For the near future, it is hard to imagine anything having a larger impact on children’s health than the need to reopen schools.

There are many social determinants of health and many of those have been, appropriately, more strongly tied to schools than to health care. Academics are important, and those are best delivered by trained educators. Nutrition is important; hot lunch programs play an important role in ensuring children don’t go hungry. Schools are a major source of day care that allows parent(s) to work and to have a career through which family income potentials increase. Schools are a location for children to socialize, to form friendships, to participate in teams, and to promote wellness. This is only a partial list, but I’m preaching to the choir with this column.

Science, though imperfect, has advanced in the 1 year since the shutdown. I am thrilled to see policy makers embracing a scientific basis for policy making. (I’ll be more thrilled if it actually happens.) There is now accumulated evidence of harm associated with children not being in schools. There is accumulated evidence that the absolute magnitude of illness transmitted in elementary schools is small, though I can’t find any researcher defining what is small enough. There is accumulated evidence that the risk of transmission of COVID-19 in schools can be mitigated with a variety of interventions that include wearing masks, spacing desks, cohorting in small classes, good ventilation, and vaccines for the teachers. It is, however, unclear how much benefit comes from each intervention. That uncertainty makes it difficult for parents and teachers to assess whether, given limited financial resources, individual school districts have prepared adequately. Teachers, like pediatricians, are dedicated to doing what is best for children. Both teachers and pediatricians are aware that sometimes administrators and politicians take unfair advantage of this commitment to children.

There is an expectation that, with 130,000 schools in the United States, some fraction of them will have outbreaks that will generate illnesses, deaths, and bad publicity. The number and degree of these outbreaks will be best mitigated by lowering the number of new cases per day in the community. Estimates are that 89%-99% of children live in so-called red zones under the Centers for Disease Control and Prevention’s guidance – meaning there is a high level of community spread of the virus. In mid-February, the CDC released new guidelines for mitigating transmission within the schools. Those guidelines seemed to make it unlikely that schools in red zones could safely reopen, but over the following week, CDC Director Rochelle Walensky walked back that notion.

So, is it “safe” to reopen the schools? As a pediatrician, I have read more on this subject than the vast majority of people in my city. I have discussed the subject with colleagues who are far more informed than I. Still, I am in not in a position to synthesize all that research. I cannot advise neighbors, parents, or church groups about this subject. This column is not going to propose a solution. I will suggest a process based on professionalism and medical ethics.

The actors in this process need to be trustworthy. Medical residents are taught that patients/parents first need to see that you are committed (to benefiting them) before they can see that you are competent. Trust in the relationship with patients is maintained with truthfulness, by embracing the professional responsibilities of a fiduciary, and by expressing commitment and compassion.

Facts should be determined based on sound science. Values should be determined with input from all stakeholders. Decision-making based on facts and values should occur transparently within trusted institutions.

Which institutions should we trust?

My recommendation, biased by my experience, is to trust the CDC. It is composed of full-time, well-funded researchers (in basic science, in medicine, and in public health policy) who have dedicated years toward lofty goals. The CDC policy-making system has recently been pressured by inappropriate political maneuvering that has shaded its integrity.

The American Academy of Pediatrics has also been providing guidance favoring reopening schools. Its committees are mostly composed of volunteers dedicated to improving the health of children. I’ve become slightly jaded by participation in the sausage-making behind its policy statements. I doubt that teachers are reassured by focusing attention on the AAP’s claims to advocate for children.

State education boards contain experts dedicated to the well-being of children. Local boards of education have less expertise and less ability to resist political persuasion, but offer disseminated decision-making.

Will parents and children heed the advice? So far, there are stories that schools which have reopened with optional and hybrid models have not seen the return of the masses. There are also many stories of schools that have stayed open throughout the pandemic without catastrophic consequences. In the near future, I would not expect more science to be persuasive. Finding a way forward will be more dependent on rebuilding trust in institutions.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

For the near future, it is hard to imagine anything having a larger impact on children’s health than the need to reopen schools.

There are many social determinants of health and many of those have been, appropriately, more strongly tied to schools than to health care. Academics are important, and those are best delivered by trained educators. Nutrition is important; hot lunch programs play an important role in ensuring children don’t go hungry. Schools are a major source of day care that allows parent(s) to work and to have a career through which family income potentials increase. Schools are a location for children to socialize, to form friendships, to participate in teams, and to promote wellness. This is only a partial list, but I’m preaching to the choir with this column.

Science, though imperfect, has advanced in the 1 year since the shutdown. I am thrilled to see policy makers embracing a scientific basis for policy making. (I’ll be more thrilled if it actually happens.) There is now accumulated evidence of harm associated with children not being in schools. There is accumulated evidence that the absolute magnitude of illness transmitted in elementary schools is small, though I can’t find any researcher defining what is small enough. There is accumulated evidence that the risk of transmission of COVID-19 in schools can be mitigated with a variety of interventions that include wearing masks, spacing desks, cohorting in small classes, good ventilation, and vaccines for the teachers. It is, however, unclear how much benefit comes from each intervention. That uncertainty makes it difficult for parents and teachers to assess whether, given limited financial resources, individual school districts have prepared adequately. Teachers, like pediatricians, are dedicated to doing what is best for children. Both teachers and pediatricians are aware that sometimes administrators and politicians take unfair advantage of this commitment to children.

There is an expectation that, with 130,000 schools in the United States, some fraction of them will have outbreaks that will generate illnesses, deaths, and bad publicity. The number and degree of these outbreaks will be best mitigated by lowering the number of new cases per day in the community. Estimates are that 89%-99% of children live in so-called red zones under the Centers for Disease Control and Prevention’s guidance – meaning there is a high level of community spread of the virus. In mid-February, the CDC released new guidelines for mitigating transmission within the schools. Those guidelines seemed to make it unlikely that schools in red zones could safely reopen, but over the following week, CDC Director Rochelle Walensky walked back that notion.

So, is it “safe” to reopen the schools? As a pediatrician, I have read more on this subject than the vast majority of people in my city. I have discussed the subject with colleagues who are far more informed than I. Still, I am in not in a position to synthesize all that research. I cannot advise neighbors, parents, or church groups about this subject. This column is not going to propose a solution. I will suggest a process based on professionalism and medical ethics.

The actors in this process need to be trustworthy. Medical residents are taught that patients/parents first need to see that you are committed (to benefiting them) before they can see that you are competent. Trust in the relationship with patients is maintained with truthfulness, by embracing the professional responsibilities of a fiduciary, and by expressing commitment and compassion.

Facts should be determined based on sound science. Values should be determined with input from all stakeholders. Decision-making based on facts and values should occur transparently within trusted institutions.

Which institutions should we trust?

My recommendation, biased by my experience, is to trust the CDC. It is composed of full-time, well-funded researchers (in basic science, in medicine, and in public health policy) who have dedicated years toward lofty goals. The CDC policy-making system has recently been pressured by inappropriate political maneuvering that has shaded its integrity.

The American Academy of Pediatrics has also been providing guidance favoring reopening schools. Its committees are mostly composed of volunteers dedicated to improving the health of children. I’ve become slightly jaded by participation in the sausage-making behind its policy statements. I doubt that teachers are reassured by focusing attention on the AAP’s claims to advocate for children.

State education boards contain experts dedicated to the well-being of children. Local boards of education have less expertise and less ability to resist political persuasion, but offer disseminated decision-making.

Will parents and children heed the advice? So far, there are stories that schools which have reopened with optional and hybrid models have not seen the return of the masses. There are also many stories of schools that have stayed open throughout the pandemic without catastrophic consequences. In the near future, I would not expect more science to be persuasive. Finding a way forward will be more dependent on rebuilding trust in institutions.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

For the near future, it is hard to imagine anything having a larger impact on children’s health than the need to reopen schools.

There are many social determinants of health and many of those have been, appropriately, more strongly tied to schools than to health care. Academics are important, and those are best delivered by trained educators. Nutrition is important; hot lunch programs play an important role in ensuring children don’t go hungry. Schools are a major source of day care that allows parent(s) to work and to have a career through which family income potentials increase. Schools are a location for children to socialize, to form friendships, to participate in teams, and to promote wellness. This is only a partial list, but I’m preaching to the choir with this column.

Science, though imperfect, has advanced in the 1 year since the shutdown. I am thrilled to see policy makers embracing a scientific basis for policy making. (I’ll be more thrilled if it actually happens.) There is now accumulated evidence of harm associated with children not being in schools. There is accumulated evidence that the absolute magnitude of illness transmitted in elementary schools is small, though I can’t find any researcher defining what is small enough. There is accumulated evidence that the risk of transmission of COVID-19 in schools can be mitigated with a variety of interventions that include wearing masks, spacing desks, cohorting in small classes, good ventilation, and vaccines for the teachers. It is, however, unclear how much benefit comes from each intervention. That uncertainty makes it difficult for parents and teachers to assess whether, given limited financial resources, individual school districts have prepared adequately. Teachers, like pediatricians, are dedicated to doing what is best for children. Both teachers and pediatricians are aware that sometimes administrators and politicians take unfair advantage of this commitment to children.

There is an expectation that, with 130,000 schools in the United States, some fraction of them will have outbreaks that will generate illnesses, deaths, and bad publicity. The number and degree of these outbreaks will be best mitigated by lowering the number of new cases per day in the community. Estimates are that 89%-99% of children live in so-called red zones under the Centers for Disease Control and Prevention’s guidance – meaning there is a high level of community spread of the virus. In mid-February, the CDC released new guidelines for mitigating transmission within the schools. Those guidelines seemed to make it unlikely that schools in red zones could safely reopen, but over the following week, CDC Director Rochelle Walensky walked back that notion.

So, is it “safe” to reopen the schools? As a pediatrician, I have read more on this subject than the vast majority of people in my city. I have discussed the subject with colleagues who are far more informed than I. Still, I am in not in a position to synthesize all that research. I cannot advise neighbors, parents, or church groups about this subject. This column is not going to propose a solution. I will suggest a process based on professionalism and medical ethics.

The actors in this process need to be trustworthy. Medical residents are taught that patients/parents first need to see that you are committed (to benefiting them) before they can see that you are competent. Trust in the relationship with patients is maintained with truthfulness, by embracing the professional responsibilities of a fiduciary, and by expressing commitment and compassion.

Facts should be determined based on sound science. Values should be determined with input from all stakeholders. Decision-making based on facts and values should occur transparently within trusted institutions.

Which institutions should we trust?

My recommendation, biased by my experience, is to trust the CDC. It is composed of full-time, well-funded researchers (in basic science, in medicine, and in public health policy) who have dedicated years toward lofty goals. The CDC policy-making system has recently been pressured by inappropriate political maneuvering that has shaded its integrity.

The American Academy of Pediatrics has also been providing guidance favoring reopening schools. Its committees are mostly composed of volunteers dedicated to improving the health of children. I’ve become slightly jaded by participation in the sausage-making behind its policy statements. I doubt that teachers are reassured by focusing attention on the AAP’s claims to advocate for children.

State education boards contain experts dedicated to the well-being of children. Local boards of education have less expertise and less ability to resist political persuasion, but offer disseminated decision-making.

Will parents and children heed the advice? So far, there are stories that schools which have reopened with optional and hybrid models have not seen the return of the masses. There are also many stories of schools that have stayed open throughout the pandemic without catastrophic consequences. In the near future, I would not expect more science to be persuasive. Finding a way forward will be more dependent on rebuilding trust in institutions.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.

Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus. Many medications have been touted as cures, even when doctors and scientists say they don’t work.

Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.

The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
 

NIH updates treatment guidelines

A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.

Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.

In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.

In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
 

Hydroxychloroquine and casirivimab + imdevimab

One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.

Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.

Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.

Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus. Many medications have been touted as cures, even when doctors and scientists say they don’t work.

Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.

The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
 

NIH updates treatment guidelines

A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.

Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.

In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.

In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
 

Hydroxychloroquine and casirivimab + imdevimab

One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.

Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.

Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

Recommendations, as well as conspiracy theories about COVID-19, have changed at distressing rates over the past year. No disease has ever been more politicized, or more polarizing.

Experts, as well as the least educated, take a stand on what they believe is the most important way to prevent and treat this virus. Many medications have been touted as cures, even when doctors and scientists say they don’t work.

Just recently, a study was published revealing that ivermectin is not effective as a COVID-19 treatment while people continue to claim it works. It has never been more important for doctors, and especially family physicians, to have accurate and updated guidelines.

The NIH and CDC have been publishing recommendations and guidelines for the prevention and treatment of COVID-19 since the start of the pandemic. Like any new disease, these have been changing to keep up as new knowledge related to the disease becomes available.
 

NIH updates treatment guidelines

A recent update to the NIH COVID-19 treatment guidelines was published on March 5, 2021. While the complete guidelines are quite extensive, spanning over 200 pages, it’s most important to understand the most recent updates in them.

Since preventative medicine is an integral part of primary care, it is important to note that no medications have been advised to prevent infection with COVID-19. In fact, taking drugs for pre-exposure prophylaxis (PrEp) is not recommended even in the highest-risk patients, such as health care workers.

In the updated guidelines, tocilizumab in a single IV dose of 8 mg/kg up to a maximum of 800 mg can be given only in combination with dexamethasone (or equivalent corticosteroid) in certain hospitalized patients exhibiting rapid respiratory decompensation. These patients include recently hospitalized patients who have been admitted to the ICU within the previous 24 hours and now require mechanical ventilation or high-flow oxygen via nasal cannula. Those not in the ICU who require rapidly increasing oxygen levels and have significantly increased levels of inflammatory markers should also receive this therapy. In the new guidance, the NIH recommends treating other hospitalized patients who require oxygen with remdesivir, remdesivir + dexamethasone, or dexamethasone alone.

In outpatients, those who have mild to moderate infection and are at increased risk of developing severe disease and/or hospitalization can be treated with bamlanivimab 700 mg + etesevimab 1,400 mg. This should be started as soon as possible after a confirmed diagnosis and within 10 days of symptom onset, according to the NIH recommendations. There is no evidence to support its use in patients hospitalized because of infection. However, it can be used in patients hospitalized for other reasons who have mild to moderate infection, but should be reserved – because of limited supply – for those with the highest risk of complications.
 

Hydroxychloroquine and casirivimab + imdevimab

One medication that has been touted in the media as a tool to treat COVID-19 has been hydroxychloroquine. Past guidelines recommended against this medication as a treatment because it lacked efficacy and posed risks for no therapeutic benefit. The most recent guidelines also recommend against the use of hydroxychloroquine for pre- and postexposure prophylaxis.

Casirivimab + imdevimab has been another talked about therapy. However, current guidelines recommend against its use in hospitalized patients. In addition, it is advised that hospitalized patients be enrolled in a clinical trial to receive it.

Since the pandemic began, the world has seen more than 120 million infections and more than 2 million deaths. Family physicians have a vital role to play as we are often the first ones patients turn to for treatment and advice. It is imperative we stay current with the guidelines and follow the most recent updates as research data are published.
 

Dr. Girgis practices family medicine in South River, N.J., and is a clinical assistant professor of family medicine at Robert Wood Johnson Medical School, New Brunswick, N.J. You can contact her at [email protected].

U.S. regulators are stepping up scrutiny of therapies that were granted an accelerated approval to treat cancers on the basis of surrogate endpoints but have failed to show clinical or survival benefits upon more extensive testing.

At issue are a number of cancer indications for immunotherapies. Four have already been withdrawn (voluntarily by the manufacturer), and six more will be reviewed at an upcoming meeting.

In recent years, the US Food and Drug Administration has granted accelerated approvals to oncology medicines on the basis of evidence that suggests a benefit for patients. Examples of such evidence relate to response rates and estimates of tumor shrinkage. But these approvals are granted on the condition that the manufacturer conducts larger clinical trials that show clinical benefit, including benefit in overall survival.

Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, has argued that the point of these conditional approvals is to find acceptable surrogate markers to allow people with “desperate illnesses” to have access to potentially helpful drugs while work continues to determine the drug’s actual benefit to patients.

Oncologists are now questioning whether the FDA has become too lenient in its approach, Daniel A. Goldstein, MD, a senior physician in medical oncology and internal medicine at the Rabin Medical Center, Petah Tikva, Israel, told this news organization.

“The main two things you want from a cancer drug is to live longer and live a higher quality of life,” said Goldstein. “But these endpoints that they’ve been using over the past few years are not really giving us confidence that these drugs are actually going to help to live longer or better.”

Dr. Pazdur said the FDA will consider withdrawing its accelerated approvals when results of further studies do not confirm expected benefit for patients.

“This is like the pendulum has swung as far as it was going to swing and now is on the backswing,” said Dr. Goldstein, also of the department of health policy and management at the University of North Carolina at Chapel Hill. “You could call this a watershed moment.”

Although there’s near universal interest in allowing people with advanced cancer access to promising medicines, there’s also rising concern about exposing patients needlessly to costly drugs with potentially tough side effects. That may prompt a shift in the standards U.S. regulators apply to cancer medicines, Dr. Goldstein said.
 

Indications withdrawn and under review

In a meeting scheduled for April 27-29, the FDA’s Oncologic Drugs Advisory Committee will review indications granted through the accelerated approval process for three immunotherapies: pembrolizumab (Keytruda), atezolizumab (Tecentriq), and nivolumab (Opdivo).

It is part of an industry-wide evaluation of accelerated approvals for cancer indications in which confirmatory trials did not confirm clinical benefit, the FDA noted.

The process has already led to voluntary withdrawals of four cancer indications by the manufacturers, including one indication each for pembrolizumab, atezolizumab, and nivolumab, and one for durvalumab (Imfinzi).

