Cardiology News

A cardiologist and alleged hacker and ransomware developer has been named in a criminal complaint filed in federal court in New York.

According to a statement from the U.S. Department of Justice, 55-year-old Moises Luis Zagala Gonzalez, MD, is charged with creating and distributing ransomware with a “doomsday” clock and sharing in profits from ransomware attacks.

Dr. Zagala, also known as “Nosophoros,” “Aesculapius,” and “Nebuchadnezzar,” is a citizen of France and Venezuela who currently lives in Ciudad Bolivar, Venezuela.

Breon Peace, U.S. attorney for the Eastern District of New York, and Michael J. Driscoll, assistant director in charge of the Federal Bureau of Investigaton’s New York Field Office, announced the charges.

“As alleged, the multitasking doctor treated patients, created and named his cyber tool after death, profited from a global ransomware ecosystem in which he sold the tools for conducting ransomware attacks, trained the attackers about how to extort victims, and then boasted about successful attacks, including by malicious actors associated with the government of Iran,” Mr. Peace said in the news release from the DOJ.

“We allege Zagala not only created and sold ransomware products to hackers, but also trained them in their use. Our actions today will prevent Zagala from further victimizing users,” Mr. Driscoll said. “However, many other malicious criminals are searching for businesses and organizations that haven’t taken steps to protect their systems – which is an incredibly vital step in stopping the next ransomware attack.”

Ransomware tools are malicious software that cybercriminals use to extort money from companies, nonprofits, and other institutions by encrypting their files and then demanding a ransom for the decryption keys.

One of Dr. Zagala’s early ransomware tools, called “Jigsaw v. 2,” had what Dr. Zagala described as a doomsday counter that kept track of how many times the user tried to remove the ransomware. “If the user kills the ransomware too many times, then it’s clear he won’t pay so better erase the whole hard drive,” Dr. Zagala wrote.

According to the DOJ, beginning in late 2019, Dr. Zagala began advertising a new tool as a “private ransomware builder,” which he called Thanos. The name appears to be in reference to a fictional villain responsible for destroying half of all life in the universe and to “Thanatos” from Greek mythology, who is associated with death.

Dr. Zagala’s Thanos software allows users to create their own unique ransomware software for personal use or to rent to other cybercriminals.

Dr. Zagala allegedly not only sold or rented out his ransomware tools to cybercriminals, but he also taught users how to deploy the tools, steal passwords from victim computers, and set up a Bitcoin address for ransom payments.

Dr. Zagala’s customers were happy with his products, the DOJ release noted. In a message posted in July 2020, one user said the ransomware was “very powerful” and claimed that he had used it to infect a network of roughly 3,000 computers.

In December 2020, another user wrote a post in Russian: “We have been working with this product for over a month now, we have a good profit! Best support I’ve met.”

Earlier in May, law enforcement agents interviewed a relative of Dr. Zagala who lives in Florida and whose PayPal account was used by Dr. Zagala to receive illicit proceeds.

According to the DOJ, the relative confirmed that Dr. Zagala lives in Venezuela and had taught himself computer programming. The relative also showed agents contact information for Dr. Zagala that matched the registered email for malicious infrastructure associated with the Thanos ransomware.

Dr. Zagala, who remains in Venezuela, faces up to 10 years in prison for attempted computer intrusions and conspiracy charges if brought to justice in the United States.

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

A cardiologist and alleged hacker and ransomware developer has been named in a criminal complaint filed in federal court in New York.

According to a statement from the U.S. Department of Justice, 55-year-old Moises Luis Zagala Gonzalez, MD, is charged with creating and distributing ransomware with a “doomsday” clock and sharing in profits from ransomware attacks.

Dr. Zagala, also known as “Nosophoros,” “Aesculapius,” and “Nebuchadnezzar,” is a citizen of France and Venezuela who currently lives in Ciudad Bolivar, Venezuela.

Breon Peace, U.S. attorney for the Eastern District of New York, and Michael J. Driscoll, assistant director in charge of the Federal Bureau of Investigaton’s New York Field Office, announced the charges.

“As alleged, the multitasking doctor treated patients, created and named his cyber tool after death, profited from a global ransomware ecosystem in which he sold the tools for conducting ransomware attacks, trained the attackers about how to extort victims, and then boasted about successful attacks, including by malicious actors associated with the government of Iran,” Mr. Peace said in the news release from the DOJ.

“We allege Zagala not only created and sold ransomware products to hackers, but also trained them in their use. Our actions today will prevent Zagala from further victimizing users,” Mr. Driscoll said. “However, many other malicious criminals are searching for businesses and organizations that haven’t taken steps to protect their systems – which is an incredibly vital step in stopping the next ransomware attack.”

Ransomware tools are malicious software that cybercriminals use to extort money from companies, nonprofits, and other institutions by encrypting their files and then demanding a ransom for the decryption keys.

One of Dr. Zagala’s early ransomware tools, called “Jigsaw v. 2,” had what Dr. Zagala described as a doomsday counter that kept track of how many times the user tried to remove the ransomware. “If the user kills the ransomware too many times, then it’s clear he won’t pay so better erase the whole hard drive,” Dr. Zagala wrote.

According to the DOJ, beginning in late 2019, Dr. Zagala began advertising a new tool as a “private ransomware builder,” which he called Thanos. The name appears to be in reference to a fictional villain responsible for destroying half of all life in the universe and to “Thanatos” from Greek mythology, who is associated with death.

Dr. Zagala’s Thanos software allows users to create their own unique ransomware software for personal use or to rent to other cybercriminals.

Dr. Zagala allegedly not only sold or rented out his ransomware tools to cybercriminals, but he also taught users how to deploy the tools, steal passwords from victim computers, and set up a Bitcoin address for ransom payments.

Dr. Zagala’s customers were happy with his products, the DOJ release noted. In a message posted in July 2020, one user said the ransomware was “very powerful” and claimed that he had used it to infect a network of roughly 3,000 computers.

In December 2020, another user wrote a post in Russian: “We have been working with this product for over a month now, we have a good profit! Best support I’ve met.”

Earlier in May, law enforcement agents interviewed a relative of Dr. Zagala who lives in Florida and whose PayPal account was used by Dr. Zagala to receive illicit proceeds.

