MDedge Endocrinology

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. What steps families ultimately take about Halloween will hinge on where they live and what the COVID infection and death rates are in their area, advised pediatrician Shelly Vaziri Flais, MD.

Courtesy Andrew Beattie

Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.

For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.

The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”

The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.

Courtesy Dr. Shelly V. Flais

“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.

In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.

Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.

“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.

AAP-recommended Do’s and Don’ts for celebrating Halloween

DO:

• Avoid large gatherings.
• Maintain 6 feet distance.
• Wear cloth masks and wash hands often.
• Use hand sanitizer before and after visiting pumpkin patches and apple orchards.

DON’T:

• Wear painted cloth masks since paints can contain toxins that should not be breathed.
• Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
• Wear cloth mask under costume mask.
• Attend indoor parties or haunted houses.

CDC safety considerations (supplemental to state and local safety laws)

• Assess current cases and overall spread in your community before making any plans.
• Choose outdoor venues or indoor facilities that are well ventilated.
• Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
• If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
• If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
• Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
• Avoid touching your nose, eyes, and mouth.
• For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.

Suggested safe, fun activities

• Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
• Participate in socially distanced outdoor community events at local parks, zoos, etc.
• Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
• Decorate pumpkins.
• Cook a Halloween-themed meal.
• If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
• When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
• Wipe down all goodies received and consider quarantining them for a few days.
• Always wash hands before and after trick-or-treating and when handling treats.

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.

Greg Pollock - Fotolia.com

When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.

When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.

The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. Here in Maine, the organizations responsible for making decisions about school sports struggled for months in making their decision. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.

Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.

There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.

Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at pdnews@mdedge.com.

Since joining the Food and Drug Administration in 1986, Janet Woodcock, MD, has built a reputation as a stalwart champion of patients and consumers, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).

During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.

Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?

Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.



Q: Who inspires you most in your work today?

Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.

Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?

Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.



Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?

Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.



Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.

Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.

*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.

dbrunk@mdedge.com

Since joining the Food and Drug Administration in 1986, Janet Woodcock, MD, has built a reputation as a stalwart champion of patients and consumers, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).

During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.

Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?

Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.



Q: Who inspires you most in your work today?

Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.

Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?

Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.



Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?

Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.



Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.

Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.

*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.

dbrunk@mdedge.com

Since joining the Food and Drug Administration in 1986, Janet Woodcock, MD, has built a reputation as a stalwart champion of patients and consumers, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).

During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.

Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?

Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.



Q: Who inspires you most in your work today?

Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.

Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?

Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.



Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?

Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.



Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.

Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.

*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.

dbrunk@mdedge.com

Inhaled corticosteroids (ICS) do not protect patients with chronic respiratory conditions against COVID-19-related death, a study of almost 1 million individuals in the United Kingdom has shown.

Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.

Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.

These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.

According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.

“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”

This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.

Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.

The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).

In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.

These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.

Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.

Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.

“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.

In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.

“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”

With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.

“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”

The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.

SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.

Inhaled corticosteroids (ICS) do not protect patients with chronic respiratory conditions against COVID-19-related death, a study of almost 1 million individuals in the United Kingdom has shown.

Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.

Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.

These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.

According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.

“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”

This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.

Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.

The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).

In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.

These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.

Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.

Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.

“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.

In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.

“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”

With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.

“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”

The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.

SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.

Inhaled corticosteroids (ICS) do not protect patients with chronic respiratory conditions against COVID-19-related death, a study of almost 1 million individuals in the United Kingdom has shown.

Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.

Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.

These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.

According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.

“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”

This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.

Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.

The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).

In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.

These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.

Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.

Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.

“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.

In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.

“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”

With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.

“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”

The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.

SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

“I worry that vaccines are going to be sold like magic powder that we sprinkle across the land and make the virus go away,” Paul Offit, MD, said at the virtual American Academy of Pediatrics (AAP) 2020 National Conference. “That’s not true.”

Even after effective vaccines for SARS-CoV-2 are in widespread use, wearing masks will still be advisable to prevent COVID-19, according to Dr. Offit, director of the Vaccine Education Center and an attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia.

“I think we can get a vaccine that’s 75%-80% effective at preventing mild to moderate disease, but that means one of every four people can still get moderate to severe disease,” Dr. Offit continued.

And that’s if there is high uptake of the vaccine, which may not be the case. Recent polls have suggested there is considerable concern about the pending vaccines.

“It’s somewhat understandable,” Dr. Offitt acknowledged, especially given the “frightening” language used to describe vaccine development. Terms such as “warp speed” may suggest that haste might trump safety considerations. Before COVID-19, the fastest vaccine ever developed was for mumps, he said, with the virus isolated in 1963 and a commercial product available in 1967.
 

Addressing hesitancy in clinics

In a wide-ranging livestream plenary presentation, Dr. Offit, coinventor of a rotavirus vaccine, shed light on SARS-CoV-2 vaccine development and his impressions of vaccine hesitancy among patients and families. He also offered advice for how to reassure those skeptical of the safety and efficacy of any SARS-COV-2 vaccine, given the accelerated development process.

With more than 180 different vaccines in various stages of investigation, Dr. Offit called the effort to develop COVID-19 vaccines “unprecedented.” Part of that is a result of governments relieving pharmaceutical companies of much of the typical financial risk – which often climbs to hundreds of millions of dollars – by underwriting the costs of vaccine development to battle the pandemic-inducing virus, he said.

But this very swiftness is also stoking antivaccine sentiment. Dr. Offit, part of vaccine advisory groups for the National Institutes of Health and U.S. Food and Drug Administration, cited recent research reporting nearly half of American adults definitely or probably would not get a COVID-19 vaccine if it were available today.

“One way you convince skeptics is with data presented in a clear, compassionate, and compelling way,” he said.

“The other group is vaccine cynics, who are basically conspiracy theorists who believe pharmaceutical companies control the world, the government, the medical establishment. I think there’s no talking them down from this.”