All of these immunotherapies are approved for numerous cancer indications, and they all remain on the market. It is only the U.S. approvals for particular cancer indications that have been withdrawn.

In the past, olaratumab (Lartruvo) was withdrawn from the market altogether. The FDA granted accelerated approval of the drug for soft tissue sarcoma, but clinical benefit was not confirmed in a phase 3 trial.
 

Issue highlighted by Dr. Prasad and Dr. Gyawali

In recent years, much of the attention on accelerated approvals was spurred by the work of a few researchers, particularly Vinay Prasad, MD, MPH, associate professor in the department of epidemiology and biostatistics, University of California, San Francisco, and Bishal Gyawali, MD, PhD, from Queen’s University Cancer Research Institute, Kingston, Ont. (Both are regular contributors to the oncology section of this news organization.)

Dr. Goldstein made this point in a tweet about the FDA’s announcement of the April ODAC meetings:

“Well done to @oncology_bg and @VPrasadMDMPH among others for highlighting in their papers that the FDA wasn’t properly evaluating accelerated approval drugs.

FDA have listened.

And I thought that the impact of academia was limited!”

Dr. Prasad has made the case for closer scrutiny of accelerated approvals in a number of journal articles and in his 2020 book, “Malignant: How Bad Policy and Bad Evidence Harm People with Cancer,” published by Johns Hopkins University Press.

The book includes highlights of a 2016 article published in Mayo Clinic Proceedings that focused on surrogate endpoints used for FDA approvals. In the article, Dr. Prasad and his coauthor report that they did not find formal analyses of the strength of the surrogate-survival correlation in 14 of 25 cases of accelerated approvals (56%) and in 11 of 30 traditional approvals (37%).

“Our results were concerning. They imply that many surrogates are based on little more than a gut feeling. You might rationalize that and argue a gut feeling is the same as ‘reasonably likely to predict,’ but no reasonable person could think a gut feeling means established,” Dr. Prasad writes in his book. “Our result suggests the FDA is using surrogate endpoints far beyond what may be fair or reasonable.”

Dr. Gyawali has argued that the process by which the FDA assesses cancer drugs for approvals has undergone a profound shift. He has most recently remarked on this in an October 2020 commentary on Medscape.

“Until the recent floodgate of approvals based on response rates from single-arm trials, the majority of cancer therapy decisions were supported by evidence generated from randomized controlled trials (RCTs),” Dr. Gyawali wrote. “The evidence base to support clinical decisions in managing therapeutic side effects has been comparatively sparse.”
 

Accelerated approval to improve access

The FDA has struggled for about 2 decades with questions of where to set the bar on evidence for promising cancer drugs.

The agency’s accelerated approval program for drugs began in 1992. During the first decade, the focus was largely on medicines related to HIV.

In the early 2000s, oncology drugs began to dominate the program.

Dr. Pazdur has presided over the FDA’s marked changes regarding the use of surrogate markers when weighing whether to allow sales of cancer medicines. Formerly a professor at the University of Texas MD Anderson Cancer Center, Houston, Dr. Pazdur joined the FDA as director of the Division of Oncology Drug Products in 1999.

Soon after his appointment, he had to field inquiries from pharmaceutical companies about how much evidence they needed to receive accelerated approvals.

Early on, he publicly expressed impatience about the drugmakers’ approach. “The purpose of accelerated approval was not accelerated drug company profits,” Dr. Padzur said at a 2004 ODAC meeting.

Rather, the point is to allow access to potentially helpful drugs while work continues to determine their actual benefit to patients, he explained.

“It wasn’t a license to do less, less, less, and less to a point now that we may be getting companies that are coming in” intent on determining the minimum evidence the FDA will take, Dr. Pazdur said. “It shouldn’t be what is the lowest. It is what is a sufficient amount to give patients and physicians a real understanding of what their drug will do.”

In a 2016 interview with The New York Times, Dr. Pazdur said that his views on cancer drug approvals have evolved with time. He described himself as being “on a jihad to streamline the review process and get things out the door faster.”

“I have evolved from regulator to regulator-advocate,” Dr. Pazdur told the newspaper.

His attitude reflected his personal experience in losing his wife to ovarian cancer in 2015, as well as shifts in science and law. In 2012, Congress passed a law that gave the FDA new resources to speed medicines for life-threatening diseases to market. In addition, advances in genetics appeared to be making some medications more effective and easier to test, Dr. Pazdur said in The New York Times interview.
 

Withdrawals seen as sign of success

Since the program’s inception, only 6% of accelerated approvals for oncology indications have been withdrawn, the FDA said.

It would be a sign that the program is working if the April meetings lead to further withdrawals of indications that have been granted accelerated approval, Julie R. Gralow, MD, chief medical officer of the American Society of Clinical Oncology, said in an interview with this news organization.

“It shouldn’t be seen as a failure,” Dr. Gralow said.

In her own practice at the Fred Hutchinson Cancer Research Center, Seattle, she has seen the value of emerging therapies for patients fighting advanced cancers. During her 25 years of clinical practice in an academic setting, she has gained access to drugs through single-patient investigative new drug applications.

However, this path is not an option for many patients who undergo treatment in facilities other than academic centers, she commented. She noted that the accelerated approval process is a way to expand access to emerging medicines, but she sees a need for caution in the use of drugs that have been given only this conditional approval. She emphasizes that such drugs may be suitable only for certain patients.

“I would say that, for metastatic patients, patients with incurable disease, we are willing to take some risk,” Dr. Gralow said. “We don’t have other options. They can’t wait the years that it would take to get a drug approved.”

One such patient is David Mitchell, who serves as the consumer representative on ODAC. He told this news organization that he is taking three drugs for multiple myeloma that received accelerated approvals: pomalidomide, bortezomib, and daratumumab.

“I want the FDA to have the option to approve drugs in an accelerated pathway, because as a patient taking three drugs granted accelerated approval, I’m benefiting – I’ve lived the benefit,” Mr. Mitchell said, “and I want other patients to have the opportunity to have that benefit.”

He believes that the FDA’s approach regarding accelerated approvals serves to get potentially beneficial medicines to patients who have few options and also fulfills the FDA’s mandate to protect the public from treatments that have little benefit but can cause harm.

Accelerated approval also offers needed flexibility to drugmakers as they develop more specifically targeted drugs for diseases that affect relatively few people, such as multiple myeloma, he said. “As the targeting of your therapies gets tighter and for smaller groups of patients, you have a harder time following the traditional model,” such as conducting large, double-blind, placebo-controlled trials that may indicate increased overall survival, he said.

“To me, this is the way the FDA intended it to work,” he added. “It’s going to offer the accelerated approval based on a surrogate endpoint for a safe drug, but it’s going to require the confirmatory trial, and if the confirmatory trial fails, it will pull the drug off the market.”

Some medicines that have received accelerated approvals may ultimately be found not to benefit patients, Mr. Mitchell acknowledged. But people in his situation, whose disease has progressed despite treatments, may want to take that risk, he added.


 

Four cancer indications recently withdrawn voluntarily by the manufacturer

• December 2020: Nivolumab for the treatment of patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy (Bristol Myers Squibb).
• February 2021: Durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (AstraZeneca).
• March 2021: Pembrolizumab for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy (Merck).
• March 2021: Atezolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing atezolizumab chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (Genentech).

Six cancer indications under review at the April 2021 ODAC meeting

• Atezolizumab indicated in combination with protein-bound  for the treatment of adults with unresectable locally advanced or metastatic triple-negative  whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.
• Atezolizumab indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Pembrolizumab indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Pembrolizumab indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score ≥1), as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
• Pembrolizumab indicated for the treatment of patients with  who have been previously treated with .
• Nivolumab indicated as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

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

U.S. regulators are stepping up scrutiny of therapies that were granted an accelerated approval to treat cancers on the basis of surrogate endpoints but have failed to show clinical or survival benefits upon more extensive testing.

At issue are a number of cancer indications for immunotherapies. Four have already been withdrawn (voluntarily by the manufacturer), and six more will be reviewed at an upcoming meeting.

In recent years, the US Food and Drug Administration has granted accelerated approvals to oncology medicines on the basis of evidence that suggests a benefit for patients. Examples of such evidence relate to response rates and estimates of tumor shrinkage. But these approvals are granted on the condition that the manufacturer conducts larger clinical trials that show clinical benefit, including benefit in overall survival.

Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, has argued that the point of these conditional approvals is to find acceptable surrogate markers to allow people with “desperate illnesses” to have access to potentially helpful drugs while work continues to determine the drug’s actual benefit to patients.

Oncologists are now questioning whether the FDA has become too lenient in its approach, Daniel A. Goldstein, MD, a senior physician in medical oncology and internal medicine at the Rabin Medical Center, Petah Tikva, Israel, told this news organization.

“The main two things you want from a cancer drug is to live longer and live a higher quality of life,” said Goldstein. “But these endpoints that they’ve been using over the past few years are not really giving us confidence that these drugs are actually going to help to live longer or better.”

Dr. Pazdur said the FDA will consider withdrawing its accelerated approvals when results of further studies do not confirm expected benefit for patients.

“This is like the pendulum has swung as far as it was going to swing and now is on the backswing,” said Dr. Goldstein, also of the department of health policy and management at the University of North Carolina at Chapel Hill. “You could call this a watershed moment.”

Although there’s near universal interest in allowing people with advanced cancer access to promising medicines, there’s also rising concern about exposing patients needlessly to costly drugs with potentially tough side effects. That may prompt a shift in the standards U.S. regulators apply to cancer medicines, Dr. Goldstein said.
 

Indications withdrawn and under review

In a meeting scheduled for April 27-29, the FDA’s Oncologic Drugs Advisory Committee will review indications granted through the accelerated approval process for three immunotherapies: pembrolizumab (Keytruda), atezolizumab (Tecentriq), and nivolumab (Opdivo).

It is part of an industry-wide evaluation of accelerated approvals for cancer indications in which confirmatory trials did not confirm clinical benefit, the FDA noted.

The process has already led to voluntary withdrawals of four cancer indications by the manufacturers, including one indication each for pembrolizumab, atezolizumab, and nivolumab, and one for durvalumab (Imfinzi).

All of these immunotherapies are approved for numerous cancer indications, and they all remain on the market. It is only the U.S. approvals for particular cancer indications that have been withdrawn.

In the past, olaratumab (Lartruvo) was withdrawn from the market altogether. The FDA granted accelerated approval of the drug for soft tissue sarcoma, but clinical benefit was not confirmed in a phase 3 trial.
 

Issue highlighted by Dr. Prasad and Dr. Gyawali

In recent years, much of the attention on accelerated approvals was spurred by the work of a few researchers, particularly Vinay Prasad, MD, MPH, associate professor in the department of epidemiology and biostatistics, University of California, San Francisco, and Bishal Gyawali, MD, PhD, from Queen’s University Cancer Research Institute, Kingston, Ont. (Both are regular contributors to the oncology section of this news organization.)

Dr. Goldstein made this point in a tweet about the FDA’s announcement of the April ODAC meetings:

“Well done to @oncology_bg and @VPrasadMDMPH among others for highlighting in their papers that the FDA wasn’t properly evaluating accelerated approval drugs.

FDA have listened.

And I thought that the impact of academia was limited!”

Dr. Prasad has made the case for closer scrutiny of accelerated approvals in a number of journal articles and in his 2020 book, “Malignant: How Bad Policy and Bad Evidence Harm People with Cancer,” published by Johns Hopkins University Press.

The book includes highlights of a 2016 article published in Mayo Clinic Proceedings that focused on surrogate endpoints used for FDA approvals. In the article, Dr. Prasad and his coauthor report that they did not find formal analyses of the strength of the surrogate-survival correlation in 14 of 25 cases of accelerated approvals (56%) and in 11 of 30 traditional approvals (37%).

“Our results were concerning. They imply that many surrogates are based on little more than a gut feeling. You might rationalize that and argue a gut feeling is the same as ‘reasonably likely to predict,’ but no reasonable person could think a gut feeling means established,” Dr. Prasad writes in his book. “Our result suggests the FDA is using surrogate endpoints far beyond what may be fair or reasonable.”

Dr. Gyawali has argued that the process by which the FDA assesses cancer drugs for approvals has undergone a profound shift. He has most recently remarked on this in an October 2020 commentary on Medscape.

“Until the recent floodgate of approvals based on response rates from single-arm trials, the majority of cancer therapy decisions were supported by evidence generated from randomized controlled trials (RCTs),” Dr. Gyawali wrote. “The evidence base to support clinical decisions in managing therapeutic side effects has been comparatively sparse.”
 

Accelerated approval to improve access

The FDA has struggled for about 2 decades with questions of where to set the bar on evidence for promising cancer drugs.

The agency’s accelerated approval program for drugs began in 1992. During the first decade, the focus was largely on medicines related to HIV.

In the early 2000s, oncology drugs began to dominate the program.

Dr. Pazdur has presided over the FDA’s marked changes regarding the use of surrogate markers when weighing whether to allow sales of cancer medicines. Formerly a professor at the University of Texas MD Anderson Cancer Center, Houston, Dr. Pazdur joined the FDA as director of the Division of Oncology Drug Products in 1999.

Soon after his appointment, he had to field inquiries from pharmaceutical companies about how much evidence they needed to receive accelerated approvals.

Early on, he publicly expressed impatience about the drugmakers’ approach. “The purpose of accelerated approval was not accelerated drug company profits,” Dr. Padzur said at a 2004 ODAC meeting.

Rather, the point is to allow access to potentially helpful drugs while work continues to determine their actual benefit to patients, he explained.

“It wasn’t a license to do less, less, less, and less to a point now that we may be getting companies that are coming in” intent on determining the minimum evidence the FDA will take, Dr. Pazdur said. “It shouldn’t be what is the lowest. It is what is a sufficient amount to give patients and physicians a real understanding of what their drug will do.”

In a 2016 interview with The New York Times, Dr. Pazdur said that his views on cancer drug approvals have evolved with time. He described himself as being “on a jihad to streamline the review process and get things out the door faster.”

“I have evolved from regulator to regulator-advocate,” Dr. Pazdur told the newspaper.

His attitude reflected his personal experience in losing his wife to ovarian cancer in 2015, as well as shifts in science and law. In 2012, Congress passed a law that gave the FDA new resources to speed medicines for life-threatening diseases to market. In addition, advances in genetics appeared to be making some medications more effective and easier to test, Dr. Pazdur said in The New York Times interview.
 

Withdrawals seen as sign of success

Since the program’s inception, only 6% of accelerated approvals for oncology indications have been withdrawn, the FDA said.

It would be a sign that the program is working if the April meetings lead to further withdrawals of indications that have been granted accelerated approval, Julie R. Gralow, MD, chief medical officer of the American Society of Clinical Oncology, said in an interview with this news organization.

“It shouldn’t be seen as a failure,” Dr. Gralow said.

In her own practice at the Fred Hutchinson Cancer Research Center, Seattle, she has seen the value of emerging therapies for patients fighting advanced cancers. During her 25 years of clinical practice in an academic setting, she has gained access to drugs through single-patient investigative new drug applications.

However, this path is not an option for many patients who undergo treatment in facilities other than academic centers, she commented. She noted that the accelerated approval process is a way to expand access to emerging medicines, but she sees a need for caution in the use of drugs that have been given only this conditional approval. She emphasizes that such drugs may be suitable only for certain patients.

“I would say that, for metastatic patients, patients with incurable disease, we are willing to take some risk,” Dr. Gralow said. “We don’t have other options. They can’t wait the years that it would take to get a drug approved.”

One such patient is David Mitchell, who serves as the consumer representative on ODAC. He told this news organization that he is taking three drugs for multiple myeloma that received accelerated approvals: pomalidomide, bortezomib, and daratumumab.

“I want the FDA to have the option to approve drugs in an accelerated pathway, because as a patient taking three drugs granted accelerated approval, I’m benefiting – I’ve lived the benefit,” Mr. Mitchell said, “and I want other patients to have the opportunity to have that benefit.”

He believes that the FDA’s approach regarding accelerated approvals serves to get potentially beneficial medicines to patients who have few options and also fulfills the FDA’s mandate to protect the public from treatments that have little benefit but can cause harm.

Accelerated approval also offers needed flexibility to drugmakers as they develop more specifically targeted drugs for diseases that affect relatively few people, such as multiple myeloma, he said. “As the targeting of your therapies gets tighter and for smaller groups of patients, you have a harder time following the traditional model,” such as conducting large, double-blind, placebo-controlled trials that may indicate increased overall survival, he said.

“To me, this is the way the FDA intended it to work,” he added. “It’s going to offer the accelerated approval based on a surrogate endpoint for a safe drug, but it’s going to require the confirmatory trial, and if the confirmatory trial fails, it will pull the drug off the market.”

Some medicines that have received accelerated approvals may ultimately be found not to benefit patients, Mr. Mitchell acknowledged. But people in his situation, whose disease has progressed despite treatments, may want to take that risk, he added.


 

Four cancer indications recently withdrawn voluntarily by the manufacturer

• December 2020: Nivolumab for the treatment of patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy (Bristol Myers Squibb).
• February 2021: Durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (AstraZeneca).
• March 2021: Pembrolizumab for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy (Merck).
• March 2021: Atezolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing atezolizumab chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (Genentech).

Six cancer indications under review at the April 2021 ODAC meeting

• Atezolizumab indicated in combination with protein-bound  for the treatment of adults with unresectable locally advanced or metastatic triple-negative  whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.
• Atezolizumab indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Pembrolizumab indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Pembrolizumab indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score ≥1), as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
• Pembrolizumab indicated for the treatment of patients with  who have been previously treated with .
• Nivolumab indicated as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

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

U.S. regulators are stepping up scrutiny of therapies that were granted an accelerated approval to treat cancers on the basis of surrogate endpoints but have failed to show clinical or survival benefits upon more extensive testing.