According to the DOJ, the relative confirmed that Dr. Zagala lives in Venezuela and had taught himself computer programming. The relative also showed agents contact information for Dr. Zagala that matched the registered email for malicious infrastructure associated with the Thanos ransomware.

Dr. Zagala, who remains in Venezuela, faces up to 10 years in prison for attempted computer intrusions and conspiracy charges if brought to justice in the United States.

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

A cardiologist and alleged hacker and ransomware developer has been named in a criminal complaint filed in federal court in New York.

According to a statement from the U.S. Department of Justice, 55-year-old Moises Luis Zagala Gonzalez, MD, is charged with creating and distributing ransomware with a “doomsday” clock and sharing in profits from ransomware attacks.

Dr. Zagala, also known as “Nosophoros,” “Aesculapius,” and “Nebuchadnezzar,” is a citizen of France and Venezuela who currently lives in Ciudad Bolivar, Venezuela.

Breon Peace, U.S. attorney for the Eastern District of New York, and Michael J. Driscoll, assistant director in charge of the Federal Bureau of Investigaton’s New York Field Office, announced the charges.

“As alleged, the multitasking doctor treated patients, created and named his cyber tool after death, profited from a global ransomware ecosystem in which he sold the tools for conducting ransomware attacks, trained the attackers about how to extort victims, and then boasted about successful attacks, including by malicious actors associated with the government of Iran,” Mr. Peace said in the news release from the DOJ.

“We allege Zagala not only created and sold ransomware products to hackers, but also trained them in their use. Our actions today will prevent Zagala from further victimizing users,” Mr. Driscoll said. “However, many other malicious criminals are searching for businesses and organizations that haven’t taken steps to protect their systems – which is an incredibly vital step in stopping the next ransomware attack.”

Ransomware tools are malicious software that cybercriminals use to extort money from companies, nonprofits, and other institutions by encrypting their files and then demanding a ransom for the decryption keys.

One of Dr. Zagala’s early ransomware tools, called “Jigsaw v. 2,” had what Dr. Zagala described as a doomsday counter that kept track of how many times the user tried to remove the ransomware. “If the user kills the ransomware too many times, then it’s clear he won’t pay so better erase the whole hard drive,” Dr. Zagala wrote.

According to the DOJ, beginning in late 2019, Dr. Zagala began advertising a new tool as a “private ransomware builder,” which he called Thanos. The name appears to be in reference to a fictional villain responsible for destroying half of all life in the universe and to “Thanatos” from Greek mythology, who is associated with death.

Dr. Zagala’s Thanos software allows users to create their own unique ransomware software for personal use or to rent to other cybercriminals.

Dr. Zagala allegedly not only sold or rented out his ransomware tools to cybercriminals, but he also taught users how to deploy the tools, steal passwords from victim computers, and set up a Bitcoin address for ransom payments.

Dr. Zagala’s customers were happy with his products, the DOJ release noted. In a message posted in July 2020, one user said the ransomware was “very powerful” and claimed that he had used it to infect a network of roughly 3,000 computers.

In December 2020, another user wrote a post in Russian: “We have been working with this product for over a month now, we have a good profit! Best support I’ve met.”

Earlier in May, law enforcement agents interviewed a relative of Dr. Zagala who lives in Florida and whose PayPal account was used by Dr. Zagala to receive illicit proceeds.

According to the DOJ, the relative confirmed that Dr. Zagala lives in Venezuela and had taught himself computer programming. The relative also showed agents contact information for Dr. Zagala that matched the registered email for malicious infrastructure associated with the Thanos ransomware.

Dr. Zagala, who remains in Venezuela, faces up to 10 years in prison for attempted computer intrusions and conspiracy charges if brought to justice in the United States.

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.
 

“Here and now is what counts. So, let’s go to work!” –Walter Orthmann, 100 years old
 

How long before you retire? If you know the answer in exact years, months, and days, you aren’t alone. For many good reasons, we doctors are more likely to be counting down the years until we retire rather than counting up the years since we started working. For me, if I’m to break the Guinness World Record, I have 69 more years, 3 months and 6 days left to go. That would surpass the current achievement for the longest career at one company, Mr. Walter Orthmann, who has been sitting at the same desk for 84 years. At 100 years old, Mr. Orthmann still shows up every Monday morning, as bright eyed and bushy tailed as a young squirrel. I’ll be 119 when I break his streak, which would also put me past Anthony Mancinelli, a New York barber who at 107 years of age was still brushing off his chair for the next customer. Unbelievable, I know! I wonder, what’s the one weird trick these guys are doing that keeps them going?

Guinness World Records

Of course, the job itself matters. Some jobs, like being a police officer, aren’t suitable for old people. Or are they? Officer L.C. “Buckshot” Smith was still keeping streets safe from his patrol car at 91 years old. After a bit of searching, I found pretty much any job you can think of has a very long-lasting Energizer Bunny story: A female surgeon who was operating at 90 years old, a 100-year-old rheumatologist who was still teaching at University of California, San Francisco, and a 105-year-old Japanese physician who was still seeing patients. There are plenty of geriatric lawyers, nurses, land surveyors, accountants, judges, you name it. So it seems it’s not the work, but the worker that matters. Why do some older workers recharge daily and carry on while many younger ones say the daily grind is burning them out? What makes the Greatest Generation so great?

We all know colleagues who hung up their white coats early. In my medical group, it’s often financially feasible to retire at 58 and many have chosen that option. Yet, we have loads of Partner Emeritus docs in their 70’s who still log on to EPIC and pitch in everyday.

“So, how do you keep going?” I asked my 105-year-old patient who still walks and manages his affairs. “Just stay healthy,” he advised. A circular argument, yet he’s right. You must both be lucky and also choose to be active mentally and physically. Mr. Mancinelli, who was barbering full time at 107 years old, had no aches and pains and all his teeth. He pruned his own bushes. The data are crystal clear that physical activity adds not only years of life, but also improves cognitive capabilities during those years.

As for beating burnout, it seems the one trick that these ultraworkers do is to focus only on the present. Mr. Orthmann’s pithy advice as quoted by NPR is, “You need to get busy with the present, not the past or the future.” These centenarian employees also frame their work not as stressful but rather as their daily series of problems to be solved.

