Crenezumab, an investigational medication designed to slow or prevent Alzheimer’s disease (AD), provides no cognitive benefit in patients at high genetic risk, 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.

Crenezumab, an investigational medication designed to slow or prevent Alzheimer’s disease (AD), provides no cognitive benefit in patients at high genetic risk, 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.

Crenezumab, an investigational medication designed to slow or prevent Alzheimer’s disease (AD), provides no cognitive benefit in patients at high genetic risk, 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.

 The U.S. Food and Drug Administration has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication – treatment of moderately to severely active Crohn’s disease in adults – 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 has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication – treatment of moderately to severely active Crohn’s disease in adults – 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 has approved risankizumab-rzaa (Skyrizi, AbbVie) for a third indication – treatment of moderately to severely active Crohn’s disease in adults – 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.

Experts engaged in a contentious debate on the usefulness of the NOVA system, which divides foods into different categories based on how much they have been processed, during a session at a virtual conference sponsored by the American Society for Nutrition.

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.

Experts engaged in a contentious debate on the usefulness of the NOVA system, which divides foods into different categories based on how much they have been processed, during a session at a virtual conference sponsored by the American Society for Nutrition.

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.

Experts engaged in a contentious debate on the usefulness of the NOVA system, which divides foods into different categories based on how much they have been processed, during a session at a virtual conference sponsored by the American Society for Nutrition.

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.

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 the 51-year-old vice chair of dermatology at the University of California, San Francisco, addressed his colleagues in his inaugural speech as president of the American Medical Association (AMA) on June 14.

Courtesy Ted Grudzinski

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 the 51-year-old vice chair of dermatology at the University of California, San Francisco, addressed his colleagues in his inaugural speech as president of the American Medical Association (AMA) on June 14.

Courtesy Ted Grudzinski

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 the 51-year-old vice chair of dermatology at the University of California, San Francisco, addressed his colleagues in his inaugural speech as president of the American Medical Association (AMA) on June 14.

Courtesy Ted Grudzinski

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.

A Florida jury has awarded approximately $7.6 million to a former firefighter who lost the lower portion of his right leg after a doctor’s misdiagnosis, 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.

A Florida jury has awarded approximately $7.6 million to a former firefighter who lost the lower portion of his right leg after a doctor’s misdiagnosis, 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.

A Florida jury has awarded approximately $7.6 million to a former firefighter who lost the lower portion of his right leg after a doctor’s misdiagnosis, 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.

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, 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.

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, 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.

The Food and Drug Administration on June 17 granted emergency use authorization (EUA) to the Moderna and Pfizer COVID-19 vaccines for use in children 6 months of age and older, 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.

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, the former emergency room physician pleaded guilty to unlawfully and knowingly entering and remaining in a restricted building or grounds. 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, the former emergency room physician pleaded guilty to unlawfully and knowingly entering and remaining in a restricted building or grounds. 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, the former emergency room physician pleaded guilty to unlawfully and knowingly entering and remaining in a restricted building or grounds. 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 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 × 10^9/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.

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 × 10^9/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.

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 × 10^9/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.

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.

A federal jury recently awarded more than $100 million to a college student whose left leg was permanently damaged as the result of care he received after a sports injury, according to a story from WCCO CBS Minnesota, among other news outlets. The award has been called the largest judgment of its kind in Minnesota history.

In January 2017, Nepalese immigrant Anuj Thapa was playing in an indoor soccer game at St. Cloud State University when another player tackled him. His left leg badly injured, Mr. Thapa was taken by ambulance to CentraCare’s St. Cloud Hospital. The orthopedic surgeon on call that day was Chad Holien, MD, who is affiliated with St. Cloud Orthopedics, a private clinic in nearby Sartell, Minn. Following preparations, and with the help of a physician assistant, Dr. Holien operated on the patient’s broken leg.

But Mr. Thapa experienced post-surgical complications – severe pain, numbness, burning, and muscle issues. Despite the complications, he was discharged from the hospital that afternoon and sent home.

Six days later, Mr. Thapa returned to St. Cloud Hospital, still complaining of severe pain. A second orthopedic surgeon operated and found that Mr. Thapa had “acute compartment syndrome,” the result of internal pressure that had built up in his leg muscles.