At issue are a number of cancer indications for immunotherapies. Four have already been withdrawn (voluntarily by the manufacturer), and six more will be reviewed at an upcoming meeting.

In recent years, the US Food and Drug Administration has granted accelerated approvals to oncology medicines on the basis of evidence that suggests a benefit for patients. Examples of such evidence relate to response rates and estimates of tumor shrinkage. But these approvals are granted on the condition that the manufacturer conducts larger clinical trials that show clinical benefit, including benefit in overall survival.

Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence, has argued that the point of these conditional approvals is to find acceptable surrogate markers to allow people with “desperate illnesses” to have access to potentially helpful drugs while work continues to determine the drug’s actual benefit to patients.

Oncologists are now questioning whether the FDA has become too lenient in its approach, Daniel A. Goldstein, MD, a senior physician in medical oncology and internal medicine at the Rabin Medical Center, Petah Tikva, Israel, told this news organization.

“The main two things you want from a cancer drug is to live longer and live a higher quality of life,” said Goldstein. “But these endpoints that they’ve been using over the past few years are not really giving us confidence that these drugs are actually going to help to live longer or better.”

Dr. Pazdur said the FDA will consider withdrawing its accelerated approvals when results of further studies do not confirm expected benefit for patients.

“This is like the pendulum has swung as far as it was going to swing and now is on the backswing,” said Dr. Goldstein, also of the department of health policy and management at the University of North Carolina at Chapel Hill. “You could call this a watershed moment.”

Although there’s near universal interest in allowing people with advanced cancer access to promising medicines, there’s also rising concern about exposing patients needlessly to costly drugs with potentially tough side effects. That may prompt a shift in the standards U.S. regulators apply to cancer medicines, Dr. Goldstein said.
 

Indications withdrawn and under review

In a meeting scheduled for April 27-29, the FDA’s Oncologic Drugs Advisory Committee will review indications granted through the accelerated approval process for three immunotherapies: pembrolizumab (Keytruda), atezolizumab (Tecentriq), and nivolumab (Opdivo).

It is part of an industry-wide evaluation of accelerated approvals for cancer indications in which confirmatory trials did not confirm clinical benefit, the FDA noted.

The process has already led to voluntary withdrawals of four cancer indications by the manufacturers, including one indication each for pembrolizumab, atezolizumab, and nivolumab, and one for durvalumab (Imfinzi).

All of these immunotherapies are approved for numerous cancer indications, and they all remain on the market. It is only the U.S. approvals for particular cancer indications that have been withdrawn.

In the past, olaratumab (Lartruvo) was withdrawn from the market altogether. The FDA granted accelerated approval of the drug for soft tissue sarcoma, but clinical benefit was not confirmed in a phase 3 trial.
 

Issue highlighted by Dr. Prasad and Dr. Gyawali

In recent years, much of the attention on accelerated approvals was spurred by the work of a few researchers, particularly Vinay Prasad, MD, MPH, associate professor in the department of epidemiology and biostatistics, University of California, San Francisco, and Bishal Gyawali, MD, PhD, from Queen’s University Cancer Research Institute, Kingston, Ont. (Both are regular contributors to the oncology section of this news organization.)

Dr. Goldstein made this point in a tweet about the FDA’s announcement of the April ODAC meetings:

“Well done to @oncology_bg and @VPrasadMDMPH among others for highlighting in their papers that the FDA wasn’t properly evaluating accelerated approval drugs.

FDA have listened.

And I thought that the impact of academia was limited!”

Dr. Prasad has made the case for closer scrutiny of accelerated approvals in a number of journal articles and in his 2020 book, “Malignant: How Bad Policy and Bad Evidence Harm People with Cancer,” published by Johns Hopkins University Press.

The book includes highlights of a 2016 article published in Mayo Clinic Proceedings that focused on surrogate endpoints used for FDA approvals. In the article, Dr. Prasad and his coauthor report that they did not find formal analyses of the strength of the surrogate-survival correlation in 14 of 25 cases of accelerated approvals (56%) and in 11 of 30 traditional approvals (37%).

“Our results were concerning. They imply that many surrogates are based on little more than a gut feeling. You might rationalize that and argue a gut feeling is the same as ‘reasonably likely to predict,’ but no reasonable person could think a gut feeling means established,” Dr. Prasad writes in his book. “Our result suggests the FDA is using surrogate endpoints far beyond what may be fair or reasonable.”

Dr. Gyawali has argued that the process by which the FDA assesses cancer drugs for approvals has undergone a profound shift. He has most recently remarked on this in an October 2020 commentary on Medscape.

“Until the recent floodgate of approvals based on response rates from single-arm trials, the majority of cancer therapy decisions were supported by evidence generated from randomized controlled trials (RCTs),” Dr. Gyawali wrote. “The evidence base to support clinical decisions in managing therapeutic side effects has been comparatively sparse.”
 

Accelerated approval to improve access

The FDA has struggled for about 2 decades with questions of where to set the bar on evidence for promising cancer drugs.

The agency’s accelerated approval program for drugs began in 1992. During the first decade, the focus was largely on medicines related to HIV.

In the early 2000s, oncology drugs began to dominate the program.

Dr. Pazdur has presided over the FDA’s marked changes regarding the use of surrogate markers when weighing whether to allow sales of cancer medicines. Formerly a professor at the University of Texas MD Anderson Cancer Center, Houston, Dr. Pazdur joined the FDA as director of the Division of Oncology Drug Products in 1999.

Soon after his appointment, he had to field inquiries from pharmaceutical companies about how much evidence they needed to receive accelerated approvals.

Early on, he publicly expressed impatience about the drugmakers’ approach. “The purpose of accelerated approval was not accelerated drug company profits,” Dr. Padzur said at a 2004 ODAC meeting.

Rather, the point is to allow access to potentially helpful drugs while work continues to determine their actual benefit to patients, he explained.

“It wasn’t a license to do less, less, less, and less to a point now that we may be getting companies that are coming in” intent on determining the minimum evidence the FDA will take, Dr. Pazdur said. “It shouldn’t be what is the lowest. It is what is a sufficient amount to give patients and physicians a real understanding of what their drug will do.”

In a 2016 interview with The New York Times, Dr. Pazdur said that his views on cancer drug approvals have evolved with time. He described himself as being “on a jihad to streamline the review process and get things out the door faster.”

“I have evolved from regulator to regulator-advocate,” Dr. Pazdur told the newspaper.

His attitude reflected his personal experience in losing his wife to ovarian cancer in 2015, as well as shifts in science and law. In 2012, Congress passed a law that gave the FDA new resources to speed medicines for life-threatening diseases to market. In addition, advances in genetics appeared to be making some medications more effective and easier to test, Dr. Pazdur said in The New York Times interview.
 

Withdrawals seen as sign of success

Since the program’s inception, only 6% of accelerated approvals for oncology indications have been withdrawn, the FDA said.

It would be a sign that the program is working if the April meetings lead to further withdrawals of indications that have been granted accelerated approval, Julie R. Gralow, MD, chief medical officer of the American Society of Clinical Oncology, said in an interview with this news organization.

“It shouldn’t be seen as a failure,” Dr. Gralow said.

In her own practice at the Fred Hutchinson Cancer Research Center, Seattle, she has seen the value of emerging therapies for patients fighting advanced cancers. During her 25 years of clinical practice in an academic setting, she has gained access to drugs through single-patient investigative new drug applications.

However, this path is not an option for many patients who undergo treatment in facilities other than academic centers, she commented. She noted that the accelerated approval process is a way to expand access to emerging medicines, but she sees a need for caution in the use of drugs that have been given only this conditional approval. She emphasizes that such drugs may be suitable only for certain patients.

“I would say that, for metastatic patients, patients with incurable disease, we are willing to take some risk,” Dr. Gralow said. “We don’t have other options. They can’t wait the years that it would take to get a drug approved.”

One such patient is David Mitchell, who serves as the consumer representative on ODAC. He told this news organization that he is taking three drugs for multiple myeloma that received accelerated approvals: pomalidomide, bortezomib, and daratumumab.

“I want the FDA to have the option to approve drugs in an accelerated pathway, because as a patient taking three drugs granted accelerated approval, I’m benefiting – I’ve lived the benefit,” Mr. Mitchell said, “and I want other patients to have the opportunity to have that benefit.”

He believes that the FDA’s approach regarding accelerated approvals serves to get potentially beneficial medicines to patients who have few options and also fulfills the FDA’s mandate to protect the public from treatments that have little benefit but can cause harm.

Accelerated approval also offers needed flexibility to drugmakers as they develop more specifically targeted drugs for diseases that affect relatively few people, such as multiple myeloma, he said. “As the targeting of your therapies gets tighter and for smaller groups of patients, you have a harder time following the traditional model,” such as conducting large, double-blind, placebo-controlled trials that may indicate increased overall survival, he said.

“To me, this is the way the FDA intended it to work,” he added. “It’s going to offer the accelerated approval based on a surrogate endpoint for a safe drug, but it’s going to require the confirmatory trial, and if the confirmatory trial fails, it will pull the drug off the market.”

Some medicines that have received accelerated approvals may ultimately be found not to benefit patients, Mr. Mitchell acknowledged. But people in his situation, whose disease has progressed despite treatments, may want to take that risk, he added.


 

Four cancer indications recently withdrawn voluntarily by the manufacturer

• December 2020: Nivolumab for the treatment of patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy (Bristol Myers Squibb).
• February 2021: Durvalumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (AstraZeneca).
• March 2021: Pembrolizumab for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy (Merck).
• March 2021: Atezolizumab for treatment of patients with locally advanced or metastatic urothelial carcinoma who experience disease progression during or following platinum-containing atezolizumab chemotherapy or disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy (Genentech).

Six cancer indications under review at the April 2021 ODAC meeting

• Atezolizumab indicated in combination with protein-bound  for the treatment of adults with unresectable locally advanced or metastatic triple-negative  whose tumors express PD-L1 (PD-L1 stained tumor-infiltrating immune cells of any intensity covering ≥1% of the tumor area), as determined by an FDA-approved test.
• Atezolizumab indicated for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Pembrolizumab indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy.
• Pembrolizumab indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 (Combined Positive Score ≥1), as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
• Pembrolizumab indicated for the treatment of patients with  who have been previously treated with .
• Nivolumab indicated as a single agent for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib.

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

The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.

Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.

The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.

Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.

Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.

The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.

Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.

The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.

Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.

Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.

The public health crisis sparked by COVID-19 has engendered much debate in the realm where politics, journalism, law, and medicine meet.

Doctors have used the media to name other doctors as sources of harmful misinformation, in some cases going so far as to invoke medical practice board oversight as a potential intervention when doctors make public statements deemed too far out of bounds scientifically. Over the past year, some physicians have been harshly criticized for speaking about off-label prescribing, a widely accepted part of everyday medical practice.

The science and ethics of off-label prescribing have not changed; what has changed is the quality of dialogue around it. As psychiatrists, it does not fall within our scope of practice to offer definitive public opinions on the treatment of COVID-19, nor is that our purpose here. However, we can speak to a process that damages patients and doctors alike by undermining trust. All of this heat around bad medical information, in our opinion, amounts to using the methods of other fields to evaluate science and clinical practice. A remedy, then, to improve the quality of public medical intelligence would be to clarify the rules of scientific debate and to once again clearly state that off-label prescribing is part and parcel of the good practice of clinical medicine.

Medical disciplinary boards and the news media were neither designed nor are they equipped to adjudicate scientific debates. Science is never settled: Hypothesis and theory are always open to testing and revision as new evidence emerges. There is a place in medicine for formal disciplinary processes, as well-delineated by professional bodies such as the APA Ethics Committee. Another important part of protecting the public is to support an environment of scientific inquiry in which diversity of opinion is welcomed. As physicians, we translate science into excellent clinical care every day in our practices, and we advance science by sharing what we learn through friendly collegial communication and collaboration.

Dr. Emmons is part-time clinical associate professor in the department of psychiatry at the University of Vermont, Burlington, and is a past chair of the Ethics Committee for the Vermont District Branch of the American Psychiatric Association. He is in private practice in Moretown, Vt., and disclosed no relevant financial relationships. Dr. Kohanski is in private practice in Dayton, N.J., and is a diplomate of the American Board of Psychiatry & Neurology. She also is the host and author of Clinical Correlation, a series of the Psychcast. Dr. Kohanski disclosed no relevant financial relationships.

The main threat to the vast majority of children with acute lymphoblastic leukemia still remains the ALL itself, according to updated recommendations released by the Leukemia Committee of the French Society for the Fight Against Cancers and Leukemias in Children and Adolescents (SFCE).

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

“The situation of the current COVID-19 pandemic is continuously evolving. We thus have taken the more recent knowledge into account to update the previous recommendations from the Leukemia Committee,” Jérémie Rouger-Gaudichon, MD, of Pediatric Hemato-Immuno-Oncology Unit, Centre Hospitalier Universitaire, Caen (France), and colleagues wrote on behalf of the SFCE.

The updated recommendations are based on data collected in a real-time prospective survey among the 30 SFCE centers since April 2020. As of December 2020, 127 cases of COVID-19 were reported, most of them being enrolled in the PEDONCOVID study (NCT04433871) according to the report. Of these, eight patients required hospitalization in intensive care unit and one patient with relapsed acute lymphoblastic leukemia (ALL) died from ARDS with multiorgan failure. This confirms earlier reports that SARS-CoV-2 infection can be severe in some children with cancer and/or having hematopoietic stem cell transplant (HSCT), according to the report, which was published online in Bulletin du Cancer.
 

Recommendations

General recommendations were provided in the report, including the following:

• Test for SARS-CoV-2 (preferably by PCR or at least by immunological tests, on nasopharyngeal swab) before starting intensive induction chemotherapy or other intensive phase of treatment, for ALL patients, with or without symptoms.
• Delay systemic treatment if possible (e.g., absence of major hyperleukocytosis) in positive patients. During later phases, if patients test positive, tests should be repeated over time until negativity, especially before the beginning of an intensive course.
• Isolate any COVID-19–negative child or adolescent to allow treatment to continue (facial mask, social distancing, barrier measures, no contact with individuals suspected of COVID-19 or COVID-19–positive), in particular for patients to be allografted.
• Limit visitation to parents and potentially siblings in patients slated for HSCT and follow all necessary sanitary procedures for those visits.

The report provides a lengthy discussion of more detailed recommendations, including the following for first-line treatment of ALL:

• For patients with high-risk ALL, an individualized decision regarding transplantation and its timing should weigh the risks of transplantation in an epidemic context of COVID-19 against the risk linked to ALL.
• Minimizing hospital visits by the use of home blood tests and partial use of telemedicine may be considered.
• A physical examination should be performed regularly to avoid any delay in the diagnosis of treatment complications or relapse and preventative measures for SARS-CoV-2 should be applied in the home.

Patients with relapsed ALL may be at more risk from the effects of COVID-19 disease, according to the others, so for ALL patients receiving second-line or more treatment the recommendations include the following:

• Testing must be performed before starting a chemotherapy block, and postponing chemotherapy in case of positive test should be discussed in accordance with each specific situation and benefits/risks ratio regarding the leukemia.
• First-relapse patients should follow the INTREALL treatment protocol as much as possible and those who reach appropriate complete remission should be considered promptly for allogeneic transplantation, despite the pandemic.
• Second relapse and refractory relapses require testing and negative results for inclusion in phase I-II trials being conducted by most if not all academic or industrial promoters.
• The indication for treatment with CAR-T cells must be weighed with the center that would perform the procedure to determine the feasibility of performing all necessary procedures including apheresis and manufacturing.

In the case of a SARS-CoV-2 infection diagnosis during the treatment of ALL, discussions should occur with regard to stopping and/or postponing all chemotherapies, according to the severity of the ALL, the stage of treatment and the severity of clinical and/or radiological signs. In addition, any specific anti-COVID-19 treatment must be discussed with the infectious diseases team, according to the report.

“Fortunately, SARS-CoV-2 infection appears nevertheless to be mild in most children with cancer/ALL. Thus, the main threat to the vast majority of children with ALL still remains the ALL itself. Long-term data including well-matched case-control studies will tell if treatment delays/modifications due to COVID-19 have impacted the outcome if children with ALL,” the authors stated. However, “despite extremely rapid advances obtained in less than one year, our knowledge of SARS-CoV-2 and its complications is still incomplete,” they concluded, adding that the recommendations will likely need to be updated within another few months.

The authors reported that they had no conflicts of interest.

[email protected]

The main threat to the vast majority of children with acute lymphoblastic leukemia still remains the ALL itself, according to updated recommendations released by the Leukemia Committee of the French Society for the Fight Against Cancers and Leukemias in Children and Adolescents (SFCE).

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

“The situation of the current COVID-19 pandemic is continuously evolving. We thus have taken the more recent knowledge into account to update the previous recommendations from the Leukemia Committee,” Jérémie Rouger-Gaudichon, MD, of Pediatric Hemato-Immuno-Oncology Unit, Centre Hospitalier Universitaire, Caen (France), and colleagues wrote on behalf of the SFCE.

The updated recommendations are based on data collected in a real-time prospective survey among the 30 SFCE centers since April 2020. As of December 2020, 127 cases of COVID-19 were reported, most of them being enrolled in the PEDONCOVID study (NCT04433871) according to the report. Of these, eight patients required hospitalization in intensive care unit and one patient with relapsed acute lymphoblastic leukemia (ALL) died from ARDS with multiorgan failure. This confirms earlier reports that SARS-CoV-2 infection can be severe in some children with cancer and/or having hematopoietic stem cell transplant (HSCT), according to the report, which was published online in Bulletin du Cancer.
 

