Feature

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Meghan Block of Weymouth, Mass., starts her search at 5 a.m. every morning – combing local retailer websites for baby formula.

Her own children have been off it for years. But her cousin in New Hampshire has a 2-month-old son who needs hypoallergenic formula, and the nationwide shortage has left the new mom scrambling to find what her baby needs.

“I’d equate this to how we were all frantically looking for vaccine appointments when they first rolled out,” Ms. Block said. “Parents are all mobilizing for each other.”

She added, “What people aren’t talking about is the stress on new mothers this is causing. If you’re on the edge of the baby blues and postpartum depression, and you can’t find food for your babies – these parents could be in crisis.”

For weeks, a pandemic-induced supply chain shortage – along with a massive recall from top formula manufacturer Abbott Nutrition – has left shelves empty and parents panicked, fearing their dwindling formula supplies will disappear entirely.

Abbott announced that its previously shuttered Michigan factory would reopen, but it remains unclear how soon that will make a noticeable difference.

The Food and Drug Administration announced Monday, May 16, that it would ease restrictions for selling foreign-made baby formula in the U.S. to broaden supply.

President Joe Biden invoked the the Defense Production Act on May 18, which requires suppliers to send resources to formula plants before giving them to other customers. The president is also authorizing the Defense Department to use commercial aircraft to pick up infant formula overseas that meets federal standards and fly it to the U.S. – a measure dubbed “Operation Fly Formula.”

But in the meantime, hospital staff and pediatricians are fielding questions from parents that they can’t always answer.

“People want to know if the shortage is ending soon, and that’s hard to predict. Even with the factory back online, the end could still be 1-3 months away,” Joshua Wechsler, MD, pediatric gastroenterologist at Ann & Robert H. Lurie Children’s Hospital of Chicago, said in an interview.

Most formulas on the market have comparable alternatives, Dr. Wechsler said, but there are fewer options for parents of special-needs babies – those with allergies and specific dietary requirements.

This has required around-the-clock work from dietitians and pediatricians to find sufficient options for these babies and monitor their ability to tolerate new kinds of formula.

“We’re advising parents not to dilute formula, not to buy it from sources you’re unfamiliar with, and no homemade formulas,” Dr. Wechsler said.

He said in some instances he has seen weight loss among babies whose supplies were stretching thin, and in very rare cases, hospitalizations.

According to recent reports, two children were hospitalized in mid-May at Le Bonheur Children’s Hospital, Memphis, Tenn., as a result of the formula shortage.

Those most affected by the crisis, doctors say, are lower-income families. Half of the infant formula purchased in the United States is through Women, Infants, and Children (WIC) benefits, a federal assistance program, which provides formula for free but only limited types and brands.

But in most cases, hospitals and pediatricians have the means to provide caregivers with supplementary formula, said Amy Hair, MD, program director of neonatal nutrition at Texas Children’s Hospital.

“Here in the hospital, we’re OK, because we’re able to switch through different options for patients and we’re sending families home with a short supply to bridge them over,” Dr. Hair said. “We encourage patients to talk to their pediatricians, who usually have in-office supplies.”

She also advises parents to look in smaller pharmacies and stores rather than bigger retailers, along with ordering it straight from the formula manufacturers online.

“We’re reassuring families we think this is temporary,” Dr. Hair said. “Providers have been dealing with this for a while, so we have some strategies in place to help caregivers through the shortage.”

In the meantime, parents continue to lean on each other for help and resources. Ms. Block’s cousin in New Hampshire, Jamie Boudreau, said she has friends and family on the lookout across the country for hypoallergenic formula for her son.

She currently has about a 1-month supply, but she worries constantly that will be depleted before the shortage ends.

“It’s definitely been very stressful,” Ms. Boudreau said. “I, as an adult, can go days without eating, but my tiny 2-month-old little boy – he can’t go more than 3 hours. What am I going to do if in 4 weeks I don’t have any more?”

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

Good hand hygiene and other cost-effective infection prevention and control (IPC) practices can eliminate between 35% and 70% of health care–setting infections in all countries regardless of economic status, the World Health Organization reports.

IPC uses a practical, evidence-based approach to help patients, health care workers, and visitors to health care facilities avoid harmful infections, which can range from infections caused by localized antibiotic-resistant bacteria to pandemic viruses. The WHO calls the report the first global analysis of IPC implementation.

“Hospitals across the world saw increased rates of health care–associated infections (HAIs) during the COVID-19 pandemic. This included SARS-CoV-2 infections and other HAIs that increased as our health care systems were stretched to the breaking point and fewer resources were available for HAI prevention,” Daniel Diekema, MD, who was not involved in the report, said in an email.

“As we enter the third year of the pandemic, this WHO report should serve as an urgent call to action,” Dr. Diekema, a clinical professor of internal medicine at University of Iowa Health Care and an associate hospital epidemiologist with University of Iowa Hospitals and Clinics, both in Iowa City, noted. “Investing more resources in IPC programs will not only improve pandemic response, it will reduce morbidity, mortality, and global costs from all HAIs.”
 

No country or health system is free of HAIs

“Disparities in IPC investments between high- and low-income countries is the greatest challenge outlined in this report,” Dr. Diekema said in an email. “If the pandemic has taught us anything, it is that an infection spread anywhere in the world can soon become a problem everywhere. Thus, it is in everyone’s interest to ensure that IPC resources are more equitably distributed across the world.”

The report notes that HAIs are among the most common adverse events experienced in health care, and many HAIs are caused by multidrug-resistant organisms. The report includes these details:

It is predicted that of every 100 patients in acute-care hospitals, an average of 7 patients in high-income countries and 15 in low- and middle-income countries will acquire at least one HAI while hospitalized; as many as 30% of patients in intensive care encounter HAIs.

Of all cases of hospital-treated sepsis, 23.6% were linked to health care; 48.7% of all sepsis cases involving organ dysfunction treated in adult intensive care were acquired in the hospital; 24.4% of patients and 52.3% of those in intensive care who were affected by health care–associated sepsis died.

The European Centre for Disease Prevention and Control calculated that 4.5 million episodes of HAIs occurred each year among patients in acute-care hospitals in countries of the European Union and the European Economic Area.

The Centers for Disease Control and Prevention estimated that on any day, 1 in 31 hospital patients and 1 in 43 nursing home residents has an HAI.

Up to 41% of hospitalized patients with confirmed COVID-19 were infected with SARS-CoV-2 in health care settings.

Over roughly the first 18 months of the pandemic, COVID-19 killed between 80,000 and 180,000 health care workers worldwide.
 

The COVID-19 pandemic highlights the need for IPC

Despite the pandemic, high-income countries were eight times more likely to implement more advanced IPC than low-income countries, and IPC national programs in low- and middle-income countries improved only slightly.

Only 4 (3.8%) of the 106 evaluated countries met all the minimum requirements for IPC in place at the national level, and only 15.2% of health care facilities met all IPC minimum requirements.

Libby A. Richards, RN, MSN, PhD, CHES, an associate professor of nursing and the director of the PhD program in the Purdue University School of Nursing in West Lafayette, Ind., welcomed the report.

“While the principles of infection prevention and control have been fundamental for well over a hundred years, the COVID-19 pandemic brought these critical issues to everyone’s attention,” Dr. Richards, who was not involved in the report, said by email. “During the pandemic, the impact on our overburdened and understaffed health care system left little or no room for other acutely ill patients.

“This report brings timely attention to the importance of IPC across health care services,” she added.

Suzanne Wagester, RN, MSN, director of infection prevention at the University of Pittsburgh Medical Center, said in an email, “The pandemic has united us as a society as we recognize that infections impact us all. We struggle with the same universal challenges that directly impact the work of infection prevention.

“IPC programs are vital to facilities, patients, and countries,” Ms. Wagester, who also was not involved in the report, added. “The WHO report highlights the call to action that will hopefully ignite the movement to advance IPC programs across the globe to combat preventable infections.”

The WHO Global IPC Portal helps health care professionals in all countries analyze, track progress, and improve IPC at facility and national levels.

The report was funded by core WHO funds. The authors and Dr. Diekema, Dr. Richards, and Ms. Wagester have disclosed no relevant financial relationships.

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

That Toxoplasma gondii looks good on you

Parasite and attractiveness don’t usually go together, but it appears that nobody told Toxoplasma gondii. The world’s most successful parasite affects 30%-50% of the world’s population, and it’s mainly thought to go after the brain in humans, possibly changing behavior and leading to neurological disorders and mental illness.

Now, are you ready to be super confused? According to a recent study, those affected with T. gondii were seen as more attractive and healthy looking, compared with noninfected people. It doesn’t make much sense to us, but it could be an evolutionary thing: The more attractive the parasite makes a person or animal, the more likely it is to spread.

RapidEye/iStock/Getty Images Plus

“Some sexually transmitted parasites, such as T. gondii, may produce changes in the appearance and behavior of the human host, either as a by-product of the infection or as the result of the manipulation of the parasite to increase its spread to new hosts,” Javier Borráz-León, PhD, of the University of Turku (Finland), and associates wrote in PeerJ.