Over time, Mr. Thapa underwent more than 20 surgeries on his leg to deal with the ongoing pain and other complications, according to WCCO.

In 2019, he filed a medical malpractice suit in U.S. district court against St. Cloud Orthopedics, the private practice that employed the surgeon and the PA. (Under Minnesota law, an employer is responsible for the actions of its employees.)

In his complaint, Mr. Thapa alleged that in treating him, “the defendants departed from accepted standards of medical practice.” Among other things, he claimed that Dr. Holien and the PA had not properly evaluated his postoperative symptoms, failed to diagnose and treat his compartment syndrome, and improperly discharged him from the hospital. These lapses, Mr. Thapa said, led to his “severe, permanent, and disabling injuries.”

The federal jury agreed. After a weeklong trial, it awarded the plaintiff $100 million for future “pain, disability, disfigurement, embarrassment, and emotional distress.” It also gave him $10 million for past suffering and a little more than $1 million for past and future medical bills.

In a postverdict statement, Mr. Thapa’s attorney said that, while the surgeon and PA are undoubtedly good providers, they made mistakes in this case.

A defense attorney for St. Cloud Orthopedics disputes this: “We maintain the care provided in this case was in accordance with accepted standards of care.”

At press time, the defense had not determined whether to appeal the jury’s $111 million verdict. “St. Cloud continues to support its providers,” said the clinic’s defense attorney. “We are evaluating our options regarding this verdict.”

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.

A federal jury recently awarded more than $100 million to a college student whose left leg was permanently damaged as the result of care he received after a sports injury, according to a story from WCCO CBS Minnesota, among other news outlets. The award has been called the largest judgment of its kind in Minnesota history.

In January 2017, Nepalese immigrant Anuj Thapa was playing in an indoor soccer game at St. Cloud State University when another player tackled him. His left leg badly injured, Mr. Thapa was taken by ambulance to CentraCare’s St. Cloud Hospital. The orthopedic surgeon on call that day was Chad Holien, MD, who is affiliated with St. Cloud Orthopedics, a private clinic in nearby Sartell, Minn. Following preparations, and with the help of a physician assistant, Dr. Holien operated on the patient’s broken leg.

But Mr. Thapa experienced post-surgical complications – severe pain, numbness, burning, and muscle issues. Despite the complications, he was discharged from the hospital that afternoon and sent home.

Six days later, Mr. Thapa returned to St. Cloud Hospital, still complaining of severe pain. A second orthopedic surgeon operated and found that Mr. Thapa had “acute compartment syndrome,” the result of internal pressure that had built up in his leg muscles.

Over time, Mr. Thapa underwent more than 20 surgeries on his leg to deal with the ongoing pain and other complications, according to WCCO.

In 2019, he filed a medical malpractice suit in U.S. district court against St. Cloud Orthopedics, the private practice that employed the surgeon and the PA. (Under Minnesota law, an employer is responsible for the actions of its employees.)

In his complaint, Mr. Thapa alleged that in treating him, “the defendants departed from accepted standards of medical practice.” Among other things, he claimed that Dr. Holien and the PA had not properly evaluated his postoperative symptoms, failed to diagnose and treat his compartment syndrome, and improperly discharged him from the hospital. These lapses, Mr. Thapa said, led to his “severe, permanent, and disabling injuries.”

The federal jury agreed. After a weeklong trial, it awarded the plaintiff $100 million for future “pain, disability, disfigurement, embarrassment, and emotional distress.” It also gave him $10 million for past suffering and a little more than $1 million for past and future medical bills.

In a postverdict statement, Mr. Thapa’s attorney said that, while the surgeon and PA are undoubtedly good providers, they made mistakes in this case.

A defense attorney for St. Cloud Orthopedics disputes this: “We maintain the care provided in this case was in accordance with accepted standards of care.”

At press time, the defense had not determined whether to appeal the jury’s $111 million verdict. “St. Cloud continues to support its providers,” said the clinic’s defense attorney. “We are evaluating our options regarding this verdict.”

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.

A federal jury recently awarded more than $100 million to a college student whose left leg was permanently damaged as the result of care he received after a sports injury, according to a story from WCCO CBS Minnesota, among other news outlets. The award has been called the largest judgment of its kind in Minnesota history.