Recommendations

General recommendations were provided in the report, including the following:

• Test for SARS-CoV-2 (preferably by PCR or at least by immunological tests, on nasopharyngeal swab) before starting intensive induction chemotherapy or other intensive phase of treatment, for ALL patients, with or without symptoms.
• Delay systemic treatment if possible (e.g., absence of major hyperleukocytosis) in positive patients. During later phases, if patients test positive, tests should be repeated over time until negativity, especially before the beginning of an intensive course.
• Isolate any COVID-19–negative child or adolescent to allow treatment to continue (facial mask, social distancing, barrier measures, no contact with individuals suspected of COVID-19 or COVID-19–positive), in particular for patients to be allografted.
• Limit visitation to parents and potentially siblings in patients slated for HSCT and follow all necessary sanitary procedures for those visits.

The report provides a lengthy discussion of more detailed recommendations, including the following for first-line treatment of ALL:

• For patients with high-risk ALL, an individualized decision regarding transplantation and its timing should weigh the risks of transplantation in an epidemic context of COVID-19 against the risk linked to ALL.
• Minimizing hospital visits by the use of home blood tests and partial use of telemedicine may be considered.
• A physical examination should be performed regularly to avoid any delay in the diagnosis of treatment complications or relapse and preventative measures for SARS-CoV-2 should be applied in the home.

Patients with relapsed ALL may be at more risk from the effects of COVID-19 disease, according to the others, so for ALL patients receiving second-line or more treatment the recommendations include the following:

• Testing must be performed before starting a chemotherapy block, and postponing chemotherapy in case of positive test should be discussed in accordance with each specific situation and benefits/risks ratio regarding the leukemia.
• First-relapse patients should follow the INTREALL treatment protocol as much as possible and those who reach appropriate complete remission should be considered promptly for allogeneic transplantation, despite the pandemic.
• Second relapse and refractory relapses require testing and negative results for inclusion in phase I-II trials being conducted by most if not all academic or industrial promoters.
• The indication for treatment with CAR-T cells must be weighed with the center that would perform the procedure to determine the feasibility of performing all necessary procedures including apheresis and manufacturing.

In the case of a SARS-CoV-2 infection diagnosis during the treatment of ALL, discussions should occur with regard to stopping and/or postponing all chemotherapies, according to the severity of the ALL, the stage of treatment and the severity of clinical and/or radiological signs. In addition, any specific anti-COVID-19 treatment must be discussed with the infectious diseases team, according to the report.

“Fortunately, SARS-CoV-2 infection appears nevertheless to be mild in most children with cancer/ALL. Thus, the main threat to the vast majority of children with ALL still remains the ALL itself. Long-term data including well-matched case-control studies will tell if treatment delays/modifications due to COVID-19 have impacted the outcome if children with ALL,” the authors stated. However, “despite extremely rapid advances obtained in less than one year, our knowledge of SARS-CoV-2 and its complications is still incomplete,” they concluded, adding that the recommendations will likely need to be updated within another few months.

The authors reported that they had no conflicts of interest.

[email protected]

The main threat to the vast majority of children with acute lymphoblastic leukemia still remains the ALL itself, according to updated recommendations released by the Leukemia Committee of the French Society for the Fight Against Cancers and Leukemias in Children and Adolescents (SFCE).

VashiDonsk/Wikimedia Commons/Creative Commons 3.0

“The situation of the current COVID-19 pandemic is continuously evolving. We thus have taken the more recent knowledge into account to update the previous recommendations from the Leukemia Committee,” Jérémie Rouger-Gaudichon, MD, of Pediatric Hemato-Immuno-Oncology Unit, Centre Hospitalier Universitaire, Caen (France), and colleagues wrote on behalf of the SFCE.

The updated recommendations are based on data collected in a real-time prospective survey among the 30 SFCE centers since April 2020. As of December 2020, 127 cases of COVID-19 were reported, most of them being enrolled in the PEDONCOVID study (NCT04433871) according to the report. Of these, eight patients required hospitalization in intensive care unit and one patient with relapsed acute lymphoblastic leukemia (ALL) died from ARDS with multiorgan failure. This confirms earlier reports that SARS-CoV-2 infection can be severe in some children with cancer and/or having hematopoietic stem cell transplant (HSCT), according to the report, which was published online in Bulletin du Cancer.
 

Recommendations

General recommendations were provided in the report, including the following:

• Test for SARS-CoV-2 (preferably by PCR or at least by immunological tests, on nasopharyngeal swab) before starting intensive induction chemotherapy or other intensive phase of treatment, for ALL patients, with or without symptoms.
• Delay systemic treatment if possible (e.g., absence of major hyperleukocytosis) in positive patients. During later phases, if patients test positive, tests should be repeated over time until negativity, especially before the beginning of an intensive course.
• Isolate any COVID-19–negative child or adolescent to allow treatment to continue (facial mask, social distancing, barrier measures, no contact with individuals suspected of COVID-19 or COVID-19–positive), in particular for patients to be allografted.
• Limit visitation to parents and potentially siblings in patients slated for HSCT and follow all necessary sanitary procedures for those visits.

The report provides a lengthy discussion of more detailed recommendations, including the following for first-line treatment of ALL:

• For patients with high-risk ALL, an individualized decision regarding transplantation and its timing should weigh the risks of transplantation in an epidemic context of COVID-19 against the risk linked to ALL.
• Minimizing hospital visits by the use of home blood tests and partial use of telemedicine may be considered.
• A physical examination should be performed regularly to avoid any delay in the diagnosis of treatment complications or relapse and preventative measures for SARS-CoV-2 should be applied in the home.

Patients with relapsed ALL may be at more risk from the effects of COVID-19 disease, according to the others, so for ALL patients receiving second-line or more treatment the recommendations include the following:

• Testing must be performed before starting a chemotherapy block, and postponing chemotherapy in case of positive test should be discussed in accordance with each specific situation and benefits/risks ratio regarding the leukemia.
• First-relapse patients should follow the INTREALL treatment protocol as much as possible and those who reach appropriate complete remission should be considered promptly for allogeneic transplantation, despite the pandemic.
• Second relapse and refractory relapses require testing and negative results for inclusion in phase I-II trials being conducted by most if not all academic or industrial promoters.
• The indication for treatment with CAR-T cells must be weighed with the center that would perform the procedure to determine the feasibility of performing all necessary procedures including apheresis and manufacturing.

In the case of a SARS-CoV-2 infection diagnosis during the treatment of ALL, discussions should occur with regard to stopping and/or postponing all chemotherapies, according to the severity of the ALL, the stage of treatment and the severity of clinical and/or radiological signs. In addition, any specific anti-COVID-19 treatment must be discussed with the infectious diseases team, according to the report.

“Fortunately, SARS-CoV-2 infection appears nevertheless to be mild in most children with cancer/ALL. Thus, the main threat to the vast majority of children with ALL still remains the ALL itself. Long-term data including well-matched case-control studies will tell if treatment delays/modifications due to COVID-19 have impacted the outcome if children with ALL,” the authors stated. However, “despite extremely rapid advances obtained in less than one year, our knowledge of SARS-CoV-2 and its complications is still incomplete,” they concluded, adding that the recommendations will likely need to be updated within another few months.

The authors reported that they had no conflicts of interest.

[email protected]

Climate change will increasingly affect the distribution and frequency of insect-borne diseases, cutaneous leishmaniasis, skin cancer, fungal diseases, and a host of other illnesses that have cutaneous manifestations or involve the skin – and dermatologists are being urged to be ready to diagnose clinical findings, counsel patients about risk mitigation, and decrease the carbon footprint of their practices and medical organizations.

“Climate change is not a far-off threat but an urgent health issue,” Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, wrote in an editorial with coauthor Mary Sun, a student at Icahn School of Medicine at Mount Sinai, New York. It was first published online in the British Journal of Dermatology last year, titled, “The climate emergency: Why should dermatologists care and how can they act?”.

Dr. Rosenbach is a founder and leader of the American Academy of Dermatology Expert Resource Group (ERG) for Climate Change and Environmental Issues, established 2 years ago. Some of the 150-plus members of the ERG have been writing about the dermatologic impacts of climate change – including content that filled the January issue of the International Journal of Women’s Dermatology – and speaking about the issues.

A session at the AAD’s virtual annual meeting in April will address climate change and dermatology – the second such session at an annual meeting – and the first two of three planned virtual symposia led by Dr. Rosenbach and his colleagues, have been hosted by the Association of Professors of Dermatology. The ERG encouraged the AAD’s adoption of a position statement in 2018 about climate change and dermatology and its membership in the Medical Society Consortium on Climate and Health.

“There’s been a lot of conversation in the medical community about the health effects of climate change, but most people leave out the skin,” said Mary L. Williams, MD, clinical professor of dermatology at the University of California, San Francisco, who is a cofounder and coleader with Dr. Rosenbach of the climate change ERG.

“That’s interesting because the skin is the most environmental of all our organs. Of course it will be impacted by all that’s going on,” she said. “We want to bring the dermatologic community and the wider medical community along with us [in appreciating and acting on this knowledge].”


 

Changing disease patterns

Dr. Rosenbach did not think much about how climate change could affect his patients and his clinical practice until he saw a severe case of hand, foot, and mouth disease in a hospitalized adult in Philadelphia about 10 years ago.

American Academy of Dermatology

A presentation of the case at an infectious disease conference spurred discussion of how the preceding winters had been warmer and of correlations reported by researchers in China between the incidence of hand, foot, and mouth disease – historically a mild infection in children – and average temperature and other meteorological factors. “I knew about climate change, but I never knew we’d see different diseases in our clinical practice, or old diseases affecting new hosts,” Dr. Rosenbach said in an interview.

He pored over the literature to deepen his understanding of climate change science and the impact of climate change on medicine, and found an “emerging focus” on climate change in some medical journals, but “very little in dermatology.” In collaboration with Benjamin Kaffenberger, MD, a dermatologist at The Ohio State University, and colleagues, including an entomologist, Dr. Rosenbach wrote a review of publications relating to climate change and skin disease in North America.

Published in 2017 in the Journal of the American Academy of Dermatology, the review details how bacteria, viruses, fungi, and parasites are responding to changing weather patterns in North America, and why dermatologists should be able to recognize changing patterns of disease. Globalization plays a role in changing disease and vector patterns, but “climate change allows expansion of the natural range of pathogens, hosts, reservoirs, and vectors that allow diseases to appear in immunologically naive populations,” they wrote.

Patterns of infectious diseases with cutaneous manifestations are already changing. The geographic range of coccidioidomycosis, or valley fever, for instance, “has basically doubled in the Southwest U.S., extending up the entire West Coast,” Dr. Rosenbach said, as the result of longer dry seasons and more frequent wind storms that aerosolize the mycosis-causing, soil-dwelling fungal spores.

Lyme disease and associated tick-borne infections continue to expand northward as Ixodes tick vectors move and breed “exactly in sync with a warming world,” Dr. Rosenbach said. “We’re seeing Lyme in Philadelphia in February, whereas in the past we may not have seen it until May ... There are derms in Maine [whose patients have Lyme disease] who may never have seen a case before, and derms in Canada who are making diagnoses of Lyme [for the first time].”

And locally acquired cases of dengue are being reported in Hawaii, Texas, and Florida – and even North Carolina, according to a review of infectious diseases with cutaneous manifestations in the issue of the International Journal of Women’s Dermatology dedicated to climate change. As with Ixodes ticks, which transmit Lyme disease, rising temperatures lead to longer breeding seasons for Aedes mosquitoes, which transmit dengue. Increased endemicity of dengue is concerning because severe illness is significantly more likely in individuals previously infected with a different serotype.

“Dermatologists should be ready to identify and diagnose these mosquito-borne diseases that we think of as occurring in Central America or tropical regions,” Dr. Rosenbach said. “In my children’s lifetime there will be tropical diseases in New York, Philadelphia, Boston and other such places.”

In his articles and talks, Dr. Rosenbach lays out the science of climate change – for instance, the change in average global temperatures above preindustrial levels (an approximate 1° C rise) , the threshold beyond which the Earth will become less hospitable (1.5° C of warming according to United Nation’s Intergovernmental Panel on Climate Change), the current projections for future warming (an increase of about 3° Celsius by 2100), and the “gold-standard” level of scientific certainty that climate change is human-caused.

Mathematical climate modeling, he emphasized in the interview, can accurately project changes in infection rates. Researchers predicted 10 years ago in a published paper, for instance, that based on global warming patterns, the sand fly vector responsible for cutaneous leishmaniasis would live in the Southern United States and cause endemic infections within 10 years.

And in 2018, Dr. Rosenbach said, a paper in JAMA Dermatology described how more than half – 59% – of the cases of cutaneous leishmaniasis diagnosed in Texas were endemic, all occurring in people with no prior travel outside the United States.

Dr. Williams’ devotion to climate change and dermatology and to the climate change ERG was inspired in large part by Dr. Rosenbach’s 2017 paper in JAAD. She had long been concerned about climate change, she said, but “the review article was really the impetus for me to think, this is really within my specialty.”

Extreme weather events, and the climate-driven migration expected to increasingly occur, have clear relevance to dermatology, Dr. Williams said. “Often, the most vexing problems that people have when they’re forced out of their homes ... are dermatologic,” she said, like infections from contaminated waters after flooding and the spread of scabies and other communicable diseases due to crowding and unsanitary conditions.

But there are other less obvious ramifications of a changing climate that affect dermatology. Dr. Williams has delved into the literature on heat-related illness, for instance, and found that most research has been in the realm of sports medicine and military health. “Most of us don’t treat serious heat-related illnesses, but our skin is responsible for keeping us cool and there’s an important role for dermatologists to play in knowing how the skin does that and who is at risk for heat illness because the skin is unable to do the full job,” she said.

Research is needed to identify which medications can interfere with the skin’s thermoregulatory responses and put patients at risk, she noted. “And a lot of the work on sweat gland physiology is probably 30 years old now. We should bring to bear contemporary research techniques.”

Dermatology is also “in the early stages of understanding the role that air pollution plays in skin disease,” Dr. Williams said. “Most of the medical literature focuses on the effects of pollution on the lungs and in cardiovascular disease.”

There is evidence linking small particulate matter found in wood smoke and other air pollutants to exacerbations of atopic dermatitis and other inflammatory skin conditions, she noted, but mechanisms need to be explored and health disparities examined. “While we know that there are health disparities in terms of [exposure to] pollution and respiratory illness, we have no idea if this is the case with our skin diseases like atopic dermatitis,” said Dr. Williams.

In general, according to the AAD position statement, low-income and minority communities, in addition to the very young and the very old, “are and will continue to be disproportionately affected by climate change.”

 

Education and the carbon footprint

Viewing climate change as a social determinant of health (SDH ) – and integrating it into medical training as such – is a topic of active discussion. At UCSF, Sarah J. Coates, MD, a fellow in pediatric dermatology, is working with colleagues to integrate climate change into formal resident education. “We know that climate change affects housing, food security, migration ... and certain populations are and will be especially vulnerable,” she said in an interview. “The effects of climate change fit squarely into the social determinant of health curriculum that we’re building here.”

Dr. Coates began to appreciate the link between climate and infectious diseases – a topic she now writes and speaks about – when she saw several patients with coccidioidomycosis as a dermatology resident at UCSF and learned that the cases represented an epidemic in the Central Valley “resulting from several years of drought.”

Her medical school and residency training were otherwise devoid of any discussion of climate change. At UCSF and nearby Stanford (Calif.) University, this is no longer the case, she and Dr. Williams said. “The medical students here have been quite active and are requesting education,” noted Dr. Williams. “The desire to know more is coming from the bottom.”

Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, sees the same interest from physicians-in-training in the Boston area. They want education about climate science, the impact of climate changes on health and risk mitigation, and ways to reduce medicine’s carbon footprint. “We need to teach them and charge them to lead in their communities,” she said in an interview.

Climate change will increasingly affect the distribution and frequency of insect-borne diseases, cutaneous leishmaniasis, skin cancer, fungal diseases, and a host of other illnesses that have cutaneous manifestations or involve the skin – and dermatologists are being urged to be ready to diagnose clinical findings, counsel patients about risk mitigation, and decrease the carbon footprint of their practices and medical organizations.

“Climate change is not a far-off threat but an urgent health issue,” Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, wrote in an editorial with coauthor Mary Sun, a student at Icahn School of Medicine at Mount Sinai, New York. It was first published online in the British Journal of Dermatology last year, titled, “The climate emergency: Why should dermatologists care and how can they act?”.

Dr. Rosenbach is a founder and leader of the American Academy of Dermatology Expert Resource Group (ERG) for Climate Change and Environmental Issues, established 2 years ago. Some of the 150-plus members of the ERG have been writing about the dermatologic impacts of climate change – including content that filled the January issue of the International Journal of Women’s Dermatology – and speaking about the issues.

A session at the AAD’s virtual annual meeting in April will address climate change and dermatology – the second such session at an annual meeting – and the first two of three planned virtual symposia led by Dr. Rosenbach and his colleagues, have been hosted by the Association of Professors of Dermatology. The ERG encouraged the AAD’s adoption of a position statement in 2018 about climate change and dermatology and its membership in the Medical Society Consortium on Climate and Health.

“There’s been a lot of conversation in the medical community about the health effects of climate change, but most people leave out the skin,” said Mary L. Williams, MD, clinical professor of dermatology at the University of California, San Francisco, who is a cofounder and coleader with Dr. Rosenbach of the climate change ERG.