When I asked my super-geriatric patient how he sleeps so well, he said, “I never worry when I get into bed, I just shut my eyes and sleep. I’ll think about tomorrow when I wake up.” Now if I can do that about 25,000 more times, I’ll have the record.

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

“Here and now is what counts. So, let’s go to work!” –Walter Orthmann, 100 years old
 

How long before you retire? If you know the answer in exact years, months, and days, you aren’t alone. For many good reasons, we doctors are more likely to be counting down the years until we retire rather than counting up the years since we started working. For me, if I’m to break the Guinness World Record, I have 69 more years, 3 months and 6 days left to go. That would surpass the current achievement for the longest career at one company, Mr. Walter Orthmann, who has been sitting at the same desk for 84 years. At 100 years old, Mr. Orthmann still shows up every Monday morning, as bright eyed and bushy tailed as a young squirrel. I’ll be 119 when I break his streak, which would also put me past Anthony Mancinelli, a New York barber who at 107 years of age was still brushing off his chair for the next customer. Unbelievable, I know! I wonder, what’s the one weird trick these guys are doing that keeps them going?

Guinness World Records

Of course, the job itself matters. Some jobs, like being a police officer, aren’t suitable for old people. Or are they? Officer L.C. “Buckshot” Smith was still keeping streets safe from his patrol car at 91 years old. After a bit of searching, I found pretty much any job you can think of has a very long-lasting Energizer Bunny story: A female surgeon who was operating at 90 years old, a 100-year-old rheumatologist who was still teaching at University of California, San Francisco, and a 105-year-old Japanese physician who was still seeing patients. There are plenty of geriatric lawyers, nurses, land surveyors, accountants, judges, you name it. So it seems it’s not the work, but the worker that matters. Why do some older workers recharge daily and carry on while many younger ones say the daily grind is burning them out? What makes the Greatest Generation so great?

We all know colleagues who hung up their white coats early. In my medical group, it’s often financially feasible to retire at 58 and many have chosen that option. Yet, we have loads of Partner Emeritus docs in their 70’s who still log on to EPIC and pitch in everyday.

“So, how do you keep going?” I asked my 105-year-old patient who still walks and manages his affairs. “Just stay healthy,” he advised. A circular argument, yet he’s right. You must both be lucky and also choose to be active mentally and physically. Mr. Mancinelli, who was barbering full time at 107 years old, had no aches and pains and all his teeth. He pruned his own bushes. The data are crystal clear that physical activity adds not only years of life, but also improves cognitive capabilities during those years.

As for beating burnout, it seems the one trick that these ultraworkers do is to focus only on the present. Mr. Orthmann’s pithy advice as quoted by NPR is, “You need to get busy with the present, not the past or the future.” These centenarian employees also frame their work not as stressful but rather as their daily series of problems to be solved.

When I asked my super-geriatric patient how he sleeps so well, he said, “I never worry when I get into bed, I just shut my eyes and sleep. I’ll think about tomorrow when I wake up.” Now if I can do that about 25,000 more times, I’ll have the record.

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

“Here and now is what counts. So, let’s go to work!” –Walter Orthmann, 100 years old
 

How long before you retire? If you know the answer in exact years, months, and days, you aren’t alone. For many good reasons, we doctors are more likely to be counting down the years until we retire rather than counting up the years since we started working. For me, if I’m to break the Guinness World Record, I have 69 more years, 3 months and 6 days left to go. That would surpass the current achievement for the longest career at one company, Mr. Walter Orthmann, who has been sitting at the same desk for 84 years. At 100 years old, Mr. Orthmann still shows up every Monday morning, as bright eyed and bushy tailed as a young squirrel. I’ll be 119 when I break his streak, which would also put me past Anthony Mancinelli, a New York barber who at 107 years of age was still brushing off his chair for the next customer. Unbelievable, I know! I wonder, what’s the one weird trick these guys are doing that keeps them going?

Guinness World Records

Of course, the job itself matters. Some jobs, like being a police officer, aren’t suitable for old people. Or are they? Officer L.C. “Buckshot” Smith was still keeping streets safe from his patrol car at 91 years old. After a bit of searching, I found pretty much any job you can think of has a very long-lasting Energizer Bunny story: A female surgeon who was operating at 90 years old, a 100-year-old rheumatologist who was still teaching at University of California, San Francisco, and a 105-year-old Japanese physician who was still seeing patients. There are plenty of geriatric lawyers, nurses, land surveyors, accountants, judges, you name it. So it seems it’s not the work, but the worker that matters. Why do some older workers recharge daily and carry on while many younger ones say the daily grind is burning them out? What makes the Greatest Generation so great?

We all know colleagues who hung up their white coats early. In my medical group, it’s often financially feasible to retire at 58 and many have chosen that option. Yet, we have loads of Partner Emeritus docs in their 70’s who still log on to EPIC and pitch in everyday.

“So, how do you keep going?” I asked my 105-year-old patient who still walks and manages his affairs. “Just stay healthy,” he advised. A circular argument, yet he’s right. You must both be lucky and also choose to be active mentally and physically. Mr. Mancinelli, who was barbering full time at 107 years old, had no aches and pains and all his teeth. He pruned his own bushes. The data are crystal clear that physical activity adds not only years of life, but also improves cognitive capabilities during those years.

As for beating burnout, it seems the one trick that these ultraworkers do is to focus only on the present. Mr. Orthmann’s pithy advice as quoted by NPR is, “You need to get busy with the present, not the past or the future.” These centenarian employees also frame their work not as stressful but rather as their daily series of problems to be solved.

When I asked my super-geriatric patient how he sleeps so well, he said, “I never worry when I get into bed, I just shut my eyes and sleep. I’ll think about tomorrow when I wake up.” Now if I can do that about 25,000 more times, I’ll have the record.

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

Advanced maternal age and maternal hypertension are a one-two punch that boosts the risk of cesarean births, a new study reports.

While the findings presented at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists aren’t surprising, the insight they provide can be helpful in counseling women at risk about delivery options, lead author and Loma Linda (Calif.) University maternal-fetal medicine physician Sarah D. Smithson, DO, said in an interview.

The prospect of a cesarean birth “can be introduced early and often, which can be important in managing expectations,” she said, especially since women can feel depression and a sense of failure if it turns out they can’t give birth vaginally as they anticipated.