Previous research has suggested that men with more testosterone are more likely to become infected because of their behavior with the extra hormones. It’s also been noted that the parasite may manipulate hormones for its own gain, but that’s not proven. Infected women were found to have a lower BMI, more confidence in their appearance, and more partners. Dr. Borráz-León and associates also found that “Toxoplasma-infected subjects had significantly lower facial fluctuating asymmetry than the noninfected people,” ScienceAlert said.

We usually perceive parasites as a bad thing, but honestly this one isn’t sounding too bad. It seems to help with some confidence boosters, and who doesn’t want that? We’re thinking that T. gondii could be the Next Big Thing. All it needs is some marketing and … what if it was covered with nonpareils?

Give it to me straight, Doc. Don’t sugar coat it.

Okay, so he’s not a doctor – not a medical doctor, anyway – but that’s exactly what he did. William H. Grover, PhD, has sugar coated drugs in the name of fraud prevention. We will explain.

The sugar coating comes in the form of nonpareils, the tiny and colorful round sprinkles often found covering small discs of chocolate. Dr. Grover, a bioengineering professor at the University of California, Riverside, who has been working on ways to ensure the authenticity of pharmaceuticals, “started wondering how many different patterns of colored nonpareils were possible on these candies,” he said in a statement from the university.

PxHere

With just eight colors and an average of 92 individual nonpareils on each candy, the combinations, he found out, are almost endless. Could the same thing be done with a pill? Could the nonpareils be applied as a coating to a pill, giving it a unique pattern that could be stored by the manufacturer and used later as identification?

After much time and effort involving edible cake-decorating glue, Tylenol capsules, smartphones, and computer simulations, he produced CandyCode, an algorithm that converts a photo of a nonpareil-covered pill “into a set of text strings suitable for storing in a computer database and querying by consumers,” the statement explained.

Dr. Grover also mentioned a side benefit: “Anecdotally, I found that CandyCoded caplets were more pleasant to swallow than plain caplets, confirming Mary Poppins’ classic observation about the relationship between sugar and medicine.”

First of all, we can’t believe we just used a Mary Poppins reference. Not exactly what you’d call MDedgey, is it? Second of all, what about the children? We’re talking about drugs that, literally, have been turned into candy. Are the kids going to love them, too? Sounds more like a job for Mr. Yuk.
 

So you want to be a superhero?

Be honest, who didn’t want to be a superhero when they were a kid? There’s a reason every other movie released in the past decade has been a superhero movie. That’s how we’ve ended up with the millionth Batman reboot and Marvel scraping the bottom of the C-list hero barrel. (Seriously, who’d actually heard of Moon Knight before now?)

rudall30/iStockphoto.com

Point is, we all like to fantasize, and now a meta-analysis from researchers in Germany and the United States has given us all a reason to strike those dashing superhero poses. Through evaluation of 130 studies and over 10,000 people, the researchers found that power posing (and perfect posture) was strongly associated with increased confidence and self-worth. It was also associated with improved behavior, though the connection was less strong.

Sadly though, the research found no connection with power posing and changes in testosterone or cortisol levels. Standing like a superhero may make you feel good, but it won’t give your body any cool powers or superhuman abilities. But don’t despair, because we’re not finished yet. In fact, it may be the biggest news we’ve ever reported for LOTME: A group of scientists from the University of Kentucky has assembled the full genome of a salamander.

Wait, we have more! Beyond having a genome ten times bigger than a human, this salamander, the axolotl from Mexico, is the model of natural regeneration. Name a body part, and the axolotl can grow it back. It can even regenerate portions of its brain. And now that we have access to the complete genome, it’s possible that one day we could use the axolotl’s regeneration for ourselves. Growing back limbs, regenerating spinal cords, the sky’s the limit. And if Wolverine and Deadpool are anything to go by, it’s all you need to get that superhero career off the ground. Salamander powers may not have the cachet of a radioactive spider, but we’ll take what we can get.
 

Post your way to financial hardship

After you pump your gas at the gas station, how do you pay? At the pump or inside? How frequently do you post to your social media pages? What kind of content are you posting?

That kind of nontraditional credit data hasn’t been considered by lenders and credit agencies, but that is changing. The reasoning? It’s opening more opportunities for those without much credit history. But according to a paper published by Janine S. Hiller of Virginia Tech and Lindsay Sain Jones, a financial regulation researcher at the University of Georgia, this just opens a can of worms.

SonerCdem/Thinkstock

Why is this so dangerous? Well, alternative credit scoring isn’t covered by the Fair Credit Reporting Act or Equal Opportunity Act, so the consumer doesn’t have the ability to dispute any data the credit agencies or lenders receive. Then there’s the “credit boost,” which some companies offer to gain access to the consumer’s data. Often there are no limitations on how long it’s kept. That purchase you made 2 years ago can come back to haunt you.

It also creates a cause for the possibility of discrimination based on “lifestyle-related data points,” which some lenders use to determine creditworthiness: zip code, age, gender, race, socioeconomic status. Even where the consumer went to college is a factor taken under consideration.

“There are all kinds of factors that can be correlated with creditworthiness, but that doesn’t mean they should be used,” Ms. Jones said in the EurekAlert statement.

Let’s say someone applies for a loan needed for a medical procedure. They could be denied because the lender or a credit-reporting agency didn’t like the data they received (most times without the consumer’s consent). Talk about a broken system.
 

That Toxoplasma gondii looks good on you

Parasite and attractiveness don’t usually go together, but it appears that nobody told Toxoplasma gondii. The world’s most successful parasite affects 30%-50% of the world’s population, and it’s mainly thought to go after the brain in humans, possibly changing behavior and leading to neurological disorders and mental illness.

Now, are you ready to be super confused? According to a recent study, those affected with T. gondii were seen as more attractive and healthy looking, compared with noninfected people. It doesn’t make much sense to us, but it could be an evolutionary thing: The more attractive the parasite makes a person or animal, the more likely it is to spread.

RapidEye/iStock/Getty Images Plus

“Some sexually transmitted parasites, such as T. gondii, may produce changes in the appearance and behavior of the human host, either as a by-product of the infection or as the result of the manipulation of the parasite to increase its spread to new hosts,” Javier Borráz-León, PhD, of the University of Turku (Finland), and associates wrote in PeerJ.

Previous research has suggested that men with more testosterone are more likely to become infected because of their behavior with the extra hormones. It’s also been noted that the parasite may manipulate hormones for its own gain, but that’s not proven. Infected women were found to have a lower BMI, more confidence in their appearance, and more partners. Dr. Borráz-León and associates also found that “Toxoplasma-infected subjects had significantly lower facial fluctuating asymmetry than the noninfected people,” ScienceAlert said.

We usually perceive parasites as a bad thing, but honestly this one isn’t sounding too bad. It seems to help with some confidence boosters, and who doesn’t want that? We’re thinking that T. gondii could be the Next Big Thing. All it needs is some marketing and … what if it was covered with nonpareils?

Give it to me straight, Doc. Don’t sugar coat it.

Okay, so he’s not a doctor – not a medical doctor, anyway – but that’s exactly what he did. William H. Grover, PhD, has sugar coated drugs in the name of fraud prevention. We will explain.

The sugar coating comes in the form of nonpareils, the tiny and colorful round sprinkles often found covering small discs of chocolate. Dr. Grover, a bioengineering professor at the University of California, Riverside, who has been working on ways to ensure the authenticity of pharmaceuticals, “started wondering how many different patterns of colored nonpareils were possible on these candies,” he said in a statement from the university.

PxHere

With just eight colors and an average of 92 individual nonpareils on each candy, the combinations, he found out, are almost endless. Could the same thing be done with a pill? Could the nonpareils be applied as a coating to a pill, giving it a unique pattern that could be stored by the manufacturer and used later as identification?

After much time and effort involving edible cake-decorating glue, Tylenol capsules, smartphones, and computer simulations, he produced CandyCode, an algorithm that converts a photo of a nonpareil-covered pill “into a set of text strings suitable for storing in a computer database and querying by consumers,” the statement explained.

Dr. Grover also mentioned a side benefit: “Anecdotally, I found that CandyCoded caplets were more pleasant to swallow than plain caplets, confirming Mary Poppins’ classic observation about the relationship between sugar and medicine.”

First of all, we can’t believe we just used a Mary Poppins reference. Not exactly what you’d call MDedgey, is it? Second of all, what about the children? We’re talking about drugs that, literally, have been turned into candy. Are the kids going to love them, too? Sounds more like a job for Mr. Yuk.
 

So you want to be a superhero?

Be honest, who didn’t want to be a superhero when they were a kid? There’s a reason every other movie released in the past decade has been a superhero movie. That’s how we’ve ended up with the millionth Batman reboot and Marvel scraping the bottom of the C-list hero barrel. (Seriously, who’d actually heard of Moon Knight before now?)

rudall30/iStockphoto.com

Point is, we all like to fantasize, and now a meta-analysis from researchers in Germany and the United States has given us all a reason to strike those dashing superhero poses. Through evaluation of 130 studies and over 10,000 people, the researchers found that power posing (and perfect posture) was strongly associated with increased confidence and self-worth. It was also associated with improved behavior, though the connection was less strong.

Sadly though, the research found no connection with power posing and changes in testosterone or cortisol levels. Standing like a superhero may make you feel good, but it won’t give your body any cool powers or superhuman abilities. But don’t despair, because we’re not finished yet. In fact, it may be the biggest news we’ve ever reported for LOTME: A group of scientists from the University of Kentucky has assembled the full genome of a salamander.

