over 35 who were living with HIV/AIDS and who were found to have patches of abnormal cells in their rectal lining.
HSILs are the cells gynecologists look for in performing a pap smear. They are precancerous cells commonly found in the cervix of persons with HPV. Finding HSILs during a gynecologic examination alerts clinicians to potential problems.
HSILs can also be found in the anal tract of men and women with HIV. Dr. Palefsky therefore hypothesized that, as with HPV and cervical cancer, these anal HSILs may be a precursor of anal cancer.
The scientists decided to treat these cells the same way they would treat them if found in the cervix and to see whether that reduced the risk of cancer. Doctors used lidocaine to numb the area, then removed the HSILs with an electric probe. The team then assessed whether the treatment prevented people from getting cancer.
It turns out that in many cases, it did. The study concluded after 30 of the participants developed anal cancer. Of those, 21 patients had not received HSIL treatment, compared with nine who did receive the treatment. The treatment resulted in a 57% reduction in the rate of anal cancer among patients who received treatment for their HSILs.
These results are encouraging, said Aasma Shaukat, MD, director of outcomes research in the Division of Gastroenterology and Hepatology at NYU Langone Health. Dr. Shaukat was not involved with the study. She believes it’s going to cause ripples across the field.
“The study is likely to change guidelines in favor of active and early treatment for HSIL and away from watchful waiting in individuals living with HIV to reduce the risk of developing anal squamous cell carcinoma, akin to removing polyps during colonoscopy to progression to and incidence of colorectal cancer,” she said in an email interview.
Treatments for this group of patients are more important now than ever. Since the beginning of the AIDS epidemic in the 1980s, the number of people with HIV has increased, Dr. Palefsky detailed in a press conference announcing the ANCHOR results. That’s partially because of new transmissions and partially owing to the fact that new treatments make it possible for people with HIV to live long, healthy lives. So as more people with HIV move into their sunset years, there are more people at risk for developing cancer, which is a disease associated with aging. Anal cancer sits at the intersection of risk for aging people who have HIV.
Any defense we have against the risk of cancer in this growing demographic is a good thing, says Hanna K. Sanoff, MD, a gastrointestinal oncologist at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, who was also not involved in the study. Although it’s not ready to be applied in doctors’ offices now, it could be a tool in the future. “Anything we can do to try and decrease the chance of precancerous lesions progressing to a real invasive cancer is of great importance. This kind of prevention work is critical to helping minimize the burden of cancer on our communities,” Dr. Sanoff said in an interview.
The study was funded by the National Cancer Institute of the National Institutes of Health and was conducted through the NCI-supported AIDS Malignancy Consortium. Dr. Shaukat and Dr. Sanoff report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
It all began with the question, “Has your butt been getting enough attention?”
Though that may seem unorthodox, it led researchers to discovering a treatment that may help prevent anal cancer in people with HIV/AIDS. It’s still featured on their study’s website, with this further explanation: “You get your viral load checked, your T-cell count checked, but what about your anus? Did you know that half of HIV+ men have cell changes in their anus caused by HPV?”
The Anal Cancer/HSIL Outcomes Research (ANCHOR) study, led by Joel Palefsky, MD, was published in The New England Journal of Medicine. Dr. Palefsky, an infectious disease expert at the University of California, San Francisco, and his team set out to determine whether a treatment that prevents cervical cancer in people with human papillomavirus (HPV) would benefit people with HIV/AIDS. The new treatment reduced the likelihood of anal cancer by more than 50%.
The team worked over 7 years, during which time they tested 4,459 men, women, transgender, and nonbinary individuals at 25 sites across the United States. The participants were sorted into two groups: Some received treatment for high-grade squamous intraepithelial lesions (HSILs), and some did not but were monitored for signs of disease. These included individuals over 35 who were living with HIV/AIDS and who were found to have patches of abnormal cells in their rectal lining.
HSILs are the cells gynecologists look for in performing a pap smear. They are precancerous cells commonly found in the cervix of persons with HPV. Finding HSILs during a gynecologic examination alerts clinicians to potential problems.
HSILs can also be found in the anal tract of men and women with HIV. Dr. Palefsky therefore hypothesized that, as with HPV and cervical cancer, these anal HSILs may be a precursor of anal cancer.
The scientists decided to treat these cells the same way they would treat them if found in the cervix and to see whether that reduced the risk of cancer. Doctors used lidocaine to numb the area, then removed the HSILs with an electric probe. The team then assessed whether the treatment prevented people from getting cancer.
It turns out that in many cases, it did. The study concluded after 30 of the participants developed anal cancer. Of those, 21 patients had not received HSIL treatment, compared with nine who did receive the treatment. The treatment resulted in a 57% reduction in the rate of anal cancer among patients who received treatment for their HSILs.
These results are encouraging, said Aasma Shaukat, MD, director of outcomes research in the Division of Gastroenterology and Hepatology at NYU Langone Health. Dr. Shaukat was not involved with the study. She believes it’s going to cause ripples across the field.
“The study is likely to change guidelines in favor of active and early treatment for HSIL and away from watchful waiting in individuals living with HIV to reduce the risk of developing anal squamous cell carcinoma, akin to removing polyps during colonoscopy to progression to and incidence of colorectal cancer,” she said in an email interview.
Treatments for this group of patients are more important now than ever. Since the beginning of the AIDS epidemic in the 1980s, the number of people with HIV has increased, Dr. Palefsky detailed in a press conference announcing the ANCHOR results. That’s partially because of new transmissions and partially owing to the fact that new treatments make it possible for people with HIV to live long, healthy lives. So as more people with HIV move into their sunset years, there are more people at risk for developing cancer, which is a disease associated with aging. Anal cancer sits at the intersection of risk for aging people who have HIV.
Any defense we have against the risk of cancer in this growing demographic is a good thing, says Hanna K. Sanoff, MD, a gastrointestinal oncologist at the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, who was also not involved in the study. Although it’s not ready to be applied in doctors’ offices now, it could be a tool in the future. “Anything we can do to try and decrease the chance of precancerous lesions progressing to a real invasive cancer is of great importance. This kind of prevention work is critical to helping minimize the burden of cancer on our communities,” Dr. Sanoff said in an interview.
The study was funded by the National Cancer Institute of the National Institutes of Health and was conducted through the NCI-supported AIDS Malignancy Consortium. Dr. Shaukat and Dr. Sanoff report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Disturbed sleep drives poor PrEP adherence in young Black sexual-minority men
Young Black sexual-minority men (YBSMM) who experience sleep disturbance at least 3-4 times a week are much more likely to miss HIV pre-exposure prophylaxis (PrEP) doses than those who rarely report sleep disturbance, according to a new study published online in the journal AIDS and Behavior.
Sleep disturbance, poor cognitive processing, and memory function deficits go hand in hand, especially among people living with HIV.
Data have suggested that poor sleep might be an important factor in common neurocognitive complaints and overall health outcomes, especially among older adults with HIV. But few studies have examined the role that sleep quality might play in driving health behaviors around prevention and PrEP adherence, especially among YBSMM, who are at highest risk for acquiring new HIV infections.
Commonly cited reasons for suboptimal HIV prevention efforts within this population often include stigma, mistrust of the medical system, and a lack of culturally appropriate care.
“We make a lot of assumptions about young people and their brains and their ability to remember things, namely [that] they should be better than older adults at remembering to take medications,” lead study investigator Jade Pagkas-Bather, MD, an infectious disease specialist at University of Chicago Medicine, told this news organization.
“In reality, many young people are not used to taking medications, [especially] for a disease that they do not have.”
Too many pills, too little sleep
The researchers examined data collected from participants in the Neighborhoods and Networks Cohort Study, Chicago, which looked at the role of social, contextual, network, and geospatial factors influencing HIV prevention and care in HIV-negative, cisgender YBSMM between 2018 and 2019.
The investigators included 70 YBSMM participants who reported current PrEP use in the analysis. All were between the ages of 16 and 24 years, self-identified as African American or Black, were assigned male at birth, and reported at least one sexual encounter with a man or transgender woman in the previous 12 months.
Sleep was measured using the Patient Health Questionnaire-9 (PHQ-9) which includes a question on frequency of sleep disturbance (that is, trouble falling asleep, staying asleep, or sleeping too much) categorized as follows: less than 1 day (rarely or none of the time), 1-2 days (some or a little of the time), 3-4 days (occasionally or a moderate amount of time), or 5-7 days (all of the time).
Almost half (47.1%) of participants self-reported some or moderate sleep disturbance, with 8.6% having sleep disturbance all of the time.
“One of the main findings was that poor sleep and having too many pills impacts people’s ability to remember to take their PrEP or is associated with missing PrEP doses,” explained Dr. Pagkas-Bather.
In adjusted models, YBSMM who reported moderate sleep disturbances cited having too many pills to take as the reason for missing or forgetting PrEP doses (adjusted odds ratio, 7.59; 95% confidence interval, 1.05-54.57), compared with peers who did not have sleep issues.
Depression was likewise an important factor. Participants who reported experiencing sleep disturbance all of the time and missing PrEP doses were also highly likely to be depressed (aOR, 11.30; 95% CI, 1.19-107.53).
“The PHQ-9 is a widely accepted measure looking at depression – and sleep as one symptom of depression,” explained Brooke Genkin Rogers, Ph.D., M.P.H., a research scientist and assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I.
Dr. Rogers, who was not involved in the study, noted, “Sleep disturbance is a sign of poor physical or mental health, particularly in an otherwise younger, healthier population.” But Dr. Rogers also had questions about sleep duration (that is, too short or too long) and whether or not it also played a role in poor adherence, information that was not pursued within the study.
“As a clinician, I see quite a few people who are young Black sexual minority men who are on PrEP, or on the converse side, people living with HIV and taking medications for HIV treatment. I would posit a guess that it’s not that people are necessarily sleeping too much, but there are other sorts of factors that interfere with being able to get 8 hours of sleep a night,” explained Dr. Pagkas-Bather.
They include structural issues like greater exposure to housing instability and neighborhood safety.
However, Dr. Pagkas-Bather pointed to an even more critical factor influencing PrEP usage and adherence, one that she refers to as “Trickle Up HIV Care.”
“We can’t just come up with interventions, drugs, and studies and say, we have all of these options, anyone who wants them, come and get them,” she said. “We really need to work very hard at educating and encouraging populations who have no high-level need for prevention and treatment.”
As a clinician who works closely with the YBSMM population, Dr. Pagkas-Bather also shared that her patients have told her that they’ve asked for PrEP and have had providers turn them down because they weren’t comfortable prescribing PrEP or made assumptions about the kind of people who are on PrEP.
“There are sometimes assumptions made about Black men and sexual promiscuity. And the data doesn’t bear that out. It’s not that Black men are having more sex than White men or any other man; it’s that the prevalence of HIV in the Black community is higher overall relative to the population,” noted Dr. Pagkas-Bather.
“We need a nuanced approach to examining these issues ... to take a look at multiple levels of influence on folks’ health and HIV risk,” said Dr. Rogers.
Both clinicians acknowledged that creative solutions have not been exhausted.
“There’s a lot of opportunity if we sit down with communities and share in decisions around HIV treatment and prevention ... if we tap into the wealth and knowledge of the Black communities to prevent HIV,” concluded Dr. Pagkas-Bather.
Dr. Pagkas-Bather reports that she is a Gilead Sciences HIV Research Scholar awardee. Dr. Rogers reports receiving a scientific research grant from Gilead Sciences.
A version of this article first appeared on Medscape.com.
Young Black sexual-minority men (YBSMM) who experience sleep disturbance at least 3-4 times a week are much more likely to miss HIV pre-exposure prophylaxis (PrEP) doses than those who rarely report sleep disturbance, according to a new study published online in the journal AIDS and Behavior.
Sleep disturbance, poor cognitive processing, and memory function deficits go hand in hand, especially among people living with HIV.
Data have suggested that poor sleep might be an important factor in common neurocognitive complaints and overall health outcomes, especially among older adults with HIV. But few studies have examined the role that sleep quality might play in driving health behaviors around prevention and PrEP adherence, especially among YBSMM, who are at highest risk for acquiring new HIV infections.
Commonly cited reasons for suboptimal HIV prevention efforts within this population often include stigma, mistrust of the medical system, and a lack of culturally appropriate care.
“We make a lot of assumptions about young people and their brains and their ability to remember things, namely [that] they should be better than older adults at remembering to take medications,” lead study investigator Jade Pagkas-Bather, MD, an infectious disease specialist at University of Chicago Medicine, told this news organization.
“In reality, many young people are not used to taking medications, [especially] for a disease that they do not have.”
Too many pills, too little sleep
The researchers examined data collected from participants in the Neighborhoods and Networks Cohort Study, Chicago, which looked at the role of social, contextual, network, and geospatial factors influencing HIV prevention and care in HIV-negative, cisgender YBSMM between 2018 and 2019.
The investigators included 70 YBSMM participants who reported current PrEP use in the analysis. All were between the ages of 16 and 24 years, self-identified as African American or Black, were assigned male at birth, and reported at least one sexual encounter with a man or transgender woman in the previous 12 months.
Sleep was measured using the Patient Health Questionnaire-9 (PHQ-9) which includes a question on frequency of sleep disturbance (that is, trouble falling asleep, staying asleep, or sleeping too much) categorized as follows: less than 1 day (rarely or none of the time), 1-2 days (some or a little of the time), 3-4 days (occasionally or a moderate amount of time), or 5-7 days (all of the time).
Almost half (47.1%) of participants self-reported some or moderate sleep disturbance, with 8.6% having sleep disturbance all of the time.
“One of the main findings was that poor sleep and having too many pills impacts people’s ability to remember to take their PrEP or is associated with missing PrEP doses,” explained Dr. Pagkas-Bather.
In adjusted models, YBSMM who reported moderate sleep disturbances cited having too many pills to take as the reason for missing or forgetting PrEP doses (adjusted odds ratio, 7.59; 95% confidence interval, 1.05-54.57), compared with peers who did not have sleep issues.
Depression was likewise an important factor. Participants who reported experiencing sleep disturbance all of the time and missing PrEP doses were also highly likely to be depressed (aOR, 11.30; 95% CI, 1.19-107.53).
“The PHQ-9 is a widely accepted measure looking at depression – and sleep as one symptom of depression,” explained Brooke Genkin Rogers, Ph.D., M.P.H., a research scientist and assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I.
Dr. Rogers, who was not involved in the study, noted, “Sleep disturbance is a sign of poor physical or mental health, particularly in an otherwise younger, healthier population.” But Dr. Rogers also had questions about sleep duration (that is, too short or too long) and whether or not it also played a role in poor adherence, information that was not pursued within the study.
“As a clinician, I see quite a few people who are young Black sexual minority men who are on PrEP, or on the converse side, people living with HIV and taking medications for HIV treatment. I would posit a guess that it’s not that people are necessarily sleeping too much, but there are other sorts of factors that interfere with being able to get 8 hours of sleep a night,” explained Dr. Pagkas-Bather.
They include structural issues like greater exposure to housing instability and neighborhood safety.
However, Dr. Pagkas-Bather pointed to an even more critical factor influencing PrEP usage and adherence, one that she refers to as “Trickle Up HIV Care.”
“We can’t just come up with interventions, drugs, and studies and say, we have all of these options, anyone who wants them, come and get them,” she said. “We really need to work very hard at educating and encouraging populations who have no high-level need for prevention and treatment.”
As a clinician who works closely with the YBSMM population, Dr. Pagkas-Bather also shared that her patients have told her that they’ve asked for PrEP and have had providers turn them down because they weren’t comfortable prescribing PrEP or made assumptions about the kind of people who are on PrEP.
“There are sometimes assumptions made about Black men and sexual promiscuity. And the data doesn’t bear that out. It’s not that Black men are having more sex than White men or any other man; it’s that the prevalence of HIV in the Black community is higher overall relative to the population,” noted Dr. Pagkas-Bather.
“We need a nuanced approach to examining these issues ... to take a look at multiple levels of influence on folks’ health and HIV risk,” said Dr. Rogers.
Both clinicians acknowledged that creative solutions have not been exhausted.
“There’s a lot of opportunity if we sit down with communities and share in decisions around HIV treatment and prevention ... if we tap into the wealth and knowledge of the Black communities to prevent HIV,” concluded Dr. Pagkas-Bather.