As Dr. Smithson noted, there’s a continuum of maternal hypertension conditions from less severe to more severe. The physicians need to hurry delivery along in the most severe cases. “The clock is clicking when you have preeclampsia, and you do not have time for an induction that could take 2-3 days if you’re having a hard time controlling blood pressure. You may consider cesarean to expedite delivery,” she said.

For the new study, Dr. Smithson and colleagues sought to understand how a combination of maternal hypertension and advanced maternal age affected cesarean delivery rates. They retrospectively tracked 1,625 women with maternal hypertension (chronic hypertension, gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features) who were treated in the Oregon Health & Science University system from 2013 to 2018.

Of the women, 450 were older than 35, and they were more likely than younger women to have cesarean deliveries (46% vs. 34%; P < .001; adjusted OR, 1.7; 95% CI, 1.0-2.7; P = .03).

“We aim to get our cesarean section rates below 20%,” Dr. Smithson said. “These are high rates, and the fact that they’re significantly higher in the advanced maternal age group is compelling.”

The cesarean rates were higher at a statistically significant rate in patients with gestational hypertension (37% in older women vs. 26% in younger women; P = .021) and in those with preeclampsia with severe features (57% vs. 44%, respectively; P = .02). However, the differences were not statistically significant in the groups with chronic hypertension and preeclampsia without severe features.

In an interview, maternal-fetal medicine specialist Alex C. Vidaeff, MD, MPH, of Baylor College of Medicine, Houston, questioned the usefulness of the subgroup analysis, which he thinks may be statistically misleading. “How would one otherwise explain that the rate difference between advanced maternal-age and non–advanced maternal-age subjects is statistically significant for gestational hypertension but not for preeclampsia without severe features?”

He added: “With the very limited information provided by this study, important questions remained unanswered. What is causing the increased rate of cesarean delivery? Provider’s bias or preferences? It would have been useful to know if the cesarean deliveries were elective, without labor, or cesarean deliveries performed during labor or even emergency cesarean deliveries.”

No study funding or disclosures are reported.

Advanced maternal age and maternal hypertension are a one-two punch that boosts the risk of cesarean births, a new study reports.

While the findings presented at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists aren’t surprising, the insight they provide can be helpful in counseling women at risk about delivery options, lead author and Loma Linda (Calif.) University maternal-fetal medicine physician Sarah D. Smithson, DO, said in an interview.

The prospect of a cesarean birth “can be introduced early and often, which can be important in managing expectations,” she said, especially since women can feel depression and a sense of failure if it turns out they can’t give birth vaginally as they anticipated.

As Dr. Smithson noted, there’s a continuum of maternal hypertension conditions from less severe to more severe. The physicians need to hurry delivery along in the most severe cases. “The clock is clicking when you have preeclampsia, and you do not have time for an induction that could take 2-3 days if you’re having a hard time controlling blood pressure. You may consider cesarean to expedite delivery,” she said.

For the new study, Dr. Smithson and colleagues sought to understand how a combination of maternal hypertension and advanced maternal age affected cesarean delivery rates. They retrospectively tracked 1,625 women with maternal hypertension (chronic hypertension, gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features) who were treated in the Oregon Health & Science University system from 2013 to 2018.

Of the women, 450 were older than 35, and they were more likely than younger women to have cesarean deliveries (46% vs. 34%; P < .001; adjusted OR, 1.7; 95% CI, 1.0-2.7; P = .03).

“We aim to get our cesarean section rates below 20%,” Dr. Smithson said. “These are high rates, and the fact that they’re significantly higher in the advanced maternal age group is compelling.”

The cesarean rates were higher at a statistically significant rate in patients with gestational hypertension (37% in older women vs. 26% in younger women; P = .021) and in those with preeclampsia with severe features (57% vs. 44%, respectively; P = .02). However, the differences were not statistically significant in the groups with chronic hypertension and preeclampsia without severe features.

In an interview, maternal-fetal medicine specialist Alex C. Vidaeff, MD, MPH, of Baylor College of Medicine, Houston, questioned the usefulness of the subgroup analysis, which he thinks may be statistically misleading. “How would one otherwise explain that the rate difference between advanced maternal-age and non–advanced maternal-age subjects is statistically significant for gestational hypertension but not for preeclampsia without severe features?”

He added: “With the very limited information provided by this study, important questions remained unanswered. What is causing the increased rate of cesarean delivery? Provider’s bias or preferences? It would have been useful to know if the cesarean deliveries were elective, without labor, or cesarean deliveries performed during labor or even emergency cesarean deliveries.”

No study funding or disclosures are reported.

Advanced maternal age and maternal hypertension are a one-two punch that boosts the risk of cesarean births, a new study reports.

While the findings presented at the 2022 annual clinical and scientific meeting of the American College of Obstetricians and Gynecologists aren’t surprising, the insight they provide can be helpful in counseling women at risk about delivery options, lead author and Loma Linda (Calif.) University maternal-fetal medicine physician Sarah D. Smithson, DO, said in an interview.

The prospect of a cesarean birth “can be introduced early and often, which can be important in managing expectations,” she said, especially since women can feel depression and a sense of failure if it turns out they can’t give birth vaginally as they anticipated.

As Dr. Smithson noted, there’s a continuum of maternal hypertension conditions from less severe to more severe. The physicians need to hurry delivery along in the most severe cases. “The clock is clicking when you have preeclampsia, and you do not have time for an induction that could take 2-3 days if you’re having a hard time controlling blood pressure. You may consider cesarean to expedite delivery,” she said.

For the new study, Dr. Smithson and colleagues sought to understand how a combination of maternal hypertension and advanced maternal age affected cesarean delivery rates. They retrospectively tracked 1,625 women with maternal hypertension (chronic hypertension, gestational hypertension, preeclampsia without severe features, and preeclampsia with severe features) who were treated in the Oregon Health & Science University system from 2013 to 2018.

Of the women, 450 were older than 35, and they were more likely than younger women to have cesarean deliveries (46% vs. 34%; P < .001; adjusted OR, 1.7; 95% CI, 1.0-2.7; P = .03).

“We aim to get our cesarean section rates below 20%,” Dr. Smithson said. “These are high rates, and the fact that they’re significantly higher in the advanced maternal age group is compelling.”