Wait, we have more! Beyond having a genome ten times bigger than a human, this salamander, the axolotl from Mexico, is the model of natural regeneration. Name a body part, and the axolotl can grow it back. It can even regenerate portions of its brain. And now that we have access to the complete genome, it’s possible that one day we could use the axolotl’s regeneration for ourselves. Growing back limbs, regenerating spinal cords, the sky’s the limit. And if Wolverine and Deadpool are anything to go by, it’s all you need to get that superhero career off the ground. Salamander powers may not have the cachet of a radioactive spider, but we’ll take what we can get.
 

Post your way to financial hardship

After you pump your gas at the gas station, how do you pay? At the pump or inside? How frequently do you post to your social media pages? What kind of content are you posting?

That kind of nontraditional credit data hasn’t been considered by lenders and credit agencies, but that is changing. The reasoning? It’s opening more opportunities for those without much credit history. But according to a paper published by Janine S. Hiller of Virginia Tech and Lindsay Sain Jones, a financial regulation researcher at the University of Georgia, this just opens a can of worms.

SonerCdem/Thinkstock

Why is this so dangerous? Well, alternative credit scoring isn’t covered by the Fair Credit Reporting Act or Equal Opportunity Act, so the consumer doesn’t have the ability to dispute any data the credit agencies or lenders receive. Then there’s the “credit boost,” which some companies offer to gain access to the consumer’s data. Often there are no limitations on how long it’s kept. That purchase you made 2 years ago can come back to haunt you.

It also creates a cause for the possibility of discrimination based on “lifestyle-related data points,” which some lenders use to determine creditworthiness: zip code, age, gender, race, socioeconomic status. Even where the consumer went to college is a factor taken under consideration.

“There are all kinds of factors that can be correlated with creditworthiness, but that doesn’t mean they should be used,” Ms. Jones said in the EurekAlert statement.

Let’s say someone applies for a loan needed for a medical procedure. They could be denied because the lender or a credit-reporting agency didn’t like the data they received (most times without the consumer’s consent). Talk about a broken system.
 

That Toxoplasma gondii looks good on you

Parasite and attractiveness don’t usually go together, but it appears that nobody told Toxoplasma gondii. The world’s most successful parasite affects 30%-50% of the world’s population, and it’s mainly thought to go after the brain in humans, possibly changing behavior and leading to neurological disorders and mental illness.

Now, are you ready to be super confused? According to a recent study, those affected with T. gondii were seen as more attractive and healthy looking, compared with noninfected people. It doesn’t make much sense to us, but it could be an evolutionary thing: The more attractive the parasite makes a person or animal, the more likely it is to spread.

RapidEye/iStock/Getty Images Plus

“Some sexually transmitted parasites, such as T. gondii, may produce changes in the appearance and behavior of the human host, either as a by-product of the infection or as the result of the manipulation of the parasite to increase its spread to new hosts,” Javier Borráz-León, PhD, of the University of Turku (Finland), and associates wrote in PeerJ.

Previous research has suggested that men with more testosterone are more likely to become infected because of their behavior with the extra hormones. It’s also been noted that the parasite may manipulate hormones for its own gain, but that’s not proven. Infected women were found to have a lower BMI, more confidence in their appearance, and more partners. Dr. Borráz-León and associates also found that “Toxoplasma-infected subjects had significantly lower facial fluctuating asymmetry than the noninfected people,” ScienceAlert said.

We usually perceive parasites as a bad thing, but honestly this one isn’t sounding too bad. It seems to help with some confidence boosters, and who doesn’t want that? We’re thinking that T. gondii could be the Next Big Thing. All it needs is some marketing and … what if it was covered with nonpareils?

Give it to me straight, Doc. Don’t sugar coat it.

Okay, so he’s not a doctor – not a medical doctor, anyway – but that’s exactly what he did. William H. Grover, PhD, has sugar coated drugs in the name of fraud prevention. We will explain.

The sugar coating comes in the form of nonpareils, the tiny and colorful round sprinkles often found covering small discs of chocolate. Dr. Grover, a bioengineering professor at the University of California, Riverside, who has been working on ways to ensure the authenticity of pharmaceuticals, “started wondering how many different patterns of colored nonpareils were possible on these candies,” he said in a statement from the university.

PxHere

With just eight colors and an average of 92 individual nonpareils on each candy, the combinations, he found out, are almost endless. Could the same thing be done with a pill? Could the nonpareils be applied as a coating to a pill, giving it a unique pattern that could be stored by the manufacturer and used later as identification?

After much time and effort involving edible cake-decorating glue, Tylenol capsules, smartphones, and computer simulations, he produced CandyCode, an algorithm that converts a photo of a nonpareil-covered pill “into a set of text strings suitable for storing in a computer database and querying by consumers,” the statement explained.

Dr. Grover also mentioned a side benefit: “Anecdotally, I found that CandyCoded caplets were more pleasant to swallow than plain caplets, confirming Mary Poppins’ classic observation about the relationship between sugar and medicine.”

First of all, we can’t believe we just used a Mary Poppins reference. Not exactly what you’d call MDedgey, is it? Second of all, what about the children? We’re talking about drugs that, literally, have been turned into candy. Are the kids going to love them, too? Sounds more like a job for Mr. Yuk.
 

So you want to be a superhero?

Be honest, who didn’t want to be a superhero when they were a kid? There’s a reason every other movie released in the past decade has been a superhero movie. That’s how we’ve ended up with the millionth Batman reboot and Marvel scraping the bottom of the C-list hero barrel. (Seriously, who’d actually heard of Moon Knight before now?)

rudall30/iStockphoto.com

Point is, we all like to fantasize, and now a meta-analysis from researchers in Germany and the United States has given us all a reason to strike those dashing superhero poses. Through evaluation of 130 studies and over 10,000 people, the researchers found that power posing (and perfect posture) was strongly associated with increased confidence and self-worth. It was also associated with improved behavior, though the connection was less strong.

Sadly though, the research found no connection with power posing and changes in testosterone or cortisol levels. Standing like a superhero may make you feel good, but it won’t give your body any cool powers or superhuman abilities. But don’t despair, because we’re not finished yet. In fact, it may be the biggest news we’ve ever reported for LOTME: A group of scientists from the University of Kentucky has assembled the full genome of a salamander.

Wait, we have more! Beyond having a genome ten times bigger than a human, this salamander, the axolotl from Mexico, is the model of natural regeneration. Name a body part, and the axolotl can grow it back. It can even regenerate portions of its brain. And now that we have access to the complete genome, it’s possible that one day we could use the axolotl’s regeneration for ourselves. Growing back limbs, regenerating spinal cords, the sky’s the limit. And if Wolverine and Deadpool are anything to go by, it’s all you need to get that superhero career off the ground. Salamander powers may not have the cachet of a radioactive spider, but we’ll take what we can get.
 

Post your way to financial hardship

After you pump your gas at the gas station, how do you pay? At the pump or inside? How frequently do you post to your social media pages? What kind of content are you posting?

That kind of nontraditional credit data hasn’t been considered by lenders and credit agencies, but that is changing. The reasoning? It’s opening more opportunities for those without much credit history. But according to a paper published by Janine S. Hiller of Virginia Tech and Lindsay Sain Jones, a financial regulation researcher at the University of Georgia, this just opens a can of worms.

SonerCdem/Thinkstock

Why is this so dangerous? Well, alternative credit scoring isn’t covered by the Fair Credit Reporting Act or Equal Opportunity Act, so the consumer doesn’t have the ability to dispute any data the credit agencies or lenders receive. Then there’s the “credit boost,” which some companies offer to gain access to the consumer’s data. Often there are no limitations on how long it’s kept. That purchase you made 2 years ago can come back to haunt you.

It also creates a cause for the possibility of discrimination based on “lifestyle-related data points,” which some lenders use to determine creditworthiness: zip code, age, gender, race, socioeconomic status. Even where the consumer went to college is a factor taken under consideration.

“There are all kinds of factors that can be correlated with creditworthiness, but that doesn’t mean they should be used,” Ms. Jones said in the EurekAlert statement.

Let’s say someone applies for a loan needed for a medical procedure. They could be denied because the lender or a credit-reporting agency didn’t like the data they received (most times without the consumer’s consent). Talk about a broken system.
 

A recent ISCHEMIA trial substudy is under scrutiny from surgeons for a data discrepancy, rekindling concerns about reliance on the landmark trial data in the latest coronary revascularization guidelines.

As previously reported, the main ISCHEMIA findings showed no significant benefit for an initial strategy of percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG) over medical therapy in patients with stable moderate to severe ischemic heart disease.

The 2021 substudy by Reynolds et al. showed that coronary artery disease (CAD) severity, classified using the modified Duke Prognostic Index score, predicted 4-year mortality and myocardial infarction in the trial, whereas ischemia severity did not.

Cardiac surgeons Joseph F. Sabik III, MD, and Faisal Bakaeen, MD, however, spotted that only 40 patients are in the Duke category 6 group (three-vessel severe stenosis of at least 70% or two-vessel severe stenosis with a proximal left anterior descending lesion) in Supplemental tables 1 and 2, whereas 659 are in the main paper.