“That’s interesting because the skin is the most environmental of all our organs. Of course it will be impacted by all that’s going on,” she said. “We want to bring the dermatologic community and the wider medical community along with us [in appreciating and acting on this knowledge].”


 

Changing disease patterns

Dr. Rosenbach did not think much about how climate change could affect his patients and his clinical practice until he saw a severe case of hand, foot, and mouth disease in a hospitalized adult in Philadelphia about 10 years ago.

American Academy of Dermatology

A presentation of the case at an infectious disease conference spurred discussion of how the preceding winters had been warmer and of correlations reported by researchers in China between the incidence of hand, foot, and mouth disease – historically a mild infection in children – and average temperature and other meteorological factors. “I knew about climate change, but I never knew we’d see different diseases in our clinical practice, or old diseases affecting new hosts,” Dr. Rosenbach said in an interview.

He pored over the literature to deepen his understanding of climate change science and the impact of climate change on medicine, and found an “emerging focus” on climate change in some medical journals, but “very little in dermatology.” In collaboration with Benjamin Kaffenberger, MD, a dermatologist at The Ohio State University, and colleagues, including an entomologist, Dr. Rosenbach wrote a review of publications relating to climate change and skin disease in North America.

Published in 2017 in the Journal of the American Academy of Dermatology, the review details how bacteria, viruses, fungi, and parasites are responding to changing weather patterns in North America, and why dermatologists should be able to recognize changing patterns of disease. Globalization plays a role in changing disease and vector patterns, but “climate change allows expansion of the natural range of pathogens, hosts, reservoirs, and vectors that allow diseases to appear in immunologically naive populations,” they wrote.

Patterns of infectious diseases with cutaneous manifestations are already changing. The geographic range of coccidioidomycosis, or valley fever, for instance, “has basically doubled in the Southwest U.S., extending up the entire West Coast,” Dr. Rosenbach said, as the result of longer dry seasons and more frequent wind storms that aerosolize the mycosis-causing, soil-dwelling fungal spores.

Lyme disease and associated tick-borne infections continue to expand northward as Ixodes tick vectors move and breed “exactly in sync with a warming world,” Dr. Rosenbach said. “We’re seeing Lyme in Philadelphia in February, whereas in the past we may not have seen it until May ... There are derms in Maine [whose patients have Lyme disease] who may never have seen a case before, and derms in Canada who are making diagnoses of Lyme [for the first time].”

And locally acquired cases of dengue are being reported in Hawaii, Texas, and Florida – and even North Carolina, according to a review of infectious diseases with cutaneous manifestations in the issue of the International Journal of Women’s Dermatology dedicated to climate change. As with Ixodes ticks, which transmit Lyme disease, rising temperatures lead to longer breeding seasons for Aedes mosquitoes, which transmit dengue. Increased endemicity of dengue is concerning because severe illness is significantly more likely in individuals previously infected with a different serotype.

“Dermatologists should be ready to identify and diagnose these mosquito-borne diseases that we think of as occurring in Central America or tropical regions,” Dr. Rosenbach said. “In my children’s lifetime there will be tropical diseases in New York, Philadelphia, Boston and other such places.”

In his articles and talks, Dr. Rosenbach lays out the science of climate change – for instance, the change in average global temperatures above preindustrial levels (an approximate 1° C rise) , the threshold beyond which the Earth will become less hospitable (1.5° C of warming according to United Nation’s Intergovernmental Panel on Climate Change), the current projections for future warming (an increase of about 3° Celsius by 2100), and the “gold-standard” level of scientific certainty that climate change is human-caused.

Mathematical climate modeling, he emphasized in the interview, can accurately project changes in infection rates. Researchers predicted 10 years ago in a published paper, for instance, that based on global warming patterns, the sand fly vector responsible for cutaneous leishmaniasis would live in the Southern United States and cause endemic infections within 10 years.

And in 2018, Dr. Rosenbach said, a paper in JAMA Dermatology described how more than half – 59% – of the cases of cutaneous leishmaniasis diagnosed in Texas were endemic, all occurring in people with no prior travel outside the United States.

Dr. Williams’ devotion to climate change and dermatology and to the climate change ERG was inspired in large part by Dr. Rosenbach’s 2017 paper in JAAD. She had long been concerned about climate change, she said, but “the review article was really the impetus for me to think, this is really within my specialty.”

Extreme weather events, and the climate-driven migration expected to increasingly occur, have clear relevance to dermatology, Dr. Williams said. “Often, the most vexing problems that people have when they’re forced out of their homes ... are dermatologic,” she said, like infections from contaminated waters after flooding and the spread of scabies and other communicable diseases due to crowding and unsanitary conditions.

But there are other less obvious ramifications of a changing climate that affect dermatology. Dr. Williams has delved into the literature on heat-related illness, for instance, and found that most research has been in the realm of sports medicine and military health. “Most of us don’t treat serious heat-related illnesses, but our skin is responsible for keeping us cool and there’s an important role for dermatologists to play in knowing how the skin does that and who is at risk for heat illness because the skin is unable to do the full job,” she said.

Research is needed to identify which medications can interfere with the skin’s thermoregulatory responses and put patients at risk, she noted. “And a lot of the work on sweat gland physiology is probably 30 years old now. We should bring to bear contemporary research techniques.”

Dermatology is also “in the early stages of understanding the role that air pollution plays in skin disease,” Dr. Williams said. “Most of the medical literature focuses on the effects of pollution on the lungs and in cardiovascular disease.”

There is evidence linking small particulate matter found in wood smoke and other air pollutants to exacerbations of atopic dermatitis and other inflammatory skin conditions, she noted, but mechanisms need to be explored and health disparities examined. “While we know that there are health disparities in terms of [exposure to] pollution and respiratory illness, we have no idea if this is the case with our skin diseases like atopic dermatitis,” said Dr. Williams.

In general, according to the AAD position statement, low-income and minority communities, in addition to the very young and the very old, “are and will continue to be disproportionately affected by climate change.”

 

Education and the carbon footprint

Viewing climate change as a social determinant of health (SDH ) – and integrating it into medical training as such – is a topic of active discussion. At UCSF, Sarah J. Coates, MD, a fellow in pediatric dermatology, is working with colleagues to integrate climate change into formal resident education. “We know that climate change affects housing, food security, migration ... and certain populations are and will be especially vulnerable,” she said in an interview. “The effects of climate change fit squarely into the social determinant of health curriculum that we’re building here.”

Dr. Coates began to appreciate the link between climate and infectious diseases – a topic she now writes and speaks about – when she saw several patients with coccidioidomycosis as a dermatology resident at UCSF and learned that the cases represented an epidemic in the Central Valley “resulting from several years of drought.”

Her medical school and residency training were otherwise devoid of any discussion of climate change. At UCSF and nearby Stanford (Calif.) University, this is no longer the case, she and Dr. Williams said. “The medical students here have been quite active and are requesting education,” noted Dr. Williams. “The desire to know more is coming from the bottom.”

Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, sees the same interest from physicians-in-training in the Boston area. They want education about climate science, the impact of climate changes on health and risk mitigation, and ways to reduce medicine’s carbon footprint. “We need to teach them and charge them to lead in their communities,” she said in an interview.

Climate change will increasingly affect the distribution and frequency of insect-borne diseases, cutaneous leishmaniasis, skin cancer, fungal diseases, and a host of other illnesses that have cutaneous manifestations or involve the skin – and dermatologists are being urged to be ready to diagnose clinical findings, counsel patients about risk mitigation, and decrease the carbon footprint of their practices and medical organizations.

“Climate change is not a far-off threat but an urgent health issue,” Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, wrote in an editorial with coauthor Mary Sun, a student at Icahn School of Medicine at Mount Sinai, New York. It was first published online in the British Journal of Dermatology last year, titled, “The climate emergency: Why should dermatologists care and how can they act?”.

Dr. Rosenbach is a founder and leader of the American Academy of Dermatology Expert Resource Group (ERG) for Climate Change and Environmental Issues, established 2 years ago. Some of the 150-plus members of the ERG have been writing about the dermatologic impacts of climate change – including content that filled the January issue of the International Journal of Women’s Dermatology – and speaking about the issues.

A session at the AAD’s virtual annual meeting in April will address climate change and dermatology – the second such session at an annual meeting – and the first two of three planned virtual symposia led by Dr. Rosenbach and his colleagues, have been hosted by the Association of Professors of Dermatology. The ERG encouraged the AAD’s adoption of a position statement in 2018 about climate change and dermatology and its membership in the Medical Society Consortium on Climate and Health.

“There’s been a lot of conversation in the medical community about the health effects of climate change, but most people leave out the skin,” said Mary L. Williams, MD, clinical professor of dermatology at the University of California, San Francisco, who is a cofounder and coleader with Dr. Rosenbach of the climate change ERG.

“That’s interesting because the skin is the most environmental of all our organs. Of course it will be impacted by all that’s going on,” she said. “We want to bring the dermatologic community and the wider medical community along with us [in appreciating and acting on this knowledge].”


 

Changing disease patterns

Dr. Rosenbach did not think much about how climate change could affect his patients and his clinical practice until he saw a severe case of hand, foot, and mouth disease in a hospitalized adult in Philadelphia about 10 years ago.

American Academy of Dermatology

A presentation of the case at an infectious disease conference spurred discussion of how the preceding winters had been warmer and of correlations reported by researchers in China between the incidence of hand, foot, and mouth disease – historically a mild infection in children – and average temperature and other meteorological factors. “I knew about climate change, but I never knew we’d see different diseases in our clinical practice, or old diseases affecting new hosts,” Dr. Rosenbach said in an interview.

He pored over the literature to deepen his understanding of climate change science and the impact of climate change on medicine, and found an “emerging focus” on climate change in some medical journals, but “very little in dermatology.” In collaboration with Benjamin Kaffenberger, MD, a dermatologist at The Ohio State University, and colleagues, including an entomologist, Dr. Rosenbach wrote a review of publications relating to climate change and skin disease in North America.

Published in 2017 in the Journal of the American Academy of Dermatology, the review details how bacteria, viruses, fungi, and parasites are responding to changing weather patterns in North America, and why dermatologists should be able to recognize changing patterns of disease. Globalization plays a role in changing disease and vector patterns, but “climate change allows expansion of the natural range of pathogens, hosts, reservoirs, and vectors that allow diseases to appear in immunologically naive populations,” they wrote.

Patterns of infectious diseases with cutaneous manifestations are already changing. The geographic range of coccidioidomycosis, or valley fever, for instance, “has basically doubled in the Southwest U.S., extending up the entire West Coast,” Dr. Rosenbach said, as the result of longer dry seasons and more frequent wind storms that aerosolize the mycosis-causing, soil-dwelling fungal spores.

Lyme disease and associated tick-borne infections continue to expand northward as Ixodes tick vectors move and breed “exactly in sync with a warming world,” Dr. Rosenbach said. “We’re seeing Lyme in Philadelphia in February, whereas in the past we may not have seen it until May ... There are derms in Maine [whose patients have Lyme disease] who may never have seen a case before, and derms in Canada who are making diagnoses of Lyme [for the first time].”

And locally acquired cases of dengue are being reported in Hawaii, Texas, and Florida – and even North Carolina, according to a review of infectious diseases with cutaneous manifestations in the issue of the International Journal of Women’s Dermatology dedicated to climate change. As with Ixodes ticks, which transmit Lyme disease, rising temperatures lead to longer breeding seasons for Aedes mosquitoes, which transmit dengue. Increased endemicity of dengue is concerning because severe illness is significantly more likely in individuals previously infected with a different serotype.

“Dermatologists should be ready to identify and diagnose these mosquito-borne diseases that we think of as occurring in Central America or tropical regions,” Dr. Rosenbach said. “In my children’s lifetime there will be tropical diseases in New York, Philadelphia, Boston and other such places.”

In his articles and talks, Dr. Rosenbach lays out the science of climate change – for instance, the change in average global temperatures above preindustrial levels (an approximate 1° C rise) , the threshold beyond which the Earth will become less hospitable (1.5° C of warming according to United Nation’s Intergovernmental Panel on Climate Change), the current projections for future warming (an increase of about 3° Celsius by 2100), and the “gold-standard” level of scientific certainty that climate change is human-caused.

Mathematical climate modeling, he emphasized in the interview, can accurately project changes in infection rates. Researchers predicted 10 years ago in a published paper, for instance, that based on global warming patterns, the sand fly vector responsible for cutaneous leishmaniasis would live in the Southern United States and cause endemic infections within 10 years.

And in 2018, Dr. Rosenbach said, a paper in JAMA Dermatology described how more than half – 59% – of the cases of cutaneous leishmaniasis diagnosed in Texas were endemic, all occurring in people with no prior travel outside the United States.

Dr. Williams’ devotion to climate change and dermatology and to the climate change ERG was inspired in large part by Dr. Rosenbach’s 2017 paper in JAAD. She had long been concerned about climate change, she said, but “the review article was really the impetus for me to think, this is really within my specialty.”

Extreme weather events, and the climate-driven migration expected to increasingly occur, have clear relevance to dermatology, Dr. Williams said. “Often, the most vexing problems that people have when they’re forced out of their homes ... are dermatologic,” she said, like infections from contaminated waters after flooding and the spread of scabies and other communicable diseases due to crowding and unsanitary conditions.

But there are other less obvious ramifications of a changing climate that affect dermatology. Dr. Williams has delved into the literature on heat-related illness, for instance, and found that most research has been in the realm of sports medicine and military health. “Most of us don’t treat serious heat-related illnesses, but our skin is responsible for keeping us cool and there’s an important role for dermatologists to play in knowing how the skin does that and who is at risk for heat illness because the skin is unable to do the full job,” she said.

Research is needed to identify which medications can interfere with the skin’s thermoregulatory responses and put patients at risk, she noted. “And a lot of the work on sweat gland physiology is probably 30 years old now. We should bring to bear contemporary research techniques.”

Dermatology is also “in the early stages of understanding the role that air pollution plays in skin disease,” Dr. Williams said. “Most of the medical literature focuses on the effects of pollution on the lungs and in cardiovascular disease.”

There is evidence linking small particulate matter found in wood smoke and other air pollutants to exacerbations of atopic dermatitis and other inflammatory skin conditions, she noted, but mechanisms need to be explored and health disparities examined. “While we know that there are health disparities in terms of [exposure to] pollution and respiratory illness, we have no idea if this is the case with our skin diseases like atopic dermatitis,” said Dr. Williams.

In general, according to the AAD position statement, low-income and minority communities, in addition to the very young and the very old, “are and will continue to be disproportionately affected by climate change.”

 

Education and the carbon footprint

Viewing climate change as a social determinant of health (SDH ) – and integrating it into medical training as such – is a topic of active discussion. At UCSF, Sarah J. Coates, MD, a fellow in pediatric dermatology, is working with colleagues to integrate climate change into formal resident education. “We know that climate change affects housing, food security, migration ... and certain populations are and will be especially vulnerable,” she said in an interview. “The effects of climate change fit squarely into the social determinant of health curriculum that we’re building here.”

Dr. Coates began to appreciate the link between climate and infectious diseases – a topic she now writes and speaks about – when she saw several patients with coccidioidomycosis as a dermatology resident at UCSF and learned that the cases represented an epidemic in the Central Valley “resulting from several years of drought.”

Her medical school and residency training were otherwise devoid of any discussion of climate change. At UCSF and nearby Stanford (Calif.) University, this is no longer the case, she and Dr. Williams said. “The medical students here have been quite active and are requesting education,” noted Dr. Williams. “The desire to know more is coming from the bottom.”

Mary E. Maloney, MD, professor of medicine and director of dermatologic surgery at the University of Massachusetts, Worcester, sees the same interest from physicians-in-training in the Boston area. They want education about climate science, the impact of climate changes on health and risk mitigation, and ways to reduce medicine’s carbon footprint. “We need to teach them and charge them to lead in their communities,” she said in an interview.

Have you ever thought you could be a leader, in your hospitalist group, in hospital administration, or at another institution? The reasons to seek a leadership role as a hospitalist are many, but there are also many drawbacks. According to hospitalists who have reached high rungs on the leadership ladder, you will need a blend of desire, enthusiasm, education, and experience if you want to succeed in leadership.

The right reasons

“People who make good leaders have a sense of purpose and want to make a difference,” said Eric Howell, MD, MHM, CEO of the Society of Hospital Medicine, and former chief of medical units at Johns Hopkins Bayview in Baltimore. “I think most hospitalists have that sense of wanting to help patients and society, so that’s a strong mission in itself. Just by training and the very design of our health care system, hospitalists are often natural leaders, and in leadership roles, because they run teams of clinicians and train medical students.”

Danielle Scheurer, MD, SFHM, chief quality officer and professor of medicine at the Medical University of South Carolina, and current president of SHM, said some hospitalists end up in leadership roles almost by accident – because there is a leadership “void” in the health system where they work, and no one else wants to step up. Others disconnect from the leadership track and are happy to simply be part of a team.

“If you are yearning to make a difference and that’s your motivation then you will find leadership is more fulfilling than difficult,” she said. “But if you take a leadership role to fill a void or think you just want to take some nonclinical time, it’s probably not a good idea. Some people think administrative leadership is easier than being a hospitalist, but it is not. Leadership should not be about getting away from something else. It should be a thoughtful career move, and if it is, being a leader can be meaningful and fulfilling.”

Nancy Spector, MD, the vice dean for faculty and executive director of the Executive Leadership in Academic Medicine program at Drexel University College of Medicine in Philadelphia, said a willingness to fail is vital for a leader. “You have to be open to successes, yes, but also to making mistakes,” she said. “It’s about honing the skills that leadership requires and be open to development and change.”