Dr. Pagkas-Bather reports that she is a Gilead Sciences HIV Research Scholar awardee. Dr. Rogers reports receiving a scientific research grant from Gilead Sciences.
A version of this article first appeared on Medscape.com.
Young Black sexual-minority men (YBSMM) who experience sleep disturbance at least 3-4 times a week are much more likely to miss HIV pre-exposure prophylaxis (PrEP) doses than those who rarely report sleep disturbance, according to a new study published online in the journal AIDS and Behavior.
Sleep disturbance, poor cognitive processing, and memory function deficits go hand in hand, especially among people living with HIV.
Data have suggested that poor sleep might be an important factor in common neurocognitive complaints and overall health outcomes, especially among older adults with HIV. But few studies have examined the role that sleep quality might play in driving health behaviors around prevention and PrEP adherence, especially among YBSMM, who are at highest risk for acquiring new HIV infections.
Commonly cited reasons for suboptimal HIV prevention efforts within this population often include stigma, mistrust of the medical system, and a lack of culturally appropriate care.
“We make a lot of assumptions about young people and their brains and their ability to remember things, namely [that] they should be better than older adults at remembering to take medications,” lead study investigator Jade Pagkas-Bather, MD, an infectious disease specialist at University of Chicago Medicine, told this news organization.
“In reality, many young people are not used to taking medications, [especially] for a disease that they do not have.”
Too many pills, too little sleep
The researchers examined data collected from participants in the Neighborhoods and Networks Cohort Study, Chicago, which looked at the role of social, contextual, network, and geospatial factors influencing HIV prevention and care in HIV-negative, cisgender YBSMM between 2018 and 2019.
The investigators included 70 YBSMM participants who reported current PrEP use in the analysis. All were between the ages of 16 and 24 years, self-identified as African American or Black, were assigned male at birth, and reported at least one sexual encounter with a man or transgender woman in the previous 12 months.
Sleep was measured using the Patient Health Questionnaire-9 (PHQ-9) which includes a question on frequency of sleep disturbance (that is, trouble falling asleep, staying asleep, or sleeping too much) categorized as follows: less than 1 day (rarely or none of the time), 1-2 days (some or a little of the time), 3-4 days (occasionally or a moderate amount of time), or 5-7 days (all of the time).
Almost half (47.1%) of participants self-reported some or moderate sleep disturbance, with 8.6% having sleep disturbance all of the time.
“One of the main findings was that poor sleep and having too many pills impacts people’s ability to remember to take their PrEP or is associated with missing PrEP doses,” explained Dr. Pagkas-Bather.
In adjusted models, YBSMM who reported moderate sleep disturbances cited having too many pills to take as the reason for missing or forgetting PrEP doses (adjusted odds ratio, 7.59; 95% confidence interval, 1.05-54.57), compared with peers who did not have sleep issues.
Depression was likewise an important factor. Participants who reported experiencing sleep disturbance all of the time and missing PrEP doses were also highly likely to be depressed (aOR, 11.30; 95% CI, 1.19-107.53).
“The PHQ-9 is a widely accepted measure looking at depression – and sleep as one symptom of depression,” explained Brooke Genkin Rogers, Ph.D., M.P.H., a research scientist and assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I.
Dr. Rogers, who was not involved in the study, noted, “Sleep disturbance is a sign of poor physical or mental health, particularly in an otherwise younger, healthier population.” But Dr. Rogers also had questions about sleep duration (that is, too short or too long) and whether or not it also played a role in poor adherence, information that was not pursued within the study.
“As a clinician, I see quite a few people who are young Black sexual minority men who are on PrEP, or on the converse side, people living with HIV and taking medications for HIV treatment. I would posit a guess that it’s not that people are necessarily sleeping too much, but there are other sorts of factors that interfere with being able to get 8 hours of sleep a night,” explained Dr. Pagkas-Bather.
They include structural issues like greater exposure to housing instability and neighborhood safety.
However, Dr. Pagkas-Bather pointed to an even more critical factor influencing PrEP usage and adherence, one that she refers to as “Trickle Up HIV Care.”
“We can’t just come up with interventions, drugs, and studies and say, we have all of these options, anyone who wants them, come and get them,” she said. “We really need to work very hard at educating and encouraging populations who have no high-level need for prevention and treatment.”
As a clinician who works closely with the YBSMM population, Dr. Pagkas-Bather also shared that her patients have told her that they’ve asked for PrEP and have had providers turn them down because they weren’t comfortable prescribing PrEP or made assumptions about the kind of people who are on PrEP.
“There are sometimes assumptions made about Black men and sexual promiscuity. And the data doesn’t bear that out. It’s not that Black men are having more sex than White men or any other man; it’s that the prevalence of HIV in the Black community is higher overall relative to the population,” noted Dr. Pagkas-Bather.
“We need a nuanced approach to examining these issues ... to take a look at multiple levels of influence on folks’ health and HIV risk,” said Dr. Rogers.
Both clinicians acknowledged that creative solutions have not been exhausted.
“There’s a lot of opportunity if we sit down with communities and share in decisions around HIV treatment and prevention ... if we tap into the wealth and knowledge of the Black communities to prevent HIV,” concluded Dr. Pagkas-Bather.
Dr. Pagkas-Bather reports that she is a Gilead Sciences HIV Research Scholar awardee. Dr. Rogers reports receiving a scientific research grant from Gilead Sciences.
A version of this article first appeared on Medscape.com.
Disappointing results for investigational Alzheimer’s drug
, new research suggests.
Top-line results for a phase 2 trial showed the novel drug, a monoclonal antibody designed to neutralize neurotoxic oligomers (a form of beta-amyloid), was not statistically superior to placebo in terms of cognitive ability or episodic memory function among cognitively unimpaired individuals with a genetic mutation for early-onset AD.
Genentech announced the negative results on June 16 together with Banner Alzheimer’s Institute, Phoenix.
During a press briefing, company representatives and researchers expressed disappointment with the initial results – but stressed numerous ongoing analyses have yet to be completed.
“This is the beginning of the story, but by no means the end of it,” Pierre N. Tariot, MD, director, Banner Alzheimer’s Institute, and one of the study leaders, said at the briefing.
API ADAD trial
The prospective, double-blind parallel-group Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer’s Disease (ADAD) phase 2 trial enrolled 252 members of the world’s largest extended family with ADAD in Colombia. A total of 94% of the participants completed the study.
Two-thirds of participants carried the Presenilin 1 (PSEN1) E280A mutation, which virtually guarantees that carriers will develop AD at an average age of 44 years and dementia at an average age of 49 years.
Study participants were randomly assigned to receive crenezumab or placebo over a period of 5-8 years. The dose of crenezumab was increased at different time points during the trial as knowledge about potential treatment approaches for AD evolved.
Dr. Tariot noted the maximum dose was not provided for the entire treatment period. “The longest people received the highest dose was about 2 years,” he added.
Coprimary endpoints were rate of change in cognitive abilities, as measured by the API ADAD composite cognitive score, or episodic memory function, measured by the Free and Cued Selective Reminding Test Cueing Index.
Results showed these outcomes were not statistically significant for those receiving the active medication.
In addition to a range of cognitive measures, researchers also assessed amyloid PET and, later in the study, tau PET. MRI and cerebrospinal fluid (CSF) measures were also examined.
The investigators did find small numerical differences favoring crenezumab across the coprimary and multiple secondary and exploratory endpoints, but these were also not statistically significant.
Finally, no new safety issues were identified with crenezumab during the study.
Further analyses of data are ongoing and additional brain imaging and CSF biomarker results will be presented at the Alzheimer’s Association International Conference on Aug. 2.
While the study was not positive, it demonstrated that prevention trials are possible, even in less-than-ideal circumstances and generated a wealth of useful data, the investigators note.
“There were some differences between the treated and untreated patients, and we still need to understand which patients were most likely to experience those differences,” Rachelle Doody, MD, PhD, global head of neurodegeneration at Roche and Genentech, told briefing attendees.
“We need to understand the biomarkers involved and what [they’re] telling us about the disease and the timing of the intervention,” Dr. Doody said.
Prevention “needs to be one of our targeted therapeutic approaches but probably not our only one,” she added.
Beyond amyloid?
Commenting on the negative results, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said they demonstrate the need to focus beyond amyloid and more on the biology of aging.
“This broader approach coupled with advances in novel biomarkers is bringing us closer to the day when physicians will be able to zero in on the root causes of each patient’s Alzheimer’s – and tailor combinations of drug therapies to provide precision medicine,” Dr. Fillit, who was not involved with the research, said in statement.
Genentech is also evaluating the potential of gantenerumab for ADAD and for the prevention of sporadic AD and treatment of early Alzheimer’s in late-stage clinical trials. Results from the phase 3 GRADUATE studies of gantenerumab in early AD are expected by the end of the year.
The study was supported by the National Institute on Aging, contributions to Banner Alzheimer’s Foundation, and Genentech.
A version of this article first appeared on Medscape.com.
, new research suggests.
Top-line results for a phase 2 trial showed the novel drug, a monoclonal antibody designed to neutralize neurotoxic oligomers (a form of beta-amyloid), was not statistically superior to placebo in terms of cognitive ability or episodic memory function among cognitively unimpaired individuals with a genetic mutation for early-onset AD.
Genentech announced the negative results on June 16 together with Banner Alzheimer’s Institute, Phoenix.
During a press briefing, company representatives and researchers expressed disappointment with the initial results – but stressed numerous ongoing analyses have yet to be completed.
“This is the beginning of the story, but by no means the end of it,” Pierre N. Tariot, MD, director, Banner Alzheimer’s Institute, and one of the study leaders, said at the briefing.
API ADAD trial
The prospective, double-blind parallel-group Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer’s Disease (ADAD) phase 2 trial enrolled 252 members of the world’s largest extended family with ADAD in Colombia. A total of 94% of the participants completed the study.
Two-thirds of participants carried the Presenilin 1 (PSEN1) E280A mutation, which virtually guarantees that carriers will develop AD at an average age of 44 years and dementia at an average age of 49 years.
Study participants were randomly assigned to receive crenezumab or placebo over a period of 5-8 years. The dose of crenezumab was increased at different time points during the trial as knowledge about potential treatment approaches for AD evolved.
Dr. Tariot noted the maximum dose was not provided for the entire treatment period. “The longest people received the highest dose was about 2 years,” he added.
Coprimary endpoints were rate of change in cognitive abilities, as measured by the API ADAD composite cognitive score, or episodic memory function, measured by the Free and Cued Selective Reminding Test Cueing Index.
Results showed these outcomes were not statistically significant for those receiving the active medication.
In addition to a range of cognitive measures, researchers also assessed amyloid PET and, later in the study, tau PET. MRI and cerebrospinal fluid (CSF) measures were also examined.
The investigators did find small numerical differences favoring crenezumab across the coprimary and multiple secondary and exploratory endpoints, but these were also not statistically significant.
Finally, no new safety issues were identified with crenezumab during the study.
Further analyses of data are ongoing and additional brain imaging and CSF biomarker results will be presented at the Alzheimer’s Association International Conference on Aug. 2.
While the study was not positive, it demonstrated that prevention trials are possible, even in less-than-ideal circumstances and generated a wealth of useful data, the investigators note.
“There were some differences between the treated and untreated patients, and we still need to understand which patients were most likely to experience those differences,” Rachelle Doody, MD, PhD, global head of neurodegeneration at Roche and Genentech, told briefing attendees.
“We need to understand the biomarkers involved and what [they’re] telling us about the disease and the timing of the intervention,” Dr. Doody said.
Prevention “needs to be one of our targeted therapeutic approaches but probably not our only one,” she added.
Beyond amyloid?
Commenting on the negative results, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said they demonstrate the need to focus beyond amyloid and more on the biology of aging.
“This broader approach coupled with advances in novel biomarkers is bringing us closer to the day when physicians will be able to zero in on the root causes of each patient’s Alzheimer’s – and tailor combinations of drug therapies to provide precision medicine,” Dr. Fillit, who was not involved with the research, said in statement.
Genentech is also evaluating the potential of gantenerumab for ADAD and for the prevention of sporadic AD and treatment of early Alzheimer’s in late-stage clinical trials. Results from the phase 3 GRADUATE studies of gantenerumab in early AD are expected by the end of the year.
The study was supported by the National Institute on Aging, contributions to Banner Alzheimer’s Foundation, and Genentech.
A version of this article first appeared on Medscape.com.
, new research suggests.
Top-line results for a phase 2 trial showed the novel drug, a monoclonal antibody designed to neutralize neurotoxic oligomers (a form of beta-amyloid), was not statistically superior to placebo in terms of cognitive ability or episodic memory function among cognitively unimpaired individuals with a genetic mutation for early-onset AD.
Genentech announced the negative results on June 16 together with Banner Alzheimer’s Institute, Phoenix.
During a press briefing, company representatives and researchers expressed disappointment with the initial results – but stressed numerous ongoing analyses have yet to be completed.
“This is the beginning of the story, but by no means the end of it,” Pierre N. Tariot, MD, director, Banner Alzheimer’s Institute, and one of the study leaders, said at the briefing.
API ADAD trial
The prospective, double-blind parallel-group Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer’s Disease (ADAD) phase 2 trial enrolled 252 members of the world’s largest extended family with ADAD in Colombia. A total of 94% of the participants completed the study.
Two-thirds of participants carried the Presenilin 1 (PSEN1) E280A mutation, which virtually guarantees that carriers will develop AD at an average age of 44 years and dementia at an average age of 49 years.
Study participants were randomly assigned to receive crenezumab or placebo over a period of 5-8 years. The dose of crenezumab was increased at different time points during the trial as knowledge about potential treatment approaches for AD evolved.
Dr. Tariot noted the maximum dose was not provided for the entire treatment period. “The longest people received the highest dose was about 2 years,” he added.
Coprimary endpoints were rate of change in cognitive abilities, as measured by the API ADAD composite cognitive score, or episodic memory function, measured by the Free and Cued Selective Reminding Test Cueing Index.
Results showed these outcomes were not statistically significant for those receiving the active medication.
In addition to a range of cognitive measures, researchers also assessed amyloid PET and, later in the study, tau PET. MRI and cerebrospinal fluid (CSF) measures were also examined.
The investigators did find small numerical differences favoring crenezumab across the coprimary and multiple secondary and exploratory endpoints, but these were also not statistically significant.
Finally, no new safety issues were identified with crenezumab during the study.
Further analyses of data are ongoing and additional brain imaging and CSF biomarker results will be presented at the Alzheimer’s Association International Conference on Aug. 2.
While the study was not positive, it demonstrated that prevention trials are possible, even in less-than-ideal circumstances and generated a wealth of useful data, the investigators note.
“There were some differences between the treated and untreated patients, and we still need to understand which patients were most likely to experience those differences,” Rachelle Doody, MD, PhD, global head of neurodegeneration at Roche and Genentech, told briefing attendees.
“We need to understand the biomarkers involved and what [they’re] telling us about the disease and the timing of the intervention,” Dr. Doody said.
Prevention “needs to be one of our targeted therapeutic approaches but probably not our only one,” she added.
Beyond amyloid?
Commenting on the negative results, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, said they demonstrate the need to focus beyond amyloid and more on the biology of aging.
“This broader approach coupled with advances in novel biomarkers is bringing us closer to the day when physicians will be able to zero in on the root causes of each patient’s Alzheimer’s – and tailor combinations of drug therapies to provide precision medicine,” Dr. Fillit, who was not involved with the research, said in statement.
Genentech is also evaluating the potential of gantenerumab for ADAD and for the prevention of sporadic AD and treatment of early Alzheimer’s in late-stage clinical trials. Results from the phase 3 GRADUATE studies of gantenerumab in early AD are expected by the end of the year.
The study was supported by the National Institute on Aging, contributions to Banner Alzheimer’s Foundation, and Genentech.
A version of this article first appeared on Medscape.com.
FDA approves risankizumab (Skyrizi) for Crohn’s disease
The U.S. Food and Drug Administration – making it the first specific anti–interleukin-23 monoclonal antibody indicated for Crohn’s disease.
The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).
Results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology in 2021.
“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and codirector of the IBD Center at Mount Sinai, New York, said in a news release from AbbVie.