Numerous strategies are being used in COVID-19 vaccine development, he noted, including messenger RNA, DNA, viral vectors, purified protein, and whole killed virus. Dr. Offit believes any candidates approved for distribution will likely be in the range of 75% effective at preventing mild to moderate symptoms.

But clinicians should be ready to face immediate questions of safety. “Even if this vaccination is given to 20,000 [trial participants] safely, that’s not 20 million,” Dr. Offit said. “Anyone could reasonably ask questions about if it causes rare, serious side effects.

“The good news is, there are systems in place,” such as adverse event reporting systems, to identify rare events, even those that occur in one in a million vaccine recipients. Reminding patients of that continued surveillance can be reassuring.

Another reassuring point is that COVID-19 vaccine trial participants have included people from many diverse populations, he said. But children, notably absent so far, should be added to trials immediately, Dr. Offit contends.

“This is going to be important when you consider strategies to get children universally back into school,” he said, which is a “critical issue” from both learning and wellness standpoints. “It breaks my heart that we’ve been unable to do this when other countries have.”
 

Transparency will be paramount

While presenting data transparently to patients is key in helping them accept COVID-19 vaccination, Dr. Offit said, he also believes “telling stories” can be just as effective, if not more so. When the varicella vaccine was approved in 1995, he said, the “uptake the first few years was pretty miserable” until public service messaging emphasized that some children die from chickenpox.

“Fear works,” he said. “You always worry about pushback of something being oversold, but hopefully we’re scared enough about this virus” to convince people that vaccination is wise. “I do think personal stories carry weight on both sides,” Dr. Offit said.

Mark Sawyer, MD, of University of California San Diego School of Medicine and Rady Children’s Hospital in San Diego, California, said Offit’s presentation offered important takeaways for clinicians about how to broach the topic of COVID-19 vaccination with patients and families.

“We need to communicate clearly and transparently to patients about what we do and don’t know” about the vaccines, Dr. Sawyer said in an interview. “We will know if they have common side effects, but we will not know about very rare side effects until we have used the vaccines for a while.

“We will know how well the vaccine works over the short-term, but we won’t know over the long term,” added Dr. Sawyer, a member of the AAP Committee on Infectious Diseases.

“We can reassure the community that SARS-CoV-2 vaccines are being evaluated in trials in the same way and with the same thoroughness as other vaccines have been,” he said. “That should give people confidence that shortcuts are not being taken with regard to safety and effectiveness evaluations.”

Dr. Offit and Dr. Sawyer have disclosed no relevant financial relationships.
 

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

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Although cases of COVID-19 in children is reported to be low, we are seeing a surge in Wisconsin with a 27.6% positivity rate reported on Sept. 27. Numerous other states across the country are reporting similar jumps of 10% or more.

According to the Wisconsin Department of Health Services as of Sept. 20, 2020, there were 10,644 cumulative cases in persons aged less than 18 years. This rise in cases is consistent with a return to school and sports. This cumulative case load amounts to 836.7/100, 000 cases. This population may not experience the level of illness seen in the older populations with hospitalization rates of only 3% under the age of 9 years and 13% of those age 10- 19-years, yet exposing older family and members of the community is driving the death rates. The combined influenza and COVID-19 season may greatly impact hospitalization rates of young and old. Additionally, we may see a surge in pediatric cancer rates and autoimmune diseases secondary to these trends.

I believe the overall number of adolescents with COVID-19 is underreported. Teens admit to a lack of understanding of symptoms. Many do not realize they have COVID-19 until someone points out the symptoms they describe such as a loss of taste or smell are COVID-19 symptoms. Others report they do not report symptoms to prevent quarantine. Additionally, others endorse ridicule from peers if they have tested positive and contract tracing identifies others potentially exposed and forced to sit out of sports because of quarantine. They have been bullied into amnesia when contract tracers call to prevent identifying others at school or in the community. All these behaviors proliferate the spread of disease within the community and will continue to drive both exposures and death rates.

Teens in high schools require increased education of the symptoms of COVID-19, promotion of the flu vaccine, and knowledge of the impact they can have on preventing the spread of viruses.

Ms. Thew is the medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She said she had no relevant financial disclosures. Email her at pdnews@mdedge.com.

Reference

COVID-19: Wisconsin Cases, Wisconsin Department of Health Services. Accessed 2020 Sep 27.

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Pediatric fractures dropped by 2.5-fold during the early months of the COVID-19 pandemic, but more breaks happened at home and on bicycles, and younger kids were more affected, new research indicates.

The study of 1,745 patients also found that those with distal radius torus fractures were more likely to receive a Velcro splint during the pandemic. Experts said this key trend points toward widespread shifts to streamline treatment, which should persist after the pandemic.

“We expected to see a drop in fracture volume, but what was a bit unexpected was the proportional rise in at-home injuries, which we weren’t immediately aware of,” said senior author Apurva Shah, MD, MBA, of Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania in Philadelphia.

“As time went on, it became more apparent that trampoline and bicycle injuries were on the rise, but at the beginning of the pandemic, we didn’t intuitively expect that,” he added.

“Whenever there’s a major shift in how the world is working, we want to understand how that impacts child safety,” Dr. Shah said in an interview. “The message to get out to parents is that it’s obviously difficult to supervise kids while working from home” during the pandemic “and that supervision obviously is not always working as well as intended.”

Joshua T. Bram, a medical student, presented the study at the virtual American Academy of Pediatrics (AAP) 2020 National Conference.

Dr. Bram, Dr. Shah, and colleagues compared patients with acute fractures who presented at CHOP between March and April 2020 with those who presented during the same months in 2018 and 2019.

Overall, the number of patients with pediatric fractures who presented to CHOP fell to an average of just under 10 per day, compared with more than 22 per day in prior years (P < .001). In addition, the age of the patients fell from an average of 9.4 years to 7.5 years (P < .001), with fewer adolescents affected in 2020.