In addition, the Supplemental tables list the following:

• 659 patients in Duke group 5, not 894 as in the paper.
• 894 patients in Duke group 4, not 743 as in the paper.
• 743 patients in Duke group 3, not 179 as in the paper.

The surgeons penned a letter to Circulation early in April flagging the discrepancies, but say it was rejected April 15 because it was submitted outside the journal’s 6-week window for letters. They posted a public comment on the Remarq research platform, as advised by Circulation’s editorial office, and reached out directly to the authors and ISCHEMIA leadership.

“They just keep saying it’s a simple formatting error. Well, if it is a simple formatting error, then fix it,” Dr. Sabik, chair of surgery at University Hospitals Cleveland Medical Center, said in an interview. “But here we are now, a month later, and they still haven’t published our letter. Why? We’re the ones who identified the problem.”

Dr. Sabik said the accuracy of the data has important implications because the recent AHA/ACC/SCAI coronary revascularization guidelines used the ISCHEMIA data to downgrade the CABG recommendation for complex multivessel disease from class 1 to class 2B. Patients with a Duke 6 score are also typically the ones referred for CABG by today’s heart teams.

Several surgical societies have contested the guidelines, questioning whether the ISCHEMIA patients are truly reflective of those seen in clinical practice and questioning the decision to treat PCI and surgery as equivalent strategies to decrease ischemic events.

Dr. Bakaeen, from the Cleveland Clinic, told this news organization they don’t want a public battle over the data like the one that befell the EXCEL trial, and that it’s entirely possible the investigators might have inadvertently upgraded all the Duke score assignments by 1.

A systematic error, however, is more plausible than a formatting error, he said, because Supplemental tables 1 and 2 correspond exactly to the Duke 1 to Duke 7 sequence, suggesting the tables are correct and that the error might have occurred downstream, including in the manuscript.

The numbers should be consistent across all the ISCHEMIA manuscripts, Dr. Bakaeen added, but currently “don’t add up,” even after adjustment for different denominators, and especially for participants with left main disease.

They hope that publication of their letter, he said, will convince the authors to publicly share the data for patients in each of the seven modified Duke categories.

Lead author of the ISCHEMIA substudy, Harmony Reynolds, MD, New York (N.Y.) University Langone Health, told this news organization via email that as a result of a “formatting error in the transfer of data from the statistical output file to a Word document, data in Supplemental tables 1 and 2 were incorrect.”

She explained that they planned to present six, not seven, rows for the Duke score in the tables, collapsing the first two categories of nonobstructive disease (Duke 1-2), as they were in all other tables and figures. However, the Supplemental tables had incorrect row headings and because the Word program is designed to fill all available rows, it inserted the data from the output file into a seven-row table shell, duplicating the values for row 1 in the last row for left main disease of at least 50%.

“The data were correctly presented in the main manuscript tables and figures and in the remainder of the supplement, with a total of 659 patients in the subset with modified Duke prognostic index category 6 on coronary CT angiography,” Dr. Reynolds said.

She noted that Circulation will issue a correction. In addition, “we are in the process of preparing the data for public sharing soon. The data will include the Duke prognostic score at all levels.”

Circulation editor-in-chief Joseph A. Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center, Dallas, declined to be interviewed but confirmed via email that Dr. Bakaeen and Dr. Sabik’s letter and the correction will be published the week of May 16.

As for the delay, he said, “I received their reach-out just over 1 week ago, and per protocol, we conducted an internal evaluation of their allegations, which took a bit of time.”
 

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

A recent ISCHEMIA trial substudy is under scrutiny from surgeons for a data discrepancy, rekindling concerns about reliance on the landmark trial data in the latest coronary revascularization guidelines.

As previously reported, the main ISCHEMIA findings showed no significant benefit for an initial strategy of percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG) over medical therapy in patients with stable moderate to severe ischemic heart disease.

The 2021 substudy by Reynolds et al. showed that coronary artery disease (CAD) severity, classified using the modified Duke Prognostic Index score, predicted 4-year mortality and myocardial infarction in the trial, whereas ischemia severity did not.

Cardiac surgeons Joseph F. Sabik III, MD, and Faisal Bakaeen, MD, however, spotted that only 40 patients are in the Duke category 6 group (three-vessel severe stenosis of at least 70% or two-vessel severe stenosis with a proximal left anterior descending lesion) in Supplemental tables 1 and 2, whereas 659 are in the main paper.

In addition, the Supplemental tables list the following:

• 659 patients in Duke group 5, not 894 as in the paper.
• 894 patients in Duke group 4, not 743 as in the paper.
• 743 patients in Duke group 3, not 179 as in the paper.

The surgeons penned a letter to Circulation early in April flagging the discrepancies, but say it was rejected April 15 because it was submitted outside the journal’s 6-week window for letters. They posted a public comment on the Remarq research platform, as advised by Circulation’s editorial office, and reached out directly to the authors and ISCHEMIA leadership.

“They just keep saying it’s a simple formatting error. Well, if it is a simple formatting error, then fix it,” Dr. Sabik, chair of surgery at University Hospitals Cleveland Medical Center, said in an interview. “But here we are now, a month later, and they still haven’t published our letter. Why? We’re the ones who identified the problem.”

Dr. Sabik said the accuracy of the data has important implications because the recent AHA/ACC/SCAI coronary revascularization guidelines used the ISCHEMIA data to downgrade the CABG recommendation for complex multivessel disease from class 1 to class 2B. Patients with a Duke 6 score are also typically the ones referred for CABG by today’s heart teams.

Several surgical societies have contested the guidelines, questioning whether the ISCHEMIA patients are truly reflective of those seen in clinical practice and questioning the decision to treat PCI and surgery as equivalent strategies to decrease ischemic events.

Dr. Bakaeen, from the Cleveland Clinic, told this news organization they don’t want a public battle over the data like the one that befell the EXCEL trial, and that it’s entirely possible the investigators might have inadvertently upgraded all the Duke score assignments by 1.

A systematic error, however, is more plausible than a formatting error, he said, because Supplemental tables 1 and 2 correspond exactly to the Duke 1 to Duke 7 sequence, suggesting the tables are correct and that the error might have occurred downstream, including in the manuscript.

The numbers should be consistent across all the ISCHEMIA manuscripts, Dr. Bakaeen added, but currently “don’t add up,” even after adjustment for different denominators, and especially for participants with left main disease.

They hope that publication of their letter, he said, will convince the authors to publicly share the data for patients in each of the seven modified Duke categories.

Lead author of the ISCHEMIA substudy, Harmony Reynolds, MD, New York (N.Y.) University Langone Health, told this news organization via email that as a result of a “formatting error in the transfer of data from the statistical output file to a Word document, data in Supplemental tables 1 and 2 were incorrect.”

She explained that they planned to present six, not seven, rows for the Duke score in the tables, collapsing the first two categories of nonobstructive disease (Duke 1-2), as they were in all other tables and figures. However, the Supplemental tables had incorrect row headings and because the Word program is designed to fill all available rows, it inserted the data from the output file into a seven-row table shell, duplicating the values for row 1 in the last row for left main disease of at least 50%.

“The data were correctly presented in the main manuscript tables and figures and in the remainder of the supplement, with a total of 659 patients in the subset with modified Duke prognostic index category 6 on coronary CT angiography,” Dr. Reynolds said.

She noted that Circulation will issue a correction. In addition, “we are in the process of preparing the data for public sharing soon. The data will include the Duke prognostic score at all levels.”

Circulation editor-in-chief Joseph A. Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center, Dallas, declined to be interviewed but confirmed via email that Dr. Bakaeen and Dr. Sabik’s letter and the correction will be published the week of May 16.

As for the delay, he said, “I received their reach-out just over 1 week ago, and per protocol, we conducted an internal evaluation of their allegations, which took a bit of time.”
 

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

A recent ISCHEMIA trial substudy is under scrutiny from surgeons for a data discrepancy, rekindling concerns about reliance on the landmark trial data in the latest coronary revascularization guidelines.

As previously reported, the main ISCHEMIA findings showed no significant benefit for an initial strategy of percutaneous coronary intervention (PCI) or coronary bypass graft surgery (CABG) over medical therapy in patients with stable moderate to severe ischemic heart disease.

The 2021 substudy by Reynolds et al. showed that coronary artery disease (CAD) severity, classified using the modified Duke Prognostic Index score, predicted 4-year mortality and myocardial infarction in the trial, whereas ischemia severity did not.

Cardiac surgeons Joseph F. Sabik III, MD, and Faisal Bakaeen, MD, however, spotted that only 40 patients are in the Duke category 6 group (three-vessel severe stenosis of at least 70% or two-vessel severe stenosis with a proximal left anterior descending lesion) in Supplemental tables 1 and 2, whereas 659 are in the main paper.

In addition, the Supplemental tables list the following:

• 659 patients in Duke group 5, not 894 as in the paper.
• 894 patients in Duke group 4, not 743 as in the paper.
• 743 patients in Duke group 3, not 179 as in the paper.

The surgeons penned a letter to Circulation early in April flagging the discrepancies, but say it was rejected April 15 because it was submitted outside the journal’s 6-week window for letters. They posted a public comment on the Remarq research platform, as advised by Circulation’s editorial office, and reached out directly to the authors and ISCHEMIA leadership.