“This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dr. Dubinsky said.
For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.
Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration – making it the first specific anti–interleukin-23 monoclonal antibody indicated for Crohn’s disease.
The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).
Results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology in 2021.
“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and codirector of the IBD Center at Mount Sinai, New York, said in a news release from AbbVie.
“This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dr. Dubinsky said.
For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.
Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration – making it the first specific anti–interleukin-23 monoclonal antibody indicated for Crohn’s disease.
The safety and efficacy of risankizumab in Crohn’s disease is supported by data from two induction clinical trials (ADVANCE and MOTIVATE) and one maintenance clinical trial (FORTIFY).
Results of the three studies were presented at the annual scientific meeting of the American College of Gastroenterology in 2021.
“In both the induction and maintenance clinical trials, a significantly greater number of adult patients saw few or no symptoms and a meaningful reduction of visible signs of intestinal inflammation, compared to placebo,” Marla Dubinsky, MD, gastroenterologist with the Mount Sinai Health System and codirector of the IBD Center at Mount Sinai, New York, said in a news release from AbbVie.
“This approval provides health care professionals with a greatly needed additional option for treating the disruptive symptoms of Crohn’s disease,” Dr. Dubinsky said.
For the treatment of Crohn’s disease, risankizumab is dosed at 600 mg administered by intravenous infusion over at least 1 hour at week 0, 4, and 8, followed by 360 mg self-administered by subcutaneous injection at week 12, and every 8 weeks thereafter.
Risankizumab is already approved in the United States for the treatment of adults with active psoriatic arthritis and moderate to severe plaque psoriasis.
A version of this article first appeared on Medscape.com.
Ultra-processed: Doctors debate whether putting this label on foods is useful
The NOVA system divides foods into “fresh or minimally processed,” such as strawberries or steel-cut oats; “processed culinary ingredients,” such as olive oil; “processed foods,” such as cheeses; and “ultra-processed foods.” UPFs are defined as “industrial formulations made by deconstructing natural food into its chemical constituents, modifying them and recombining them with additives into products liable to displace all other NOVA food groups.”
According to doctors who presented during the meeting, ultra-processed foods are drawing increased attention, because researchers have been examining them in National Institutes of Health–funded studies and journalists have been writing about them.
During the debate session at the meeting, some experts said that, with obesity and poor health skyrocketing, increased awareness and labeling of UPFs can only be a good thing. In contrast others noted at the meeting that the classification system that has come to be used for identifying UPFs – the NOVA Food Classification system – is too mushy, confusing, and, ultimately unhelpful.
Carlos Monteiro, MD, PhD, professor of nutrition and public health at the University of Sao Paolo, was part of the group favoring the NOVA system’s classifying certain foods as UPFs, during the debate. He drew attention to the extent to which the world’s population is getting its calories from UPFs.
Mexico and France get about 30% of calories from these foods. In Canada, it’s 48%. And in the United States, it’s 57%, Dr. Monteiro said.
Studies have found that UPFs, many of which are designed to be exceedingly flavorful and intended to replace consumption of unprocessed whole foods, lead to more overall energy intake, more added sugar in the diet, and less fiber and protein intake, he said.
To further support his arguments, Dr. Monteiro pointed to studies suggesting that it is not just the resulting change in the nutritional intake that is unhealthy, but the UPF manufacturing process itself. When adjusting for fat, sugar, and sodium intake, for example, health outcomes associated with UPFs remain poor, he explained.
“I’m sorry,” he said in the debate. “If you don’t reduce this, you don’t reduce your obesity, your diabetes prevalence.”
A study presented by Jacqueline Vernarelli, PhD, during a different session at the meeting suggested there may be other downsides to consuming UPFs. This research, which was based on the U.S. National Youth Fitness Survey, found that poorer locomotor skills among children aged 3-5 and poorer cardiovascular fitness among those aged 12-15 were associated with getting more calories from UPFs.
Those with lower cardiovascular fitness consumed 1,234 calories a day from UPFs, and those with higher cardiovascular fitness consumed 1,007 calories a day from UPFs (P = .002), according to the new research.
“It’s notable here that, although these differences are significant, both groups are consuming a pretty high proportion of their diet from ultra-processed foods,” said Dr. Vernarelli, associate professor of public health at Sacred Heart University, Fairfield, Conn., during her presentation.
In the debate session, Arne Astrup, MD, PhD, senior project director at the Healthy Weight Center at the Novo Nordisk Foundation, Hellerup, Denmark, presented an opposing view.
He said the definition of UPFs makes it too difficult to categorize many foods, pointing to a study from this year in which about 150 nutrition experts, doctors, and dietitians classified 120 foods. Only three marketed foods and one generic food were classified the same by all the evaluators.
Referring to the study Dr. Astrup cited, Dr. Monteiro said it was a mere “exercise,” and the experts involved in it had conflicts of interest.
Dr. Astrup touted this study’s size and its appearance in the peer-reviewed journal the European Journal of Clinical Nutrition.
Defending his point of view, Dr. Astrup said, “The definition and classification is so ambiguous, and the risk of misclassification is so extremely high, I think we really miss the basic requirement of science, namely that we know what we are talking about,” he said.
If you take an unprocessed food, and insert a “little additive … suddenly it’s an ultra-processed food,” he added.
UPF definition doesn’t flag some unhealthy foods
Susan Roberts, PhD, professor of nutrition at Tufts University, Boston, was a discussant at the debate and touched on the merits of both sides. She noted that the UPF definition doesn’t flag some “clearly unhealthy foods,” such as table sugar, but does flag some healthy ones, such as plant-based burgers – to which Dr. Monteiro said that the system was not a system meant to divide foods into healthy and unhealthy groups, during the debate session.
The inclusion of both healthy and unhealthy foods in NOVA’s definition of a UPF is a serious problem, Dr. Roberts said.
“It’s almost like it’s an emotional classification designed to get at the food industry rather than focusing on health – and I think that’s asking for trouble because it’s just going to be such a mess to tell consumers, ‘Well, this ultra-processed food is healthy and this one isn’t,’ ” she said. What’s happening is the term ultra-processed is being used interchangeably with unhealthy.
The discussion that the UPF classification has generated is useful, Dr. Roberts continued. “This definition grew out of that recognition that we’re engaged in an unprecedented experiment of how unhealthy can you make the world without having a major catastrophe.”
She added that the UPF concept deserves a more formalized and rigorous evaluation.
“This is an important topic for the future of public health, and I think it needs big committees to address it seriously,” she said. “I think we should not be dealing with this individually in different labs.”
Doctor’s take on usefulness of discussing UPF concept with patients
Mark Corkins, MD, who did not participate in the debate at the meeting, said he talks to parents and children about nutrition at every office visit in which he sees a child with an unhealthy weight.
“Persistence wears down resistance,” said the chair of the American Academy of Pediatrics nutrition committee, in an interview.“A consistent message – you say the same thing and you say it multiple times.”
The idea of “ultra-processed foods” plays a role in those conversations, but largely in the background. It’s a topic that’s important for pediatric health, Dr. Corkins said – but he doesn’t make it the focal point.
“It’s not a direct attack on ultra-processed foods that usually I take as my direction,” said Dr. Corkins, who is also chief of pediatric gastroenterology at Le Bonheur Children’s Hospital in Memphis, Tenn.. “What I try to focus on, and what I think the American Academy of Pediatrics would focus on, is that we need to focus on making the diet better.”
He added, “Parents are aware – they don’t call it ultra-processed food, they call it junk food.”
Dr. Corkins continued that he is reluctant to directly challenge parents on feeding their children unhealthy foods – ultra-processed or not – lest he shame them and harm the relationship.
“Guilt as a motivator isn’t really highly successful,” he said, in an interview.
Dr. Astrup reported advisory committee or board member involvement with Green Leaf Medical and RNPC, France. Dr. Roberts reported advisory committee or board member involvement with Danone, and an ownership interest in Instinct Health Science. Dr. Monteiro and Dr. Corkins reported no relevant disclosures.
The NOVA system divides foods into “fresh or minimally processed,” such as strawberries or steel-cut oats; “processed culinary ingredients,” such as olive oil; “processed foods,” such as cheeses; and “ultra-processed foods.” UPFs are defined as “industrial formulations made by deconstructing natural food into its chemical constituents, modifying them and recombining them with additives into products liable to displace all other NOVA food groups.”
According to doctors who presented during the meeting, ultra-processed foods are drawing increased attention, because researchers have been examining them in National Institutes of Health–funded studies and journalists have been writing about them.
During the debate session at the meeting, some experts said that, with obesity and poor health skyrocketing, increased awareness and labeling of UPFs can only be a good thing. In contrast others noted at the meeting that the classification system that has come to be used for identifying UPFs – the NOVA Food Classification system – is too mushy, confusing, and, ultimately unhelpful.
Carlos Monteiro, MD, PhD, professor of nutrition and public health at the University of Sao Paolo, was part of the group favoring the NOVA system’s classifying certain foods as UPFs, during the debate. He drew attention to the extent to which the world’s population is getting its calories from UPFs.
Mexico and France get about 30% of calories from these foods. In Canada, it’s 48%. And in the United States, it’s 57%, Dr. Monteiro said.
Studies have found that UPFs, many of which are designed to be exceedingly flavorful and intended to replace consumption of unprocessed whole foods, lead to more overall energy intake, more added sugar in the diet, and less fiber and protein intake, he said.
To further support his arguments, Dr. Monteiro pointed to studies suggesting that it is not just the resulting change in the nutritional intake that is unhealthy, but the UPF manufacturing process itself. When adjusting for fat, sugar, and sodium intake, for example, health outcomes associated with UPFs remain poor, he explained.
“I’m sorry,” he said in the debate. “If you don’t reduce this, you don’t reduce your obesity, your diabetes prevalence.”
A study presented by Jacqueline Vernarelli, PhD, during a different session at the meeting suggested there may be other downsides to consuming UPFs. This research, which was based on the U.S. National Youth Fitness Survey, found that poorer locomotor skills among children aged 3-5 and poorer cardiovascular fitness among those aged 12-15 were associated with getting more calories from UPFs.
Those with lower cardiovascular fitness consumed 1,234 calories a day from UPFs, and those with higher cardiovascular fitness consumed 1,007 calories a day from UPFs (P = .002), according to the new research.
“It’s notable here that, although these differences are significant, both groups are consuming a pretty high proportion of their diet from ultra-processed foods,” said Dr. Vernarelli, associate professor of public health at Sacred Heart University, Fairfield, Conn., during her presentation.
In the debate session, Arne Astrup, MD, PhD, senior project director at the Healthy Weight Center at the Novo Nordisk Foundation, Hellerup, Denmark, presented an opposing view.
He said the definition of UPFs makes it too difficult to categorize many foods, pointing to a study from this year in which about 150 nutrition experts, doctors, and dietitians classified 120 foods. Only three marketed foods and one generic food were classified the same by all the evaluators.
Referring to the study Dr. Astrup cited, Dr. Monteiro said it was a mere “exercise,” and the experts involved in it had conflicts of interest.
Dr. Astrup touted this study’s size and its appearance in the peer-reviewed journal the European Journal of Clinical Nutrition.
Defending his point of view, Dr. Astrup said, “The definition and classification is so ambiguous, and the risk of misclassification is so extremely high, I think we really miss the basic requirement of science, namely that we know what we are talking about,” he said.
If you take an unprocessed food, and insert a “little additive … suddenly it’s an ultra-processed food,” he added.
UPF definition doesn’t flag some unhealthy foods
Susan Roberts, PhD, professor of nutrition at Tufts University, Boston, was a discussant at the debate and touched on the merits of both sides. She noted that the UPF definition doesn’t flag some “clearly unhealthy foods,” such as table sugar, but does flag some healthy ones, such as plant-based burgers – to which Dr. Monteiro said that the system was not a system meant to divide foods into healthy and unhealthy groups, during the debate session.
The inclusion of both healthy and unhealthy foods in NOVA’s definition of a UPF is a serious problem, Dr. Roberts said.
“It’s almost like it’s an emotional classification designed to get at the food industry rather than focusing on health – and I think that’s asking for trouble because it’s just going to be such a mess to tell consumers, ‘Well, this ultra-processed food is healthy and this one isn’t,’ ” she said. What’s happening is the term ultra-processed is being used interchangeably with unhealthy.
The discussion that the UPF classification has generated is useful, Dr. Roberts continued. “This definition grew out of that recognition that we’re engaged in an unprecedented experiment of how unhealthy can you make the world without having a major catastrophe.”
She added that the UPF concept deserves a more formalized and rigorous evaluation.
“This is an important topic for the future of public health, and I think it needs big committees to address it seriously,” she said. “I think we should not be dealing with this individually in different labs.”
Doctor’s take on usefulness of discussing UPF concept with patients
Mark Corkins, MD, who did not participate in the debate at the meeting, said he talks to parents and children about nutrition at every office visit in which he sees a child with an unhealthy weight.
“Persistence wears down resistance,” said the chair of the American Academy of Pediatrics nutrition committee, in an interview.“A consistent message – you say the same thing and you say it multiple times.”
The idea of “ultra-processed foods” plays a role in those conversations, but largely in the background. It’s a topic that’s important for pediatric health, Dr. Corkins said – but he doesn’t make it the focal point.
“It’s not a direct attack on ultra-processed foods that usually I take as my direction,” said Dr. Corkins, who is also chief of pediatric gastroenterology at Le Bonheur Children’s Hospital in Memphis, Tenn.. “What I try to focus on, and what I think the American Academy of Pediatrics would focus on, is that we need to focus on making the diet better.”
He added, “Parents are aware – they don’t call it ultra-processed food, they call it junk food.”
Dr. Corkins continued that he is reluctant to directly challenge parents on feeding their children unhealthy foods – ultra-processed or not – lest he shame them and harm the relationship.
“Guilt as a motivator isn’t really highly successful,” he said, in an interview.
Dr. Astrup reported advisory committee or board member involvement with Green Leaf Medical and RNPC, France. Dr. Roberts reported advisory committee or board member involvement with Danone, and an ownership interest in Instinct Health Science. Dr. Monteiro and Dr. Corkins reported no relevant disclosures.
The NOVA system divides foods into “fresh or minimally processed,” such as strawberries or steel-cut oats; “processed culinary ingredients,” such as olive oil; “processed foods,” such as cheeses; and “ultra-processed foods.” UPFs are defined as “industrial formulations made by deconstructing natural food into its chemical constituents, modifying them and recombining them with additives into products liable to displace all other NOVA food groups.”
According to doctors who presented during the meeting, ultra-processed foods are drawing increased attention, because researchers have been examining them in National Institutes of Health–funded studies and journalists have been writing about them.
During the debate session at the meeting, some experts said that, with obesity and poor health skyrocketing, increased awareness and labeling of UPFs can only be a good thing. In contrast others noted at the meeting that the classification system that has come to be used for identifying UPFs – the NOVA Food Classification system – is too mushy, confusing, and, ultimately unhelpful.
Carlos Monteiro, MD, PhD, professor of nutrition and public health at the University of Sao Paolo, was part of the group favoring the NOVA system’s classifying certain foods as UPFs, during the debate. He drew attention to the extent to which the world’s population is getting its calories from UPFs.
Mexico and France get about 30% of calories from these foods. In Canada, it’s 48%. And in the United States, it’s 57%, Dr. Monteiro said.
Studies have found that UPFs, many of which are designed to be exceedingly flavorful and intended to replace consumption of unprocessed whole foods, lead to more overall energy intake, more added sugar in the diet, and less fiber and protein intake, he said.
To further support his arguments, Dr. Monteiro pointed to studies suggesting that it is not just the resulting change in the nutritional intake that is unhealthy, but the UPF manufacturing process itself. When adjusting for fat, sugar, and sodium intake, for example, health outcomes associated with UPFs remain poor, he explained.
“I’m sorry,” he said in the debate. “If you don’t reduce this, you don’t reduce your obesity, your diabetes prevalence.”
A study presented by Jacqueline Vernarelli, PhD, during a different session at the meeting suggested there may be other downsides to consuming UPFs. This research, which was based on the U.S. National Youth Fitness Survey, found that poorer locomotor skills among children aged 3-5 and poorer cardiovascular fitness among those aged 12-15 were associated with getting more calories from UPFs.