“I think when you cancel a 14-year-old’s baseball season” because of the pandemic, “unfortunately, that lost outdoor time might be substituted with time on a screen,” he explained. “But canceling a 6-year-old’s soccer season might mean substituting that with more time outside on bikes or on a trampoline.”

As noted, because of the pandemic, a higher proportion of pediatric fractures occurred at home (57.8% vs. 32.5%; P < .001) or on bicycles (18.3% vs. 8.2%; P < .001), but there were fewer organized sports–related (7.2% vs. 26.0%; P < .001) or playground-related injuries (5.2% vs. 9.0%; P < .001).

In the study period this year, the researchers saw no increase in the amount of time between injury and presentation. However, data suggest that, in more recent months, “kids are presenting with fractures late, with sometimes great consequences,” Dr. Shah said.

“What has changed is that a lot of adults have lost their jobs, and as a consequence, a lot of children have lost their access to private insurance,” he said. “But fracture is really a major injury, and this is a reminder for pediatricians and primary care physicians to recognize that families are going through these changes and that delays in care can really be detrimental to children.”
 

Velcro splints more common

A potential upside to shifts seen during the pandemic, Dr. Shah said, is the finding that distal radius torus fractures were more likely to be treated with a Velcro splint than in previous years (44.2% vs. 25.9%; P = .010).

“This is hitting on something important – that sometimes it’s crisis that forces us as physicians to evolve,” he said. “This is something I think is here to stay.

“Although research had already been there suggesting a close equivalent between splints and casting, culturally, a lot of surgeons hadn’t made that shift when historically the gold standard had been casting,” Dr. Shah added. “But with the pandemic, the shift to minimize contact with the health care system to keep families safe in their COVID bubble helped [usage of] splints take off.

“I suspect – and we’ll only know when we’re on the other side of this – when physicians see good results in splints in their own patients, they’re going to adopt those strategies more permanently,” he said.

Benjamin Shore, MD, MPH, of Boston Children’s Hospital, agreed with Dr. Shah’s prediction that fracture care will be more streamlined after the pandemic. Dr. Shore, who wasn’t involved in the study, said not only are more orthopedic providers treating patients with Velcro splints and bivalve casts, but they are also monitoring patients via telehealth.

“All of these are great examples of innovation, and one of the unique parts of the pandemic is it created a lot of rapid change across healthcare because it caused us to scrutinize the ways we practice and make a change,” Dr. Shore said in an interview.

“It wasn’t a very fancy study, but it’s very important in terms of demonstrating a change in practice,” Dr. Shore said. “The research here basically validated what many of us are seeing and hopefully will help us in future pandemics – which hopefully won’t happen – to tell families what to be proactive about.”

Dr. Shah and Dr. Shore agreed that, because fewer fractures are occurring in kids during the pandemic, there is an opportunity to redeploy orthopedic providers to other clinical areas on the basis of volume and need.

Dr. Shah and Dr. Shore have disclosed no relevant financial relationships.
 

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

Roughly half of American adults have hypertension, and about 71% of these cases are uncontrolled, according to data from the American Heart Association.

If left uncontrolled, hypertension can increase risk for conditions including heart disease, stroke, kidney disease, pregnancy complications, and cognitive decline, surgeon general Vice Adm. Jerome M. Adams, MD, said in a teleconference on Oct. 7. Hispanic and Black individuals are disproportionately affected, he added.

“We cannot wait to deal with this epidemic of uncontrolled high blood pressure,” even in the midst of the ongoing COVID-19 pandemic, said Dr. Adams. “We know what works” to help control hypertension, he added, citing his own use of a blood pressure monitoring device at home.

The Department of Health & Human Services has issued a Call to Action to Control Hypertension based on the latest science and research.

Dr. Adams outlined three goals to improve hypertension control, starting with making it a national priority. The Call to Action supports increasing awareness of the health risks associated with hypertension, recognizing the economic impact, overcoming barriers to controlling hypertension, and promoting health equity.

“In 2020, disparities in the burden of disease – especially among minority populations – have been recognized during the COVID-19 pandemic. A growing body of evidence has shown that people with underlying health conditions, including cardiovascular disease, are at increased risk of worse outcomes related to COVID-19 infection,” according to the Call to Action.

A second goal is to build and sustain communities that support individuals in taking responsibility for their health and blood pressure control, Dr. Adams said. He cited the need to create places for safe physical activity, access to healthy food, and opportunities to connect to resources to support lifestyle changes.

Finally, clinicians should continue to use standardized treatment approaches and promote team-based care to maximize outcomes for patients, Dr. Adams said.

Success starts with making hypertension control a priority across the leadership team, regardless of the size, location, or demographic population at a health care setting, he said. Dr. Adams cited the Million Hearts 2022 program, an ongoing initiative to prevent 1 million heart attacks in the United States over 5 years, as a way that HHS is recognizing and rewarding success stories in hypertension control from across the country.

Empowering patients and equipping them to take charge of their hypertension essential to reducing the epidemic of high blood pressure, especially during the ongoing pandemic, Dr. Adams said. His message to clinicians to extend to patients is that it is safe to visit their doctors. Hospitals have worked to create a safe environment, however, patients can and should monitor their blood pressure regularly at home, using a self-measured blood pressure monitoring (SMBP) device, which may be covered by some insurers.

“I would encourage people to know their numbers,” and that 130/80 mm Hg is considered high and a risk factor for poor health outcomes, Dr. Adams said. Clinicians also should continue to support patients in lifestyle changes such as healthy eating and exercising regularly to help control high blood pressure.

The AHA expressed support for the surgeon general’s Call to Action. “Today’s call to action references updated hypertension guidelines the AHA and the American College of Cardiology issued in 2017 that apply the latest science to help clinicians work with patients to control their blood pressure,” the AHA said in a statement. The AHA also called on the Centers for Medicare & Medicaid Services and other insurance providers “to include coverage of SMBP devices for treatment and management of hypertension.”