In January 2017, Nepalese immigrant Anuj Thapa was playing in an indoor soccer game at St. Cloud State University when another player tackled him. His left leg badly injured, Mr. Thapa was taken by ambulance to CentraCare’s St. Cloud Hospital. The orthopedic surgeon on call that day was Chad Holien, MD, who is affiliated with St. Cloud Orthopedics, a private clinic in nearby Sartell, Minn. Following preparations, and with the help of a physician assistant, Dr. Holien operated on the patient’s broken leg.

But Mr. Thapa experienced post-surgical complications – severe pain, numbness, burning, and muscle issues. Despite the complications, he was discharged from the hospital that afternoon and sent home.

Six days later, Mr. Thapa returned to St. Cloud Hospital, still complaining of severe pain. A second orthopedic surgeon operated and found that Mr. Thapa had “acute compartment syndrome,” the result of internal pressure that had built up in his leg muscles.

Over time, Mr. Thapa underwent more than 20 surgeries on his leg to deal with the ongoing pain and other complications, according to WCCO.

In 2019, he filed a medical malpractice suit in U.S. district court against St. Cloud Orthopedics, the private practice that employed the surgeon and the PA. (Under Minnesota law, an employer is responsible for the actions of its employees.)

In his complaint, Mr. Thapa alleged that in treating him, “the defendants departed from accepted standards of medical practice.” Among other things, he claimed that Dr. Holien and the PA had not properly evaluated his postoperative symptoms, failed to diagnose and treat his compartment syndrome, and improperly discharged him from the hospital. These lapses, Mr. Thapa said, led to his “severe, permanent, and disabling injuries.”

The federal jury agreed. After a weeklong trial, it awarded the plaintiff $100 million for future “pain, disability, disfigurement, embarrassment, and emotional distress.” It also gave him $10 million for past suffering and a little more than $1 million for past and future medical bills.

In a postverdict statement, Mr. Thapa’s attorney said that, while the surgeon and PA are undoubtedly good providers, they made mistakes in this case.

A defense attorney for St. Cloud Orthopedics disputes this: “We maintain the care provided in this case was in accordance with accepted standards of care.”

At press time, the defense had not determined whether to appeal the jury’s $111 million verdict. “St. Cloud continues to support its providers,” said the clinic’s defense attorney. “We are evaluating our options regarding this verdict.”

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.

ATLANTA – U.S. clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association and a major international nephrology organization presented during the annual scientific sessions of the American Diabetes Association (ADA).

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an ACE inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

“We’re going to try to make this feasible. We have to; I don’t think we have a choice,” commented Amy K. Mottl, MD, a nephrologist at the University of North Carolina, Chapel Hill. Dr. Mottl was not involved with writing the consensus statement but has been active in the Diabetic Kidney Disease Collaborative of the American Society of Nephrology, another group promoting a more aggressive multidrug-class approach to treating CKD in people with diabetes.
 

Wider use of costly drugs

Adoption of this evidence-based approach by U.S. clinicians will both increase the number of agents that many patients receive and drive a significant uptick in the cost and complexity of patient care, a consequence acknowledged by the authors of the joint statement as well as outside experts.

But they view this as unavoidable given what’s now known about the high incidence of worsening CKD in patients with diabetes and the types of interventions proven to blunt this.

Much of the financial implication stems from the price of agents from the new drug classes now emphasized in the consensus recommendations – SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists. All these drugs currently remain on-patent with relatively expensive retail prices in the range of about $600 to $1,000/month.

Commenting on the cost concerns, Dr. Mottl highlighted that she currently has several patients in her practice on agents from two or more of these newer classes, and she has generally found it possible for patients to get much of their expenses covered by insurers and through drug-company assistance programs.

“The major gap is patients on Medicare,” she noted in an interview, because the Federal health insurance program does not allow beneficiaries to receive rebates for their drug costs. “The Diabetic Kidney Disease Collaborative is currently lobbying members of Congress to lift that barrier,” she emphasized.
 

Improved alignment

Details of the KDIGO recommendations feature in a guideline from that organization that appeared as a draft document online in March 2022. The ADA’s version recently appeared as an update to its Standards of Medical Care in Diabetes – 2022, as reported by this news organization. A panel of five KDIGO representatives and four members appointed by the ADA produced the harmonization statement.