Those with lower cardiovascular fitness consumed 1,234 calories a day from UPFs, and those with higher cardiovascular fitness consumed 1,007 calories a day from UPFs (P = .002), according to the new research.
“It’s notable here that, although these differences are significant, both groups are consuming a pretty high proportion of their diet from ultra-processed foods,” said Dr. Vernarelli, associate professor of public health at Sacred Heart University, Fairfield, Conn., during her presentation.
In the debate session, Arne Astrup, MD, PhD, senior project director at the Healthy Weight Center at the Novo Nordisk Foundation, Hellerup, Denmark, presented an opposing view.
He said the definition of UPFs makes it too difficult to categorize many foods, pointing to a study from this year in which about 150 nutrition experts, doctors, and dietitians classified 120 foods. Only three marketed foods and one generic food were classified the same by all the evaluators.
Referring to the study Dr. Astrup cited, Dr. Monteiro said it was a mere “exercise,” and the experts involved in it had conflicts of interest.
Dr. Astrup touted this study’s size and its appearance in the peer-reviewed journal the European Journal of Clinical Nutrition.
Defending his point of view, Dr. Astrup said, “The definition and classification is so ambiguous, and the risk of misclassification is so extremely high, I think we really miss the basic requirement of science, namely that we know what we are talking about,” he said.
If you take an unprocessed food, and insert a “little additive … suddenly it’s an ultra-processed food,” he added.
UPF definition doesn’t flag some unhealthy foods
Susan Roberts, PhD, professor of nutrition at Tufts University, Boston, was a discussant at the debate and touched on the merits of both sides. She noted that the UPF definition doesn’t flag some “clearly unhealthy foods,” such as table sugar, but does flag some healthy ones, such as plant-based burgers – to which Dr. Monteiro said that the system was not a system meant to divide foods into healthy and unhealthy groups, during the debate session.
The inclusion of both healthy and unhealthy foods in NOVA’s definition of a UPF is a serious problem, Dr. Roberts said.
“It’s almost like it’s an emotional classification designed to get at the food industry rather than focusing on health – and I think that’s asking for trouble because it’s just going to be such a mess to tell consumers, ‘Well, this ultra-processed food is healthy and this one isn’t,’ ” she said. What’s happening is the term ultra-processed is being used interchangeably with unhealthy.
The discussion that the UPF classification has generated is useful, Dr. Roberts continued. “This definition grew out of that recognition that we’re engaged in an unprecedented experiment of how unhealthy can you make the world without having a major catastrophe.”
She added that the UPF concept deserves a more formalized and rigorous evaluation.
“This is an important topic for the future of public health, and I think it needs big committees to address it seriously,” she said. “I think we should not be dealing with this individually in different labs.”
Doctor’s take on usefulness of discussing UPF concept with patients
Mark Corkins, MD, who did not participate in the debate at the meeting, said he talks to parents and children about nutrition at every office visit in which he sees a child with an unhealthy weight.
“Persistence wears down resistance,” said the chair of the American Academy of Pediatrics nutrition committee, in an interview.“A consistent message – you say the same thing and you say it multiple times.”
The idea of “ultra-processed foods” plays a role in those conversations, but largely in the background. It’s a topic that’s important for pediatric health, Dr. Corkins said – but he doesn’t make it the focal point.
“It’s not a direct attack on ultra-processed foods that usually I take as my direction,” said Dr. Corkins, who is also chief of pediatric gastroenterology at Le Bonheur Children’s Hospital in Memphis, Tenn.. “What I try to focus on, and what I think the American Academy of Pediatrics would focus on, is that we need to focus on making the diet better.”
He added, “Parents are aware – they don’t call it ultra-processed food, they call it junk food.”
Dr. Corkins continued that he is reluctant to directly challenge parents on feeding their children unhealthy foods – ultra-processed or not – lest he shame them and harm the relationship.
“Guilt as a motivator isn’t really highly successful,” he said, in an interview.
Dr. Astrup reported advisory committee or board member involvement with Green Leaf Medical and RNPC, France. Dr. Roberts reported advisory committee or board member involvement with Danone, and an ownership interest in Instinct Health Science. Dr. Monteiro and Dr. Corkins reported no relevant disclosures.
FROM NUTRITION 2022
Ready to make a difference, dermatologist takes the helm as AMA president
Jack S. Resneck Jr., MD, is not usually the loudest voice in the room, but when he speaks, his words carry a heft and an appeal that is straightforward and undeniable.
That was on full display as.
He did not mince words when it came to describing the current landscape. “I doubt you imagined a divided country such as this, where physicians and public health officials often face antiscience aggression and threats of violence simply for doing our jobs,” he said. “You probably didn’t plan on insurers questioning every prescription and every procedure you asked for. Or government criminalizing routine and vital health care, enshrining discrimination against our LGBTQ patients or attacking a woman’s right to control health care decisions that should only be between her and her doctor,” said Dr. Resneck.
But, he added, all was not lost. “While it would be easy to get overwhelmed by despair as I begin this new role, I’ve never been prouder of my physician colleagues,” he said.
Dr. Resneck is the first dermatologist to lead the 175-year-old organization since 1925. Colleagues in the field speak of pride in having one of their own at the top, and they are even more complimentary about his depth of health policy knowledge, his communications skills, and his ability to find common ground.
“He loves looking at both sides,” said Marta J. Van Beek, MD, clinical professor of dermatology at the University of Iowa, Iowa City. “That’s how he builds consensus,” said Dr. Van Beek, who has known Dr. Resneck for more than 20 years, since they were chief dermatology residents – she at Iowa and he at UCSF.
Dr. Van Beek and Dr. Resneck have a deep interest in health policy and have long worked side by side on committees at both the American Academy of Dermatology (AAD) and the AMA. She looks back to the lead-up period before the 2010 passage of the Affordable Care Act as one of Dr. Resneck’s shining moments. “Those were contentious times in medicine,” Dr. Van Beek told this news organization. Dr. Resneck, as chair of the AAD’s Council on Government Affairs and Health Policy from 2008 to 2012, rallied the board to agree on a set of health care reform principles, she noted.
Dr. Resneck is “really very unifying,” agreed Bruce A. Brod, MD, clinical professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Brod has worked with Dr. Resneck for 2 decades on various committees at the AAD. They’ve also known each other through the AMA House of Delegates.
Now Dr. Brod is following in Dr. Resneck’s footsteps as chair of the AAD’s Council on Government Affairs and Health Policy. “Big shoes to fill there,” said Dr. Brod. He said he’s been inspired by Dr. Resneck’s always-positive approach, punctuated by his ever-constant belief that “there’s a lot more common ground than meets the eye here.”
“I really think he’s the perfect leader at this time,” he said.
Outgoing AMA President Gerald E. Harmon, MD, said that Dr. Resneck’s long experience as a teacher and a mentor, and what he describes as a “good, active listening talent,” have been integral to his success as a leader. He expects those qualities to make Dr. Resneck an effective advocate for all of medicine. “He identifies the problem, he identifies the gap, and then he establishes a workable, executable plan to close that gap,” Dr. Harmon told this news organization, adding that he’s seen this at work in AMA board meetings.
“He was a good teacher for me,” said Dr. Harmon, who had known Dr. Resneck through the House of Delegates and various AMA councils for at least a decade before they both joined the AMA board. “He can be such a mentor to all age groups, including senior physicians like myself,” said Dr. Harmon.
Dr. Resneck is excited, but also measured. “This has been a tumultuous couple of years in the country with the pandemic and with the fractured politics,” he said in an interview. Thinking about taking on the AMA presidency, he said, “I’ve had some moments of trepidation. I wanted to be sure that I was going to be able to make a difference.”
Long interest in health policy
Growing up in Shreveport, La., as the son of a dermatologist, Dr. Resneck said, “at first, I swore I was going to do something other than medicine.” It was not out of rebellion. He got along fine with his father. He wanted to pursue his own journey.
Dr. Resneck began his long love affair with health policy at Brown University, graduating magna cum laude with honors in public policy. A 1991 U.S. Department of Health & Human Services internship between his junior and senior years helped inform his honors thesis on health care financing policy.
Ultimately, Dr. Resneck did not stray far from his father’s career path. While still at Brown, he decided to go to medical school, entering UCSF in the fall of 1993. “At the end of the day, there was this undeniable influence that he loved his job,” Dr. Resneck said in the interview. His father was energized by the work and helping patients. “If burnout was in his vocabulary, I never heard it,” said Dr. Resneck.
Initially, he did a 1-year internal medicine residency at UCSF, but then switched to dermatology and became chief resident in 2000.
He was quickly pegged as a leader and an inspirational speaker. The AAD gave him its Young Physician Leadership Development Award in 2001, and the AMA gave Dr. Resneck its Excellence in Medicine National Award for Young Physician Leadership in 2004. He began giving talks at national meetings in 2002 and has been busy ever since, addressing the AMA, the AAD, state medical and dermatology societies, subspecialty groups such as the American College of Mohs Surgery and the Association of Professors of Dermatology, and other organizations such as the American Telemedicine Association.
He’s a sought-after speaker in part because of his ability to simply communicate health policy, said Dr. Brod. “He can connect the real-world issues really well to the policy needs and communicate it very well, and come in at just the right level,” he said.
Dr. Resneck has been immersed in policy and practice issues since the start of his career, serving on AAD and AMA committees addressing quality measures, data collection, access to care, workforce issues, and telemedicine. He started writing about dermatology workforce challenges in 2001 and has revisited that topic with regularity.
He has published often on the difficulties of patient access, looking at wait times for appointments, among other issues. In 2018, he expressed concern in a commentary in JAMA Dermatology that private equity purchases of dermatology practices might lead to an improper focus on profits over patients and that it could reduce the diversity of practice models.
At heart, Dr. Resneck is an institutionalist, someone who believes that the “collaborative, collective voice can make change,” said Dr. Brod. Dr. Resneck said as much in his inaugural speech. “I believe those who show up can use levers of power to confront our system’s flaws,” he said. “This is the nerdy policy part of my life, which my friends will force me to admit is most of my life,” said Dr. Resneck.
Prior authorization, telemedicine, equity
Beneath the reserved exterior lies an intense yearning to act on his passions, both at work and at play.
Dr. Resneck notes almost in passing that he likes to ski when he’s not practicing medicine or serving on a committee. Dr. Van Beek – whose family has vacationed with Dr. Resneck, his wife, Ellen Hufbauer, MD, a family medicine physician in Concord, Calif., and their two teenaged children Zachary and Amelia – said he’s “a very good skier.”
She noted that he and his children share the same enthusiasm for researching every aspect of wherever they travel, including the best places to eat. “He embraces work and life with an incredible amount of intellectual curiosity,” Dr. Van Beek said.
That curiosity – and the passion to make a difference – has driven his deep dives into what he sees as the corrosive practice of prior authorization and the promise of telemedicine, which he has explained and supported in testimony on Capitol Hill.
Dr. Brod said that Dr. Resneck was among those who helped convince the federal government to expand coverage for telemedicine during the COVID-19 pandemic. “He brought together his patient experience in dermatology and his policy experience,” and was able to deftly explain how it could increase access during the shutdown, said Dr. Brod.
Prior authorization gets him fired up. “We’ve reached a point where there’s almost not anything I will write a prescription for that doesn’t oftentimes require all of these hoops that we have to jump through,” he told this news organization. Prescriptions for generic topical cortisones that have been around for 50 years “now all of the sudden require a week of arguing,” said Dr. Resneck. In the meantime, patients aren’t getting treatment, he said.
Dr. Resneck’s passion for health equity is borne in part out of the racism witnessed by him and his family, including an uncle who started an antisegregationist newspaper and was kicked out of medical school for his views in the 1950s. Dr. Resneck said he had a rudimentary understanding of racism as a youngster. But he told the AMA delegates, “I knew enough at age 16 to write an op-ed in our city’s newspaper about the need to remove Confederate monuments from our courthouse lawn.” Added Dr. Resneck, “You can imagine how that went over in 1987.”
The pandemic shined a bright light on inequities and heightened awareness of “the institutionalized systems that have perpetuated racism and gender discrimination in medicine for as far back as we want to look,” Dr. Resneck said during his inaugural speech. Pointedly, he told his colleagues that “the AMA has not always been on the right side of history,” adding, “Each of us must do our part to eliminate health inequities by engaging in antiracist and antisexist work.”
That kind of talk is signature Resneck, said Dr. Brod. “He’s not afraid to exhibit very brave leadership,” especially “when there are issues that jeopardize the needs of patient access or patient safety,” he said.
“He’ll be a tremendous AMA president,” said Dr. Van Beek. “He’s present, he’s devoted, and he’s typically the expert in the room.”
Dr. Harmon said that Dr. Resneck is “cut from the same cloth that I am. He believes that if you get an opportunity to make things better, you take it.”
His advice to Dr. Resneck: “Rarely turn an opportunity down.” Dr. Harmon has little doubt that Dr. Resneck is up to the job but said, “I’m going to encourage him to keep that energy and enthusiasm up.”
Dr. Resneck told physician colleagues not to worry: “I will keep relentlessly showing up.”
A version of this article first appeared on Medscape.com.
Jack S. Resneck Jr., MD, is not usually the loudest voice in the room, but when he speaks, his words carry a heft and an appeal that is straightforward and undeniable.
That was on full display as.
He did not mince words when it came to describing the current landscape. “I doubt you imagined a divided country such as this, where physicians and public health officials often face antiscience aggression and threats of violence simply for doing our jobs,” he said. “You probably didn’t plan on insurers questioning every prescription and every procedure you asked for. Or government criminalizing routine and vital health care, enshrining discrimination against our LGBTQ patients or attacking a woman’s right to control health care decisions that should only be between her and her doctor,” said Dr. Resneck.
But, he added, all was not lost. “While it would be easy to get overwhelmed by despair as I begin this new role, I’ve never been prouder of my physician colleagues,” he said.
Dr. Resneck is the first dermatologist to lead the 175-year-old organization since 1925. Colleagues in the field speak of pride in having one of their own at the top, and they are even more complimentary about his depth of health policy knowledge, his communications skills, and his ability to find common ground.
“He loves looking at both sides,” said Marta J. Van Beek, MD, clinical professor of dermatology at the University of Iowa, Iowa City. “That’s how he builds consensus,” said Dr. Van Beek, who has known Dr. Resneck for more than 20 years, since they were chief dermatology residents – she at Iowa and he at UCSF.
Dr. Van Beek and Dr. Resneck have a deep interest in health policy and have long worked side by side on committees at both the American Academy of Dermatology (AAD) and the AMA. She looks back to the lead-up period before the 2010 passage of the Affordable Care Act as one of Dr. Resneck’s shining moments. “Those were contentious times in medicine,” Dr. Van Beek told this news organization. Dr. Resneck, as chair of the AAD’s Council on Government Affairs and Health Policy from 2008 to 2012, rallied the board to agree on a set of health care reform principles, she noted.
Dr. Resneck is “really very unifying,” agreed Bruce A. Brod, MD, clinical professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Brod has worked with Dr. Resneck for 2 decades on various committees at the AAD. They’ve also known each other through the AMA House of Delegates.
Now Dr. Brod is following in Dr. Resneck’s footsteps as chair of the AAD’s Council on Government Affairs and Health Policy. “Big shoes to fill there,” said Dr. Brod. He said he’s been inspired by Dr. Resneck’s always-positive approach, punctuated by his ever-constant belief that “there’s a lot more common ground than meets the eye here.”
“I really think he’s the perfect leader at this time,” he said.
Outgoing AMA President Gerald E. Harmon, MD, said that Dr. Resneck’s long experience as a teacher and a mentor, and what he describes as a “good, active listening talent,” have been integral to his success as a leader. He expects those qualities to make Dr. Resneck an effective advocate for all of medicine. “He identifies the problem, he identifies the gap, and then he establishes a workable, executable plan to close that gap,” Dr. Harmon told this news organization, adding that he’s seen this at work in AMA board meetings.
“He was a good teacher for me,” said Dr. Harmon, who had known Dr. Resneck through the House of Delegates and various AMA councils for at least a decade before they both joined the AMA board. “He can be such a mentor to all age groups, including senior physicians like myself,” said Dr. Harmon.