The Call to Action was accompanied by a Viewpoint from Dr. Adams and Janet S. Wright, MD, also of the HHS, published in JAMA. Dr. Adams and Dr. Wright emphasized that the timing of the Call to Action recognizes that many of the same social factors that support or impede successful high blood pressure control are factors in worse outcomes from COVID-19 infections as well.

“When coupled with widespread implementation of best practices in clinical settings and empowering individuals to actively manage their blood pressure, acknowledging and addressing a community’s social conditions may generate sustained improvements in control of both hypertension and COVID-19,” they said.

Read and download the full Call to Action here, and read the Executive Summary at hhs.gov.

Roughly half of American adults have hypertension, and about 71% of these cases are uncontrolled, according to data from the American Heart Association.

If left uncontrolled, hypertension can increase risk for conditions including heart disease, stroke, kidney disease, pregnancy complications, and cognitive decline, surgeon general Vice Adm. Jerome M. Adams, MD, said in a teleconference on Oct. 7. Hispanic and Black individuals are disproportionately affected, he added.

“We cannot wait to deal with this epidemic of uncontrolled high blood pressure,” even in the midst of the ongoing COVID-19 pandemic, said Dr. Adams. “We know what works” to help control hypertension, he added, citing his own use of a blood pressure monitoring device at home.

The Department of Health & Human Services has issued a Call to Action to Control Hypertension based on the latest science and research.

Dr. Adams outlined three goals to improve hypertension control, starting with making it a national priority. The Call to Action supports increasing awareness of the health risks associated with hypertension, recognizing the economic impact, overcoming barriers to controlling hypertension, and promoting health equity.

“In 2020, disparities in the burden of disease – especially among minority populations – have been recognized during the COVID-19 pandemic. A growing body of evidence has shown that people with underlying health conditions, including cardiovascular disease, are at increased risk of worse outcomes related to COVID-19 infection,” according to the Call to Action.

A second goal is to build and sustain communities that support individuals in taking responsibility for their health and blood pressure control, Dr. Adams said. He cited the need to create places for safe physical activity, access to healthy food, and opportunities to connect to resources to support lifestyle changes.

Finally, clinicians should continue to use standardized treatment approaches and promote team-based care to maximize outcomes for patients, Dr. Adams said.

Success starts with making hypertension control a priority across the leadership team, regardless of the size, location, or demographic population at a health care setting, he said. Dr. Adams cited the Million Hearts 2022 program, an ongoing initiative to prevent 1 million heart attacks in the United States over 5 years, as a way that HHS is recognizing and rewarding success stories in hypertension control from across the country.

Empowering patients and equipping them to take charge of their hypertension essential to reducing the epidemic of high blood pressure, especially during the ongoing pandemic, Dr. Adams said. His message to clinicians to extend to patients is that it is safe to visit their doctors. Hospitals have worked to create a safe environment, however, patients can and should monitor their blood pressure regularly at home, using a self-measured blood pressure monitoring (SMBP) device, which may be covered by some insurers.

“I would encourage people to know their numbers,” and that 130/80 mm Hg is considered high and a risk factor for poor health outcomes, Dr. Adams said. Clinicians also should continue to support patients in lifestyle changes such as healthy eating and exercising regularly to help control high blood pressure.

The AHA expressed support for the surgeon general’s Call to Action. “Today’s call to action references updated hypertension guidelines the AHA and the American College of Cardiology issued in 2017 that apply the latest science to help clinicians work with patients to control their blood pressure,” the AHA said in a statement. The AHA also called on the Centers for Medicare & Medicaid Services and other insurance providers “to include coverage of SMBP devices for treatment and management of hypertension.”

The Call to Action was accompanied by a Viewpoint from Dr. Adams and Janet S. Wright, MD, also of the HHS, published in JAMA. Dr. Adams and Dr. Wright emphasized that the timing of the Call to Action recognizes that many of the same social factors that support or impede successful high blood pressure control are factors in worse outcomes from COVID-19 infections as well.

“When coupled with widespread implementation of best practices in clinical settings and empowering individuals to actively manage their blood pressure, acknowledging and addressing a community’s social conditions may generate sustained improvements in control of both hypertension and COVID-19,” they said.

Read and download the full Call to Action here, and read the Executive Summary at hhs.gov.

Roughly half of American adults have hypertension, and about 71% of these cases are uncontrolled, according to data from the American Heart Association.

If left uncontrolled, hypertension can increase risk for conditions including heart disease, stroke, kidney disease, pregnancy complications, and cognitive decline, surgeon general Vice Adm. Jerome M. Adams, MD, said in a teleconference on Oct. 7. Hispanic and Black individuals are disproportionately affected, he added.

“We cannot wait to deal with this epidemic of uncontrolled high blood pressure,” even in the midst of the ongoing COVID-19 pandemic, said Dr. Adams. “We know what works” to help control hypertension, he added, citing his own use of a blood pressure monitoring device at home.

The Department of Health & Human Services has issued a Call to Action to Control Hypertension based on the latest science and research.

Dr. Adams outlined three goals to improve hypertension control, starting with making it a national priority. The Call to Action supports increasing awareness of the health risks associated with hypertension, recognizing the economic impact, overcoming barriers to controlling hypertension, and promoting health equity.

“In 2020, disparities in the burden of disease – especially among minority populations – have been recognized during the COVID-19 pandemic. A growing body of evidence has shown that people with underlying health conditions, including cardiovascular disease, are at increased risk of worse outcomes related to COVID-19 infection,” according to the Call to Action.

A second goal is to build and sustain communities that support individuals in taking responsibility for their health and blood pressure control, Dr. Adams said. He cited the need to create places for safe physical activity, access to healthy food, and opportunities to connect to resources to support lifestyle changes.