Recommendations from both organizations were largely in agreement at the outset, but following the panel’s review, the two groups are now “very well-aligned,” said Peter Rossing, MD, DMSc, a diabetologist and professor at the Steno Diabetes Center, Copenhagen, and a KDIGO representative to the writing committee, who presented the joint statement at the ADA meeting.

“These are very important drugs that are vastly underused,” commented Josef Coresh, MD, PhD, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in CKD and was not involved with the new statement.

“Coherence and simplicity are what we need so that there are no excuses about moving forward” with the recommended combination treatment, he stressed.

Moving too slow

“No one is resisting using these new medications, but they are just moving too slowly, and data now show that it’s moving more slowly in the United States than elsewhere. That may be partly because U.S. patients are charged much more for these drugs, and partly because U.S. health care is so much more fragmented,” Dr. Coresh said in an interview.

The new joint consensus statement may help, “but the fragmentation of the United States system and COVID-19 are big enemies” for any short-term increased use of the highlighted agents, he added.

Evidence for low U.S. use of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists is becoming well known.

Dr. Rossing cited a 2019 report from the CURE-CKD registry of more than 600,000 U.S. patients with CKD showing that less than 1% received an SGLT2 inhibitor and less than 1% a GLP-1 receptor agonist. Not all these patients had diabetes, but a subgroup analysis of those with diabetes, prediabetes, or hypertension showed that usage of each of these two classes remained at less than 1% even in this group.

A separate report at the ADA meeting documented that of more than 1.3 million people with type 2 diabetes in the U.S. Veterans Affairs Healthcare System during 2019 and 2020, just 10% received an SGLT2 inhibitor and 7% a GLP-1 receptor agonist. And this is in a setting where drug cost is not a limiting factor.

In addition to focusing on the updated scheme for drug intervention in the consensus statement, Dr. Rossing highlighted several other important points that the writing committee emphasized.

Lifestyle optimization is a core first-line element of managing patients with diabetes and CKD, including a healthy diet, exercise, smoking cessation, and weight control. Other key steps for management include optimization of blood pressure, glucose, and lipids. The statement also calls out a potentially helpful role for continuous glucose monitoring in patients with type 1 or type 2 diabetes and CKD.

The statement notes that patients who also have atherosclerotic cardiovascular disease usually qualify for and could potentially benefit from more intensified lipid management with ezetimibe or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, as well as a potential role for treatment with antiplatelet agents.
 

‘If you don’t screen, you won’t find it’

Dr. Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2, as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol), have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place, recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

“If you don’t screen, you won’t find it, and you won’t be able to treat,” Dr. Rossing warned. He also highlighted the panel’s recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that “discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices,” write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Dr. Tuttle, who is executive director for research at Providence Healthcare, Spokane, Washington, and a KDIGO representative on the statement writing panel.

Dr. Mottl has reported being a consultant to Bayer. Dr. Rossing has reported being a consultant to or speaker on behalf of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, MSD, Mundipharma, Novo Nordisk, Sanofi Aventis, and Vifor, as well as receiving research grants from AstraZeneca and Novo Nordisk. Dr. Coresh has reported no relevant financial relationships. Dr. Tuttle has reported being a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Goldfinch Bio, Janssen, Novo Nordisk, and Travere; receiving honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Novo Nordisk, and Travere; and receiving research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, Goldfinch Bio, Novo Nordisk, and Travere.

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

ATLANTA – U.S. clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association and a major international nephrology organization presented during the annual scientific sessions of the American Diabetes Association (ADA).

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an ACE inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

“We’re going to try to make this feasible. We have to; I don’t think we have a choice,” commented Amy K. Mottl, MD, a nephrologist at the University of North Carolina, Chapel Hill. Dr. Mottl was not involved with writing the consensus statement but has been active in the Diabetic Kidney Disease Collaborative of the American Society of Nephrology, another group promoting a more aggressive multidrug-class approach to treating CKD in people with diabetes.
 