Dr. Resneck is excited, but also measured. “This has been a tumultuous couple of years in the country with the pandemic and with the fractured politics,” he said in an interview. Thinking about taking on the AMA presidency, he said, “I’ve had some moments of trepidation. I wanted to be sure that I was going to be able to make a difference.”
Long interest in health policy
Growing up in Shreveport, La., as the son of a dermatologist, Dr. Resneck said, “at first, I swore I was going to do something other than medicine.” It was not out of rebellion. He got along fine with his father. He wanted to pursue his own journey.
Dr. Resneck began his long love affair with health policy at Brown University, graduating magna cum laude with honors in public policy. A 1991 U.S. Department of Health & Human Services internship between his junior and senior years helped inform his honors thesis on health care financing policy.
Ultimately, Dr. Resneck did not stray far from his father’s career path. While still at Brown, he decided to go to medical school, entering UCSF in the fall of 1993. “At the end of the day, there was this undeniable influence that he loved his job,” Dr. Resneck said in the interview. His father was energized by the work and helping patients. “If burnout was in his vocabulary, I never heard it,” said Dr. Resneck.
Initially, he did a 1-year internal medicine residency at UCSF, but then switched to dermatology and became chief resident in 2000.
He was quickly pegged as a leader and an inspirational speaker. The AAD gave him its Young Physician Leadership Development Award in 2001, and the AMA gave Dr. Resneck its Excellence in Medicine National Award for Young Physician Leadership in 2004. He began giving talks at national meetings in 2002 and has been busy ever since, addressing the AMA, the AAD, state medical and dermatology societies, subspecialty groups such as the American College of Mohs Surgery and the Association of Professors of Dermatology, and other organizations such as the American Telemedicine Association.
He’s a sought-after speaker in part because of his ability to simply communicate health policy, said Dr. Brod. “He can connect the real-world issues really well to the policy needs and communicate it very well, and come in at just the right level,” he said.
Dr. Resneck has been immersed in policy and practice issues since the start of his career, serving on AAD and AMA committees addressing quality measures, data collection, access to care, workforce issues, and telemedicine. He started writing about dermatology workforce challenges in 2001 and has revisited that topic with regularity.
He has published often on the difficulties of patient access, looking at wait times for appointments, among other issues. In 2018, he expressed concern in a commentary in JAMA Dermatology that private equity purchases of dermatology practices might lead to an improper focus on profits over patients and that it could reduce the diversity of practice models.
At heart, Dr. Resneck is an institutionalist, someone who believes that the “collaborative, collective voice can make change,” said Dr. Brod. Dr. Resneck said as much in his inaugural speech. “I believe those who show up can use levers of power to confront our system’s flaws,” he said. “This is the nerdy policy part of my life, which my friends will force me to admit is most of my life,” said Dr. Resneck.
Prior authorization, telemedicine, equity
Beneath the reserved exterior lies an intense yearning to act on his passions, both at work and at play.
Dr. Resneck notes almost in passing that he likes to ski when he’s not practicing medicine or serving on a committee. Dr. Van Beek – whose family has vacationed with Dr. Resneck, his wife, Ellen Hufbauer, MD, a family medicine physician in Concord, Calif., and their two teenaged children Zachary and Amelia – said he’s “a very good skier.”
She noted that he and his children share the same enthusiasm for researching every aspect of wherever they travel, including the best places to eat. “He embraces work and life with an incredible amount of intellectual curiosity,” Dr. Van Beek said.
That curiosity – and the passion to make a difference – has driven his deep dives into what he sees as the corrosive practice of prior authorization and the promise of telemedicine, which he has explained and supported in testimony on Capitol Hill.
Dr. Brod said that Dr. Resneck was among those who helped convince the federal government to expand coverage for telemedicine during the COVID-19 pandemic. “He brought together his patient experience in dermatology and his policy experience,” and was able to deftly explain how it could increase access during the shutdown, said Dr. Brod.
Prior authorization gets him fired up. “We’ve reached a point where there’s almost not anything I will write a prescription for that doesn’t oftentimes require all of these hoops that we have to jump through,” he told this news organization. Prescriptions for generic topical cortisones that have been around for 50 years “now all of the sudden require a week of arguing,” said Dr. Resneck. In the meantime, patients aren’t getting treatment, he said.
Dr. Resneck’s passion for health equity is borne in part out of the racism witnessed by him and his family, including an uncle who started an antisegregationist newspaper and was kicked out of medical school for his views in the 1950s. Dr. Resneck said he had a rudimentary understanding of racism as a youngster. But he told the AMA delegates, “I knew enough at age 16 to write an op-ed in our city’s newspaper about the need to remove Confederate monuments from our courthouse lawn.” Added Dr. Resneck, “You can imagine how that went over in 1987.”
The pandemic shined a bright light on inequities and heightened awareness of “the institutionalized systems that have perpetuated racism and gender discrimination in medicine for as far back as we want to look,” Dr. Resneck said during his inaugural speech. Pointedly, he told his colleagues that “the AMA has not always been on the right side of history,” adding, “Each of us must do our part to eliminate health inequities by engaging in antiracist and antisexist work.”
That kind of talk is signature Resneck, said Dr. Brod. “He’s not afraid to exhibit very brave leadership,” especially “when there are issues that jeopardize the needs of patient access or patient safety,” he said.
“He’ll be a tremendous AMA president,” said Dr. Van Beek. “He’s present, he’s devoted, and he’s typically the expert in the room.”
Dr. Harmon said that Dr. Resneck is “cut from the same cloth that I am. He believes that if you get an opportunity to make things better, you take it.”
His advice to Dr. Resneck: “Rarely turn an opportunity down.” Dr. Harmon has little doubt that Dr. Resneck is up to the job but said, “I’m going to encourage him to keep that energy and enthusiasm up.”
Dr. Resneck told physician colleagues not to worry: “I will keep relentlessly showing up.”
A version of this article first appeared on Medscape.com.
Jack S. Resneck Jr., MD, is not usually the loudest voice in the room, but when he speaks, his words carry a heft and an appeal that is straightforward and undeniable.
That was on full display as.
He did not mince words when it came to describing the current landscape. “I doubt you imagined a divided country such as this, where physicians and public health officials often face antiscience aggression and threats of violence simply for doing our jobs,” he said. “You probably didn’t plan on insurers questioning every prescription and every procedure you asked for. Or government criminalizing routine and vital health care, enshrining discrimination against our LGBTQ patients or attacking a woman’s right to control health care decisions that should only be between her and her doctor,” said Dr. Resneck.
But, he added, all was not lost. “While it would be easy to get overwhelmed by despair as I begin this new role, I’ve never been prouder of my physician colleagues,” he said.
Dr. Resneck is the first dermatologist to lead the 175-year-old organization since 1925. Colleagues in the field speak of pride in having one of their own at the top, and they are even more complimentary about his depth of health policy knowledge, his communications skills, and his ability to find common ground.
“He loves looking at both sides,” said Marta J. Van Beek, MD, clinical professor of dermatology at the University of Iowa, Iowa City. “That’s how he builds consensus,” said Dr. Van Beek, who has known Dr. Resneck for more than 20 years, since they were chief dermatology residents – she at Iowa and he at UCSF.
Dr. Van Beek and Dr. Resneck have a deep interest in health policy and have long worked side by side on committees at both the American Academy of Dermatology (AAD) and the AMA. She looks back to the lead-up period before the 2010 passage of the Affordable Care Act as one of Dr. Resneck’s shining moments. “Those were contentious times in medicine,” Dr. Van Beek told this news organization. Dr. Resneck, as chair of the AAD’s Council on Government Affairs and Health Policy from 2008 to 2012, rallied the board to agree on a set of health care reform principles, she noted.
Dr. Resneck is “really very unifying,” agreed Bruce A. Brod, MD, clinical professor of dermatology at the University of Pennsylvania, Philadelphia. Dr. Brod has worked with Dr. Resneck for 2 decades on various committees at the AAD. They’ve also known each other through the AMA House of Delegates.
Now Dr. Brod is following in Dr. Resneck’s footsteps as chair of the AAD’s Council on Government Affairs and Health Policy. “Big shoes to fill there,” said Dr. Brod. He said he’s been inspired by Dr. Resneck’s always-positive approach, punctuated by his ever-constant belief that “there’s a lot more common ground than meets the eye here.”
“I really think he’s the perfect leader at this time,” he said.
Outgoing AMA President Gerald E. Harmon, MD, said that Dr. Resneck’s long experience as a teacher and a mentor, and what he describes as a “good, active listening talent,” have been integral to his success as a leader. He expects those qualities to make Dr. Resneck an effective advocate for all of medicine. “He identifies the problem, he identifies the gap, and then he establishes a workable, executable plan to close that gap,” Dr. Harmon told this news organization, adding that he’s seen this at work in AMA board meetings.
“He was a good teacher for me,” said Dr. Harmon, who had known Dr. Resneck through the House of Delegates and various AMA councils for at least a decade before they both joined the AMA board. “He can be such a mentor to all age groups, including senior physicians like myself,” said Dr. Harmon.
Dr. Resneck is excited, but also measured. “This has been a tumultuous couple of years in the country with the pandemic and with the fractured politics,” he said in an interview. Thinking about taking on the AMA presidency, he said, “I’ve had some moments of trepidation. I wanted to be sure that I was going to be able to make a difference.”
Long interest in health policy
Growing up in Shreveport, La., as the son of a dermatologist, Dr. Resneck said, “at first, I swore I was going to do something other than medicine.” It was not out of rebellion. He got along fine with his father. He wanted to pursue his own journey.
Dr. Resneck began his long love affair with health policy at Brown University, graduating magna cum laude with honors in public policy. A 1991 U.S. Department of Health & Human Services internship between his junior and senior years helped inform his honors thesis on health care financing policy.
Ultimately, Dr. Resneck did not stray far from his father’s career path. While still at Brown, he decided to go to medical school, entering UCSF in the fall of 1993. “At the end of the day, there was this undeniable influence that he loved his job,” Dr. Resneck said in the interview. His father was energized by the work and helping patients. “If burnout was in his vocabulary, I never heard it,” said Dr. Resneck.
Initially, he did a 1-year internal medicine residency at UCSF, but then switched to dermatology and became chief resident in 2000.
He was quickly pegged as a leader and an inspirational speaker. The AAD gave him its Young Physician Leadership Development Award in 2001, and the AMA gave Dr. Resneck its Excellence in Medicine National Award for Young Physician Leadership in 2004. He began giving talks at national meetings in 2002 and has been busy ever since, addressing the AMA, the AAD, state medical and dermatology societies, subspecialty groups such as the American College of Mohs Surgery and the Association of Professors of Dermatology, and other organizations such as the American Telemedicine Association.
He’s a sought-after speaker in part because of his ability to simply communicate health policy, said Dr. Brod. “He can connect the real-world issues really well to the policy needs and communicate it very well, and come in at just the right level,” he said.
Dr. Resneck has been immersed in policy and practice issues since the start of his career, serving on AAD and AMA committees addressing quality measures, data collection, access to care, workforce issues, and telemedicine. He started writing about dermatology workforce challenges in 2001 and has revisited that topic with regularity.
He has published often on the difficulties of patient access, looking at wait times for appointments, among other issues. In 2018, he expressed concern in a commentary in JAMA Dermatology that private equity purchases of dermatology practices might lead to an improper focus on profits over patients and that it could reduce the diversity of practice models.
At heart, Dr. Resneck is an institutionalist, someone who believes that the “collaborative, collective voice can make change,” said Dr. Brod. Dr. Resneck said as much in his inaugural speech. “I believe those who show up can use levers of power to confront our system’s flaws,” he said. “This is the nerdy policy part of my life, which my friends will force me to admit is most of my life,” said Dr. Resneck.
Prior authorization, telemedicine, equity
Beneath the reserved exterior lies an intense yearning to act on his passions, both at work and at play.
Dr. Resneck notes almost in passing that he likes to ski when he’s not practicing medicine or serving on a committee. Dr. Van Beek – whose family has vacationed with Dr. Resneck, his wife, Ellen Hufbauer, MD, a family medicine physician in Concord, Calif., and their two teenaged children Zachary and Amelia – said he’s “a very good skier.”
She noted that he and his children share the same enthusiasm for researching every aspect of wherever they travel, including the best places to eat. “He embraces work and life with an incredible amount of intellectual curiosity,” Dr. Van Beek said.
That curiosity – and the passion to make a difference – has driven his deep dives into what he sees as the corrosive practice of prior authorization and the promise of telemedicine, which he has explained and supported in testimony on Capitol Hill.
Dr. Brod said that Dr. Resneck was among those who helped convince the federal government to expand coverage for telemedicine during the COVID-19 pandemic. “He brought together his patient experience in dermatology and his policy experience,” and was able to deftly explain how it could increase access during the shutdown, said Dr. Brod.
Prior authorization gets him fired up. “We’ve reached a point where there’s almost not anything I will write a prescription for that doesn’t oftentimes require all of these hoops that we have to jump through,” he told this news organization. Prescriptions for generic topical cortisones that have been around for 50 years “now all of the sudden require a week of arguing,” said Dr. Resneck. In the meantime, patients aren’t getting treatment, he said.
Dr. Resneck’s passion for health equity is borne in part out of the racism witnessed by him and his family, including an uncle who started an antisegregationist newspaper and was kicked out of medical school for his views in the 1950s. Dr. Resneck said he had a rudimentary understanding of racism as a youngster. But he told the AMA delegates, “I knew enough at age 16 to write an op-ed in our city’s newspaper about the need to remove Confederate monuments from our courthouse lawn.” Added Dr. Resneck, “You can imagine how that went over in 1987.”
The pandemic shined a bright light on inequities and heightened awareness of “the institutionalized systems that have perpetuated racism and gender discrimination in medicine for as far back as we want to look,” Dr. Resneck said during his inaugural speech. Pointedly, he told his colleagues that “the AMA has not always been on the right side of history,” adding, “Each of us must do our part to eliminate health inequities by engaging in antiracist and antisexist work.”
That kind of talk is signature Resneck, said Dr. Brod. “He’s not afraid to exhibit very brave leadership,” especially “when there are issues that jeopardize the needs of patient access or patient safety,” he said.
“He’ll be a tremendous AMA president,” said Dr. Van Beek. “He’s present, he’s devoted, and he’s typically the expert in the room.”
Dr. Harmon said that Dr. Resneck is “cut from the same cloth that I am. He believes that if you get an opportunity to make things better, you take it.”
His advice to Dr. Resneck: “Rarely turn an opportunity down.” Dr. Harmon has little doubt that Dr. Resneck is up to the job but said, “I’m going to encourage him to keep that energy and enthusiasm up.”
Dr. Resneck told physician colleagues not to worry: “I will keep relentlessly showing up.”
A version of this article first appeared on Medscape.com.
Doc’s misdiagnosis causes former firefighter to lose leg from flesh-eating bacterial infection
, as a story in the Pensacola News Journal indicates.
In September 2016, the former firefighter visited a hospital-affiliated urgent care center after he developed an ache and a blue discoloration in his right leg. Prior to this, the story says, he had been “exposed to the waters of Pensacola Bay,” which might have caused the infection.
At the urgent care center, he was examined by a primary care physician, who diagnosed him with an ankle sprain. Instructed to ice and elevate his leg, the former firefighter was given crutches and sent home.
The following day, still in pain, he visited a local podiatrist, who “immediately suspected ... [the patient] was suffering from an ongoing aggressive bacterial infection.” The podiatrist then arranged for the patient to be seen at a nearby hospital emergency department. There, doctors diagnosed a “necrotizing bacterial infection that need[ed] to be aggressively treated with antibodies and the removal of dead tissue.”
But despite their best efforts to control the infection and remove the necrotized tissue, the doctors eventually had to amputate the patient’s right leg above the knee.
The former firefighter and his wife then sued the primary care physician and the hospital where the physician worked.
After an 8-day civil trial, the jury awarded the plaintiff and his wife $6,805,071 and $787,371, respectively.
“What happened to [my clients] should never have happened,” said the attorney representing the plaintiffs.
The hospital declined to comment to the Pensacola News Journal about the case.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
, as a story in the Pensacola News Journal indicates.