Finally, clinicians should continue to use standardized treatment approaches and promote team-based care to maximize outcomes for patients, Dr. Adams said.

Success starts with making hypertension control a priority across the leadership team, regardless of the size, location, or demographic population at a health care setting, he said. Dr. Adams cited the Million Hearts 2022 program, an ongoing initiative to prevent 1 million heart attacks in the United States over 5 years, as a way that HHS is recognizing and rewarding success stories in hypertension control from across the country.

Empowering patients and equipping them to take charge of their hypertension essential to reducing the epidemic of high blood pressure, especially during the ongoing pandemic, Dr. Adams said. His message to clinicians to extend to patients is that it is safe to visit their doctors. Hospitals have worked to create a safe environment, however, patients can and should monitor their blood pressure regularly at home, using a self-measured blood pressure monitoring (SMBP) device, which may be covered by some insurers.

“I would encourage people to know their numbers,” and that 130/80 mm Hg is considered high and a risk factor for poor health outcomes, Dr. Adams said. Clinicians also should continue to support patients in lifestyle changes such as healthy eating and exercising regularly to help control high blood pressure.

The AHA expressed support for the surgeon general’s Call to Action. “Today’s call to action references updated hypertension guidelines the AHA and the American College of Cardiology issued in 2017 that apply the latest science to help clinicians work with patients to control their blood pressure,” the AHA said in a statement. The AHA also called on the Centers for Medicare & Medicaid Services and other insurance providers “to include coverage of SMBP devices for treatment and management of hypertension.”

The Call to Action was accompanied by a Viewpoint from Dr. Adams and Janet S. Wright, MD, also of the HHS, published in JAMA. Dr. Adams and Dr. Wright emphasized that the timing of the Call to Action recognizes that many of the same social factors that support or impede successful high blood pressure control are factors in worse outcomes from COVID-19 infections as well.

“When coupled with widespread implementation of best practices in clinical settings and empowering individuals to actively manage their blood pressure, acknowledging and addressing a community’s social conditions may generate sustained improvements in control of both hypertension and COVID-19,” they said.

Read and download the full Call to Action here, and read the Executive Summary at hhs.gov.

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services will send letters on October 7 to all 6,200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call.

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.

Rick Pollack, president and CEO of the American Hospital Association called the CMS rule an “overly heavy-handed approach that could jeopardize access to hospital care for all Americans.” He noted in a statement that barring hospitals from Medicare and Medicaid could harm beneficiaries and the effort to provide COVID care.

Pollack also noted that AHA has “observed errors in data processing and confusion about exactly what was being requested at the hospital, state, contractor, and federal level, and has worked diligently with the federal agencies to identify and correct those problems.”

The document that lays out U.S. Department of Health and Human Services (HHS) Protect reporting requirements were updated again on October 6 to add influenza data. The hospitals must report on total patients with laboratory-confirmed flu; previous day’s flu admissions; total ICU patients with lab-confirmed flu; total inpatients with either flu or COVID-19; and the previous day’s deaths for flu and COVID.

CDC Director Robert Redfield, MD, said on the press call that the new data will give the agency crucial hospital-level information and perhaps better estimates of the flu burden. Flu trends have been tracked using the CDC’s Influenza Hospitalization Surveillance Network (FluSurv-NET), which will not be replaced, Redfield said. But that network only tracks hospitalizations in 14 states and does not provide information in “nearly real-time,” he said.

Having the new data “will give us a true situational awareness of severe respiratory illness, provide local hospitalization trends, and help direct resources such as antiretrovirals to address potential increased impact of flu and COVID cocirculation,” Redfield said.

This article first appeared on Medscape.com.

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services will send letters on October 7 to all 6,200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call.

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.

Rick Pollack, president and CEO of the American Hospital Association called the CMS rule an “overly heavy-handed approach that could jeopardize access to hospital care for all Americans.” He noted in a statement that barring hospitals from Medicare and Medicaid could harm beneficiaries and the effort to provide COVID care.

Pollack also noted that AHA has “observed errors in data processing and confusion about exactly what was being requested at the hospital, state, contractor, and federal level, and has worked diligently with the federal agencies to identify and correct those problems.”

The document that lays out U.S. Department of Health and Human Services (HHS) Protect reporting requirements were updated again on October 6 to add influenza data. The hospitals must report on total patients with laboratory-confirmed flu; previous day’s flu admissions; total ICU patients with lab-confirmed flu; total inpatients with either flu or COVID-19; and the previous day’s deaths for flu and COVID.

CDC Director Robert Redfield, MD, said on the press call that the new data will give the agency crucial hospital-level information and perhaps better estimates of the flu burden. Flu trends have been tracked using the CDC’s Influenza Hospitalization Surveillance Network (FluSurv-NET), which will not be replaced, Redfield said. But that network only tracks hospitalizations in 14 states and does not provide information in “nearly real-time,” he said.

Having the new data “will give us a true situational awareness of severe respiratory illness, provide local hospitalization trends, and help direct resources such as antiretrovirals to address potential increased impact of flu and COVID cocirculation,” Redfield said.

This article first appeared on Medscape.com.

The federal government is giving hospitals 14 weeks to comply with daily reporting requirements for COVID-19.

Hospitals that fail to meet the requirements will be barred from participating in Medicare and Medicaid, as announced in late August in a final rule.

The Centers for Medicare & Medicaid Services will send letters on October 7 to all 6,200 hospitals that receive reimbursement from the two federal health programs informing them of how well they are doing now, said CMS Administrator Seema Verma on a press call.

Verma would not give an estimate on how many hospitals are currently not compliant. But Deborah Birx, MD, a member of the White House Coronavirus Task Force, said on the call that 86% of hospitals are currently reporting daily.