“They just keep saying it’s a simple formatting error. Well, if it is a simple formatting error, then fix it,” Dr. Sabik, chair of surgery at University Hospitals Cleveland Medical Center, said in an interview. “But here we are now, a month later, and they still haven’t published our letter. Why? We’re the ones who identified the problem.”

Dr. Sabik said the accuracy of the data has important implications because the recent AHA/ACC/SCAI coronary revascularization guidelines used the ISCHEMIA data to downgrade the CABG recommendation for complex multivessel disease from class 1 to class 2B. Patients with a Duke 6 score are also typically the ones referred for CABG by today’s heart teams.

Several surgical societies have contested the guidelines, questioning whether the ISCHEMIA patients are truly reflective of those seen in clinical practice and questioning the decision to treat PCI and surgery as equivalent strategies to decrease ischemic events.

Dr. Bakaeen, from the Cleveland Clinic, told this news organization they don’t want a public battle over the data like the one that befell the EXCEL trial, and that it’s entirely possible the investigators might have inadvertently upgraded all the Duke score assignments by 1.

A systematic error, however, is more plausible than a formatting error, he said, because Supplemental tables 1 and 2 correspond exactly to the Duke 1 to Duke 7 sequence, suggesting the tables are correct and that the error might have occurred downstream, including in the manuscript.

The numbers should be consistent across all the ISCHEMIA manuscripts, Dr. Bakaeen added, but currently “don’t add up,” even after adjustment for different denominators, and especially for participants with left main disease.

They hope that publication of their letter, he said, will convince the authors to publicly share the data for patients in each of the seven modified Duke categories.

Lead author of the ISCHEMIA substudy, Harmony Reynolds, MD, New York (N.Y.) University Langone Health, told this news organization via email that as a result of a “formatting error in the transfer of data from the statistical output file to a Word document, data in Supplemental tables 1 and 2 were incorrect.”

She explained that they planned to present six, not seven, rows for the Duke score in the tables, collapsing the first two categories of nonobstructive disease (Duke 1-2), as they were in all other tables and figures. However, the Supplemental tables had incorrect row headings and because the Word program is designed to fill all available rows, it inserted the data from the output file into a seven-row table shell, duplicating the values for row 1 in the last row for left main disease of at least 50%.

“The data were correctly presented in the main manuscript tables and figures and in the remainder of the supplement, with a total of 659 patients in the subset with modified Duke prognostic index category 6 on coronary CT angiography,” Dr. Reynolds said.

She noted that Circulation will issue a correction. In addition, “we are in the process of preparing the data for public sharing soon. The data will include the Duke prognostic score at all levels.”

Circulation editor-in-chief Joseph A. Hill, MD, PhD, chief of cardiology at UT Southwestern Medical Center, Dallas, declined to be interviewed but confirmed via email that Dr. Bakaeen and Dr. Sabik’s letter and the correction will be published the week of May 16.

As for the delay, he said, “I received their reach-out just over 1 week ago, and per protocol, we conducted an internal evaluation of their allegations, which took a bit of time.”
 

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

It’s no secret that, for decades, the participants in clinical trials for new drugs and medical devices haven’t accurately represented the diverse groups of patients the drugs and devices were designed for.

In a recently published draft guidance, the Food and Drug Administration recommended that companies in charge of running these trials should submit a proposal to the agency that would address how they plan to enroll more “clinically relevant populations” and historically underrepresented racial and ethnic groups.

It’s an issue that the U.S. has been trying to fix for years. In 1993, the NIH Revitalization Act was passed into law. It mandated the appropriate inclusion of women and racial minorities in all National Institutes of Health–funded research.

Since then, the FDA has put out plans that encourage trial sponsors to recruit more diverse enrollees, offering strategies and best practices rather than establishing requirements or quotas that companies would be forced to meet. Despite its efforts to encourage inclusion, people of color continue to be largely underrepresented in clinical trials.

Experts aren’t just calling for trial cohorts to reflect U.S. census data. Rather, the demographics of participants should match those of the diagnosis being studied. An analysis of 24 clinical trials of cardiovascular drugs, for example, found that Black Americans made up 2.9% of trial participants, compared with 83.1% for White people. Given that cardiovascular diseases affect Black Americans at almost the same rate as Whites (23.5% and 23.7%, respectively) – and keeping in mind that Black Americans make up 13.4% of the population and White people represent 76.3% – the degree of underrepresentation is glaring.

One commonly cited reason for this lack of representation is that people of color, especially Black Americans, have lingering feelings of mistrust toward the medical field. The U.S.-run Tuskegee study – during which researchers documented the natural progression of syphilis in hundreds of Black men who were kept from life-saving treatment – is, justifiably, often named as a notable source of that suspicion.

But blaming the disproportionately low numbers of Black participants in clinical trials on medical mistrust is an easy answer to a much more complicated issue, said cardiologist Clyde Yancy, MD, who also serves as the vice dean for diversity and inclusion at Northwestern University’s Feinberg School of Medicine, Chicago.

“We need to not put the onus on the back of the patient cohort, and say they are the problem,” Dr. Yancy said, adding that many trials add financial barriers and don’t provide proper transportation for participants who may live farther away.

The diversity of the study team itself – the institutions, researchers, and recruiters – also contributes to a lack of diversity in the participant pool. When considering all of these factors, “you begin to understand the complexity and the multidimensionality of why we have underrepresentation,” said Dr. Yancy. “So I would not promulgate the notion that this is simply because patients don’t trust the system.”

Soumya Niranjan, PhD, worked as a study coordinator at the Tulane Cancer Center in New Orleans, La., where she recruited patients for a prostate cancer study. After researching the impact of clinicians’ biases on the recruitment of racial and ethnic minorities in oncology trials, she found that some recruiters view patients of color as less promising participants.

“Who ends up being approached for a clinical trial is based on a preset rubric that one has in mind about a patient who may be eligible for a cancer study,” said Dr. Niranjan. “There is a characterization of, ‘we want to make sure this patient is compliant, that they will be a good historian and seem responsible.’ ... Our study showed that it kind of fell along racial lines.”

In her study, published in the journal Cancer in 2020, Dr. Niranjan wrote that researchers sometimes “perceived racial minority groups to have low knowledge of cancer clinical trials. This was considered to be a hindrance while explaining cancer clinical trials in the face of limited provider time during a clinical encounter.”

Some researchers believed minority participants, especially Black women, would be less likely to file study protocols. Others said people of color are more likely to be selfish.

She quoted one research investigator as saying Black people are less knowledgeable.

“African Americans I think have less knowledge,” the unnamed researcher said. “We take a little bit more time to explain to African American [sic]. I think ... they have more questions because we know they are not more knowledgeable so I think it takes time. They have a lot of questions.”
 

Progress over the years

The FDA’s recent draft builds upon a guidance from 2016, which already recommended that trial teams submit an inclusion plan to the agency at the earliest phase of development. While the recent announcement is another step in the right direction, it may not be substantial enough.

“There’s always an enrollment plan,” Dr. Niranjan said. “But those enrollment plans are not enforced. So if it’s not enforced, what does that look like?”

In an emailed statement to this news organization, Lola Fashoyin-Aje, MD, the deputy director of the FDA Oncology Center of Excellence’s division to expand diversity, emphasized that the draft guidance does not require anything, but that the agency “expect[s] sponsors will follow FDA’s recommendations as described in the draft guidance.”

Without requirements, it’s up to the sponsor to make the effort to enroll people with varied racial and ethnic backgrounds. During the development of the COVID-19 vaccine, Moderna announced that the company would slow the trial’s enrollment to ensure minority groups were properly represented.

Not every sponsor is as motivated to make this a concerted effort, and some simply don’t have the funds to allocate to strengthening the enrollment process.

“There’s so much red tape and paperwork to get the funding for a clinical trial,” said Julie Silver, MD, professor of physical medicine and rehabilitation at Harvard Medical School, Boston, who studies workforce diversity and inclusion. “Even when people are equitably included, the amount of funding they have to do the trial might not be enough to do an analysis that shows potential differences.”

Whether the FDA will enforce enrollment plans in the future remains an open question; however, Dr. Yancy said the most effective way to do this would be through incentives, rather than penalties.

According to Dr. Fashoyin-Aje, the FDA and sponsors “will learn from these submissions and over time, whether and how these diversity plans lead to meaningful changes in clinical trial representation will need to be assessed, including whether additional steps need to be taken.”

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

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

The latest increase in new child COVID-19 cases seems to be picking up steam, rising by 50% in the last week, according to the American Academy of Pediatrics and the Children’s Hospital Association.

The new-case count was over 93,000 for the week of May 6-12, compared with 62,000 the previous week. That 50% week-to-week change follows increases of 17%, 44%, 12%, and 28% since the nationwide weekly total fell to its low point for the year (25,915) in the beginning of April, the AAP and CHA said in their weekly COVID report.

By comparison, the Centers for Disease Control and Prevention put the total number of cases in children aged 0-17 at 12.7 million, although that figure is based on a cumulative number of 73.4 million cases among all ages, which is well short of the reported total of almost 82.4 million as of May 16. COVID cases in children have led to 1,536 deaths so far, the CDC said.