The cesarean rates were higher at a statistically significant rate in patients with gestational hypertension (37% in older women vs. 26% in younger women; P = .021) and in those with preeclampsia with severe features (57% vs. 44%, respectively; P = .02). However, the differences were not statistically significant in the groups with chronic hypertension and preeclampsia without severe features.

In an interview, maternal-fetal medicine specialist Alex C. Vidaeff, MD, MPH, of Baylor College of Medicine, Houston, questioned the usefulness of the subgroup analysis, which he thinks may be statistically misleading. “How would one otherwise explain that the rate difference between advanced maternal-age and non–advanced maternal-age subjects is statistically significant for gestational hypertension but not for preeclampsia without severe features?”

He added: “With the very limited information provided by this study, important questions remained unanswered. What is causing the increased rate of cesarean delivery? Provider’s bias or preferences? It would have been useful to know if the cesarean deliveries were elective, without labor, or cesarean deliveries performed during labor or even emergency cesarean deliveries.”

No study funding or disclosures are reported.

A new study highlights the importance of avoiding both exogenous hyperthyroidism and exogenous hypothyroidism to decrease cardiovascular risk and death among patients receiving thyroid hormone treatment.

“Our findings suggest that clinicians should make every effort to maintain euthyroidism in patients on thyroid hormone treatment, regardless of underlying cardiovascular risk, particularly in vulnerable populations, such as older adults,” senior author Maria Papaleontiou, MD, said in an interview.

Commenting on the study, David S. Cooper, MD, of Johns Hopkins University School of Medicine, Baltimore, agreed that the findings are significant.

“Both undertreatment and overtreatment were associated with adverse cardiovascular outcomes, meaning that patients’ thyroid function needs to be monitored, and levothyroxine adjusted if need be, on an ongoing basis,” he told this news organization.
 

Getting the balance right: a tricky task

Variations in thyroid hormone levels falling above or below target ranges are common with thyroid hormone therapy, as a wide array of factors can prompt the need to regularly adjust dosing to maintain “index” levels. And while guidelines from the American Thyroid Association (ATA) recommend maintaining serum thyroid stimulating hormone (TSH) levels in the normal ranges during treatment, the task is tricky.

“Despite these [ATA] guidelines, prior studies in adults with hypothyroidism have shown that up to 30% are undertreated and up to 48% are overtreated,” said Dr. Papaleontiou, an assistant professor in the Division of Metabolism, Endocrinology at the University of Michigan, Ann Arbor.

In a previous study, Dr. Papaleontiou and colleagues showed that the intensity of thyroid hormone treatment is a modifiable risk factor for incident atrial fibrillation and stroke, however, less is understood about the association with cardiovascular mortality.

For the new study, published in JAMA Network Open, Josh M. Evron, MD, of the University of North Carolina, Chapel Hill, and colleagues further investigated the issue in a large, retrospective cohort of 705,307 adults in the Veterans Health Administration Corporate Data Warehouse treated with thyroid hormone during 2004-2017 who had a median follow-up of 4 years.

They investigated the roles of TSH as well as free thyroxine (FT4) levels among 701,929 adults in the group with data on TSH and 373,981 patients with FT4 measurements.

The mean age of participants was 67 years and 88.7% were male.

Over the course of the study, 10.8% of patients (75,963) died of cardiovascular causes.

Compared with patients with normal thyroid levels, those with exogenous hyperthyroidism related to thyroid hormone treatment had an increased risk of cardiovascular mortality, specifically including when TSH levels were below 0.1 mIU/L (adjusted hazard ratio, 1.39) and when FT4 levels were above 1.9 ng/dL (AHR, 1.29), independent of factors including age, sex, and traditional cardiovascular risk factors, including hypertension, smoking, and previous cardiovascular disease or arrhythmia.

In addition, the increased risk of cardiovascular mortality was observed with exogenous hypothyroidism, specifically among those with TSH levels above 20 mIU/L (AHR, 2.67) and FT4 levels below 0.7 ng/dL (AHR, 1.56), after multivariate adjustment.

Of note, the risk of cardiovascular mortality was dose-dependent, with the risk increasing progressively with the lower and higher TSH levels, compared with normal levels.

The increased mortality risk in relation to TSH levels was more pronounced among older patients, compared with FT4 associations, the authors note.

“From a clinical perspective, older adults, and particularly the oldest old (aged 85 years), appear to be the most vulnerable, with increased risk of cardiovascular mortality with both exogenous hyperthyroidism and hypothyroidism,” they report.

Among key limitations is that women, who make up the majority of patients with thyroid disease, are under-represented in the predominantly male population of the Veterans Health Administration.

Nevertheless, “because the risk of cardiovascular disease is higher for men than for women, and because more than 70,000 women were included in this cohort, the results of this study are highly clinically relevant,” the authors note.

Addressing over- and under-treatment will avoid harm

The results are also important considering the status of levothyroxine (for hypothyroidism) as consistently ranking among the top three prescription medications in the United States.

And with the common occurrence of exogenous hyperthyroidism or hypothyroidism, the findings have important implications.

“Addressing over- and under-treatment of hypothyroidism promptly will help reduce patient harm, particularly in vulnerable populations such as older adults who are at higher risk for adverse effects,” Dr. Papaleontiou said.

Dr. Cooper further commented that the findings underscore the need to be aware of treatment adjustments and targets that may vary according to patient age.

“In older persons, over 65-70, the target TSH may be higher [for example, 2-4 mIU/L] than in younger persons, and in patients above ages 70 or 80, serum TSH levels may be allowed to rise even further into the 4-6 mIU/L range,” he explained.

“The older the patient, the higher the chance for an adverse cardiovascular outcome if the TSH is subnormal due to iatrogenic thyrotoxicosis,” Dr. Cooper explained.

“In contrast, in younger individuals, an elevated TSH, indicating mild [subclinical] hypothyroidism may be associated with increased cardiovascular risk, especially with serum TSH levels greater than 7 mIU/L.”

The authors have reported no relevant financial relationships.

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

A new study highlights the importance of avoiding both exogenous hyperthyroidism and exogenous hypothyroidism to decrease cardiovascular risk and death among patients receiving thyroid hormone treatment.

“Our findings suggest that clinicians should make every effort to maintain euthyroidism in patients on thyroid hormone treatment, regardless of underlying cardiovascular risk, particularly in vulnerable populations, such as older adults,” senior author Maria Papaleontiou, MD, said in an interview.