Federal officials on the call also announced that hospitals would have the option to begin reporting certain data on influenza starting October 19, but that it would become mandatory a few weeks later.

The reporting is important “to really ensure that we’re triangulating all data to understand where this epidemic is, how it’s moving through different populations, and ensuring that we’re meeting the needs of specific hospitals and communities,” Birx said.

The federal government began a new hospital reporting system in April but did not require hospitals to participate until it quietly issued guidance in mid-July informing facilities that they should no longer report to the Centers for Disease Control and Prevention (CDC).

The move perplexed many public health experts and epidemiologists, who expressed concern that asking hospitals to use a new data system during a pandemic could result in delays and lost information. The new HHS data collection site, HHS Protect, is being managed by a private contractor, not the CDC, which also raised alarms.

The final CMS rule issued in August went into effect immediately, without any chance for comment or revision. CMS said at the time that the pandemic was reason enough to skip over the normal bureaucratic process.

Hospitals were not pleased. But Verma claimed that since then CMS had been working with hospital organizations on enforcement.

“We’re going to do everything we can to facilitate reporting, including an enforcement timeline that will provide hospitals ample opportunity to come into compliance,” she said.

Hospitals that do not comply will get a notice every 3 weeks. Three weeks after the second notice, they’ll get weekly notices for a month, and a final termination notice at 14 weeks.

The Federation of American Hospitals (FAH), however, said their members were still not happy. “It is both inappropriate and frankly overkill for CMS to tie compliance with reporting to Medicare conditions of participation,” said FAH President and CEO Chip Kahn in a statement. He called the CMS proposal “sledgehammer enforcement,” and said that the continuing data request might weaken hospitals’ response to the pandemic because it would divert time and money away from patient care.

Rick Pollack, president and CEO of the American Hospital Association called the CMS rule an “overly heavy-handed approach that could jeopardize access to hospital care for all Americans.” He noted in a statement that barring hospitals from Medicare and Medicaid could harm beneficiaries and the effort to provide COVID care.

Pollack also noted that AHA has “observed errors in data processing and confusion about exactly what was being requested at the hospital, state, contractor, and federal level, and has worked diligently with the federal agencies to identify and correct those problems.”

The document that lays out U.S. Department of Health and Human Services (HHS) Protect reporting requirements were updated again on October 6 to add influenza data. The hospitals must report on total patients with laboratory-confirmed flu; previous day’s flu admissions; total ICU patients with lab-confirmed flu; total inpatients with either flu or COVID-19; and the previous day’s deaths for flu and COVID.

CDC Director Robert Redfield, MD, said on the press call that the new data will give the agency crucial hospital-level information and perhaps better estimates of the flu burden. Flu trends have been tracked using the CDC’s Influenza Hospitalization Surveillance Network (FluSurv-NET), which will not be replaced, Redfield said. But that network only tracks hospitalizations in 14 states and does not provide information in “nearly real-time,” he said.

Having the new data “will give us a true situational awareness of severe respiratory illness, provide local hospitalization trends, and help direct resources such as antiretrovirals to address potential increased impact of flu and COVID cocirculation,” Redfield said.

This article first appeared on Medscape.com.

Creeping fat in Crohn’s disease is likely caused by microbial translocation from the gut to neighboring mesenteric adipose tissue (MAT), based on a recent study.

This finding may lead to early risk stratification for creeping fat, and nonsurgical interventions, according to principal author Suzanne Devkota, PhD, assistant professor at Cedars-Sinai Medical Center in Los Angeles.

Creeping fat, which is unique to Crohn’s disease, is characterized by hyperplastic MAT that grips areas of intestinal inflammation with invasive “fingerlike projections,” the investigators wrote in Cell. This phenomenon was first described by the eponymous Dr. Crohn in 1932; since then, despite associations with fibrotic strictures that may require surgical resection, underlying mechanisms have remained mysterious and largely unexplored.

That changed during a session of grand rounds at Cedars-Sinai in September 2016; Dr. Devkota was discussing adipose tissue when her surgeon colleague, Phillip Fleshner, MD, asked: “What about creeping fat?”

“Yeah, that’s cool,” Dr. Devkota replied, “but I don’t have access to creeping fat.”

“I see it all the time,” Dr. Fleshner said. “I can get you some.”

And so a partnership was born, allowing Dr. Devkota and colleagues to pursue the translocation hypothesis.

The present report involved tissue samples from 11 patients with Crohn’s disease and 13 patients with ulcerative colitis. Healthy tissue controls were taken from four subjects without inflammatory bowel disease who underwent ileostomy.

Microbial cultivation of Crohn’s disease and healthy patient samples revealed bacteria in the mesenteric tissue of both groups, suggesting that microbial translocation from the gut to MAT “may not be unusual;” however, Crohn’s disease samples were associated with an exclusive consortium of five species: Clostridium innocuum, Erysipeloclostridium ramosum, Parabacteroides distasonis, Clostridium symbiosum, and Bifidobacterium pseudolongum. 

C. innocuum was isolated most frequently; and its unique characteristics increased suspicions that it was the creeping fat culprit.

“Core genomic features of C. innocuum include type IV pili and twitching motility, a preference for lipid-derived metabolic substrates, and multiple genes for lipid catabolism, as well as a functional substrate preference for b-hydroxybutyrate, a byproduct of fatty acid oxidation,” the investigators wrote. “This suggests that C. innocuum is well suited for, and perhaps prefers, a lipid-rich environment and seeks these out when the opportunity arises.”

To observe this opportunism firsthand, the investigators gavaged gnotobiotic mice with C. innocuum. Indeed, these mice demonstrated “dramatic mesenteric adiposity,” compared with controls.

Cotreatment with dextran sulfate sodium (DSS) was unnecessary to induce translocation of C. innocuum, which “suggests that overt inflammation is not a prerequisite for its translocation,” the investigators noted.