The recent upward trend in new cases also can be seen in the CDC’s data, which show the weekly rate rising from 35 per 100,000 population on March 26 to 102 per 100,000 on May 7 in children aged 0-14 years, with commensurate increases seen among older children over the same period. In turn, the rate of new admissions for children aged 0-17 has gone from a low of 0.13 per 100,000 as late as April 10 up to 0.23 on May 13, the CDC said on its COVID Data Tracker.

One thing not going up these days is vaccinations among the youngest eligible children. The number of 5- to 11-year-olds receiving their initial dose was down to 40,000 for the week of May 5-11, the fewest since the vaccine was approved for that age group. For a change of pace, the number increased among children aged 12-17, as 37,000 got initial vaccinations that week, compared with 29,000 a week earlier, the AAP said in its weekly vaccination report.

rfranki@mdedge.com

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Almost forgotten today, tuberculosis is still one of the deadliest infectious diseases in the world. In an interview with Coliquio, Ronald D. Gerste, MD, PhD, an ophthalmologist and historian, looked back on this disease’s eventful history, which encompasses outstanding discoveries and catastrophic failures in diagnosis and treatment from the Middle Ages to the present day.

Under different names, TB has affected mankind for millennia. One of these names was the “aesthetic disease,” because it led to weight loss and pallor in the younger patients that it often affected. This was considered the ideal of beauty in the Victorian era. Many celebrities suffered from the disease, including poets and artists such as Friedrich Schiller, Lord Byron, and the Bronte family. As recently as the early 1990s, the disease almost changed world history, because Nelson Mandela became ill before the negotiations that led to the end of apartheid in South Africa.

Today, the global community is still not on track to meet its self-imposed targets for controlling the infectious disease, as reported by the World Health Organization on World TB Day in late March. Children and young people are the leading victims. In 2020 alone, 1.1 million children and adolescents under age 15 years were infected with TB, and 226,000 died of the disease, according to the WHO.
 

Q: Nelson Mandela was ill with tuberculosis during his imprisonment. How did the disease manifest itself in the future Nobel Peace Prize winner, and what is known about the treatment?

Ronald D. Gerste: Nelson Mandela contracted tuberculosis in 1988. At that time, he was 70 years old and had been in prison for 26 years. The disease presented in him with the almost classic symptom: He was coughing up blood and was also increasingly fatigued and losing weight. After doctors initially suspected a viral infection, but then TB was proven, he was treated with medication, and fluid was also drained from his lungs. [Mr.] Mandela was hospitalized for six weeks at Tygerberg Hospital in Cape Town, the second largest hospital in South Africa. The therapy worked well, but [Mr.] Mandela’s lungs remained damaged. He was subsequently prone to pneumonia and was repeatedly hospitalized for pneumonia in 2012 and 2013.
 

Q: Mandela was lucky that the treatment worked for him. A few years later, the first antibiotic-resistant pathogen strains developed. How did medical research respond to this development?

Gerste: The emergence of multidrug resistant (MDR) strains of the pathogen prompted the WHO to declare a “global health emergency” in 1993. Three years later, World TB Day was proclaimed to raise awareness of the threat posed by this disease, which has been known since ancient times. It always takes place on March 24, the day in 1882 when Robert Koch gave his famous lecture in Berlin in which he announced the discovery of the pathogen Mycobacterium tuberculosis.

Medical research has introduced new drugs into TB therapy, such as bedaquiline and delamanid. But MDR tuberculosis therapy remains a global challenge and has diminished hopes of eradicating tuberculosis, as we did with smallpox some 40 years ago. Today, only 56% of all MDR-TB patients worldwide are successfully treated.
 

Q: As already mentioned, the TB pathogen was discovered by Robert Koch. How did this come about?

Gerste: Along with cholera, TB was a great epidemic of the 19th century. For an ambitious researcher like Robert Koch, who had made a name for himself with the discovery of anthrax in 1876, there was no more rewarding goal than to find the cause of this infectious disease, which claimed the lives of many famous people such as Kafka, Dostoevsky, and Schiller, as well as many whose names are forgotten today.

[Dr.] Koch worked with his cultures for several years; the method of staining with methylene blue that was developed by the young Paul Ehrlich represented a breakthrough. To this method, [Dr.] Koch added a second, brownish dye. After countless experiments, this allowed slightly curved bacilli to be identified in tuberculous material under the microscope.

On the evening of March 24, 1882, [Dr.] Koch gave a lecture at the Institute of Physiology in Berlin with the title “Etiology of TB,” which sounded less than sensational on the invitations. One or two dozen participants had been expected, but more than one hundred came; numerous listeners had to make do with standing room behind the rows of chairs in the lecture hall. After a rather dry presentation ([Dr.] Koch was not a great orator nor a self-promoter), he presented his results to those present.

His assistants had set up a series of microscopes in the lecture hall through which everyone could get a glimpse of this enemy of humanity: the tubercle bacillus. When [Dr.] Koch had finished his remarks, there was silence in the hall. There was no burst of applause; the audience was too deeply aware that they had witnessed a historic moment. Paul Ehrlich later said that this evening had been the most significant scientific experience of his life. Over the next few weeks, the newspapers made a national hero out of Robert Koch, and the Emperor appointed him a Privy Councilor of the Government. The country doctor from Pomerania was now the figurehead of science in the young German Empire.
 

Q: Shortly after his discovery, [Dr.] Koch advertised a vaccination against TB with the active ingredient tuberculin. Was he able to convince with that too?

Gerste: No, this was the big flop, almost the disaster of a remarkable scientific career. The preparation of attenuated tubercle bacilli with water and glycerin not only did not prevent infection at all, it proved fatal for numerous users. However, tuberculin has survived in a modified form: as a tuberculin test, in which a characteristic skin rash indicates that a tested person has already had contact with the Mycobacterium.
 

Q: How have diagnostic options and treatment of the disease evolved since Robert Koch’s lifetime?

Gerste: A very decisive advance was made in diagnostics. With the rather accidental discovery of the rays soon named after him by Wilhelm Conrad Röntgen in the last days of 1895, it became possible to visualize the lung changes that tuberculosis caused in an unexpected way on living patients; the serial examinations for TB by X-rays were the logical consequence. Both scientists received Nobel Prizes, which were still new at the time, within a few years of each other: [Dr.] Röntgen in 1901 for physics, and [Dr]. Koch in 1905 for medicine and physiology.

Effective drugs were practically unavailable toward the end of the 19th century. For those who could afford it, however, a whole new world of (hoped-for or perceived) healing from “consumption” opened up: the sanatorium, located high in the mountains, surrounded by “fresh air.” The most famous of these climatic health resorts is probably Davos. It is no disrespect to the Swiss Confederation, which I hold in high esteem, to point out that Switzerland owes its high status as a tourist destination and thus its prosperity in part to TB.
 

Q: Things were quite different in earlier times. Until 250 years ago, the hopes of many patients rested on the medieval healing method of the “royal touch.” What’s that all about?

Gerste: In the Middle Ages, a “healing method” emerged from which not only lepers and other seriously ill people but also those suffering from consumption expected to be saved: the “royal touch,” which was first described by the Frankish king Clovis in 496. This ceremony was based on the idea that the king or queen, anointed by God, could improve or even cure the ailment of a sick person through a brief touch.

With the transition from the Middle Ages to the early modern period, this act, during which thousands often gathered in front of the ruler’s residence, was practiced on a large scale. The sufferers passed by the anointed ruler as if in a procession and were briefly touched by him or her. The extremely few “successes” were of course exploited by royal propaganda to proclaim the blessing that the reign of the king or queen meant for the country. But on those who nevertheless fell victim to TB or another ailment, the chroniclers remained silent.

Charles II of England, who ruled from 1660 to 1685 during the Restoration after the English Civil War, is said to have touched 92,102 sick people during this period, according to contemporary counts. The record for a single day’s performance is probably held by Louis XVI of France, who is said to have touched a total of 2,400 sufferers on June 14, 1775. Some of them may have stood and cheered in the Paris crowd 18 years later as the king climbed the steps to the guillotine.
 

Q: Another invention associated with TB diagnosis is the stethoscope. How did it come about?

Gerste: A young physician named René-Théophile-Hyacinthe Laënnec had already experienced the importance of diagnosing TB in his student years. His teacher in Paris was Xavier Bichat, considered the founder of histology, who died of TB in [Dr.] Laënnec’s second year at the age of only 30. [Dr.] Laënnec was a devotee of auscultation and made it work with a massively overweight patient by rolling up a sheet of paper, then placing this on the woman’s thorax to listen to her heart sounds. He developed the idea further and built a hollow wooden tube with a metal earpiece. In 1818, he presented the device at the meeting of the Academy of Sciences in Paris; he called it a stethoscope. He used his new instrument primarily to auscultate the lungs of patients with TB and distinguished the sounds of TB cavities from those of other lung diseases such as pneumonia and emphysema.
 

Q: Back to the present day: The WHO wants to eradicate TB once and for all. What are the hopes and fears in the fight against this disease?

Gerste: There is no doubt that we are currently taking a step backwards in these efforts, and this is not only due to multiresistant pathogens. Especially in poorer countries particularly affected by TB, treatment and screening programs have been disrupted by lockdown measures targeting COVID-19. The WHO suspects that in the first pandemic year, 2020, about half a million additional people may have died from TB because they never received a diagnosis.