Commenting on the study, David S. Cooper, MD, of Johns Hopkins University School of Medicine, Baltimore, agreed that the findings are significant.

“Both undertreatment and overtreatment were associated with adverse cardiovascular outcomes, meaning that patients’ thyroid function needs to be monitored, and levothyroxine adjusted if need be, on an ongoing basis,” he told this news organization.
 

Getting the balance right: a tricky task

Variations in thyroid hormone levels falling above or below target ranges are common with thyroid hormone therapy, as a wide array of factors can prompt the need to regularly adjust dosing to maintain “index” levels. And while guidelines from the American Thyroid Association (ATA) recommend maintaining serum thyroid stimulating hormone (TSH) levels in the normal ranges during treatment, the task is tricky.

“Despite these [ATA] guidelines, prior studies in adults with hypothyroidism have shown that up to 30% are undertreated and up to 48% are overtreated,” said Dr. Papaleontiou, an assistant professor in the Division of Metabolism, Endocrinology at the University of Michigan, Ann Arbor.

In a previous study, Dr. Papaleontiou and colleagues showed that the intensity of thyroid hormone treatment is a modifiable risk factor for incident atrial fibrillation and stroke, however, less is understood about the association with cardiovascular mortality.

For the new study, published in JAMA Network Open, Josh M. Evron, MD, of the University of North Carolina, Chapel Hill, and colleagues further investigated the issue in a large, retrospective cohort of 705,307 adults in the Veterans Health Administration Corporate Data Warehouse treated with thyroid hormone during 2004-2017 who had a median follow-up of 4 years.

They investigated the roles of TSH as well as free thyroxine (FT4) levels among 701,929 adults in the group with data on TSH and 373,981 patients with FT4 measurements.

The mean age of participants was 67 years and 88.7% were male.

Over the course of the study, 10.8% of patients (75,963) died of cardiovascular causes.

Compared with patients with normal thyroid levels, those with exogenous hyperthyroidism related to thyroid hormone treatment had an increased risk of cardiovascular mortality, specifically including when TSH levels were below 0.1 mIU/L (adjusted hazard ratio, 1.39) and when FT4 levels were above 1.9 ng/dL (AHR, 1.29), independent of factors including age, sex, and traditional cardiovascular risk factors, including hypertension, smoking, and previous cardiovascular disease or arrhythmia.

In addition, the increased risk of cardiovascular mortality was observed with exogenous hypothyroidism, specifically among those with TSH levels above 20 mIU/L (AHR, 2.67) and FT4 levels below 0.7 ng/dL (AHR, 1.56), after multivariate adjustment.

Of note, the risk of cardiovascular mortality was dose-dependent, with the risk increasing progressively with the lower and higher TSH levels, compared with normal levels.

The increased mortality risk in relation to TSH levels was more pronounced among older patients, compared with FT4 associations, the authors note.

“From a clinical perspective, older adults, and particularly the oldest old (aged 85 years), appear to be the most vulnerable, with increased risk of cardiovascular mortality with both exogenous hyperthyroidism and hypothyroidism,” they report.

Among key limitations is that women, who make up the majority of patients with thyroid disease, are under-represented in the predominantly male population of the Veterans Health Administration.

Nevertheless, “because the risk of cardiovascular disease is higher for men than for women, and because more than 70,000 women were included in this cohort, the results of this study are highly clinically relevant,” the authors note.

Addressing over- and under-treatment will avoid harm

The results are also important considering the status of levothyroxine (for hypothyroidism) as consistently ranking among the top three prescription medications in the United States.

And with the common occurrence of exogenous hyperthyroidism or hypothyroidism, the findings have important implications.

“Addressing over- and under-treatment of hypothyroidism promptly will help reduce patient harm, particularly in vulnerable populations such as older adults who are at higher risk for adverse effects,” Dr. Papaleontiou said.

Dr. Cooper further commented that the findings underscore the need to be aware of treatment adjustments and targets that may vary according to patient age.

“In older persons, over 65-70, the target TSH may be higher [for example, 2-4 mIU/L] than in younger persons, and in patients above ages 70 or 80, serum TSH levels may be allowed to rise even further into the 4-6 mIU/L range,” he explained.

“The older the patient, the higher the chance for an adverse cardiovascular outcome if the TSH is subnormal due to iatrogenic thyrotoxicosis,” Dr. Cooper explained.

“In contrast, in younger individuals, an elevated TSH, indicating mild [subclinical] hypothyroidism may be associated with increased cardiovascular risk, especially with serum TSH levels greater than 7 mIU/L.”

The authors have reported no relevant financial relationships.

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

A new study highlights the importance of avoiding both exogenous hyperthyroidism and exogenous hypothyroidism to decrease cardiovascular risk and death among patients receiving thyroid hormone treatment.

“Our findings suggest that clinicians should make every effort to maintain euthyroidism in patients on thyroid hormone treatment, regardless of underlying cardiovascular risk, particularly in vulnerable populations, such as older adults,” senior author Maria Papaleontiou, MD, said in an interview.

Commenting on the study, David S. Cooper, MD, of Johns Hopkins University School of Medicine, Baltimore, agreed that the findings are significant.

“Both undertreatment and overtreatment were associated with adverse cardiovascular outcomes, meaning that patients’ thyroid function needs to be monitored, and levothyroxine adjusted if need be, on an ongoing basis,” he told this news organization.
 

Getting the balance right: a tricky task

Variations in thyroid hormone levels falling above or below target ranges are common with thyroid hormone therapy, as a wide array of factors can prompt the need to regularly adjust dosing to maintain “index” levels. And while guidelines from the American Thyroid Association (ATA) recommend maintaining serum thyroid stimulating hormone (TSH) levels in the normal ranges during treatment, the task is tricky.

“Despite these [ATA] guidelines, prior studies in adults with hypothyroidism have shown that up to 30% are undertreated and up to 48% are overtreated,” said Dr. Papaleontiou, an assistant professor in the Division of Metabolism, Endocrinology at the University of Michigan, Ann Arbor.

In a previous study, Dr. Papaleontiou and colleagues showed that the intensity of thyroid hormone treatment is a modifiable risk factor for incident atrial fibrillation and stroke, however, less is understood about the association with cardiovascular mortality.