In September 2016, the former firefighter visited a hospital-affiliated urgent care center after he developed an ache and a blue discoloration in his right leg. Prior to this, the story says, he had been “exposed to the waters of Pensacola Bay,” which might have caused the infection.
At the urgent care center, he was examined by a primary care physician, who diagnosed him with an ankle sprain. Instructed to ice and elevate his leg, the former firefighter was given crutches and sent home.
The following day, still in pain, he visited a local podiatrist, who “immediately suspected ... [the patient] was suffering from an ongoing aggressive bacterial infection.” The podiatrist then arranged for the patient to be seen at a nearby hospital emergency department. There, doctors diagnosed a “necrotizing bacterial infection that need[ed] to be aggressively treated with antibodies and the removal of dead tissue.”
But despite their best efforts to control the infection and remove the necrotized tissue, the doctors eventually had to amputate the patient’s right leg above the knee.
The former firefighter and his wife then sued the primary care physician and the hospital where the physician worked.
After an 8-day civil trial, the jury awarded the plaintiff and his wife $6,805,071 and $787,371, respectively.
“What happened to [my clients] should never have happened,” said the attorney representing the plaintiffs.
The hospital declined to comment to the Pensacola News Journal about the case.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
, as a story in the Pensacola News Journal indicates.
In September 2016, the former firefighter visited a hospital-affiliated urgent care center after he developed an ache and a blue discoloration in his right leg. Prior to this, the story says, he had been “exposed to the waters of Pensacola Bay,” which might have caused the infection.
At the urgent care center, he was examined by a primary care physician, who diagnosed him with an ankle sprain. Instructed to ice and elevate his leg, the former firefighter was given crutches and sent home.
The following day, still in pain, he visited a local podiatrist, who “immediately suspected ... [the patient] was suffering from an ongoing aggressive bacterial infection.” The podiatrist then arranged for the patient to be seen at a nearby hospital emergency department. There, doctors diagnosed a “necrotizing bacterial infection that need[ed] to be aggressively treated with antibodies and the removal of dead tissue.”
But despite their best efforts to control the infection and remove the necrotized tissue, the doctors eventually had to amputate the patient’s right leg above the knee.
The former firefighter and his wife then sued the primary care physician and the hospital where the physician worked.
After an 8-day civil trial, the jury awarded the plaintiff and his wife $6,805,071 and $787,371, respectively.
“What happened to [my clients] should never have happened,” said the attorney representing the plaintiffs.
The hospital declined to comment to the Pensacola News Journal about the case.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
FDA authorizes COVID vaccines in kids as young as 6 months
, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.
The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.
“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.
The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.
The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.
Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.
If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.
Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.
A version of this article first appeared on WebMD.com.
, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.
The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.
“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.
The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.
The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.
Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.
If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.
Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.
A version of this article first appeared on WebMD.com.
, one of the final steps in a long-awaited authorization process to extend protection to the youngest of Americans.
The agency’s move comes after a closely watched FDA advisory group vote earlier this week, which resulted in a unanimous vote in favor of the FDA authorizing both vaccines in this age group.
“The FDA’s evaluation and analysis of the safety, effectiveness, and manufacturing data of these vaccines was rigorous and comprehensive, supporting the EUAs,” the agency said in a news release.
The data show that the “known and potential benefits” of the vaccines outweigh any potential risks, the agency said.
The Moderna vaccine is authorized as a two-dose primary series in children 6 months to 17 years of age. The Pfizer vaccine is now authorized as a three-dose primary series in children 6 months up to 4 years of age. Pfizer’s vaccine was already authorized in children 5 years old and older.
Now all eyes are on the Centers for Disease Control and Prevention, which is expected to decide on the final regulatory hurdle at a meeting June 18. The CDC’s Advisory Committee on Immunization Practices has scheduled a vote on whether to give the vaccines the green light.
If ACIP gives the OK, CDC Director Rochelle Walensky, MD, MPH, is expected to issue recommendations for use shortly thereafter.
Following these final regulatory steps, parents could start bringing their children to pediatricians, family doctors, or local pharmacies for vaccination as early as June 20.
A version of this article first appeared on WebMD.com.
Anti-vaccine physician sentenced to prison for role in Capitol riot
Simone Gold, MD, JD, a leader in the anti-vaccine movement and founder of noted anti-vaccine group America’s Frontline Doctors, has been sentenced to 2 months in prison for her role in the storming of the U.S. Capitol on January 6, 2021.
In March, As a part of the plea agreement, additional charges of obstructing an official proceeding and intent to disrupt the orderly conduct of government business were dropped. Although she insisted at the time that her actions were peaceful, Dr. Gold did admit, according to news reports, that she witnessed the assault of a police officer while inside the building.
America’s Frontline Doctors is an organization noted for spreading misinformation about COVID-19 and promoting unproven and potentially dangerous drugs, including ivermectin, for treating the illness. The group issued a statement saying that while Dr. Gold did express regret for “being involved in a situation that later became unpredictable,” her sentence is an example of “selective prosecution.”
“Dr. Gold remains committed to her advocacy for physicians’ free speech,” the statement noted, adding that Dr. Gold has been targeted by attacks attempting to “cancel” her since July 2020, when the California Medical Board threatened to revoke her license for what the statement calls an “unfounded claim” that she was sharing dangerous disinformation.
According to Associated Press reporting, U.S. District Judge Christopher Cooper did not consider Dr. Gold’s anti-vaccine activity when determining the sentence. However, Judge Cooper did say that Dr. Gold was not a “casual bystander” on January 6 and criticized the organization for misleading its supporters into believing that her prosecution was a politically motivated violation of her free-speech rights.
Prosecutors accused Dr. Gold of trying to profit from her crime, according to AP reports, noting in a court filing that America’s Frontline Doctors has raised more than $430,000 for her defense. “It beggars belief that [Dr.] Gold could have incurred anywhere near $430,000 in costs for her criminal defense: After all, she pleaded guilty – in the face of indisputable evidence – without filing a single motion.”
In the past, Dr. Gold has worked at Providence St. Joseph Medical Center, Santa Monica, Calif., and Cedars-Sinai, Los Angeles. These institutions have disassociated themselves from her. Her medical license remains active, but she noted on her website that she “voluntarily refused” to renew her board certification last year “due to the unethical behavior of the medical boards.” Dr. Gold is also a licensed attorney, having earned a law degree in health policy analysis at Stanford Law School.
The AP reports that since her arrest, Dr. Gold has moved from California to Florida.
In addition to the prison time, Judge Cooper ordered Dr. Gold to pay a $9,500 fine, and she will be subject to 12 months of supervised release after completing her sentence, according to media reports. At press time, the U.S. Department of Justice has not released an official announcement on the sentencing.
A version of this article first appeared on Medscape.com.
Simone Gold, MD, JD, a leader in the anti-vaccine movement and founder of noted anti-vaccine group America’s Frontline Doctors, has been sentenced to 2 months in prison for her role in the storming of the U.S. Capitol on January 6, 2021.
In March, As a part of the plea agreement, additional charges of obstructing an official proceeding and intent to disrupt the orderly conduct of government business were dropped. Although she insisted at the time that her actions were peaceful, Dr. Gold did admit, according to news reports, that she witnessed the assault of a police officer while inside the building.
America’s Frontline Doctors is an organization noted for spreading misinformation about COVID-19 and promoting unproven and potentially dangerous drugs, including ivermectin, for treating the illness. The group issued a statement saying that while Dr. Gold did express regret for “being involved in a situation that later became unpredictable,” her sentence is an example of “selective prosecution.”
“Dr. Gold remains committed to her advocacy for physicians’ free speech,” the statement noted, adding that Dr. Gold has been targeted by attacks attempting to “cancel” her since July 2020, when the California Medical Board threatened to revoke her license for what the statement calls an “unfounded claim” that she was sharing dangerous disinformation.
According to Associated Press reporting, U.S. District Judge Christopher Cooper did not consider Dr. Gold’s anti-vaccine activity when determining the sentence. However, Judge Cooper did say that Dr. Gold was not a “casual bystander” on January 6 and criticized the organization for misleading its supporters into believing that her prosecution was a politically motivated violation of her free-speech rights.
Prosecutors accused Dr. Gold of trying to profit from her crime, according to AP reports, noting in a court filing that America’s Frontline Doctors has raised more than $430,000 for her defense. “It beggars belief that [Dr.] Gold could have incurred anywhere near $430,000 in costs for her criminal defense: After all, she pleaded guilty – in the face of indisputable evidence – without filing a single motion.”
In the past, Dr. Gold has worked at Providence St. Joseph Medical Center, Santa Monica, Calif., and Cedars-Sinai, Los Angeles. These institutions have disassociated themselves from her. Her medical license remains active, but she noted on her website that she “voluntarily refused” to renew her board certification last year “due to the unethical behavior of the medical boards.” Dr. Gold is also a licensed attorney, having earned a law degree in health policy analysis at Stanford Law School.
The AP reports that since her arrest, Dr. Gold has moved from California to Florida.
In addition to the prison time, Judge Cooper ordered Dr. Gold to pay a $9,500 fine, and she will be subject to 12 months of supervised release after completing her sentence, according to media reports. At press time, the U.S. Department of Justice has not released an official announcement on the sentencing.
A version of this article first appeared on Medscape.com.
Simone Gold, MD, JD, a leader in the anti-vaccine movement and founder of noted anti-vaccine group America’s Frontline Doctors, has been sentenced to 2 months in prison for her role in the storming of the U.S. Capitol on January 6, 2021.
In March, As a part of the plea agreement, additional charges of obstructing an official proceeding and intent to disrupt the orderly conduct of government business were dropped. Although she insisted at the time that her actions were peaceful, Dr. Gold did admit, according to news reports, that she witnessed the assault of a police officer while inside the building.
America’s Frontline Doctors is an organization noted for spreading misinformation about COVID-19 and promoting unproven and potentially dangerous drugs, including ivermectin, for treating the illness. The group issued a statement saying that while Dr. Gold did express regret for “being involved in a situation that later became unpredictable,” her sentence is an example of “selective prosecution.”
“Dr. Gold remains committed to her advocacy for physicians’ free speech,” the statement noted, adding that Dr. Gold has been targeted by attacks attempting to “cancel” her since July 2020, when the California Medical Board threatened to revoke her license for what the statement calls an “unfounded claim” that she was sharing dangerous disinformation.
According to Associated Press reporting, U.S. District Judge Christopher Cooper did not consider Dr. Gold’s anti-vaccine activity when determining the sentence. However, Judge Cooper did say that Dr. Gold was not a “casual bystander” on January 6 and criticized the organization for misleading its supporters into believing that her prosecution was a politically motivated violation of her free-speech rights.
Prosecutors accused Dr. Gold of trying to profit from her crime, according to AP reports, noting in a court filing that America’s Frontline Doctors has raised more than $430,000 for her defense. “It beggars belief that [Dr.] Gold could have incurred anywhere near $430,000 in costs for her criminal defense: After all, she pleaded guilty – in the face of indisputable evidence – without filing a single motion.”
In the past, Dr. Gold has worked at Providence St. Joseph Medical Center, Santa Monica, Calif., and Cedars-Sinai, Los Angeles. These institutions have disassociated themselves from her. Her medical license remains active, but she noted on her website that she “voluntarily refused” to renew her board certification last year “due to the unethical behavior of the medical boards.” Dr. Gold is also a licensed attorney, having earned a law degree in health policy analysis at Stanford Law School.
The AP reports that since her arrest, Dr. Gold has moved from California to Florida.
In addition to the prison time, Judge Cooper ordered Dr. Gold to pay a $9,500 fine, and she will be subject to 12 months of supervised release after completing her sentence, according to media reports. At press time, the U.S. Department of Justice has not released an official announcement on the sentencing.
A version of this article first appeared on Medscape.com.
Rheumatologic Perspective on Persistent Right-Hand Tenosynovitis Secondary to Mycobacterium marinum Infection
Rheumatologic conditions and infections may imitate each other, often making diagnosis challenging. Therefore, it is imperative to obtain adequate histories and have a keen eye for these potentially confounding differential diagnoses. Immunosuppressants used in managing rheumatologic etiologies have detrimental consequences in undiagnosed underlying infections. Consequently, worsening symptoms with standard therapy should raise awareness to a different diagnosis.
Nontuberculous mycobacteria (NTM) are slow-growing organisms difficult to yield in culture. Initial negative synovial fluid stains and cultures when suspecting NTM infectious arthritis or tenosynovitis should not exclude the diagnosis if there is a strong clinical scenario. The identification of Mycobacterium marinum (M marinum) infection in the hand is of utmost importance given that delayed treatment may cause significant and even permanent disability.
We present the case of a 73-year-old male patient with progressively worsening right-hand tenosynovitis who was evaluated for crystal-induced and sarcoid arthropathies in the setting of negative synovial biopsy cultures but was subsequently diagnosed with M marinum infectious tenosynovitis after a second surgical debridement.
Case Presentation
A 73-year-old male patient with history of type 2 diabetes mellitus, hypertension, hyperlipidemia, hypothyroidism, bilateral knee osteoarthritis, obstructive sleep apnea, and posttraumatic stress disorder presented to the emergency department (ED) with right wrist swelling and pain for 4 days. The patient reported that he was working in his garden when symptoms started. He did not recall any skin abrasions or wounds, insect bites, thorn punctures, trauma, or exposure to swimming pools or fish tanks. Patient was afebrile, and vital signs were within normal range. On physical examination, there was erythema, swelling, and tenderness in the dorsum of the right hand and over the dorsal aspect of the fourth metacarpophalangeal joint (Figure 1). The skin was intact.
Symptoms had not responded to 7 days of cefalexin nor to a short course of oral steroids. Leukocytosis of 14.35 × 109/L (reference range, 3.90-9.90 × 109/L) with neutrophilia at 11.10 × 109/L (reference range, 1.73-6.37 × 109/L) was noted. Sedimentation rate and C-reactive protein levels were normal. Right-hand X-ray was remarkable for chondrocalcinosis in the triangular fibrocartilage. Right upper extremity magnetic resonance imaging (MRI) revealed diffuse inflammation in the right wrist and hand (Figure 2). There was no evidence of septic arthritis or osteomyelitis. Consequently, orthopedic service recommended no surgical intervention. Additionally, the patient had preserved range of motion that further indicated tenosynovitis, which could be medically managed with antibiotics, rather than a septic joint.
One dose of IV piperacillin/tazobactam was given at the ED, and he was admitted to the internal medicine ward with right hand and wrist cellulitis and indolent suppurative tenosynovitis. Empiric IV ceftriaxone and vancomycin were started as per infectious disease (ID) service with adequate response defined as a reduction of the swelling, erythema, and tenderness of the right hand and wrist. Differential diagnosis included sporotrichosis, nocardia vs NTM infection.
Interventional radiology was consulted for right wrist drainage. However, only 1 mL of fluid was obtained. Synovial fluid was sent for cell count and differential, crystal analysis, bacterial cultures, fungal cultures, and acid-fast bacilli (AFB) stains and culture. Neutrophils were 43% and lymphocytes were 57%. Crystal analysis was negative. Bacterial culture and mycology were negative. AFB stain and culture results were negative after 6 weeks. Based on gardening history and risk of thorn exposure and low suspicion for common bacterial pathogens, ID service switched antibiotics to moxifloxacin, minocycline, and linezolid for broad coverage to complete 3 weeks as outpatient. The patient reported significantly improved pain and handgrip with notable decrease in swelling. Nonetheless, 3 weeks after completing antibiotics, the right-hand pain recurred, raising concern for complex regional syndrome vs crystalline arthropathy.
The patient was referred to rheumatology service for evaluation of crystal-induced arthropathy given chondrocalcinosis. Physical examination revealed right third proximal interphalangeal joint swelling and tenderness with overimposed tophilike nodule. No erythema or palpable effusions were appreciated. Range of motion was preserved. Laboratory workup showed resolved leukocytosis and neutrophilia, and normal sedimentation rate or C-reactive protein levels. Antinuclear antibody panel, rheumatoid factor, and anti–cyclic citrullinated peptide levels were normal. Serum uric acid levels were 5.9 mg/dL. Chlamydia, gonorrhea, and HIV tests were negative. Short course of low-dose oral prednisone starting at 15 mg daily with tapering by 5 mg every 3 days was given for presumptive calcium pyrophosphate deposition vs gout. Nevertheless, right-hand swelling and pain worsened after steroids. Repeat right upper extremity MRI showed persistent soft tissue edema and inflammation along the dorsum of the hand extending to the digits, tenosynovitis, and fluid in the third metacarpophalangeal that could represent a superficial abscess. The patient was hospitalized given concerns of infection.