Wider use of costly drugs

Adoption of this evidence-based approach by U.S. clinicians will both increase the number of agents that many patients receive and drive a significant uptick in the cost and complexity of patient care, a consequence acknowledged by the authors of the joint statement as well as outside experts.

But they view this as unavoidable given what’s now known about the high incidence of worsening CKD in patients with diabetes and the types of interventions proven to blunt this.

Much of the financial implication stems from the price of agents from the new drug classes now emphasized in the consensus recommendations – SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists. All these drugs currently remain on-patent with relatively expensive retail prices in the range of about $600 to $1,000/month.

Commenting on the cost concerns, Dr. Mottl highlighted that she currently has several patients in her practice on agents from two or more of these newer classes, and she has generally found it possible for patients to get much of their expenses covered by insurers and through drug-company assistance programs.

“The major gap is patients on Medicare,” she noted in an interview, because the Federal health insurance program does not allow beneficiaries to receive rebates for their drug costs. “The Diabetic Kidney Disease Collaborative is currently lobbying members of Congress to lift that barrier,” she emphasized.
 

Improved alignment

Details of the KDIGO recommendations feature in a guideline from that organization that appeared as a draft document online in March 2022. The ADA’s version recently appeared as an update to its Standards of Medical Care in Diabetes – 2022, as reported by this news organization. A panel of five KDIGO representatives and four members appointed by the ADA produced the harmonization statement.

Recommendations from both organizations were largely in agreement at the outset, but following the panel’s review, the two groups are now “very well-aligned,” said Peter Rossing, MD, DMSc, a diabetologist and professor at the Steno Diabetes Center, Copenhagen, and a KDIGO representative to the writing committee, who presented the joint statement at the ADA meeting.

“These are very important drugs that are vastly underused,” commented Josef Coresh, MD, PhD, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in CKD and was not involved with the new statement.

“Coherence and simplicity are what we need so that there are no excuses about moving forward” with the recommended combination treatment, he stressed.

Moving too slow

“No one is resisting using these new medications, but they are just moving too slowly, and data now show that it’s moving more slowly in the United States than elsewhere. That may be partly because U.S. patients are charged much more for these drugs, and partly because U.S. health care is so much more fragmented,” Dr. Coresh said in an interview.

The new joint consensus statement may help, “but the fragmentation of the United States system and COVID-19 are big enemies” for any short-term increased use of the highlighted agents, he added.

Evidence for low U.S. use of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists is becoming well known.

Dr. Rossing cited a 2019 report from the CURE-CKD registry of more than 600,000 U.S. patients with CKD showing that less than 1% received an SGLT2 inhibitor and less than 1% a GLP-1 receptor agonist. Not all these patients had diabetes, but a subgroup analysis of those with diabetes, prediabetes, or hypertension showed that usage of each of these two classes remained at less than 1% even in this group.

A separate report at the ADA meeting documented that of more than 1.3 million people with type 2 diabetes in the U.S. Veterans Affairs Healthcare System during 2019 and 2020, just 10% received an SGLT2 inhibitor and 7% a GLP-1 receptor agonist. And this is in a setting where drug cost is not a limiting factor.

In addition to focusing on the updated scheme for drug intervention in the consensus statement, Dr. Rossing highlighted several other important points that the writing committee emphasized.

Lifestyle optimization is a core first-line element of managing patients with diabetes and CKD, including a healthy diet, exercise, smoking cessation, and weight control. Other key steps for management include optimization of blood pressure, glucose, and lipids. The statement also calls out a potentially helpful role for continuous glucose monitoring in patients with type 1 or type 2 diabetes and CKD.

The statement notes that patients who also have atherosclerotic cardiovascular disease usually qualify for and could potentially benefit from more intensified lipid management with ezetimibe or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, as well as a potential role for treatment with antiplatelet agents.
 

‘If you don’t screen, you won’t find it’

Dr. Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2, as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol), have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place, recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

“If you don’t screen, you won’t find it, and you won’t be able to treat,” Dr. Rossing warned. He also highlighted the panel’s recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that “discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices,” write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Dr. Tuttle, who is executive director for research at Providence Healthcare, Spokane, Washington, and a KDIGO representative on the statement writing panel.