Kierstin Cates Kennedy, MD, SFHM, chief of hospital medicine at the University of Alabama at Birmingham, said that a hospitalist fresh out of residency will gain insight into whether leadership is the right path by acquiring a deeper understanding of how health care institutions work.

Still up for it?

If you think you have the commitment and desire for leadership as an early career hospitalist, how would you continue down the leadership path?

“A great way is to find a person you want to be like, who could be a mentor. Find a successful leader that you admire, and one who is willing to guide you,” Dr. Howell said. “Books are helpful as well, and I still find I’m learning today – I have a list that includes Drive by Daniel Pink and Good to Great by Jim Collins. There are Malcolm Gladwell books that also have terrific knowledge to impart.”

Mark W. Shen, MD, SFHM, associate professor at Dell Medical School at the University of Texas at Austin and former president of St. Louis Children’s Hospital, said potential hospitalist leaders must be aware of their fellow clinicians.

“Pay attention to the needs of the hospitalist group as they are articulated by the lead hospitalist, the administration, and the patients,” he said. “There are so many activities that come up on a day-in, day-out basis. You should jump in and volunteer to take the lead on some of those activities. Leading your peers is often one of the most challenging parts of leadership. I think taking on even just a small activity like, say, working on a clinical pathway for the group, will result in a lot of preparation for future leadership roles.”

An example of an early career activity that Dr. Shen felt was valuable to future leaders was helping in the development of a hospitalist core curriculum. “We would use the core curriculum to educate students and residents coming through our rotation and have some degree of commonality or standardization,” he said. “So even though I wasn’t an explicit leader of the hospitalist group at the time, I’d say that helping develop the core curriculum aided me in understanding what leadership was all about.”

Getting started in a leadership role, Dr. Spector said, can be helped by embracing a knowledge of the business of medicine. “Business and finance are a reality you shouldn’t avoid,” she said. “Another way to learn is to partner with your local administrators or whoever is running your division or your department. There are business managers and business partners in every institution, and you can learn a great deal from them. It’s important to network and get to know people because we’re a people business, and opportunity comes when people know who you are.”

Dr. Howell noted that advocating for yourself is sometimes hard, and it can be a red flag in some circumstances, but you should tell your bosses where you want to go professionally.

“You can say that you want to grow professionally, and let’s face it, there are naturally-inclined leaders. We all need to be transparent in goal paths,” he said. “But if you want a leadership role for power, money, and prestige then you’re not applying the right thinking. If you want to help others and you have a mission you believe in, then communicate that to your bosses.”

Dr. Scheurer believes choosing between clinical and administrative leadership is not so clear cut, because in the health care setting they tend to morph into each other. “Many times clinicians will end up taking on a leadership role that has a significant administrative component to it,” she said. “I do think if clinicians make a career move and get the right training then they can be exemplary leaders in health care, but I do worry a little about clinicians going into leadership roles without any formal training. They are usually well-intentioned but that’s not enough. It’s not any different than medical training. If you want to be a good leader you need training to develop your skills, and a lot of those skills do not come naturally or easily. We thrust good clinicians into leadership roles because they are good clinicians, but if they don’t have the right skills, being a leader can be a problem.”
 

How do leaders improve?

If you have made it to a leadership position, and have been in that role for a while, you might start to feel you are stuck in your growth trajectory. If so, how do you continue to improve?

According to Dr. Kennedy, whether you are looking to get into leadership or want to improve, focusing on emotional intelligence is important. “A book like Emotional Intelligence 2.0 by Travis Bradbury is a great introduction,” she said. “With my leadership team, we did a book club where we read Primal Leadership, which is focused on emotional intelligence and on aspects like setting a culture.”

Dr. Howell said that to grow as a leader, be careful what you say no to. “I used to talk about having a tag line that was ‘just say yes,’” he said. “At least try to say yes most of the time because it opens up opportunities and shows you are looking to do more, not less.”

Also, Dr. Howell recommends that leaders look for tools that minimize blind spots and get information from staff through survey assessments. “Get the input of others on your strengths and weaknesses,” he said. “Nurses, doctors, and sometimes patients can give you good information that will help you grow as a leader. Don’t be afraid of feedback.”
 

Never stop learning

Dr. Scheurer said it is important to recognize that you are never finished learning when you are a leader.

“See leadership as a continuous learning journey. You can never be too good of a leader in medicine,” she said. “Never stop learning, because the field keeps changing and you have to constantly learn and find pleasure in that learning. You should look at leadership the same way. A lot of leadership theories change with the times and you should always try to get good advice. You don’t take every piece of advice – just like in medicine when you read an article and you try to apply it to patients in your practice. Take some advice, leave some advice, and develop a leadership style that is genuine and authentic.”

Dr. Kennedy believes that a hospitalist’s leadership potential may be limited if you see continued learning as a chore, rather than an opportunity.

“If you resent it learning about leadership, then is it really for you?” she asked. “I find myself reading on the topic or talking about it, and it’s fun. How do you make an environment work better, how do you inspire people, how do you help them grow? These are some of the most important questions leaders face. Isn’t it fun if you can find some answers?”
 

Have you ever thought you could be a leader, in your hospitalist group, in hospital administration, or at another institution? The reasons to seek a leadership role as a hospitalist are many, but there are also many drawbacks. According to hospitalists who have reached high rungs on the leadership ladder, you will need a blend of desire, enthusiasm, education, and experience if you want to succeed in leadership.

The right reasons

“People who make good leaders have a sense of purpose and want to make a difference,” said Eric Howell, MD, MHM, CEO of the Society of Hospital Medicine, and former chief of medical units at Johns Hopkins Bayview in Baltimore. “I think most hospitalists have that sense of wanting to help patients and society, so that’s a strong mission in itself. Just by training and the very design of our health care system, hospitalists are often natural leaders, and in leadership roles, because they run teams of clinicians and train medical students.”

Danielle Scheurer, MD, SFHM, chief quality officer and professor of medicine at the Medical University of South Carolina, and current president of SHM, said some hospitalists end up in leadership roles almost by accident – because there is a leadership “void” in the health system where they work, and no one else wants to step up. Others disconnect from the leadership track and are happy to simply be part of a team.

“If you are yearning to make a difference and that’s your motivation then you will find leadership is more fulfilling than difficult,” she said. “But if you take a leadership role to fill a void or think you just want to take some nonclinical time, it’s probably not a good idea. Some people think administrative leadership is easier than being a hospitalist, but it is not. Leadership should not be about getting away from something else. It should be a thoughtful career move, and if it is, being a leader can be meaningful and fulfilling.”

Nancy Spector, MD, the vice dean for faculty and executive director of the Executive Leadership in Academic Medicine program at Drexel University College of Medicine in Philadelphia, said a willingness to fail is vital for a leader. “You have to be open to successes, yes, but also to making mistakes,” she said. “It’s about honing the skills that leadership requires and be open to development and change.”

Kierstin Cates Kennedy, MD, SFHM, chief of hospital medicine at the University of Alabama at Birmingham, said that a hospitalist fresh out of residency will gain insight into whether leadership is the right path by acquiring a deeper understanding of how health care institutions work.

Still up for it?

If you think you have the commitment and desire for leadership as an early career hospitalist, how would you continue down the leadership path?

“A great way is to find a person you want to be like, who could be a mentor. Find a successful leader that you admire, and one who is willing to guide you,” Dr. Howell said. “Books are helpful as well, and I still find I’m learning today – I have a list that includes Drive by Daniel Pink and Good to Great by Jim Collins. There are Malcolm Gladwell books that also have terrific knowledge to impart.”

Mark W. Shen, MD, SFHM, associate professor at Dell Medical School at the University of Texas at Austin and former president of St. Louis Children’s Hospital, said potential hospitalist leaders must be aware of their fellow clinicians.

“Pay attention to the needs of the hospitalist group as they are articulated by the lead hospitalist, the administration, and the patients,” he said. “There are so many activities that come up on a day-in, day-out basis. You should jump in and volunteer to take the lead on some of those activities. Leading your peers is often one of the most challenging parts of leadership. I think taking on even just a small activity like, say, working on a clinical pathway for the group, will result in a lot of preparation for future leadership roles.”

An example of an early career activity that Dr. Shen felt was valuable to future leaders was helping in the development of a hospitalist core curriculum. “We would use the core curriculum to educate students and residents coming through our rotation and have some degree of commonality or standardization,” he said. “So even though I wasn’t an explicit leader of the hospitalist group at the time, I’d say that helping develop the core curriculum aided me in understanding what leadership was all about.”

Getting started in a leadership role, Dr. Spector said, can be helped by embracing a knowledge of the business of medicine. “Business and finance are a reality you shouldn’t avoid,” she said. “Another way to learn is to partner with your local administrators or whoever is running your division or your department. There are business managers and business partners in every institution, and you can learn a great deal from them. It’s important to network and get to know people because we’re a people business, and opportunity comes when people know who you are.”

Dr. Howell noted that advocating for yourself is sometimes hard, and it can be a red flag in some circumstances, but you should tell your bosses where you want to go professionally.

“You can say that you want to grow professionally, and let’s face it, there are naturally-inclined leaders. We all need to be transparent in goal paths,” he said. “But if you want a leadership role for power, money, and prestige then you’re not applying the right thinking. If you want to help others and you have a mission you believe in, then communicate that to your bosses.”

Dr. Scheurer believes choosing between clinical and administrative leadership is not so clear cut, because in the health care setting they tend to morph into each other. “Many times clinicians will end up taking on a leadership role that has a significant administrative component to it,” she said. “I do think if clinicians make a career move and get the right training then they can be exemplary leaders in health care, but I do worry a little about clinicians going into leadership roles without any formal training. They are usually well-intentioned but that’s not enough. It’s not any different than medical training. If you want to be a good leader you need training to develop your skills, and a lot of those skills do not come naturally or easily. We thrust good clinicians into leadership roles because they are good clinicians, but if they don’t have the right skills, being a leader can be a problem.”
 

How do leaders improve?

If you have made it to a leadership position, and have been in that role for a while, you might start to feel you are stuck in your growth trajectory. If so, how do you continue to improve?

According to Dr. Kennedy, whether you are looking to get into leadership or want to improve, focusing on emotional intelligence is important. “A book like Emotional Intelligence 2.0 by Travis Bradbury is a great introduction,” she said. “With my leadership team, we did a book club where we read Primal Leadership, which is focused on emotional intelligence and on aspects like setting a culture.”

Dr. Howell said that to grow as a leader, be careful what you say no to. “I used to talk about having a tag line that was ‘just say yes,’” he said. “At least try to say yes most of the time because it opens up opportunities and shows you are looking to do more, not less.”

Also, Dr. Howell recommends that leaders look for tools that minimize blind spots and get information from staff through survey assessments. “Get the input of others on your strengths and weaknesses,” he said. “Nurses, doctors, and sometimes patients can give you good information that will help you grow as a leader. Don’t be afraid of feedback.”
 

Never stop learning

Dr. Scheurer said it is important to recognize that you are never finished learning when you are a leader.

“See leadership as a continuous learning journey. You can never be too good of a leader in medicine,” she said. “Never stop learning, because the field keeps changing and you have to constantly learn and find pleasure in that learning. You should look at leadership the same way. A lot of leadership theories change with the times and you should always try to get good advice. You don’t take every piece of advice – just like in medicine when you read an article and you try to apply it to patients in your practice. Take some advice, leave some advice, and develop a leadership style that is genuine and authentic.”

Dr. Kennedy believes that a hospitalist’s leadership potential may be limited if you see continued learning as a chore, rather than an opportunity.

“If you resent it learning about leadership, then is it really for you?” she asked. “I find myself reading on the topic or talking about it, and it’s fun. How do you make an environment work better, how do you inspire people, how do you help them grow? These are some of the most important questions leaders face. Isn’t it fun if you can find some answers?”
 

Have you ever thought you could be a leader, in your hospitalist group, in hospital administration, or at another institution? The reasons to seek a leadership role as a hospitalist are many, but there are also many drawbacks. According to hospitalists who have reached high rungs on the leadership ladder, you will need a blend of desire, enthusiasm, education, and experience if you want to succeed in leadership.

The right reasons

“People who make good leaders have a sense of purpose and want to make a difference,” said Eric Howell, MD, MHM, CEO of the Society of Hospital Medicine, and former chief of medical units at Johns Hopkins Bayview in Baltimore. “I think most hospitalists have that sense of wanting to help patients and society, so that’s a strong mission in itself. Just by training and the very design of our health care system, hospitalists are often natural leaders, and in leadership roles, because they run teams of clinicians and train medical students.”

Danielle Scheurer, MD, SFHM, chief quality officer and professor of medicine at the Medical University of South Carolina, and current president of SHM, said some hospitalists end up in leadership roles almost by accident – because there is a leadership “void” in the health system where they work, and no one else wants to step up. Others disconnect from the leadership track and are happy to simply be part of a team.

“If you are yearning to make a difference and that’s your motivation then you will find leadership is more fulfilling than difficult,” she said. “But if you take a leadership role to fill a void or think you just want to take some nonclinical time, it’s probably not a good idea. Some people think administrative leadership is easier than being a hospitalist, but it is not. Leadership should not be about getting away from something else. It should be a thoughtful career move, and if it is, being a leader can be meaningful and fulfilling.”

Nancy Spector, MD, the vice dean for faculty and executive director of the Executive Leadership in Academic Medicine program at Drexel University College of Medicine in Philadelphia, said a willingness to fail is vital for a leader. “You have to be open to successes, yes, but also to making mistakes,” she said. “It’s about honing the skills that leadership requires and be open to development and change.”

Kierstin Cates Kennedy, MD, SFHM, chief of hospital medicine at the University of Alabama at Birmingham, said that a hospitalist fresh out of residency will gain insight into whether leadership is the right path by acquiring a deeper understanding of how health care institutions work.

Still up for it?

If you think you have the commitment and desire for leadership as an early career hospitalist, how would you continue down the leadership path?

“A great way is to find a person you want to be like, who could be a mentor. Find a successful leader that you admire, and one who is willing to guide you,” Dr. Howell said. “Books are helpful as well, and I still find I’m learning today – I have a list that includes Drive by Daniel Pink and Good to Great by Jim Collins. There are Malcolm Gladwell books that also have terrific knowledge to impart.”

Mark W. Shen, MD, SFHM, associate professor at Dell Medical School at the University of Texas at Austin and former president of St. Louis Children’s Hospital, said potential hospitalist leaders must be aware of their fellow clinicians.

“Pay attention to the needs of the hospitalist group as they are articulated by the lead hospitalist, the administration, and the patients,” he said. “There are so many activities that come up on a day-in, day-out basis. You should jump in and volunteer to take the lead on some of those activities. Leading your peers is often one of the most challenging parts of leadership. I think taking on even just a small activity like, say, working on a clinical pathway for the group, will result in a lot of preparation for future leadership roles.”

An example of an early career activity that Dr. Shen felt was valuable to future leaders was helping in the development of a hospitalist core curriculum. “We would use the core curriculum to educate students and residents coming through our rotation and have some degree of commonality or standardization,” he said. “So even though I wasn’t an explicit leader of the hospitalist group at the time, I’d say that helping develop the core curriculum aided me in understanding what leadership was all about.”

Getting started in a leadership role, Dr. Spector said, can be helped by embracing a knowledge of the business of medicine. “Business and finance are a reality you shouldn’t avoid,” she said. “Another way to learn is to partner with your local administrators or whoever is running your division or your department. There are business managers and business partners in every institution, and you can learn a great deal from them. It’s important to network and get to know people because we’re a people business, and opportunity comes when people know who you are.”

Dr. Howell noted that advocating for yourself is sometimes hard, and it can be a red flag in some circumstances, but you should tell your bosses where you want to go professionally.

“You can say that you want to grow professionally, and let’s face it, there are naturally-inclined leaders. We all need to be transparent in goal paths,” he said. “But if you want a leadership role for power, money, and prestige then you’re not applying the right thinking. If you want to help others and you have a mission you believe in, then communicate that to your bosses.”

Dr. Scheurer believes choosing between clinical and administrative leadership is not so clear cut, because in the health care setting they tend to morph into each other. “Many times clinicians will end up taking on a leadership role that has a significant administrative component to it,” she said. “I do think if clinicians make a career move and get the right training then they can be exemplary leaders in health care, but I do worry a little about clinicians going into leadership roles without any formal training. They are usually well-intentioned but that’s not enough. It’s not any different than medical training. If you want to be a good leader you need training to develop your skills, and a lot of those skills do not come naturally or easily. We thrust good clinicians into leadership roles because they are good clinicians, but if they don’t have the right skills, being a leader can be a problem.”
 

How do leaders improve?

If you have made it to a leadership position, and have been in that role for a while, you might start to feel you are stuck in your growth trajectory. If so, how do you continue to improve?

According to Dr. Kennedy, whether you are looking to get into leadership or want to improve, focusing on emotional intelligence is important. “A book like Emotional Intelligence 2.0 by Travis Bradbury is a great introduction,” she said. “With my leadership team, we did a book club where we read Primal Leadership, which is focused on emotional intelligence and on aspects like setting a culture.”

Dr. Howell said that to grow as a leader, be careful what you say no to. “I used to talk about having a tag line that was ‘just say yes,’” he said. “At least try to say yes most of the time because it opens up opportunities and shows you are looking to do more, not less.”

Also, Dr. Howell recommends that leaders look for tools that minimize blind spots and get information from staff through survey assessments. “Get the input of others on your strengths and weaknesses,” he said. “Nurses, doctors, and sometimes patients can give you good information that will help you grow as a leader. Don’t be afraid of feedback.”
 

Never stop learning

Dr. Scheurer said it is important to recognize that you are never finished learning when you are a leader.