Dr. Gerste, born in 1957, is a physician and historian. Dr. Gerste has lived for many years as a correspondent and book author in Washington, D.C., where he writes primarily for the New Journal of Zürich, the FAS, Back Then, the German Medical Journal, and other academic journals.

This article was translated from Coliquio.

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

Early in the COVID-19 pandemic, Trisha Pasricha, MD, a gastroenterologist and research fellow at Massachusetts General Hospital in Boston, was talking to a patient who had been hospitalized for a peptic ulcer.

Like other physicians in her institution, Dr. Pasricha was wearing scrubs instead of a white coat, out of concern that the white coat might be more prone to accumulating or transmitting COVID-19 pathogens. Her badge identified her as a physician, and she introduced herself clearly as “Dr. Pasricha.”

The patient “required an emergent procedure, which I discussed with him,” Dr. Pasricha told this news organization. “I went over what the procedure entailed, the risks and benefits, and the need for informed consent. The patient nodded and seemed to understand, but at the end of the discussion he said: ‘That all sounds fine, but I need to speak to the doctor first.’ ”

Dr. Pasricha was taken aback. She wondered: “Who did he think I was the whole time that I was reviewing medical concerns, explaining medical concepts, and describing a procedure in a way that a physician would describe it?”

She realized the reason he didn’t correctly identify her was that, clad only in scrubs, she was less easily recognizable as a physician. And while this type of misidentification happened to physicians of both genders wearing scrubs and no white coat, it was more common for female than for male physicians to be misidentified as technicians, nurses, physician assistants, or other health care professionals, according to Dr. Pasricha.

Dr. Pasricha said she has been the recipient of this “implicit bias” not only from patients but also from members of the health care team, and added that other female colleagues have told her that they’ve had similar experiences, especially when they’re not wearing a white coat.
 

Changing times, changing trends

When COVID-19 began to spread, “there was an initial concern that COVID-19 was passed through surfaces, and concerns about whether white coats could carry viral particles,” according to Jordan Steinberg, MD, PhD, surgical director of the craniofacial program at Nicklaus Children’s Pediatric Specialists/Nicklaus Children’s Health System, Miami. “Hospitals didn’t want to launder the white coats as frequently as scrubs, due to cost concerns. There was also a concern raised that a necktie might dangle in patients’ faces, coming in closer contact with pathogens, so more physicians were wearing scrubs.”

Yet even before the pandemic, physician attire in hospital and outpatient settings had started to change. Dr. Steinberg, who is also a clinical associate professor at Florida International University, Miami, told this news organization that, in his previous appointment at Johns Hopkins University, Baltimore, he and his colleagues “had noticed in our institution, as well as other facilities, an increasing trend that moved from white coats worn over professional attire toward more casual dress among medical staff – increased wearing of casual fleece or softshell jackets with the institutional logo.”

This was especially true with trainees and the “younger generation,” who were preferring “what I would almost call ‘warm-up clothes,’ gym clothes, and less shirt-tie-white-coat attire for men or white-coats-and-business attire for women.” Dr. Steinberg thinks that some physicians prefer the fleece with the institutional logo “because it’s like wearing your favorite sports team jersey. It gives a sense of belonging.”

Todd Shaffer, MD, MBA, a family physician at University Physicians Associates, Truman Medical Centers and the Lakewood Medical Pavilion, Kansas City, Mo., has been at his institution for 30 years and has seen a similar trend. “At one point, things were very formal,” he told this news organization. But attire was already becoming less formal before the pandemic, and new changes took place during the pandemic, as physicians began wearing scrubs instead of white coats because of fears of viral contamination.

Now, there is less concern about potential viral contamination with the white coat. Yet many physicians continue to wear scrubs – especially those who interact with patients with COVID – and it has become more acceptable to do so, or to wear personal protective equipment (PPE) over ordinary clothing, but it is less common in routine clinical practice, said Dr. Shaffer, a member of the board of directors of the American Academy of Family Physicians.

“The world has changed since COVID. People feel more comfortable dressing more casually during professional Zoom calls, when they have the convenience of working from home,” said Dr. Shaffer, who is also a professor of family medicine at University of Missouri–Kansas City.

Dr. Shaffer himself hasn’t worn a white coat for years. “I’m more likely to wear medium casual pants. I’ve bought some nicer shirts, so I still look professional and upbeat. I don’t always tuck in my shirt, and I don’t dress as formally.” He wears PPE and a mask and/or face shield when treating patients with COVID-19. And he wears a white coat “when someone wants a photograph taken with the doctors – with the stethoscope draped around my neck.”
 

Traditional symbol of medicine

Because of the changing mores, Dr. Steinberg and colleagues at Johns Hopkins wondered if there might still be a role for professional attire and white coats and what patients prefer. To investigate the question, they surveyed 487 U.S. adults in the spring of 2020.

Respondents were asked where and how frequently they see health care professionals wearing white coats, scrubs, and fleece or softshell jackets. They were also shown photographs depicting models wearing various types of attire commonly seen in health care settings and were asked to rank the “health care provider’s” level of experience, professionalism, and friendliness.

The majority of participants said they had seen health care practitioners in white coats “most of the time,” in scrubs “sometimes,” and in fleece or softshell jackets “rarely.” Models in white coats were regarded by respondents as more experienced and professional, although those in softshell jackets were perceived as friendlier.

There were age as well as regional differences in the responses, Dr. Steinberg said. Older respondents were significantly more likely than their younger counterparts to perceive a model wearing a white coat over business attire as being more experienced, and – in all regions of the United States except the West coast – respondents gave lower professionalism scores to providers wearing fleece jackets with scrubs underneath.

Respondents tended to prefer surgeons wearing a white coat with scrubs underneath, while a white coat over business attire was the preferred dress code for family physicians and dermatologists.

“People tended to respond as if there was a more professional element in the white coat. The age-old symbol of the white coat still marked something important,” Dr. Steinberg said. “Our data suggest that the white coat isn’t ready to die just yet. People still see an air of authority and a traditional symbol of medicine. Nevertheless, I do think it will become less common than it used to be, especially in certain regions of the country.”
 

Organic, subtle changes

Christopher Petrilli, MD, assistant professor at New York University, conducted research in 2018 regarding physician attire by surveying over 4,000 patients in 10 U.S. academic hospitals. His team found that most patients continued to prefer physicians to wear formal attire under a white coat, especially older respondents.

Dr. Petrilli and colleagues have been studying the issue of physician attire since 2015. “The big issue when we did our initial study – which might not be accurate anymore – is that few hospitals actually had a uniform dress code,” said Dr. Petrilli, the medical director of clinical documentation improvement and the clinical lead of value-based medicine at NYU Langone Hospitals. “When we looked at ‘honor roll hospitals’ during our study, we cold-called these hospitals and also looked online for their dress code policies. Except for the Mayo Clinic, hospitals that had dress code policies were more generic.”

For example, the American Medical Association guidance merely states that attire should be “clean, unsoiled, and appropriate to the setting of care” and recommends weighing research findings regarding textile transmission of health care–associated infections when individual institutions determine their dress code policies. The AMA’s last policy discussion took place in 2015 and its guidance has not changed since the pandemic.

Regardless of what institutions and patients prefer, some research suggests that many physicians would prefer to stay with wearing scrubs rather than reverting to the white coat. One study of 151 hospitalists, conducted in Ireland, found that three-quarters wanted scrubs to remain standard attire, despite the fact that close to half had experienced changes in patients› perception in the absence of their white coat and “professional attire.”

Jennifer Workman, MD, assistant professor of pediatrics, division of pediatric critical care, University of Utah, Salt Lake City, said in an interview that, as the pandemic has “waxed and waned, some trends have reverted to what they were prepandemic, but other physicians have stayed with wearing scrubs.”

Much depends on practice setting, said Dr. Workman, who is also the medical director of pediatric sepsis at Intermountain Care. In pediatrics, for example, many physicians prefer not to wear white coats when they are interacting with young children or adolescents.

Like Dr. Shaffer, Dr. Workman has seen changes in physicians’ attire during video meetings, where they often dress more casually, perhaps wearing sweatshirts. And in the hospital, more are continuing to wear scrubs. “But I don’t see it as people trying to consciously experiment or push boundaries,” she said. “I see it as a more organic, subtle shift.”

Dr. Petrilli thinks that, at this juncture, it’s “pretty heterogeneous as to who is going to return to formal attire and a white coat and who won’t.” Further research needs to be done into currently evolving trends. “We need a more thorough survey looking at changes. We need to ask [physician respondents]: ‘What is your current attire, and how has it changed?’ ”
 

Navigating the gender divide

In their study, Dr. Steinberg and colleagues found that respondents perceived a male model wearing business attire underneath any type of outerwear (white coat or fleece) to be significantly more professional than a female model wearing the same attire. Respondents also perceived males wearing scrubs to be more professional than females wearing scrubs.

Male models in white coats over business attire were also more likely to be identified as physicians, compared with female models in the same attire. Females were also more likely to be misidentified as nonphysician health care professionals.

Shikha Jain, MD, assistant professor of medicine at the University of Illinois Cancer Center in Chicago, said that Dr. Steinberg’s study confirmed experiences that she and other female physicians have had. Wearing a white coat makes it more likely that a patient will identify you as a physician, but women are less likely to be identified as physicians, regardless of what they wear.