For the new study, published in JAMA Network Open, Josh M. Evron, MD, of the University of North Carolina, Chapel Hill, and colleagues further investigated the issue in a large, retrospective cohort of 705,307 adults in the Veterans Health Administration Corporate Data Warehouse treated with thyroid hormone during 2004-2017 who had a median follow-up of 4 years.

They investigated the roles of TSH as well as free thyroxine (FT4) levels among 701,929 adults in the group with data on TSH and 373,981 patients with FT4 measurements.

The mean age of participants was 67 years and 88.7% were male.

Over the course of the study, 10.8% of patients (75,963) died of cardiovascular causes.

Compared with patients with normal thyroid levels, those with exogenous hyperthyroidism related to thyroid hormone treatment had an increased risk of cardiovascular mortality, specifically including when TSH levels were below 0.1 mIU/L (adjusted hazard ratio, 1.39) and when FT4 levels were above 1.9 ng/dL (AHR, 1.29), independent of factors including age, sex, and traditional cardiovascular risk factors, including hypertension, smoking, and previous cardiovascular disease or arrhythmia.

In addition, the increased risk of cardiovascular mortality was observed with exogenous hypothyroidism, specifically among those with TSH levels above 20 mIU/L (AHR, 2.67) and FT4 levels below 0.7 ng/dL (AHR, 1.56), after multivariate adjustment.

Of note, the risk of cardiovascular mortality was dose-dependent, with the risk increasing progressively with the lower and higher TSH levels, compared with normal levels.

The increased mortality risk in relation to TSH levels was more pronounced among older patients, compared with FT4 associations, the authors note.

“From a clinical perspective, older adults, and particularly the oldest old (aged 85 years), appear to be the most vulnerable, with increased risk of cardiovascular mortality with both exogenous hyperthyroidism and hypothyroidism,” they report.

Among key limitations is that women, who make up the majority of patients with thyroid disease, are under-represented in the predominantly male population of the Veterans Health Administration.

Nevertheless, “because the risk of cardiovascular disease is higher for men than for women, and because more than 70,000 women were included in this cohort, the results of this study are highly clinically relevant,” the authors note.

Addressing over- and under-treatment will avoid harm

The results are also important considering the status of levothyroxine (for hypothyroidism) as consistently ranking among the top three prescription medications in the United States.

And with the common occurrence of exogenous hyperthyroidism or hypothyroidism, the findings have important implications.

“Addressing over- and under-treatment of hypothyroidism promptly will help reduce patient harm, particularly in vulnerable populations such as older adults who are at higher risk for adverse effects,” Dr. Papaleontiou said.

Dr. Cooper further commented that the findings underscore the need to be aware of treatment adjustments and targets that may vary according to patient age.

“In older persons, over 65-70, the target TSH may be higher [for example, 2-4 mIU/L] than in younger persons, and in patients above ages 70 or 80, serum TSH levels may be allowed to rise even further into the 4-6 mIU/L range,” he explained.

“The older the patient, the higher the chance for an adverse cardiovascular outcome if the TSH is subnormal due to iatrogenic thyrotoxicosis,” Dr. Cooper explained.

“In contrast, in younger individuals, an elevated TSH, indicating mild [subclinical] hypothyroidism may be associated with increased cardiovascular risk, especially with serum TSH levels greater than 7 mIU/L.”

The authors have reported no relevant financial relationships.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

Vaccinated people who have a breakthrough case of Omicron will have better protection against COVID-19 variants than vaccinated people who receive a booster shot, two preprint studies show.

The University of Washington, Seattle, working with Vir Biotechnology of San Francisco, looked at blood samples of vaccinated people who had breakthrough cases of Delta or Omicron and compared the samples with three other groups: people who caught COVID and were later vaccinated, vaccinated people who were never infected, and people who were infected and never vaccinated.

The vaccinated people who had a breakthrough case of Omicron produced antibodies that helped protect against coronavirus variants, whereas unvaccinated people who caught Omicron didn’t produce as many antibodies, the study showed.

BioNTech, the German biotechnology company, found that people who’d been double and triple vaccinated and then became infected with Omicron had a better B-cell response than people who’d gotten a booster shot but had not been infected.

The University of Washington research team also came up with similar findings about B cells.

The findings don’t mean people should deliberately try to become infected with COVID, said Alexandra Walls, PhD, one of the University of Washington scientists, according to Business Standard.

But the study does indicate “that we are at the point where we may want to consider having a different vaccine to boost people,” said David Veesler, PhD, of the University of Washington team.

“We should think about breakthrough infections as essentially equivalent to another dose of vaccine,” John Wherry, PhD, a professor and director of the Institute for Immunology at the University of Pennsylvania, Philadelphia, told Business Standard. Dr. Wherry was not involved in the studies but reviewed the BioNTech study.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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

In the run up to the midterm elections in November, President Biden has warmed to student loan forgiveness. However, before even being proposed, severe restrictions have been attached to the forgiveness that would severely limit any effective forgiveness for physicians.

What was the plan?

During the 2020 election, student loan forgiveness was a hot topic as the COVID epidemic raged. The CARES Act has placed all federal student loans in forbearance, with no payments made and the interest rate set to 0% to prevent further accrual. While this was tremendously useful to 45 million borrowers around the country (including the author), nothing material was done to deal with the loans.

The Biden Administration’s approach at that time was multi-tiered and chaotic. Plans were put forward that either expanded Public Service Loan Forgiveness (PSLF) or capped it. Plans were put forward that either extended free undergraduate or severely limited it through Pell Grants. Unfortunately, that duality continues today, with current plans not having a clear goal or a target group of beneficiaries.
 

Necessary CARES Act extensions

The Biden Administration has attempted repeatedly to turn the student loan apparatus back on, restarting payments en masse. However, each time, they are beset by challenges, ranging from repeat COVID spikes to servicer withdrawals or macroeconomic indicators of a recession.

At each step, the administration has had little choice but to extend the CARES Act forbearance, lest they suffer retribution for hastily resuming payments for 45 million borrowers without the apparatus to do so. Two years ago, the major federal servicers laid off hundreds, if not thousands, of staffers responsible for payment processing, accounting, customer care, and taxation. Hiring, training, and staffing these positions is nontrivial.