The relapse of tenosynovitis raised concerns for a persistent infection secondary to a fastidious organism, such as NTM. Thus, inquiries specifically pertaining to any contact with bodies of water were entertained. The patient remembered that he had gone scuba diving in the ocean weeks before symptom onset. This meant scuba diving could then be the inciting event rather than gardening, which placed NTM higher in the differential. ID service did not recommend antibiotics until new cultures were available. Orthopedic service was consulted for surgical debridement. The right dorsal hand, wrist, and distal forearm tendon sheaths were surgically opened to obtain a synovial biopsy.
Synovial fluid was sent for fungal, bacterial, and AFB cultures, and synovial biopsy for AFB stains, PCR amplification/sequencing assay, and cultures. Results showed nonnecrotizing granulomas and all cultures were negative (Figures 3, 4). Rheumatology was again consulted for evaluation for sarcoidosis given negative cultures and noncaseating granulomas. Review of systems was completely negative for sarcoidosis. Computed tomography (CT) of the thorax did not show any pulmonary abnormalities, lymphadenopathy, and hilar adenopathy. Serum calcium and angiotensin-converting enzyme levels were normal. ID service recommended against empiric antibiotics given negative culture. Given persistent pain, and reported cases of isolated sarcoid tenosynovitis, low-dose oral prednisone 20 mg daily was given after clearance by ID service. Nonetheless, the right wrist and hand swelling, erythema, and tenderness relapsed with 1 dose of prednisone, leading to a repeat right upper extremity synovial biopsy due to high suspicion for persistent infection with a fastidious organism. New synovial tissue biopsy revealed fibro-adipose tissue with prominent vessels and fibrosis, nonnecrotizing, sarcoidlike granuloma with giant cell granulomatous reaction. The AFB and Grocott methenamine silver stains were negative. PCR was negative for AFB. No crystals were reported. After 5 weeks, the synovial biopsy culture was positive for M marinum. Patient was started on oral azithromycin 500 mg daily, rifabutin 300 mg daily, and ethambutol 15 mg/kg daily. At the time of this report, the patient was still completing antibiotic therapy with adequate response and undergoing occupational therapy rehabilitation (Figure 5).
Discussion
M marinum is an NTM found in bodies of water and marine settings. Infection arises after direct contact of lacerated skin with contaminated water. In a review article of 5 cases of M marinum tenosynovitis, they found that all individuals had wounds with exposure to fish or shrimp while in the water or while handling seafood.1 The incidence of this infection is infrequent, estimated to be 0.04 cases per 100,000, with only about 25% of these cases presenting as tenosynovitis.2 The incubation period ranges from 2 to 4 weeks.3 Late identification of this organism is common because of its slow development. For example, presentation from first exposure to symptom onset may take as long as 32 days.1 In addition, in the same review, surgical intervention occurred in 63 days.1 It has been reported that AFB stains are positive in just 9% of cases, which confounds diagnosis even more.4 After synovial tissue culture is obtained, it takes approximately 6 weeks for the organism to grow. Moreover, diagnosis may take longer if it is not suspected.5
Four types of M marinum infections have been described.5 The status of the immune system plays a role in how the manifestations present. The first type is limited, which is seen in immunocompetent persons, characterized by skin involvement, such as erythematous nodular lesions, that may improve on their own in months or years.4 Conversely, in immunosuppressed patients, the second type of infection may cause sporotrichoid spreading described as following lymphangitic pattern. The third type presents with musculoskeletal findings, such as arthritis, tenosynovitis, bursitis, or osteomyelitis, as seen in our patient. The fourth type consists of systemic manifestations.5 Medications that lower the immune system, such as corticosteroids, chemotherapy, and biologic disease modifying agents, may increase the risk for developing this entity.4 Specifically, antitumor necrosis factor inhibitors have been historically associated with mycobacterium infections.6
Patients are frequently diagnosed with soft tissue infection, such as abscesses or cellulitis, as in our case. They may at times be found to have other musculoskeletal conditions such as trigger finger.1 Other similar presenting entities are psoriatic arthritis, rheumatoid arthritis, and remitting seronegative arthritis.4 These clinical resemblances complicate the scenario, especially when initial cultures are negative, as the treatment for these rheumatic diseases is immunosuppression, which adversely impact the fastidious infection. In our case, the improved swelling and range of motion after the 3-week course of empiric antibiotics for suppurative tenosynovitis was initially reassuring that the previous infection had been successfully treated. Subsequently, the presence of chondrocalcinosis in the triangular fibrocartilage in the right-hand X-rays, persistent pain, and the tophi-like appearance of the right third proximal interphalangeal nodule raised concerns for crystalline arthropathies, such as calcium pyrophosphate deposition vs gout. Nonetheless, given the lack of response to low-dose steroids, an ongoing infectious process was strongly considered.
Sarcoidosis was a concern after the first synovial biopsy revealed noncaseating granulomas and negative stains and cultures. Sarcoid tenosynovitis is rare with only 22 cases described as per a 2015 report.7 Musculoskeletal involvement in sarcoidosis has been reported in 1 to 13% of sarcoid patients.7 Once again, unresponsiveness to steroids led to another synovial biopsy for culture due to potential infection. Akin to other cases, more than one surgical debridement was required to diagnose our patient.
Conclusions
Our case reinforces the vital role of history gathering in establishing diagnoses. It underscores the value of clinical suspicion especially in patients unresponsive to standard treatment for inflammatory arthritis, namely corticosteroids. Tissue biopsy with culture for AFB is crucial for accurate diagnosis in NTM infection, which may imitate rheumatic inflammatory arthritis. Clinicians should be keenly aware of this fastidious, indolent organism in the setting of persistent localized tenosynovitis.
1. Pang HN, Lee JY, Puhaindran ME, Tan SH, Tan AB, Yong FC. Mycobacterium marinum as a cause of chronic granulomatous tenosynovitis in the hand. J Infect. 2007;54(6):584-588. doi:10.1016/j.jinf.2006.11.014
2. Wongworawat MD, Holtom P, Learch TJ, Fedenko A, Stevanovic MV. A prolonged case of Mycobacterium marinum flexor tenosynovitis: radiographic and histological correlation, and review of the literature. Skeletal Radiol. 2003;32(9):542-545. doi:10.1007/s00256-003-0636-y
3. Schubert N, Schill T, Plüß M, Korsten P. Flare or foe? - Mycobacterium marinum infection mimicking rheumatoid arthritis tenosynovitis: case report and literature review. BMC Rheumatol. 2020;4:11. Published 2020 Mar 16. doi:10.1186/s41927-020-0114-3
4. Lam A, Toma W, Schlesinger N. Mycobacterium marinum arthritis mimicking rheumatoid arthritis. J Rheumatol. 2006;33(4):817-819.
5. Hashish E, Merwad A, Elgaml S, et al. Mycobacterium marinum infection in fish and man: epidemiology, pathophysiology and management; a review. Vet Q. 2018;38(1):35-46. doi:10.1080/01652176.2018.1447171
6. Thanou-Stavraki A, Sawalha AH, Crowson AN, Harley JB. Noodling and Mycobacterium marinum infection mimicking seronegative rheumatoid arthritis complicated by anti-tumor necrosis factor α therapy. Arthritis Care Res (Hoboken). 2011;63(1):160-164. doi:10.1002/acr.20303
7. Al-Ani Z, Oh TC, Macphie E, Woodruff MJ. Sarcoid tenosynovitis, rare presentation of a common disease. Case report and literature review. J Radiol Case Rep. 2015;9(8):16-23. Published 2015 Aug 31. doi:10.3941/jrcr.v9i8.2311
Rheumatologic conditions and infections may imitate each other, often making diagnosis challenging. Therefore, it is imperative to obtain adequate histories and have a keen eye for these potentially confounding differential diagnoses. Immunosuppressants used in managing rheumatologic etiologies have detrimental consequences in undiagnosed underlying infections. Consequently, worsening symptoms with standard therapy should raise awareness to a different diagnosis.
Nontuberculous mycobacteria (NTM) are slow-growing organisms difficult to yield in culture. Initial negative synovial fluid stains and cultures when suspecting NTM infectious arthritis or tenosynovitis should not exclude the diagnosis if there is a strong clinical scenario. The identification of Mycobacterium marinum (M marinum) infection in the hand is of utmost importance given that delayed treatment may cause significant and even permanent disability.
We present the case of a 73-year-old male patient with progressively worsening right-hand tenosynovitis who was evaluated for crystal-induced and sarcoid arthropathies in the setting of negative synovial biopsy cultures but was subsequently diagnosed with M marinum infectious tenosynovitis after a second surgical debridement.
Case Presentation
A 73-year-old male patient with history of type 2 diabetes mellitus, hypertension, hyperlipidemia, hypothyroidism, bilateral knee osteoarthritis, obstructive sleep apnea, and posttraumatic stress disorder presented to the emergency department (ED) with right wrist swelling and pain for 4 days. The patient reported that he was working in his garden when symptoms started. He did not recall any skin abrasions or wounds, insect bites, thorn punctures, trauma, or exposure to swimming pools or fish tanks. Patient was afebrile, and vital signs were within normal range. On physical examination, there was erythema, swelling, and tenderness in the dorsum of the right hand and over the dorsal aspect of the fourth metacarpophalangeal joint (Figure 1). The skin was intact.
Symptoms had not responded to 7 days of cefalexin nor to a short course of oral steroids. Leukocytosis of 14.35 × 109/L (reference range, 3.90-9.90 × 109/L) with neutrophilia at 11.10 × 109/L (reference range, 1.73-6.37 × 109/L) was noted. Sedimentation rate and C-reactive protein levels were normal. Right-hand X-ray was remarkable for chondrocalcinosis in the triangular fibrocartilage. Right upper extremity magnetic resonance imaging (MRI) revealed diffuse inflammation in the right wrist and hand (Figure 2). There was no evidence of septic arthritis or osteomyelitis. Consequently, orthopedic service recommended no surgical intervention. Additionally, the patient had preserved range of motion that further indicated tenosynovitis, which could be medically managed with antibiotics, rather than a septic joint.
One dose of IV piperacillin/tazobactam was given at the ED, and he was admitted to the internal medicine ward with right hand and wrist cellulitis and indolent suppurative tenosynovitis. Empiric IV ceftriaxone and vancomycin were started as per infectious disease (ID) service with adequate response defined as a reduction of the swelling, erythema, and tenderness of the right hand and wrist. Differential diagnosis included sporotrichosis, nocardia vs NTM infection.
Interventional radiology was consulted for right wrist drainage. However, only 1 mL of fluid was obtained. Synovial fluid was sent for cell count and differential, crystal analysis, bacterial cultures, fungal cultures, and acid-fast bacilli (AFB) stains and culture. Neutrophils were 43% and lymphocytes were 57%. Crystal analysis was negative. Bacterial culture and mycology were negative. AFB stain and culture results were negative after 6 weeks. Based on gardening history and risk of thorn exposure and low suspicion for common bacterial pathogens, ID service switched antibiotics to moxifloxacin, minocycline, and linezolid for broad coverage to complete 3 weeks as outpatient. The patient reported significantly improved pain and handgrip with notable decrease in swelling. Nonetheless, 3 weeks after completing antibiotics, the right-hand pain recurred, raising concern for complex regional syndrome vs crystalline arthropathy.
The patient was referred to rheumatology service for evaluation of crystal-induced arthropathy given chondrocalcinosis. Physical examination revealed right third proximal interphalangeal joint swelling and tenderness with overimposed tophilike nodule. No erythema or palpable effusions were appreciated. Range of motion was preserved. Laboratory workup showed resolved leukocytosis and neutrophilia, and normal sedimentation rate or C-reactive protein levels. Antinuclear antibody panel, rheumatoid factor, and anti–cyclic citrullinated peptide levels were normal. Serum uric acid levels were 5.9 mg/dL. Chlamydia, gonorrhea, and HIV tests were negative. Short course of low-dose oral prednisone starting at 15 mg daily with tapering by 5 mg every 3 days was given for presumptive calcium pyrophosphate deposition vs gout. Nevertheless, right-hand swelling and pain worsened after steroids. Repeat right upper extremity MRI showed persistent soft tissue edema and inflammation along the dorsum of the hand extending to the digits, tenosynovitis, and fluid in the third metacarpophalangeal that could represent a superficial abscess. The patient was hospitalized given concerns of infection.
The relapse of tenosynovitis raised concerns for a persistent infection secondary to a fastidious organism, such as NTM. Thus, inquiries specifically pertaining to any contact with bodies of water were entertained. The patient remembered that he had gone scuba diving in the ocean weeks before symptom onset. This meant scuba diving could then be the inciting event rather than gardening, which placed NTM higher in the differential. ID service did not recommend antibiotics until new cultures were available. Orthopedic service was consulted for surgical debridement. The right dorsal hand, wrist, and distal forearm tendon sheaths were surgically opened to obtain a synovial biopsy.
Synovial fluid was sent for fungal, bacterial, and AFB cultures, and synovial biopsy for AFB stains, PCR amplification/sequencing assay, and cultures. Results showed nonnecrotizing granulomas and all cultures were negative (Figures 3, 4). Rheumatology was again consulted for evaluation for sarcoidosis given negative cultures and noncaseating granulomas. Review of systems was completely negative for sarcoidosis. Computed tomography (CT) of the thorax did not show any pulmonary abnormalities, lymphadenopathy, and hilar adenopathy. Serum calcium and angiotensin-converting enzyme levels were normal. ID service recommended against empiric antibiotics given negative culture. Given persistent pain, and reported cases of isolated sarcoid tenosynovitis, low-dose oral prednisone 20 mg daily was given after clearance by ID service. Nonetheless, the right wrist and hand swelling, erythema, and tenderness relapsed with 1 dose of prednisone, leading to a repeat right upper extremity synovial biopsy due to high suspicion for persistent infection with a fastidious organism. New synovial tissue biopsy revealed fibro-adipose tissue with prominent vessels and fibrosis, nonnecrotizing, sarcoidlike granuloma with giant cell granulomatous reaction. The AFB and Grocott methenamine silver stains were negative. PCR was negative for AFB. No crystals were reported. After 5 weeks, the synovial biopsy culture was positive for M marinum. Patient was started on oral azithromycin 500 mg daily, rifabutin 300 mg daily, and ethambutol 15 mg/kg daily. At the time of this report, the patient was still completing antibiotic therapy with adequate response and undergoing occupational therapy rehabilitation (Figure 5).
Discussion
M marinum is an NTM found in bodies of water and marine settings. Infection arises after direct contact of lacerated skin with contaminated water. In a review article of 5 cases of M marinum tenosynovitis, they found that all individuals had wounds with exposure to fish or shrimp while in the water or while handling seafood.1 The incidence of this infection is infrequent, estimated to be 0.04 cases per 100,000, with only about 25% of these cases presenting as tenosynovitis.2 The incubation period ranges from 2 to 4 weeks.3 Late identification of this organism is common because of its slow development. For example, presentation from first exposure to symptom onset may take as long as 32 days.1 In addition, in the same review, surgical intervention occurred in 63 days.1 It has been reported that AFB stains are positive in just 9% of cases, which confounds diagnosis even more.4 After synovial tissue culture is obtained, it takes approximately 6 weeks for the organism to grow. Moreover, diagnosis may take longer if it is not suspected.5
Four types of M marinum infections have been described.5 The status of the immune system plays a role in how the manifestations present. The first type is limited, which is seen in immunocompetent persons, characterized by skin involvement, such as erythematous nodular lesions, that may improve on their own in months or years.4 Conversely, in immunosuppressed patients, the second type of infection may cause sporotrichoid spreading described as following lymphangitic pattern. The third type presents with musculoskeletal findings, such as arthritis, tenosynovitis, bursitis, or osteomyelitis, as seen in our patient. The fourth type consists of systemic manifestations.5 Medications that lower the immune system, such as corticosteroids, chemotherapy, and biologic disease modifying agents, may increase the risk for developing this entity.4 Specifically, antitumor necrosis factor inhibitors have been historically associated with mycobacterium infections.6
Patients are frequently diagnosed with soft tissue infection, such as abscesses or cellulitis, as in our case. They may at times be found to have other musculoskeletal conditions such as trigger finger.1 Other similar presenting entities are psoriatic arthritis, rheumatoid arthritis, and remitting seronegative arthritis.4 These clinical resemblances complicate the scenario, especially when initial cultures are negative, as the treatment for these rheumatic diseases is immunosuppression, which adversely impact the fastidious infection. In our case, the improved swelling and range of motion after the 3-week course of empiric antibiotics for suppurative tenosynovitis was initially reassuring that the previous infection had been successfully treated. Subsequently, the presence of chondrocalcinosis in the triangular fibrocartilage in the right-hand X-rays, persistent pain, and the tophi-like appearance of the right third proximal interphalangeal nodule raised concerns for crystalline arthropathies, such as calcium pyrophosphate deposition vs gout. Nonetheless, given the lack of response to low-dose steroids, an ongoing infectious process was strongly considered.