“I think that individuals of color and especially people with intersectional identities – such as women of color – are even more frequently targeted and stereotyped. Numerous studies have shown that a person of color is less likely to be seen as an authority figure, and studies have shown that physicians of color are less likely to be identified as ‘physicians,’ compared to a Caucasian individual,” she said.

Does that mean that female physicians should revert back to prepandemic white coats rather than scrubs or more casual attire? Not necessarily, according to Dr. Jain.

“The typical dress code guidance is that physicians should dress ‘professionally,’ but what that means is a question that needs to be addressed,” Dr. Jain said. “Medicine has evolved from the days of house calls, in which one’s patient population is a very small, intimate group of people in the physician’s community. Yet now, we’ve given rebirth to the ‘house call’ when we do telemedicine with a patient in his or her home. And in the old days, doctors often had offices their homes and now, with telemedicine, patients often see the interior of their physician’s home.” As the delivery of medicine evolves, concepts of “professionalism” – what is defined as “casual” and what is defined as “formal” – is also evolving.

The more important issue, according to Dr. Jain, is to “continue the conversation” about the discrepancies between how men and women are treated in medicine. Attire is one arena in which this issue plays out, and it’s a “bigger picture” that goes beyond the white coat.

Dr. Jain has been “told by patients that a particular outfit doesn’t make me look like a doctor or that scrubs make me look younger. I don’t think my male colleagues have been subjected to these types of remarks, but my female colleagues have heard them as well.”

Even fellow health care providers have commented on Dr. Jain’s clothing. She was presenting at a major medical conference via video and was wearing a similar outfit to the one she wore for her headshot. “Thirty seconds before beginning my talk, one of the male physicians said: ‘Are you wearing the same outfit you wore for your headshot?’ I can’t imagine a man commenting that another man was wearing the same jacket or tie that he wore in the photograph. I found it odd that this was something that someone felt the need to comment on right before I was about to address a large group of people in a professional capacity.”

Addressing these systemic issues “needs to be done and amplified not only by women but also by men in medicine,” said Dr. Jain, founder and director of  Women in Medicine, an organization consisting of women physicians whose goal is to “find and implement solutions to gender inequity.”

Dr. Jain said the organization offers an Inclusive Leadership Development Lab – a course specifically for men in health care leadership positions to learn how to be more equitable, inclusive leaders.
 

A personal decision

Dr. Pasricha hopes she “handled the patient’s misidentification graciously.” She explained to him that she would be the physician conducting the procedure. The patient was initially “a little embarrassed” that he had misidentified her, but she put him at ease and “we moved forward quickly.”

At this point, although some of her colleagues have continued to wear scrubs or have returned to wearing fleeces with hospital logos, Dr. Pasricha prefers to wear a white coat in both inpatient and outpatient settings because it reduces the likelihood of misidentification.

And white coats can be more convenient – for example, Dr. Jain likes the fact that the white coat has pockets where she can put her stethoscope and other items, while some of her professional clothes don’t always have pockets.

Dr. Jain noted that there are some institutions where everyone seems to wear white coats, not only the physician – “from the chaplain to the phlebotomist to the social worker.” In those settings, the white coat no longer distinguishes physicians from nonphysicians, and so wearing a white coat may not confer additional credibility as a physician.

Nevertheless, “if you want to wear a white coat, if you feel it gives you that added level of authority, if you feel it tells people more clearly that you’re a physician, by all means go ahead and do so,” she said. “There’s no ‘one-size-fits-all’ strategy or solution. What’s more important than your clothing is your professionalism.”

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

A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.

The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.

It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.

CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.

“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.

“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.

Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
 

Morally wrong

Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.

“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.

Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.

The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.

Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.

Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.

CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.

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

A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.

The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.

It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.

CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.

“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.

“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.

Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
 

Morally wrong

Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.

“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.

Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.

The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.

Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.

Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.

CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.

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

A complaint filed with the U.S. Department of Justice (DOJ) alleges that Alabama’s Medicaid program is illegally denying curative drug treatment for hepatitis C virus (HCV) infection to people with substance use disorder.

The complaint was filed May 9 by the Center for Health Law and Policy Innovation (CHLPI) of Harvard Law School, in partnership with AIDS Alabama.

It alleges that Alabama Medicaid has a policy of denying HCV treatment to people who have used illegal drugs or alcohol in the past 6 months.

CHLPI and AIDS Alabama argue that these restrictions violate the Americans With Disabilities Act, which protects people who are disabled because of substance use disorder.

“Forced sobriety policies don’t just unfairly prevent people with substance use disorder from accessing life-saving treatment; they also severely hamper public health efforts to stop the spread of the disease,” Kevin Costello, CHLPI’s litigation director, said in a statement.

“These policies are rooted in stigma, not science, and they violate antidiscrimination provisions of the Americans With Disabilities Act,” Mr. Costello said.

Filing an administrative complaint against Alabama is “an important milestone in fighting sobriety restrictions,” he added.
 

Morally wrong

Kathie Hiers, CEO of AIDS Alabama, noted that Alabama’s health outcomes are among the worst in the nation.

“Policies that prevent adequate medical care from being provided must end. HCV now has a cure, and withholding that cure from Alabamians based on a moral judgment is wrong and certainly doesn’t follow the science,” Ms. Hiers added.

Direct-acting antiviral (DAA) therapy can cure up to 99% of people living with HCV.

The complaint against Alabama Medicaid builds on CHLPI’s successful policy advocacy and litigation campaigns to expand access to DAA therapy in state Medicaid programs across the country.

Since 2017, 19 states have removed treatment restrictions that were based on drug or alcohol use. In other states, however, “severe, illegal sobriety restrictions remain,” according to CHLPI.

Alabama, Mississippi, Arkansas, South Carolina, and South Dakota still require Medicaid enrollees with HCV to prove they have not used drugs or alcohol for 6 months before they can receive treatment. Iowa, North Dakota, and West Virginia have a 3-month abstinence requirement.

The American Association for the Study of Liver Diseases and the Infectious Diseases Society of America recommend DAA therapy for all patients with chronic HCV infection, regardless of drug or alcohol use.

CHLPI intends to expand this “enforcement campaign” to all states where sobriety restrictions persist.

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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

A Pennsylvania-based internist was sentenced to 20 years in prison by a federal judge on May 10 for running a prescription “pill mill” from his medical practice.

Since May 2005, Andrew Berkowitz, MD, 62, of Huntington Valley, Pa., was president and CEO of A+ Pain Management, a clinic in the Philadelphia area, according to his LinkedIn profile.

Prosecutors said patients, no matter their complaint, would leave Dr. Berkowitz’s offices with “goodie bags” filled with a selection of drugs. A typical haul included topical analgesics, such as Relyyt and/or lidocaine; muscle relaxants, including chlorzoxazone and/or cyclobenzaprine; anti-inflammatories, such as celecoxib and/or fenoprofen; and schedule IV substances, including tramadol, eszopiclone, and quazepam.

The practice was registered in Pennsylvania as a nonpharmacy dispensing site, allowing Dr. Berkowitz to bill insurers for the drugs, according to The Pennsylvania Record, a journal covering Pennsylvania’s legal system. Dr. Berkowitz also prescribed oxycodone for “pill seeking” patients, who gave him their tacit approval of submitting claims to their insurance providers, which included Medicare, Aetna, and others, for the items in the goodie bag.

In addition, Dr. Berkowitz fraudulently billed insurers for medically unnecessary physical therapy, acupuncture, and chiropractic adjustments, as well as for treatments that were never provided, according to federal officials.

According to the Department of Justice, Dr. Berkowitz collected more than $4,000 per bag from insurers. From 2015 to 2018, prosecutors estimate that Dr. Berkowitz took in more than $4 million in fraudulent proceeds from his scheme.

The pill mill came to the attention of federal authorities after Blue Cross investigators forwarded to the FBI several complaints it had received about Dr. Berkowitz. In 2017, the FBI sent a cooperating witness to Dr. Berkowitz’s clinic. The undercover patient received a prescription for oxycodone, Motrin, and Flexeril and paid $185, according to The Record.

After being indicted in 2019, Dr. Berkowitz pleaded guilty in January 2020 to 19 counts of health care fraud and to 23 counts of distributing oxycodone outside the course of professional practice and without a legitimate medical purpose.

On May 10, he was sentenced to 20 years in prison, followed by 5 years of supervised release. In addition, he was ordered to pay a $40,000 fine and almost $4 million in restitution. As a result of civil False Claims Act liability for false claims submitted to Medicare, he is also obligated to pay approximately $1.8 million and is subject to a permanent prohibition on prescribing, distributing, or dispensing controlled substances.

Dr. Berkowitz’s actions were deemed especially egregious in light of the opioid epidemic.

“Doctors are supposed to treat illness, not feed it,” said Jacqueline Maguire, special agent in charge of the FBI’s Philadelphia division. “Andrew Berkowitz prescribed patients unnecessary pills and handed out opioids to addicts.” Jennifer Arbittier Williams, acting U.S. Attorney, added upon announcing the sentence, “Doctors who dare engage in health care fraud and drug diversion, two drivers of the opioid epidemic ravaging our communities, should heed this sentence as a warning that they will be held responsible, criminally and financially.”

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