Dr. Mottl has reported being a consultant to Bayer. Dr. Rossing has reported being a consultant to or speaker on behalf of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, MSD, Mundipharma, Novo Nordisk, Sanofi Aventis, and Vifor, as well as receiving research grants from AstraZeneca and Novo Nordisk. Dr. Coresh has reported no relevant financial relationships. Dr. Tuttle has reported being a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Goldfinch Bio, Janssen, Novo Nordisk, and Travere; receiving honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Novo Nordisk, and Travere; and receiving research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, Goldfinch Bio, Novo Nordisk, and Travere.

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

ATLANTA – U.S. clinicians caring for people with diabetes should take a more aggressive approach to using combined medical treatments proven to slow the otherwise relentless progression of chronic kidney disease (CKD), according to a new joint statement by the American Diabetes Association and a major international nephrology organization presented during the annual scientific sessions of the American Diabetes Association (ADA).

The statement elevates treatment with an agent from the sodium-glucose cotransporter 2 (SGLT2) inhibitor class to first-line for people with diabetes and laboratory-based evidence of advancing CKD. It also re-emphasizes the key role of concurrent first-line treatment with a renin-angiotensin system inhibitor (an ACE inhibitor or angiotensin-receptor blocker), metformin, and a statin.

The new statement also urges clinicians to rapidly add treatment with the new nonsteroidal mineralocorticoid receptor antagonist finerenone (Kerendia) for further renal protection in the many patients suitable for treatment with this agent, and it recommends the second-line addition of a glucagon-like peptide-1 (GLP-1) receptor agonist as the best add-on for any patient who needs additional glycemic control on top of metformin and an SGLT2 inhibitor.

The consensus joint statement with these updates came from a nine-member writing group assembled by the ADA and the Kidney Disease: Improving Global Outcomes (KDIGO) organization.

“We’re going to try to make this feasible. We have to; I don’t think we have a choice,” commented Amy K. Mottl, MD, a nephrologist at the University of North Carolina, Chapel Hill. Dr. Mottl was not involved with writing the consensus statement but has been active in the Diabetic Kidney Disease Collaborative of the American Society of Nephrology, another group promoting a more aggressive multidrug-class approach to treating CKD in people with diabetes.
 

Wider use of costly drugs

Adoption of this evidence-based approach by U.S. clinicians will both increase the number of agents that many patients receive and drive a significant uptick in the cost and complexity of patient care, a consequence acknowledged by the authors of the joint statement as well as outside experts.

But they view this as unavoidable given what’s now known about the high incidence of worsening CKD in patients with diabetes and the types of interventions proven to blunt this.

Much of the financial implication stems from the price of agents from the new drug classes now emphasized in the consensus recommendations – SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists. All these drugs currently remain on-patent with relatively expensive retail prices in the range of about $600 to $1,000/month.

Commenting on the cost concerns, Dr. Mottl highlighted that she currently has several patients in her practice on agents from two or more of these newer classes, and she has generally found it possible for patients to get much of their expenses covered by insurers and through drug-company assistance programs.

“The major gap is patients on Medicare,” she noted in an interview, because the Federal health insurance program does not allow beneficiaries to receive rebates for their drug costs. “The Diabetic Kidney Disease Collaborative is currently lobbying members of Congress to lift that barrier,” she emphasized.
 

Improved alignment

Details of the KDIGO recommendations feature in a guideline from that organization that appeared as a draft document online in March 2022. The ADA’s version recently appeared as an update to its Standards of Medical Care in Diabetes – 2022, as reported by this news organization. A panel of five KDIGO representatives and four members appointed by the ADA produced the harmonization statement.

Recommendations from both organizations were largely in agreement at the outset, but following the panel’s review, the two groups are now “very well-aligned,” said Peter Rossing, MD, DMSc, a diabetologist and professor at the Steno Diabetes Center, Copenhagen, and a KDIGO representative to the writing committee, who presented the joint statement at the ADA meeting.

“These are very important drugs that are vastly underused,” commented Josef Coresh, MD, PhD, an epidemiologist and professor at Johns Hopkins Bloomberg School of Public Health, Baltimore, who specializes in CKD and was not involved with the new statement.

“Coherence and simplicity are what we need so that there are no excuses about moving forward” with the recommended combination treatment, he stressed.