“See leadership as a continuous learning journey. You can never be too good of a leader in medicine,” she said. “Never stop learning, because the field keeps changing and you have to constantly learn and find pleasure in that learning. You should look at leadership the same way. A lot of leadership theories change with the times and you should always try to get good advice. You don’t take every piece of advice – just like in medicine when you read an article and you try to apply it to patients in your practice. Take some advice, leave some advice, and develop a leadership style that is genuine and authentic.”

Dr. Kennedy believes that a hospitalist’s leadership potential may be limited if you see continued learning as a chore, rather than an opportunity.

“If you resent it learning about leadership, then is it really for you?” she asked. “I find myself reading on the topic or talking about it, and it’s fun. How do you make an environment work better, how do you inspire people, how do you help them grow? These are some of the most important questions leaders face. Isn’t it fun if you can find some answers?”
 

In my last column, I explained how I’m like Tom Brady. I’m not really. Brady is a Super Bowl–winning quarterback worth over $200 million. No, I’m like Oprah. Well, trying anyway.

Brady and Oprah, in addition to being gazillionaires, have in common that they’re arguably the GOATs (Greatest Of All Time) in their fields. Watching Oprah interview Meghan Markle and Prince Harry was like watching Tom Brady on the jumbotron – she made it look easy. Her ability to create conversation and coax information from guests is hall-of-fame good. But although they are both admirable, trying to be like Brady is useful only for next Thanksgiving when you’re trying to beat your cousins from Massachusetts in touch football. Trying to be like Oprah can help you be better in clinic tomorrow. If we break down what she’s doing, it’s just fundamentals done exceedingly well.

1. Prepare ahead. It’s clear that Oprah has binders of notes about her guests and thoroughly reviewed them before she invites them to sit down. We should do the same. Open the chart and read as much as you can before you open the door. Have important information in your head so you don’t have to break from your interview to refer to it.

2. Sprinkle pleasantry. She’d never start an interview with: So why are you here? Nor should we. Even one nonscripted question or comment can help build a little rapport before getting to the work.

3. Be brief. Oprah gets her question out fast, then gets out of the way. And as a bonus, this is the easiest place to shave a few minutes from your appointments from your own end. Think for a second before you speak and try to find the shortest route to your question. Try to keep your questions to just a sentence or two.

4. Stay on it. Once you’ve discovered something relevant, stay with it, resisting the urge to finish the review of symptoms. This is not just to make a diagnosis, but as importantly, trying to diagnose “the real reason” for the visit. Then, when the question is done, own the transition. Oprah uses: “Let’s move on.” This is a bit abrupt for us, but it can be helpful if used sparingly and gently. I might soften this a little by adding “I want to be sure we have enough time to get through everything for you.”

5. Wait. A few seconds seems an eternity on the air (and in clinic), but sometimes the silent pause is just what’s needed to help the patient expand and share.

6. Be nonjudgmental. Most of us believe we’re pretty good at this, yet, it’s sometimes a blind spot. It’s easy to blame the obese patient for his stasis dermatitis or the hidradenitis patient who hasn’t stop smoking for her cysts. It also helps to be nontransactional. If you make patients feel that you’re asking questions only to extract information, you’ll never reach Oprah level.

7. Be in the moment. It is difficult, but when possible, avoid typing notes while you’re still interviewing. We’re not just there to get the facts, we’re also trying to get the story and that sometimes takes really listening.

I’m no more like Oprah than Brady, of course. But it is more fun to close my eyes and imagine myself being her when I see my next patient. That is, until Thanksgiving. Watch out, Bedards from Attleboro.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

In my last column, I explained how I’m like Tom Brady. I’m not really. Brady is a Super Bowl–winning quarterback worth over $200 million. No, I’m like Oprah. Well, trying anyway.

Brady and Oprah, in addition to being gazillionaires, have in common that they’re arguably the GOATs (Greatest Of All Time) in their fields. Watching Oprah interview Meghan Markle and Prince Harry was like watching Tom Brady on the jumbotron – she made it look easy. Her ability to create conversation and coax information from guests is hall-of-fame good. But although they are both admirable, trying to be like Brady is useful only for next Thanksgiving when you’re trying to beat your cousins from Massachusetts in touch football. Trying to be like Oprah can help you be better in clinic tomorrow. If we break down what she’s doing, it’s just fundamentals done exceedingly well.

1. Prepare ahead. It’s clear that Oprah has binders of notes about her guests and thoroughly reviewed them before she invites them to sit down. We should do the same. Open the chart and read as much as you can before you open the door. Have important information in your head so you don’t have to break from your interview to refer to it.

2. Sprinkle pleasantry. She’d never start an interview with: So why are you here? Nor should we. Even one nonscripted question or comment can help build a little rapport before getting to the work.

3. Be brief. Oprah gets her question out fast, then gets out of the way. And as a bonus, this is the easiest place to shave a few minutes from your appointments from your own end. Think for a second before you speak and try to find the shortest route to your question. Try to keep your questions to just a sentence or two.

4. Stay on it. Once you’ve discovered something relevant, stay with it, resisting the urge to finish the review of symptoms. This is not just to make a diagnosis, but as importantly, trying to diagnose “the real reason” for the visit. Then, when the question is done, own the transition. Oprah uses: “Let’s move on.” This is a bit abrupt for us, but it can be helpful if used sparingly and gently. I might soften this a little by adding “I want to be sure we have enough time to get through everything for you.”

5. Wait. A few seconds seems an eternity on the air (and in clinic), but sometimes the silent pause is just what’s needed to help the patient expand and share.

6. Be nonjudgmental. Most of us believe we’re pretty good at this, yet, it’s sometimes a blind spot. It’s easy to blame the obese patient for his stasis dermatitis or the hidradenitis patient who hasn’t stop smoking for her cysts. It also helps to be nontransactional. If you make patients feel that you’re asking questions only to extract information, you’ll never reach Oprah level.

7. Be in the moment. It is difficult, but when possible, avoid typing notes while you’re still interviewing. We’re not just there to get the facts, we’re also trying to get the story and that sometimes takes really listening.

I’m no more like Oprah than Brady, of course. But it is more fun to close my eyes and imagine myself being her when I see my next patient. That is, until Thanksgiving. Watch out, Bedards from Attleboro.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

In my last column, I explained how I’m like Tom Brady. I’m not really. Brady is a Super Bowl–winning quarterback worth over $200 million. No, I’m like Oprah. Well, trying anyway.

Brady and Oprah, in addition to being gazillionaires, have in common that they’re arguably the GOATs (Greatest Of All Time) in their fields. Watching Oprah interview Meghan Markle and Prince Harry was like watching Tom Brady on the jumbotron – she made it look easy. Her ability to create conversation and coax information from guests is hall-of-fame good. But although they are both admirable, trying to be like Brady is useful only for next Thanksgiving when you’re trying to beat your cousins from Massachusetts in touch football. Trying to be like Oprah can help you be better in clinic tomorrow. If we break down what she’s doing, it’s just fundamentals done exceedingly well.

1. Prepare ahead. It’s clear that Oprah has binders of notes about her guests and thoroughly reviewed them before she invites them to sit down. We should do the same. Open the chart and read as much as you can before you open the door. Have important information in your head so you don’t have to break from your interview to refer to it.

2. Sprinkle pleasantry. She’d never start an interview with: So why are you here? Nor should we. Even one nonscripted question or comment can help build a little rapport before getting to the work.

3. Be brief. Oprah gets her question out fast, then gets out of the way. And as a bonus, this is the easiest place to shave a few minutes from your appointments from your own end. Think for a second before you speak and try to find the shortest route to your question. Try to keep your questions to just a sentence or two.

4. Stay on it. Once you’ve discovered something relevant, stay with it, resisting the urge to finish the review of symptoms. This is not just to make a diagnosis, but as importantly, trying to diagnose “the real reason” for the visit. Then, when the question is done, own the transition. Oprah uses: “Let’s move on.” This is a bit abrupt for us, but it can be helpful if used sparingly and gently. I might soften this a little by adding “I want to be sure we have enough time to get through everything for you.”

5. Wait. A few seconds seems an eternity on the air (and in clinic), but sometimes the silent pause is just what’s needed to help the patient expand and share.

6. Be nonjudgmental. Most of us believe we’re pretty good at this, yet, it’s sometimes a blind spot. It’s easy to blame the obese patient for his stasis dermatitis or the hidradenitis patient who hasn’t stop smoking for her cysts. It also helps to be nontransactional. If you make patients feel that you’re asking questions only to extract information, you’ll never reach Oprah level.

7. Be in the moment. It is difficult, but when possible, avoid typing notes while you’re still interviewing. We’re not just there to get the facts, we’re also trying to get the story and that sometimes takes really listening.

I’m no more like Oprah than Brady, of course. But it is more fun to close my eyes and imagine myself being her when I see my next patient. That is, until Thanksgiving. Watch out, Bedards from Attleboro.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Hooray for back to school! But not for everyone. ... what to do with those who have trouble transitioning back?

As we have now passed a year since COVID-19–related shutdowns were implemented throughout the United States; and with returns to in-person schooling continuing to vary based on location, many of us either in our personal lives, or through conversations with patients and families, are experiencing a yearning for the “good old days” of fully in-person schooling. As the place where children and adolescents spend a good portion of their waking hours, school is integral to not just children’s academic development, but to emotional and social development as well. One interesting phenomenon I’ve seen working with many children and families is that the strong desire to go back to school is not universal. Some of my patients are perfectly happy to be doing “remote schooling”, as it reduces the stress that they were experiencing in this setting before the pandemic.¹ These families find themselves wondering – how will I get my child to return to school? As we (hopefully) turn the corner toward a return to normalcy, I believe many of us may find ourselves counseling families on whether a return to in-person schooling is in their child’s best interest. Even when a family decides it is best for their child to return, we might encounter scenarios in which children and adolescents outright refuse to go to school, or engage in avoidant behavior, which is broadly known as “school refusal.” Discussion of a treatment approach to this often challenging clinical scenario is warranted.

The first step in addressing the issue is defining it. School refusal is not a “diagnosis” in psychiatric lexicon, rather it describes a behavior which may be a symptom or manifestation of any number of underlying factors. One helpful definition proposed is (a) missing 25% of total school time for at least 2 weeks or (b) experiencing difficulty attending school such that there is significant interference in the child’s or family’s daily routine for at least 2 weeks, or (c) missing at least 10 days of school over a period of 15 weeks.² The common thread of this, and any other definition, is sustained absenteeism or avoidance with significant impact to education, family life, or both. It is estimated that the prevalence of this phenomenon is between 1% and 2% of school-aged children.

Next to consider is what might be prompting or underlying the behavior. A comprehensive evaluation approach should include consideration of environmental factors such as bullying and learning difficulties, as well as presence of an anxiety or depressive disorder. Awareness of whether the child/adolescent has a 504 plan or individualized education program (IEP) is vital, as these can be marshaled for additional support. Family factors, including parental illness (medical and/or psychiatric), should also be considered. As school avoidance behaviors often include somatic symptoms of anxiety such as palpitations, shortness of breath, and abdominal pain; a rule out of medical etiology is recommended, as well as a caution to consider both medical and behavioral factors simultaneously, as focus on either separately can lead to missing the other.

Separation anxiety and social anxiety disorders are two specific conditions that may manifest in school refusal and should be evaluated for specifically. Separation anxiety is characterized by developmentally inappropriate, excessive worry or distress associated with separation from a primary caregiver or major attachment figure. Social anxiety is characterized by excessive fear or worry about being negatively evaluated by others in social situations.³ One publicly available tool that can be helpful for screening for a variety of anxiety disorders in children and adolescents is the SCARED.⁴ The PHQ-9 Adolescent⁵ is one such screening instrument for depression, which can be a driving factor or co-occur in children with school refusal.

When it comes to treatment, the best evidence out there is for a cognitive-behavioral therapy (CBT)–based approach motivated toward a return to the school setting as soon as possible.^6,7 This will involve looking at how thoughts, behaviors, and feelings are interacting with each other in the clinical scenario and how these might be challenged or changed in a positive manner. Coping and problem-solving skills are often incorporated. This approach may also involve gradual exposure to the anxiety-producing situation in a hierarchical fashion starting with less anxiety-provoking scenarios and moving toward increasingly challenging ones. CBT for school refusal is likely most effective when including both school and family involvement to ensure consistency across settings. Making sure that there are not inadvertent reinforcing factors motivating staying home (for instance unrestricted access to electronic devices) is an important step to consider. If anxiety or depression is moderately to severely impairing – which is frequently the case when school refusal comes to clinical attention, consider use of medication as part of the treatment strategy. Selective serotonin reuptake inhibitors as a class are the most commonly used medications and deserve strong consideration.

To summarize, school refusal can occur for a variety of reasons. Early identification and comprehensive treatment taking into account child and family preference and using a multimodal approach to encourage and support a quick return to the school environment is considered best practice.
 

Dr. Hoffnung is a pediatric psychiatrist at the University of Vermont Children’s Hospital and an assistant professor of psychiatry at the Robert Larner, M.D. College of Medicine at the University of Vermont, both in Burlington. He has no relevant financial disclosures. Email him at [email protected].

References

1. See, for example: www.npr.org/2021/03/08/971457441/as-many-parents-fret-over-remote-learning-some-find-their-kids-are-thriving.

2. Kearney CA. Educ Psychol Rev. 2008;20:257-82.

3. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, Va.: American Psychiatric Association, 2013.

4. Available at: www.pediatricbipolar.pitt.edu/resources/instruments.

5. Available at: www.aacap.org/App_Themes/AACAP/docs/member_resources/toolbox_for_clinical_practice_and_outcomes/symptoms/GLAD-PC_PHQ-9.pdf.

6. Elliott JG and Place M. J Child Psychol Psychiatry. 2019;60(1):4-15.

7. Prabhuswamy M. J Paed Child Health. 2018;54(10):1117-20.

Hooray for back to school! But not for everyone. ... what to do with those who have trouble transitioning back?

As we have now passed a year since COVID-19–related shutdowns were implemented throughout the United States; and with returns to in-person schooling continuing to vary based on location, many of us either in our personal lives, or through conversations with patients and families, are experiencing a yearning for the “good old days” of fully in-person schooling. As the place where children and adolescents spend a good portion of their waking hours, school is integral to not just children’s academic development, but to emotional and social development as well. One interesting phenomenon I’ve seen working with many children and families is that the strong desire to go back to school is not universal. Some of my patients are perfectly happy to be doing “remote schooling”, as it reduces the stress that they were experiencing in this setting before the pandemic.¹ These families find themselves wondering – how will I get my child to return to school? As we (hopefully) turn the corner toward a return to normalcy, I believe many of us may find ourselves counseling families on whether a return to in-person schooling is in their child’s best interest. Even when a family decides it is best for their child to return, we might encounter scenarios in which children and adolescents outright refuse to go to school, or engage in avoidant behavior, which is broadly known as “school refusal.” Discussion of a treatment approach to this often challenging clinical scenario is warranted.

The first step in addressing the issue is defining it. School refusal is not a “diagnosis” in psychiatric lexicon, rather it describes a behavior which may be a symptom or manifestation of any number of underlying factors. One helpful definition proposed is (a) missing 25% of total school time for at least 2 weeks or (b) experiencing difficulty attending school such that there is significant interference in the child’s or family’s daily routine for at least 2 weeks, or (c) missing at least 10 days of school over a period of 15 weeks.² The common thread of this, and any other definition, is sustained absenteeism or avoidance with significant impact to education, family life, or both. It is estimated that the prevalence of this phenomenon is between 1% and 2% of school-aged children.

Next to consider is what might be prompting or underlying the behavior. A comprehensive evaluation approach should include consideration of environmental factors such as bullying and learning difficulties, as well as presence of an anxiety or depressive disorder. Awareness of whether the child/adolescent has a 504 plan or individualized education program (IEP) is vital, as these can be marshaled for additional support. Family factors, including parental illness (medical and/or psychiatric), should also be considered. As school avoidance behaviors often include somatic symptoms of anxiety such as palpitations, shortness of breath, and abdominal pain; a rule out of medical etiology is recommended, as well as a caution to consider both medical and behavioral factors simultaneously, as focus on either separately can lead to missing the other.

Separation anxiety and social anxiety disorders are two specific conditions that may manifest in school refusal and should be evaluated for specifically. Separation anxiety is characterized by developmentally inappropriate, excessive worry or distress associated with separation from a primary caregiver or major attachment figure. Social anxiety is characterized by excessive fear or worry about being negatively evaluated by others in social situations.³ One publicly available tool that can be helpful for screening for a variety of anxiety disorders in children and adolescents is the SCARED.⁴ The PHQ-9 Adolescent⁵ is one such screening instrument for depression, which can be a driving factor or co-occur in children with school refusal.

When it comes to treatment, the best evidence out there is for a cognitive-behavioral therapy (CBT)–based approach motivated toward a return to the school setting as soon as possible.^6,7 This will involve looking at how thoughts, behaviors, and feelings are interacting with each other in the clinical scenario and how these might be challenged or changed in a positive manner. Coping and problem-solving skills are often incorporated. This approach may also involve gradual exposure to the anxiety-producing situation in a hierarchical fashion starting with less anxiety-provoking scenarios and moving toward increasingly challenging ones. CBT for school refusal is likely most effective when including both school and family involvement to ensure consistency across settings. Making sure that there are not inadvertent reinforcing factors motivating staying home (for instance unrestricted access to electronic devices) is an important step to consider. If anxiety or depression is moderately to severely impairing – which is frequently the case when school refusal comes to clinical attention, consider use of medication as part of the treatment strategy. Selective serotonin reuptake inhibitors as a class are the most commonly used medications and deserve strong consideration.