The profibrotic potential of C. innocuum was supported by in vitro experiments, in which adipose-derived stem cells and primary fibroblasts from Crohn’s disease MAT were exposed to either C. innocuum lysate or macrophage-conditioned media from C. innocuum–exposed macrophages. While the lysate alone did not alter genes involved in fibrosis and remodeling, the macrophage-conditioned media did, indicating that C. innocuum alters MAT indirectly via macrophage activity.

Although multiple signs suggest that C. innocuum causes creeping fat, Dr. Devkota noted that systematic testing is needed to confirm this likelihood.

“But I do think we’ve honed in on the consortium that is at play,” she said, referring to the five identified species.

According to Dr. Devkota, awareness of these microbes could lead to diagnostic and interventional benefits for patients with Crohn’s disease. For example, gut microbiota profiling could be used to measure levels of C. innocuum in newly diagnosed patients, thereby stratifying risk of creeping fat. And phage therapy, with its high specificity for bacterial species, could be an ideal intervention.

“I’m very eager to hear from the surgeons, and hear what their opinion is, and whether this will affect their treatment or how they approach [creeping fat],” Dr. Devkota said.

Beyond Crohn’s disease, the study findings could inform obesity research, as bacterial DNA has been found in obese adipose tissue, which is characteristically fibrotic.

“There are a lot of gene-expression patterns [in the present study], that are also seen in obesity literature,” Dr. Devkota said.

“Obviously there’s a lifestyle caloric aspect to [obesity],” she added. “I definitely don’t claim that microbes are the end-all and be-all of obesity – I want to make that clear. But it could be possible, and particularly related to abdominal fat. Expanded abdominal fat could be a sign that there’s underlying intestinal inflammation ... that there’s something deeper going on that may be unrelated to a metabolic defect.”

The study was funded by Leona M. and Harry B. Helmsley Charitable Trust and the National Institutes of Health. Dr. Devkota and Dr. Ha are inventors on U.S. patent application #62/679,624.

SOURCE: Ha CWY et al. Cell. 2020 Oct 29. doi: 10.1016/j.cell.2020.09.009.

Creeping fat in Crohn’s disease is likely caused by microbial translocation from the gut to neighboring mesenteric adipose tissue (MAT), based on a recent study.

This finding may lead to early risk stratification for creeping fat, and nonsurgical interventions, according to principal author Suzanne Devkota, PhD, assistant professor at Cedars-Sinai Medical Center in Los Angeles.

Creeping fat, which is unique to Crohn’s disease, is characterized by hyperplastic MAT that grips areas of intestinal inflammation with invasive “fingerlike projections,” the investigators wrote in Cell. This phenomenon was first described by the eponymous Dr. Crohn in 1932; since then, despite associations with fibrotic strictures that may require surgical resection, underlying mechanisms have remained mysterious and largely unexplored.

That changed during a session of grand rounds at Cedars-Sinai in September 2016; Dr. Devkota was discussing adipose tissue when her surgeon colleague, Phillip Fleshner, MD, asked: “What about creeping fat?”

“Yeah, that’s cool,” Dr. Devkota replied, “but I don’t have access to creeping fat.”

“I see it all the time,” Dr. Fleshner said. “I can get you some.”

And so a partnership was born, allowing Dr. Devkota and colleagues to pursue the translocation hypothesis.

The present report involved tissue samples from 11 patients with Crohn’s disease and 13 patients with ulcerative colitis. Healthy tissue controls were taken from four subjects without inflammatory bowel disease who underwent ileostomy.

Microbial cultivation of Crohn’s disease and healthy patient samples revealed bacteria in the mesenteric tissue of both groups, suggesting that microbial translocation from the gut to MAT “may not be unusual;” however, Crohn’s disease samples were associated with an exclusive consortium of five species: Clostridium innocuum, Erysipeloclostridium ramosum, Parabacteroides distasonis, Clostridium symbiosum, and Bifidobacterium pseudolongum. 

C. innocuum was isolated most frequently; and its unique characteristics increased suspicions that it was the creeping fat culprit.

“Core genomic features of C. innocuum include type IV pili and twitching motility, a preference for lipid-derived metabolic substrates, and multiple genes for lipid catabolism, as well as a functional substrate preference for b-hydroxybutyrate, a byproduct of fatty acid oxidation,” the investigators wrote. “This suggests that C. innocuum is well suited for, and perhaps prefers, a lipid-rich environment and seeks these out when the opportunity arises.”

To observe this opportunism firsthand, the investigators gavaged gnotobiotic mice with C. innocuum. Indeed, these mice demonstrated “dramatic mesenteric adiposity,” compared with controls.

Cotreatment with dextran sulfate sodium (DSS) was unnecessary to induce translocation of C. innocuum, which “suggests that overt inflammation is not a prerequisite for its translocation,” the investigators noted.

The profibrotic potential of C. innocuum was supported by in vitro experiments, in which adipose-derived stem cells and primary fibroblasts from Crohn’s disease MAT were exposed to either C. innocuum lysate or macrophage-conditioned media from C. innocuum–exposed macrophages. While the lysate alone did not alter genes involved in fibrosis and remodeling, the macrophage-conditioned media did, indicating that C. innocuum alters MAT indirectly via macrophage activity.

Although multiple signs suggest that C. innocuum causes creeping fat, Dr. Devkota noted that systematic testing is needed to confirm this likelihood.

“But I do think we’ve honed in on the consortium that is at play,” she said, referring to the five identified species.

According to Dr. Devkota, awareness of these microbes could lead to diagnostic and interventional benefits for patients with Crohn’s disease. For example, gut microbiota profiling could be used to measure levels of C. innocuum in newly diagnosed patients, thereby stratifying risk of creeping fat. And phage therapy, with its high specificity for bacterial species, could be an ideal intervention.