Sarcoidosis was a concern after the first synovial biopsy revealed noncaseating granulomas and negative stains and cultures. Sarcoid tenosynovitis is rare with only 22 cases described as per a 2015 report.7 Musculoskeletal involvement in sarcoidosis has been reported in 1 to 13% of sarcoid patients.7 Once again, unresponsiveness to steroids led to another synovial biopsy for culture due to potential infection. Akin to other cases, more than one surgical debridement was required to diagnose our patient.
Conclusions
Our case reinforces the vital role of history gathering in establishing diagnoses. It underscores the value of clinical suspicion especially in patients unresponsive to standard treatment for inflammatory arthritis, namely corticosteroids. Tissue biopsy with culture for AFB is crucial for accurate diagnosis in NTM infection, which may imitate rheumatic inflammatory arthritis. Clinicians should be keenly aware of this fastidious, indolent organism in the setting of persistent localized tenosynovitis.
Rheumatologic conditions and infections may imitate each other, often making diagnosis challenging. Therefore, it is imperative to obtain adequate histories and have a keen eye for these potentially confounding differential diagnoses. Immunosuppressants used in managing rheumatologic etiologies have detrimental consequences in undiagnosed underlying infections. Consequently, worsening symptoms with standard therapy should raise awareness to a different diagnosis.
Nontuberculous mycobacteria (NTM) are slow-growing organisms difficult to yield in culture. Initial negative synovial fluid stains and cultures when suspecting NTM infectious arthritis or tenosynovitis should not exclude the diagnosis if there is a strong clinical scenario. The identification of Mycobacterium marinum (M marinum) infection in the hand is of utmost importance given that delayed treatment may cause significant and even permanent disability.
We present the case of a 73-year-old male patient with progressively worsening right-hand tenosynovitis who was evaluated for crystal-induced and sarcoid arthropathies in the setting of negative synovial biopsy cultures but was subsequently diagnosed with M marinum infectious tenosynovitis after a second surgical debridement.
Case Presentation
A 73-year-old male patient with history of type 2 diabetes mellitus, hypertension, hyperlipidemia, hypothyroidism, bilateral knee osteoarthritis, obstructive sleep apnea, and posttraumatic stress disorder presented to the emergency department (ED) with right wrist swelling and pain for 4 days. The patient reported that he was working in his garden when symptoms started. He did not recall any skin abrasions or wounds, insect bites, thorn punctures, trauma, or exposure to swimming pools or fish tanks. Patient was afebrile, and vital signs were within normal range. On physical examination, there was erythema, swelling, and tenderness in the dorsum of the right hand and over the dorsal aspect of the fourth metacarpophalangeal joint (Figure 1). The skin was intact.
Symptoms had not responded to 7 days of cefalexin nor to a short course of oral steroids. Leukocytosis of 14.35 × 109/L (reference range, 3.90-9.90 × 109/L) with neutrophilia at 11.10 × 109/L (reference range, 1.73-6.37 × 109/L) was noted. Sedimentation rate and C-reactive protein levels were normal. Right-hand X-ray was remarkable for chondrocalcinosis in the triangular fibrocartilage. Right upper extremity magnetic resonance imaging (MRI) revealed diffuse inflammation in the right wrist and hand (Figure 2). There was no evidence of septic arthritis or osteomyelitis. Consequently, orthopedic service recommended no surgical intervention. Additionally, the patient had preserved range of motion that further indicated tenosynovitis, which could be medically managed with antibiotics, rather than a septic joint.
One dose of IV piperacillin/tazobactam was given at the ED, and he was admitted to the internal medicine ward with right hand and wrist cellulitis and indolent suppurative tenosynovitis. Empiric IV ceftriaxone and vancomycin were started as per infectious disease (ID) service with adequate response defined as a reduction of the swelling, erythema, and tenderness of the right hand and wrist. Differential diagnosis included sporotrichosis, nocardia vs NTM infection.
Interventional radiology was consulted for right wrist drainage. However, only 1 mL of fluid was obtained. Synovial fluid was sent for cell count and differential, crystal analysis, bacterial cultures, fungal cultures, and acid-fast bacilli (AFB) stains and culture. Neutrophils were 43% and lymphocytes were 57%. Crystal analysis was negative. Bacterial culture and mycology were negative. AFB stain and culture results were negative after 6 weeks. Based on gardening history and risk of thorn exposure and low suspicion for common bacterial pathogens, ID service switched antibiotics to moxifloxacin, minocycline, and linezolid for broad coverage to complete 3 weeks as outpatient. The patient reported significantly improved pain and handgrip with notable decrease in swelling. Nonetheless, 3 weeks after completing antibiotics, the right-hand pain recurred, raising concern for complex regional syndrome vs crystalline arthropathy.
The patient was referred to rheumatology service for evaluation of crystal-induced arthropathy given chondrocalcinosis. Physical examination revealed right third proximal interphalangeal joint swelling and tenderness with overimposed tophilike nodule. No erythema or palpable effusions were appreciated. Range of motion was preserved. Laboratory workup showed resolved leukocytosis and neutrophilia, and normal sedimentation rate or C-reactive protein levels. Antinuclear antibody panel, rheumatoid factor, and anti–cyclic citrullinated peptide levels were normal. Serum uric acid levels were 5.9 mg/dL. Chlamydia, gonorrhea, and HIV tests were negative. Short course of low-dose oral prednisone starting at 15 mg daily with tapering by 5 mg every 3 days was given for presumptive calcium pyrophosphate deposition vs gout. Nevertheless, right-hand swelling and pain worsened after steroids. Repeat right upper extremity MRI showed persistent soft tissue edema and inflammation along the dorsum of the hand extending to the digits, tenosynovitis, and fluid in the third metacarpophalangeal that could represent a superficial abscess. The patient was hospitalized given concerns of infection.
The relapse of tenosynovitis raised concerns for a persistent infection secondary to a fastidious organism, such as NTM. Thus, inquiries specifically pertaining to any contact with bodies of water were entertained. The patient remembered that he had gone scuba diving in the ocean weeks before symptom onset. This meant scuba diving could then be the inciting event rather than gardening, which placed NTM higher in the differential. ID service did not recommend antibiotics until new cultures were available. Orthopedic service was consulted for surgical debridement. The right dorsal hand, wrist, and distal forearm tendon sheaths were surgically opened to obtain a synovial biopsy.
Synovial fluid was sent for fungal, bacterial, and AFB cultures, and synovial biopsy for AFB stains, PCR amplification/sequencing assay, and cultures. Results showed nonnecrotizing granulomas and all cultures were negative (Figures 3, 4). Rheumatology was again consulted for evaluation for sarcoidosis given negative cultures and noncaseating granulomas. Review of systems was completely negative for sarcoidosis. Computed tomography (CT) of the thorax did not show any pulmonary abnormalities, lymphadenopathy, and hilar adenopathy. Serum calcium and angiotensin-converting enzyme levels were normal. ID service recommended against empiric antibiotics given negative culture. Given persistent pain, and reported cases of isolated sarcoid tenosynovitis, low-dose oral prednisone 20 mg daily was given after clearance by ID service. Nonetheless, the right wrist and hand swelling, erythema, and tenderness relapsed with 1 dose of prednisone, leading to a repeat right upper extremity synovial biopsy due to high suspicion for persistent infection with a fastidious organism. New synovial tissue biopsy revealed fibro-adipose tissue with prominent vessels and fibrosis, nonnecrotizing, sarcoidlike granuloma with giant cell granulomatous reaction. The AFB and Grocott methenamine silver stains were negative. PCR was negative for AFB. No crystals were reported. After 5 weeks, the synovial biopsy culture was positive for M marinum. Patient was started on oral azithromycin 500 mg daily, rifabutin 300 mg daily, and ethambutol 15 mg/kg daily. At the time of this report, the patient was still completing antibiotic therapy with adequate response and undergoing occupational therapy rehabilitation (Figure 5).
Discussion
M marinum is an NTM found in bodies of water and marine settings. Infection arises after direct contact of lacerated skin with contaminated water. In a review article of 5 cases of M marinum tenosynovitis, they found that all individuals had wounds with exposure to fish or shrimp while in the water or while handling seafood.1 The incidence of this infection is infrequent, estimated to be 0.04 cases per 100,000, with only about 25% of these cases presenting as tenosynovitis.2 The incubation period ranges from 2 to 4 weeks.3 Late identification of this organism is common because of its slow development. For example, presentation from first exposure to symptom onset may take as long as 32 days.1 In addition, in the same review, surgical intervention occurred in 63 days.1 It has been reported that AFB stains are positive in just 9% of cases, which confounds diagnosis even more.4 After synovial tissue culture is obtained, it takes approximately 6 weeks for the organism to grow. Moreover, diagnosis may take longer if it is not suspected.5
Four types of M marinum infections have been described.5 The status of the immune system plays a role in how the manifestations present. The first type is limited, which is seen in immunocompetent persons, characterized by skin involvement, such as erythematous nodular lesions, that may improve on their own in months or years.4 Conversely, in immunosuppressed patients, the second type of infection may cause sporotrichoid spreading described as following lymphangitic pattern. The third type presents with musculoskeletal findings, such as arthritis, tenosynovitis, bursitis, or osteomyelitis, as seen in our patient. The fourth type consists of systemic manifestations.5 Medications that lower the immune system, such as corticosteroids, chemotherapy, and biologic disease modifying agents, may increase the risk for developing this entity.4 Specifically, antitumor necrosis factor inhibitors have been historically associated with mycobacterium infections.6
Patients are frequently diagnosed with soft tissue infection, such as abscesses or cellulitis, as in our case. They may at times be found to have other musculoskeletal conditions such as trigger finger.1 Other similar presenting entities are psoriatic arthritis, rheumatoid arthritis, and remitting seronegative arthritis.4 These clinical resemblances complicate the scenario, especially when initial cultures are negative, as the treatment for these rheumatic diseases is immunosuppression, which adversely impact the fastidious infection. In our case, the improved swelling and range of motion after the 3-week course of empiric antibiotics for suppurative tenosynovitis was initially reassuring that the previous infection had been successfully treated. Subsequently, the presence of chondrocalcinosis in the triangular fibrocartilage in the right-hand X-rays, persistent pain, and the tophi-like appearance of the right third proximal interphalangeal nodule raised concerns for crystalline arthropathies, such as calcium pyrophosphate deposition vs gout. Nonetheless, given the lack of response to low-dose steroids, an ongoing infectious process was strongly considered.
Sarcoidosis was a concern after the first synovial biopsy revealed noncaseating granulomas and negative stains and cultures. Sarcoid tenosynovitis is rare with only 22 cases described as per a 2015 report.7 Musculoskeletal involvement in sarcoidosis has been reported in 1 to 13% of sarcoid patients.7 Once again, unresponsiveness to steroids led to another synovial biopsy for culture due to potential infection. Akin to other cases, more than one surgical debridement was required to diagnose our patient.
Conclusions
Our case reinforces the vital role of history gathering in establishing diagnoses. It underscores the value of clinical suspicion especially in patients unresponsive to standard treatment for inflammatory arthritis, namely corticosteroids. Tissue biopsy with culture for AFB is crucial for accurate diagnosis in NTM infection, which may imitate rheumatic inflammatory arthritis. Clinicians should be keenly aware of this fastidious, indolent organism in the setting of persistent localized tenosynovitis.
1. Pang HN, Lee JY, Puhaindran ME, Tan SH, Tan AB, Yong FC. Mycobacterium marinum as a cause of chronic granulomatous tenosynovitis in the hand. J Infect. 2007;54(6):584-588. doi:10.1016/j.jinf.2006.11.014
2. Wongworawat MD, Holtom P, Learch TJ, Fedenko A, Stevanovic MV. A prolonged case of Mycobacterium marinum flexor tenosynovitis: radiographic and histological correlation, and review of the literature. Skeletal Radiol. 2003;32(9):542-545. doi:10.1007/s00256-003-0636-y
3. Schubert N, Schill T, Plüß M, Korsten P. Flare or foe? - Mycobacterium marinum infection mimicking rheumatoid arthritis tenosynovitis: case report and literature review. BMC Rheumatol. 2020;4:11. Published 2020 Mar 16. doi:10.1186/s41927-020-0114-3
4. Lam A, Toma W, Schlesinger N. Mycobacterium marinum arthritis mimicking rheumatoid arthritis. J Rheumatol. 2006;33(4):817-819.
5. Hashish E, Merwad A, Elgaml S, et al. Mycobacterium marinum infection in fish and man: epidemiology, pathophysiology and management; a review. Vet Q. 2018;38(1):35-46. doi:10.1080/01652176.2018.1447171
6. Thanou-Stavraki A, Sawalha AH, Crowson AN, Harley JB. Noodling and Mycobacterium marinum infection mimicking seronegative rheumatoid arthritis complicated by anti-tumor necrosis factor α therapy. Arthritis Care Res (Hoboken). 2011;63(1):160-164. doi:10.1002/acr.20303
7. Al-Ani Z, Oh TC, Macphie E, Woodruff MJ. Sarcoid tenosynovitis, rare presentation of a common disease. Case report and literature review. J Radiol Case Rep. 2015;9(8):16-23. Published 2015 Aug 31. doi:10.3941/jrcr.v9i8.2311
1. Pang HN, Lee JY, Puhaindran ME, Tan SH, Tan AB, Yong FC. Mycobacterium marinum as a cause of chronic granulomatous tenosynovitis in the hand. J Infect. 2007;54(6):584-588. doi:10.1016/j.jinf.2006.11.014
2. Wongworawat MD, Holtom P, Learch TJ, Fedenko A, Stevanovic MV. A prolonged case of Mycobacterium marinum flexor tenosynovitis: radiographic and histological correlation, and review of the literature. Skeletal Radiol. 2003;32(9):542-545. doi:10.1007/s00256-003-0636-y
3. Schubert N, Schill T, Plüß M, Korsten P. Flare or foe? - Mycobacterium marinum infection mimicking rheumatoid arthritis tenosynovitis: case report and literature review. BMC Rheumatol. 2020;4:11. Published 2020 Mar 16. doi:10.1186/s41927-020-0114-3
4. Lam A, Toma W, Schlesinger N. Mycobacterium marinum arthritis mimicking rheumatoid arthritis. J Rheumatol. 2006;33(4):817-819.
5. Hashish E, Merwad A, Elgaml S, et al. Mycobacterium marinum infection in fish and man: epidemiology, pathophysiology and management; a review. Vet Q. 2018;38(1):35-46. doi:10.1080/01652176.2018.1447171
6. Thanou-Stavraki A, Sawalha AH, Crowson AN, Harley JB. Noodling and Mycobacterium marinum infection mimicking seronegative rheumatoid arthritis complicated by anti-tumor necrosis factor α therapy. Arthritis Care Res (Hoboken). 2011;63(1):160-164. doi:10.1002/acr.20303
7. Al-Ani Z, Oh TC, Macphie E, Woodruff MJ. Sarcoid tenosynovitis, rare presentation of a common disease. Case report and literature review. J Radiol Case Rep. 2015;9(8):16-23. Published 2015 Aug 31. doi:10.3941/jrcr.v9i8.2311