Moving too slow

“No one is resisting using these new medications, but they are just moving too slowly, and data now show that it’s moving more slowly in the United States than elsewhere. That may be partly because U.S. patients are charged much more for these drugs, and partly because U.S. health care is so much more fragmented,” Dr. Coresh said in an interview.

The new joint consensus statement may help, “but the fragmentation of the United States system and COVID-19 are big enemies” for any short-term increased use of the highlighted agents, he added.

Evidence for low U.S. use of SGLT2 inhibitors, finerenone, and GLP-1 receptor agonists is becoming well known.

Dr. Rossing cited a 2019 report from the CURE-CKD registry of more than 600,000 U.S. patients with CKD showing that less than 1% received an SGLT2 inhibitor and less than 1% a GLP-1 receptor agonist. Not all these patients had diabetes, but a subgroup analysis of those with diabetes, prediabetes, or hypertension showed that usage of each of these two classes remained at less than 1% even in this group.

A separate report at the ADA meeting documented that of more than 1.3 million people with type 2 diabetes in the U.S. Veterans Affairs Healthcare System during 2019 and 2020, just 10% received an SGLT2 inhibitor and 7% a GLP-1 receptor agonist. And this is in a setting where drug cost is not a limiting factor.

In addition to focusing on the updated scheme for drug intervention in the consensus statement, Dr. Rossing highlighted several other important points that the writing committee emphasized.

Lifestyle optimization is a core first-line element of managing patients with diabetes and CKD, including a healthy diet, exercise, smoking cessation, and weight control. Other key steps for management include optimization of blood pressure, glucose, and lipids. The statement also calls out a potentially helpful role for continuous glucose monitoring in patients with type 1 or type 2 diabetes and CKD.

The statement notes that patients who also have atherosclerotic cardiovascular disease usually qualify for and could potentially benefit from more intensified lipid management with ezetimibe or a PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor, as well as a potential role for treatment with antiplatelet agents.
 

‘If you don’t screen, you won’t find it’

Dr. Rossing also stressed the importance of regular screening for the onset of advanced CKD in patients. Patients whose estimated glomerular filtration rate (eGFR) drops below 60 mL/min/1.73m2, as well as those who develop microalbuminuria with a urinary albumin-to-creatinine ratio of at least 30 mg/g (30 mg/mmol), have a stage of CKD that warrants the drug interventions he outlined.

Guidelines from both the ADA and KDIGO were already in place, recommending annual screening of patients with diabetes for both these parameters starting at diagnosis of type 2 diabetes or 5 years following initial diagnosis of type 1 diabetes.

“If you don’t screen, you won’t find it, and you won’t be able to treat,” Dr. Rossing warned. He also highlighted the panel’s recommendation to treat these patients with an SGLT2 inhibitor as long as their eGFR is at least 20 mL/min/1.73m2. Treatment can then continue even when their eGFR drops lower.

Starting treatment with finerenone requires that patients have a normal level of serum potassium, he emphasized.

One reason for developing the new ADA and KDIGO statement is that “discrepancies in clinical practice guideline recommendations from various professional organizations add to confusion that impedes understanding of best practices,” write Katherine R. Tuttle, MD, and associates in a recent commentary.

The goal of the new statement is to harmonize and promote the shared recommendations of the two organizations, added Dr. Tuttle, who is executive director for research at Providence Healthcare, Spokane, Washington, and a KDIGO representative on the statement writing panel.

Dr. Mottl has reported being a consultant to Bayer. Dr. Rossing has reported being a consultant to or speaker on behalf of Astellas, AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, MSD, Mundipharma, Novo Nordisk, Sanofi Aventis, and Vifor, as well as receiving research grants from AstraZeneca and Novo Nordisk. Dr. Coresh has reported no relevant financial relationships. Dr. Tuttle has reported being a consultant to AstraZeneca, Bayer, Boehringer Ingelheim, Goldfinch Bio, Janssen, Novo Nordisk, and Travere; receiving honoraria from AstraZeneca, Bayer, Boehringer Ingelheim, Gilead, Goldfinch Bio, Novo Nordisk, and Travere; and receiving research funding from AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, Gilead, Goldfinch Bio, Novo Nordisk, and Travere.

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