The administration has been out of step with servicers such that three of the largest have chosen not to renew their contracts: Navient, MyFedLoan, and Granite State Management and Resources. This has left 15 million borrowers in the lurch, not knowing who their servicer is – and, even worse, losing track of qualifying payments toward programs like PSLF.
 

Avenues of forgiveness

There are two major pathways to forgiveness. It is widely believed that the executive branch has the authority to broadly forgive student loans under executive order and managed through the U.S. Department of Education.

The alternative is through congressional action, voting on forgiveness as an economic stimulus plan. There is little appetite in Congress for forgiveness, and prominent congresspeople like Senator Warren and Senator Schumer have both pushed the executive branch for forgiveness in recognition of this.
 

What has been proposed?

First, it’s important to state that as headline-grabbing as it is to see that $50,000 of forgiveness has been proposed, the reality is that President Biden has repeatedly stated that he will not be in favor of that level of forgiveness. Instead, the number most commonly being discussed is $10,000. This would represent an unprecedented amount of support, alleviating 35% of borrowers of all student debt.

The impact of proposed forgiveness plans for physicians

For the medical community, sadly, this doesn’t represent a significant amount of forgiveness. At graduation, the average MD has $203,000 in debt, and the average DO has $258,000 in debt. These numbers grow during residency for years before any meaningful payments are made.

Further weakening forgiveness plans for physicians has been two caps proposed by the administration in recent days. The first is an income cap of $125,000. While this would maintain forgiveness for nearly all residents and fellows, this would exclude nearly every practicing physician. The alternative to an income cap is specific exclusion of certain careers seen to be high-earning: doctors and lawyers.
 

The bottom line

Physicians are unlikely to be included in any forgiveness plans being proposed recently by the Biden Administration. If they are considered, it will be for exclusion from any forgiveness offered.

For physicians no longer eligible for PSLF, this exclusion needs to be considered in managing the student loan debt associated with becoming a doctor.

Dr. Palmer is a part-time instructor, department of pediatrics, Harvard Medical School, Boston, and staff physician, department of medical critical care, Boston Children’s Hospital. He disclosed that he serves as director for Panacea Financial.

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.

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.

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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

COVID-19 forced consumers to adopt digital and virtual platforms to receive medical care, and more than 2 years after the start of the pandemic, it doesn’t appear that that will change.

“During the pandemic we witnessed a very steep rise in the utilization of digital health care transactions. And as we have now witnessed a plateau, we see that digital health care transactions have not fallen back to the way things were prepandemic,” said Bart M. Demaerschalk, MD, professor and chair of cerebrovascular diseases for digital health research at the Mayo Clinic in Phoenix, Ariz. “At Mayo Clinic and other health care organizations, approximately 20% ... of the composite care is occurring by digital means.”

Dr. Demaerschalk was among a panel representing retail and traditional health care organizations at the American Telemedicine Association conference in Boston.

The pandemic created this new reality, and health care leaders are now trying to make the most of all digital tools. Marcus Osborne, former senior vice president at Walmart Health, said that to progress, the health care industry needs to move beyond the conception of a world in which consumers interact with care providers via one-off in-person or digital experiences.

“What we’re actually seeing in other sectors and in life in general is that the world is not multichannel. The world is omnichannel,” Mr. Osborne said. Under an omnichannel paradigm, provider organizations integrate multiple digital and in-person health delivery methods, making it possible to “create whole new experiences for consumers that no one channel could deliver,” he added.

Creagh Milford, DO, vice president and head of enterprise virtual care at CVS Health, agreed and added that “the retail footprint will evolve” from offering separate physical and virtual care experiences to a “blended” experience.

Three key digital technology strategies

In addition to supporting an omnichannel experience, the panelists pointed out that traditional and retail health care providers can make the most of digital technologies in a few different ways.

One is by helping consumers manage innovation. With venture capital investments in digital technologies at an all-time high, the health care industry is drowning in innovation, <r/ Osborne pointed out.

“So on one hand, we have been blessed with this eruption of innovation. On the other hand – and I’m saying this as a consumer – it [doesn’t] really matter. I’m overwhelmed, and I think the market is overwhelmed,” Mr. Osborne said. “So if we’re overwhelmed, it means we’re not going to leverage that innovation as effectively as we should.” The challenge, then, is to find a way to “not get overwhelmed by the sheer force of innovations occurring” and to instead leverage these new technologies to drive real transformation in our health care system.

To meet this challenge, health care organizations will have to provide consumers with “some guidance as to how to tailor that journey,” Dr. Demaerschalk said. “It’s the responsibility of all of us to be creating that tailored and individual guidance for our patients.” By doing so, health care organizations ultimately can help consumers feel less overwhelmed.

Another strategy is to ensure that the use of technology promotes health equity. Mr. Osborne pointed out that events such as the pandemic and George Floyd’s murder have resulted in a “much more robust conversation around the need to address health inequities in America. I’ve also heard a lot of people say they believe that digital health solutions are the answer.”

As such, health care organizations need to ensure that digital innovations are leveraged to “fundamentally address the inequities that we’re facing today and support the care of all Americans,” Mr. Osborne noted.

To move in this direction, leaders need to address one glaring gap: “We talk all the time about fancy technology, like artificial intelligence. Most of my clients, they’re just trying to get basic Internet access at home,” Dr. McCann said. “So, there’s a technology challenge we first have to solve.”

Once this hurdle is overcome, however, digital technologies could pay off in spades, especially for consumers who struggle to access in-person services because they live 2 or 3 hours away from the hospital, are working two jobs, and have child care responsibilities, Dr. McCann noted.

Health care must also address staffing issues, said the panelists. Leaders need to create new career paths for clinicians as digital care delivery becomes more prominent.

Some health care organizations have already discovered that using digital technologies to support hospital-at-home programs can also enhance the work lives of clinicians.

When working in hospital-at-home programs, clinicians can “deliver care in the way that they have always wanted to but have never been able to within an acute inpatient facility. They’re able to go into patients’ homes and spend an hour with them, actually develop a proper relationship and look at social determinants of health and medications and do things in a way they’ve never been able to do before. And that has dramatically reduced rates of burnout,” Dr. McCann said.

While these strategies will help organizations support “this exciting digital ecosystem,” health care technology innovators need to “really study the costs and the health outcomes related to these digital health transactions in order to move the entire field and the science forward,” Dr. Demaerschalk concluded.

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