“I’m very eager to hear from the surgeons, and hear what their opinion is, and whether this will affect their treatment or how they approach [creeping fat],” Dr. Devkota said.

Beyond Crohn’s disease, the study findings could inform obesity research, as bacterial DNA has been found in obese adipose tissue, which is characteristically fibrotic.

“There are a lot of gene-expression patterns [in the present study], that are also seen in obesity literature,” Dr. Devkota said.

“Obviously there’s a lifestyle caloric aspect to [obesity],” she added. “I definitely don’t claim that microbes are the end-all and be-all of obesity – I want to make that clear. But it could be possible, and particularly related to abdominal fat. Expanded abdominal fat could be a sign that there’s underlying intestinal inflammation ... that there’s something deeper going on that may be unrelated to a metabolic defect.”

The study was funded by Leona M. and Harry B. Helmsley Charitable Trust and the National Institutes of Health. Dr. Devkota and Dr. Ha are inventors on U.S. patent application #62/679,624.

SOURCE: Ha CWY et al. Cell. 2020 Oct 29. doi: 10.1016/j.cell.2020.09.009.

Creeping fat in Crohn’s disease is likely caused by microbial translocation from the gut to neighboring mesenteric adipose tissue (MAT), based on a recent study.

This finding may lead to early risk stratification for creeping fat, and nonsurgical interventions, according to principal author Suzanne Devkota, PhD, assistant professor at Cedars-Sinai Medical Center in Los Angeles.

Creeping fat, which is unique to Crohn’s disease, is characterized by hyperplastic MAT that grips areas of intestinal inflammation with invasive “fingerlike projections,” the investigators wrote in Cell. This phenomenon was first described by the eponymous Dr. Crohn in 1932; since then, despite associations with fibrotic strictures that may require surgical resection, underlying mechanisms have remained mysterious and largely unexplored.

That changed during a session of grand rounds at Cedars-Sinai in September 2016; Dr. Devkota was discussing adipose tissue when her surgeon colleague, Phillip Fleshner, MD, asked: “What about creeping fat?”

“Yeah, that’s cool,” Dr. Devkota replied, “but I don’t have access to creeping fat.”

“I see it all the time,” Dr. Fleshner said. “I can get you some.”

And so a partnership was born, allowing Dr. Devkota and colleagues to pursue the translocation hypothesis.

The present report involved tissue samples from 11 patients with Crohn’s disease and 13 patients with ulcerative colitis. Healthy tissue controls were taken from four subjects without inflammatory bowel disease who underwent ileostomy.

Microbial cultivation of Crohn’s disease and healthy patient samples revealed bacteria in the mesenteric tissue of both groups, suggesting that microbial translocation from the gut to MAT “may not be unusual;” however, Crohn’s disease samples were associated with an exclusive consortium of five species: Clostridium innocuum, Erysipeloclostridium ramosum, Parabacteroides distasonis, Clostridium symbiosum, and Bifidobacterium pseudolongum. 

C. innocuum was isolated most frequently; and its unique characteristics increased suspicions that it was the creeping fat culprit.

“Core genomic features of C. innocuum include type IV pili and twitching motility, a preference for lipid-derived metabolic substrates, and multiple genes for lipid catabolism, as well as a functional substrate preference for b-hydroxybutyrate, a byproduct of fatty acid oxidation,” the investigators wrote. “This suggests that C. innocuum is well suited for, and perhaps prefers, a lipid-rich environment and seeks these out when the opportunity arises.”

To observe this opportunism firsthand, the investigators gavaged gnotobiotic mice with C. innocuum. Indeed, these mice demonstrated “dramatic mesenteric adiposity,” compared with controls.

Cotreatment with dextran sulfate sodium (DSS) was unnecessary to induce translocation of C. innocuum, which “suggests that overt inflammation is not a prerequisite for its translocation,” the investigators noted.

The profibrotic potential of C. innocuum was supported by in vitro experiments, in which adipose-derived stem cells and primary fibroblasts from Crohn’s disease MAT were exposed to either C. innocuum lysate or macrophage-conditioned media from C. innocuum–exposed macrophages. While the lysate alone did not alter genes involved in fibrosis and remodeling, the macrophage-conditioned media did, indicating that C. innocuum alters MAT indirectly via macrophage activity.

Although multiple signs suggest that C. innocuum causes creeping fat, Dr. Devkota noted that systematic testing is needed to confirm this likelihood.

“But I do think we’ve honed in on the consortium that is at play,” she said, referring to the five identified species.

According to Dr. Devkota, awareness of these microbes could lead to diagnostic and interventional benefits for patients with Crohn’s disease. For example, gut microbiota profiling could be used to measure levels of C. innocuum in newly diagnosed patients, thereby stratifying risk of creeping fat. And phage therapy, with its high specificity for bacterial species, could be an ideal intervention.

“I’m very eager to hear from the surgeons, and hear what their opinion is, and whether this will affect their treatment or how they approach [creeping fat],” Dr. Devkota said.

Beyond Crohn’s disease, the study findings could inform obesity research, as bacterial DNA has been found in obese adipose tissue, which is characteristically fibrotic.

“There are a lot of gene-expression patterns [in the present study], that are also seen in obesity literature,” Dr. Devkota said.

“Obviously there’s a lifestyle caloric aspect to [obesity],” she added. “I definitely don’t claim that microbes are the end-all and be-all of obesity – I want to make that clear. But it could be possible, and particularly related to abdominal fat. Expanded abdominal fat could be a sign that there’s underlying intestinal inflammation ... that there’s something deeper going on that may be unrelated to a metabolic defect.”

The study was funded by Leona M. and Harry B. Helmsley Charitable Trust and the National Institutes of Health. Dr. Devkota and Dr. Ha are inventors on U.S. patent application #62/679,624.

SOURCE: Ha CWY et al. Cell. 2020 Oct 29. doi: 10.1016/j.cell.2020.09.009.