To summarize, school refusal can occur for a variety of reasons. Early identification and comprehensive treatment taking into account child and family preference and using a multimodal approach to encourage and support a quick return to the school environment is considered best practice.
 

Dr. Hoffnung is a pediatric psychiatrist at the University of Vermont Children’s Hospital and an assistant professor of psychiatry at the Robert Larner, M.D. College of Medicine at the University of Vermont, both in Burlington. He has no relevant financial disclosures. Email him at [email protected].

References

1. See, for example: www.npr.org/2021/03/08/971457441/as-many-parents-fret-over-remote-learning-some-find-their-kids-are-thriving.

2. Kearney CA. Educ Psychol Rev. 2008;20:257-82.

3. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, Va.: American Psychiatric Association, 2013.

4. Available at: www.pediatricbipolar.pitt.edu/resources/instruments.

5. Available at: www.aacap.org/App_Themes/AACAP/docs/member_resources/toolbox_for_clinical_practice_and_outcomes/symptoms/GLAD-PC_PHQ-9.pdf.

6. Elliott JG and Place M. J Child Psychol Psychiatry. 2019;60(1):4-15.

7. Prabhuswamy M. J Paed Child Health. 2018;54(10):1117-20.

Hooray for back to school! But not for everyone. ... what to do with those who have trouble transitioning back?

As we have now passed a year since COVID-19–related shutdowns were implemented throughout the United States; and with returns to in-person schooling continuing to vary based on location, many of us either in our personal lives, or through conversations with patients and families, are experiencing a yearning for the “good old days” of fully in-person schooling. As the place where children and adolescents spend a good portion of their waking hours, school is integral to not just children’s academic development, but to emotional and social development as well. One interesting phenomenon I’ve seen working with many children and families is that the strong desire to go back to school is not universal. Some of my patients are perfectly happy to be doing “remote schooling”, as it reduces the stress that they were experiencing in this setting before the pandemic.¹ These families find themselves wondering – how will I get my child to return to school? As we (hopefully) turn the corner toward a return to normalcy, I believe many of us may find ourselves counseling families on whether a return to in-person schooling is in their child’s best interest. Even when a family decides it is best for their child to return, we might encounter scenarios in which children and adolescents outright refuse to go to school, or engage in avoidant behavior, which is broadly known as “school refusal.” Discussion of a treatment approach to this often challenging clinical scenario is warranted.

The first step in addressing the issue is defining it. School refusal is not a “diagnosis” in psychiatric lexicon, rather it describes a behavior which may be a symptom or manifestation of any number of underlying factors. One helpful definition proposed is (a) missing 25% of total school time for at least 2 weeks or (b) experiencing difficulty attending school such that there is significant interference in the child’s or family’s daily routine for at least 2 weeks, or (c) missing at least 10 days of school over a period of 15 weeks.² The common thread of this, and any other definition, is sustained absenteeism or avoidance with significant impact to education, family life, or both. It is estimated that the prevalence of this phenomenon is between 1% and 2% of school-aged children.

Next to consider is what might be prompting or underlying the behavior. A comprehensive evaluation approach should include consideration of environmental factors such as bullying and learning difficulties, as well as presence of an anxiety or depressive disorder. Awareness of whether the child/adolescent has a 504 plan or individualized education program (IEP) is vital, as these can be marshaled for additional support. Family factors, including parental illness (medical and/or psychiatric), should also be considered. As school avoidance behaviors often include somatic symptoms of anxiety such as palpitations, shortness of breath, and abdominal pain; a rule out of medical etiology is recommended, as well as a caution to consider both medical and behavioral factors simultaneously, as focus on either separately can lead to missing the other.

Separation anxiety and social anxiety disorders are two specific conditions that may manifest in school refusal and should be evaluated for specifically. Separation anxiety is characterized by developmentally inappropriate, excessive worry or distress associated with separation from a primary caregiver or major attachment figure. Social anxiety is characterized by excessive fear or worry about being negatively evaluated by others in social situations.³ One publicly available tool that can be helpful for screening for a variety of anxiety disorders in children and adolescents is the SCARED.⁴ The PHQ-9 Adolescent⁵ is one such screening instrument for depression, which can be a driving factor or co-occur in children with school refusal.

When it comes to treatment, the best evidence out there is for a cognitive-behavioral therapy (CBT)–based approach motivated toward a return to the school setting as soon as possible.^6,7 This will involve looking at how thoughts, behaviors, and feelings are interacting with each other in the clinical scenario and how these might be challenged or changed in a positive manner. Coping and problem-solving skills are often incorporated. This approach may also involve gradual exposure to the anxiety-producing situation in a hierarchical fashion starting with less anxiety-provoking scenarios and moving toward increasingly challenging ones. CBT for school refusal is likely most effective when including both school and family involvement to ensure consistency across settings. Making sure that there are not inadvertent reinforcing factors motivating staying home (for instance unrestricted access to electronic devices) is an important step to consider. If anxiety or depression is moderately to severely impairing – which is frequently the case when school refusal comes to clinical attention, consider use of medication as part of the treatment strategy. Selective serotonin reuptake inhibitors as a class are the most commonly used medications and deserve strong consideration.

To summarize, school refusal can occur for a variety of reasons. Early identification and comprehensive treatment taking into account child and family preference and using a multimodal approach to encourage and support a quick return to the school environment is considered best practice.
 

Dr. Hoffnung is a pediatric psychiatrist at the University of Vermont Children’s Hospital and an assistant professor of psychiatry at the Robert Larner, M.D. College of Medicine at the University of Vermont, both in Burlington. He has no relevant financial disclosures. Email him at [email protected].

References

1. See, for example: www.npr.org/2021/03/08/971457441/as-many-parents-fret-over-remote-learning-some-find-their-kids-are-thriving.

2. Kearney CA. Educ Psychol Rev. 2008;20:257-82.

3. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Arlington, Va.: American Psychiatric Association, 2013.

4. Available at: www.pediatricbipolar.pitt.edu/resources/instruments.

5. Available at: www.aacap.org/App_Themes/AACAP/docs/member_resources/toolbox_for_clinical_practice_and_outcomes/symptoms/GLAD-PC_PHQ-9.pdf.

6. Elliott JG and Place M. J Child Psychol Psychiatry. 2019;60(1):4-15.

7. Prabhuswamy M. J Paed Child Health. 2018;54(10):1117-20.

How many epidemics can one country contain? Nearly all of our national attention has been focused on the COVID-19 epidemic but, lest we forget, there’s still another one to be reckoned with: the HIV epidemic is still going strong. In fact, it’s gathering strength, in part, because of the economic and health devastation wrought by COVID.

                Over nearly 4 decades, the epidemiology of HIV has changed, according to The Lancet’s HIV in the USA series. Current data, the report says, “illustrate an epidemic defined by stark health inequities that largely fall along lines of disadvantages in economic opportunity and social capital.” Moreover, the US, the authors say, “continues to lag behind other G-7 nations when it comes to controlling its HIV epidemic and is the only high-income country among the top 10 countries most affected by HIV.”

                The 6-paper series’ release comes 2 years after the launch of the US Department of Health and Human Services’ (HHS) announcement of its goal to reduce HIV transmissions by at least 90% by 2030.

                The authors analyzed publicly available HIV surveillance and census data to describe current prevalence and new HIV diagnoses by region, race, ethnicity, and age, as well as trends in those categories over time. They also reviewed literature to “explore the reasons” for the distribution of cases and important disparities in prevalence. Among other things, the researchers found “pronounced” racial, sexual, and gender disparities, “substantial” gaps in domestic program funding, and a “patchwork healthcare system” that limited access to treatment and prevention services.

                Although when it began, the HIV epidemic was focused largely on the bicoastal big cities, mainly New York and San Francisco, in recent years the South has been hit particularly hard, with 52% of new HIV transmissions in 2018, despite representing only 37% of the US population. Six Southern states (Florida, Georgia, Louisiana, Maryland, Mississippi, and Tennessee) and the District of Columbia had the highest annual HIV diagnosis rates between 2010 and 2018, likely reflecting the higher burden of infection among black residents: In 2018, 38% of all new HIV diagnoses among men who have sex with men (MSM) were in the black population, and 63% of those were in the South.

                The South’s HIV problem is intensified by disparities, the report says, that are probably driven by the restricted expansion of Medicaid, health care provider shortages, low health literacy, and stigma. The South also has the lowest number of pre-exposure prophylaxis (PrEP) users per new HIV diagnosis, in part because of the longer distances to PrEP services relative to other regions. More than half of MSM who live at least 60 minutes away from PrEP services live in the South. While HIV in the rural South largely is due to sexual transmission, the researchers note, the largest clusters of the concurrent opioid epidemic have been detected in rural and periurban counties of West Virginia and Indiana.

                Identifying HIV transmission clusters and outbreaks has traditionally been challenging for several reasons, the researchers say, including delays between infection and diagnosis, mobility of populations, and limitations in tracing sex and drug partners. They suggest that analysis of molecular data can help overcome some of those barriers, making it possible to identify clusters of ongoing HIV transmission.

                The report also recommends other approaches to better understand and respond to ongoing HIV infections, such as mapping and data visualization, telemedicine, and automated data systems to facilitate linkage to care. However, the authors add, gaps in data and data systems remain that prevent full understanding of some key impacts of the epidemic. But any interventions to promote HIV prevention and treatment adherence, the authors suggested, should take a multifaceted approach and address the whole individual.

                Chris Beyrer, MD, MPH, investigator at the Johns Hopkins Bloomberg School of Public Health, Baltimore, and a lead author on the series, says, “We have incredible tools to prevent and treat HIV, but people may not fully utilize them if they are facing personal or structural issues that pose more immediate hardship, like substance use and mental health disorders. You may struggle to take a daily medication if you are facing food insecurity or cannot find affordable treatment for your substance use disorder.”

                Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and now also Chief Medical Advisor to President Biden, says, “To end the HIV epidemic, we must continue to develop and deploy novel HIV treatment and prevention strategies suited to the different needs and preferences of diverse populations disproportionately affected by HIV. It is also essential that HIV health services continue during the COVID-19 pandemic.”

How many epidemics can one country contain? Nearly all of our national attention has been focused on the COVID-19 epidemic but, lest we forget, there’s still another one to be reckoned with: the HIV epidemic is still going strong. In fact, it’s gathering strength, in part, because of the economic and health devastation wrought by COVID.

                Over nearly 4 decades, the epidemiology of HIV has changed, according to The Lancet’s HIV in the USA series. Current data, the report says, “illustrate an epidemic defined by stark health inequities that largely fall along lines of disadvantages in economic opportunity and social capital.” Moreover, the US, the authors say, “continues to lag behind other G-7 nations when it comes to controlling its HIV epidemic and is the only high-income country among the top 10 countries most affected by HIV.”

                The 6-paper series’ release comes 2 years after the launch of the US Department of Health and Human Services’ (HHS) announcement of its goal to reduce HIV transmissions by at least 90% by 2030.

                The authors analyzed publicly available HIV surveillance and census data to describe current prevalence and new HIV diagnoses by region, race, ethnicity, and age, as well as trends in those categories over time. They also reviewed literature to “explore the reasons” for the distribution of cases and important disparities in prevalence. Among other things, the researchers found “pronounced” racial, sexual, and gender disparities, “substantial” gaps in domestic program funding, and a “patchwork healthcare system” that limited access to treatment and prevention services.

                Although when it began, the HIV epidemic was focused largely on the bicoastal big cities, mainly New York and San Francisco, in recent years the South has been hit particularly hard, with 52% of new HIV transmissions in 2018, despite representing only 37% of the US population. Six Southern states (Florida, Georgia, Louisiana, Maryland, Mississippi, and Tennessee) and the District of Columbia had the highest annual HIV diagnosis rates between 2010 and 2018, likely reflecting the higher burden of infection among black residents: In 2018, 38% of all new HIV diagnoses among men who have sex with men (MSM) were in the black population, and 63% of those were in the South.

                The South’s HIV problem is intensified by disparities, the report says, that are probably driven by the restricted expansion of Medicaid, health care provider shortages, low health literacy, and stigma. The South also has the lowest number of pre-exposure prophylaxis (PrEP) users per new HIV diagnosis, in part because of the longer distances to PrEP services relative to other regions. More than half of MSM who live at least 60 minutes away from PrEP services live in the South. While HIV in the rural South largely is due to sexual transmission, the researchers note, the largest clusters of the concurrent opioid epidemic have been detected in rural and periurban counties of West Virginia and Indiana.

                Identifying HIV transmission clusters and outbreaks has traditionally been challenging for several reasons, the researchers say, including delays between infection and diagnosis, mobility of populations, and limitations in tracing sex and drug partners. They suggest that analysis of molecular data can help overcome some of those barriers, making it possible to identify clusters of ongoing HIV transmission.

                The report also recommends other approaches to better understand and respond to ongoing HIV infections, such as mapping and data visualization, telemedicine, and automated data systems to facilitate linkage to care. However, the authors add, gaps in data and data systems remain that prevent full understanding of some key impacts of the epidemic. But any interventions to promote HIV prevention and treatment adherence, the authors suggested, should take a multifaceted approach and address the whole individual.

                Chris Beyrer, MD, MPH, investigator at the Johns Hopkins Bloomberg School of Public Health, Baltimore, and a lead author on the series, says, “We have incredible tools to prevent and treat HIV, but people may not fully utilize them if they are facing personal or structural issues that pose more immediate hardship, like substance use and mental health disorders. You may struggle to take a daily medication if you are facing food insecurity or cannot find affordable treatment for your substance use disorder.”

                Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and now also Chief Medical Advisor to President Biden, says, “To end the HIV epidemic, we must continue to develop and deploy novel HIV treatment and prevention strategies suited to the different needs and preferences of diverse populations disproportionately affected by HIV. It is also essential that HIV health services continue during the COVID-19 pandemic.”

How many epidemics can one country contain? Nearly all of our national attention has been focused on the COVID-19 epidemic but, lest we forget, there’s still another one to be reckoned with: the HIV epidemic is still going strong. In fact, it’s gathering strength, in part, because of the economic and health devastation wrought by COVID.

                Over nearly 4 decades, the epidemiology of HIV has changed, according to The Lancet’s HIV in the USA series. Current data, the report says, “illustrate an epidemic defined by stark health inequities that largely fall along lines of disadvantages in economic opportunity and social capital.” Moreover, the US, the authors say, “continues to lag behind other G-7 nations when it comes to controlling its HIV epidemic and is the only high-income country among the top 10 countries most affected by HIV.”

                The 6-paper series’ release comes 2 years after the launch of the US Department of Health and Human Services’ (HHS) announcement of its goal to reduce HIV transmissions by at least 90% by 2030.

                The authors analyzed publicly available HIV surveillance and census data to describe current prevalence and new HIV diagnoses by region, race, ethnicity, and age, as well as trends in those categories over time. They also reviewed literature to “explore the reasons” for the distribution of cases and important disparities in prevalence. Among other things, the researchers found “pronounced” racial, sexual, and gender disparities, “substantial” gaps in domestic program funding, and a “patchwork healthcare system” that limited access to treatment and prevention services.

                Although when it began, the HIV epidemic was focused largely on the bicoastal big cities, mainly New York and San Francisco, in recent years the South has been hit particularly hard, with 52% of new HIV transmissions in 2018, despite representing only 37% of the US population. Six Southern states (Florida, Georgia, Louisiana, Maryland, Mississippi, and Tennessee) and the District of Columbia had the highest annual HIV diagnosis rates between 2010 and 2018, likely reflecting the higher burden of infection among black residents: In 2018, 38% of all new HIV diagnoses among men who have sex with men (MSM) were in the black population, and 63% of those were in the South.

                The South’s HIV problem is intensified by disparities, the report says, that are probably driven by the restricted expansion of Medicaid, health care provider shortages, low health literacy, and stigma. The South also has the lowest number of pre-exposure prophylaxis (PrEP) users per new HIV diagnosis, in part because of the longer distances to PrEP services relative to other regions. More than half of MSM who live at least 60 minutes away from PrEP services live in the South. While HIV in the rural South largely is due to sexual transmission, the researchers note, the largest clusters of the concurrent opioid epidemic have been detected in rural and periurban counties of West Virginia and Indiana.

                Identifying HIV transmission clusters and outbreaks has traditionally been challenging for several reasons, the researchers say, including delays between infection and diagnosis, mobility of populations, and limitations in tracing sex and drug partners. They suggest that analysis of molecular data can help overcome some of those barriers, making it possible to identify clusters of ongoing HIV transmission.

                The report also recommends other approaches to better understand and respond to ongoing HIV infections, such as mapping and data visualization, telemedicine, and automated data systems to facilitate linkage to care. However, the authors add, gaps in data and data systems remain that prevent full understanding of some key impacts of the epidemic. But any interventions to promote HIV prevention and treatment adherence, the authors suggested, should take a multifaceted approach and address the whole individual.

                Chris Beyrer, MD, MPH, investigator at the Johns Hopkins Bloomberg School of Public Health, Baltimore, and a lead author on the series, says, “We have incredible tools to prevent and treat HIV, but people may not fully utilize them if they are facing personal or structural issues that pose more immediate hardship, like substance use and mental health disorders. You may struggle to take a daily medication if you are facing food insecurity or cannot find affordable treatment for your substance use disorder.”

                Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, and now also Chief Medical Advisor to President Biden, says, “To end the HIV epidemic, we must continue to develop and deploy novel HIV treatment and prevention strategies suited to the different needs and preferences of diverse populations disproportionately affected by HIV. It is also essential that HIV health services continue during the COVID-19 pandemic.”