MDedge Neurology

Pigs have been long used in medical schools to teach surgical techniques and, more recently, in research trials and experimental xenotransplantation procedures. But given the rise of alternative simulation technology and mounting pressure from animal rights groups and lawmakers, animal labs for medical training have become less common.

Just last month, the Physicians Committee for Responsible Medicine, a nonprofit group with a decades-long stance against the use of animals in medical education and research, placed billboards around the Portland, Ore., area demanding that Oregon Health and Science University stop using pigs to teach surgical residents.

Undergraduate medical programs no longer use live animals. But a small number of graduate medical education programs still use animals, predominantly pigs, to train physicians in subspecialties like internal medicine, emergency medicine, surgery, and anesthesiology, John Pippin, MD, FACC, director of academic affairs at PCRM, told this news organization.

Dr. Pippin says residents practice establishing emergency airways, inserting chest tubes, and accessing blood vessels on anesthetized pigs before euthanizing them.

Swine lab advocates say pigs make ideal training subjects because of their similarities to humans, including comparably sized organs like the heart, lungs, and kidneys. Pigs share about 85% of their DNA with people. Where pig skin alternatives may suffice for less invasive procedures, supporters say residents’ experiences with live tissue are irreplaceable.

In a statement, Sara Hottman, associate director of media relations at Oregon Health and Science University, told this news organization the school “only uses animal models in its surgical training program when nonanimal methods are inadequate or too dangerous for human participants.”

“We believe that the education and experience surgical trainees gain through the use of relevant animal models are essential to ensuring future surgeons have the knowledge and skills necessary to provide safe, high-quality care.”

Ms. Hottman also noted that the university continues to evaluate alternatives and looks forward to when nonanimal “surgical training methods are capable of faithfully modeling the complexity of a living system,” such as in the management of critical internal complications.

But Dr. Pippin argues that residents can gain sufficient expertise through simulators and hands-on training in the operating room, and that the differences between humans and pigs are too vast to provide meaningful clinical data or skills.

“Pigs have different genetic influences and very thick, tough skin,” he said. If you use the same pressure on a human that you learned on a pig, he added, “you’d slice right through the trachea. Whatever you think you find out in animals, you have to learn all over again with humans.”

Undergraduate medical education programs in the United States and Canada abandoned the practice of using live animals, including pigs, by 2016, with Johns Hopkins University, Baltimore, and the University of Tennessee, Chattanooga, last to announce their shift away from the controversial teaching model following campaigns by PCRM.

Today, most residency training programs have followed suit. Pippin said that pediatric residencies no longer use animals, and all trauma and anesthesiology programs have ceased such practices except two. Just 3% of emergency medicine programs continue to use animals, as do about 21% of surgical residencies, he said, based on PCRM’s latest surveys.
 

A public debate

Occasionally, PCRM goes public with a campaign against a residency program “if that’s the only way to win,” Dr. Pippin said.

In addition to billboards, the group has held protests, circulated petitions, and filed complaints with the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service, the entity responsible for overseeing the health and welfare of animals used in medical training and research.

In 2021, spurred by a complaint from PCRM, APHIS launched an investigation into the University of Cincinnati’s surgical residency program. At the time, a university spokesperson acknowledged the school’s limited use of pigs to train “highly-skilled, well-prepared surgeons in the most advanced, complex, real-world needs, procedures, and techniques,” adding that the training methods were endorsed by the American College of Surgeons and in compliance with federal guidelines.

Residency programs have caught the attention of state lawmakers, too. In 2020, bills introduced in both the Rhode Island House and Senate sought to ban the use of live animals in medical training when “there is an alternate teaching method that teaches the medical procedure or lesson without the use of an animal.” Violators would incur misdemeanor charges and monetary fines of up to $1,000 per animal.

The bills – backed by PCRM – targeted Brown University’s emergency medicine residency program, Providence, R.I., which sponsoring legislators said was the last program in New England still using the “outdated” and “unnecessary” method.

In testimony before lawmakers, the school said fewer than 15 pigs participate in the annual training, and faculty spoke about the benefits of the experience.

“If it was your brother or sister, or your mother or father who had to come in and get this procedure done, would you want the physician who’s doing it to be the one who does it for the very first time on a human being, on live tissue? Or do you want that provider to have only practiced on plastic and rubber?” said Nicholas Musisca, MD, an assistant program director with Brown University’s emergency medicine residency, NBC affiliate WJAR reported.

The bills have since stalled, and PCRM held a protest at Brown University in October 2022. In response, a university spokesperson told the Brown Daily Herald, “effective synthetic model alternatives simply do not exist for every complex medical procedure that an emergency physician must be prepared to perform,” including establishing an airway in adults and pediatric patients with severe facial trauma.
 

By the numbers

Annual reports from APHIS do not show the number of pigs dedicated solely to residency training. Instead, reporting indicates the number of animals “upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.”

For fiscal year 2021 – the most recent data available – Oregon Health and Science University had 154 pigs under its control, while the University of Cincinnati and Brown University had 118 and 71 pigs, respectively, according to APHIS. Primates were more commonly used at Oregon Health and Science University and guinea pigs at the University of Cincinnati.

Similarly, the Association of American Medical Colleges supports the “use of animals to meet essential educational objectives [across] the medical education continuum. ... Further restrictions on the use of animals in biomedical and behavioral research and education threatens progress in health care and disease prevention.”

The debate will likely rage on. “The one thing we don’t do is give up,” Dr. Pippin said.

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

Pigs have been long used in medical schools to teach surgical techniques and, more recently, in research trials and experimental xenotransplantation procedures. But given the rise of alternative simulation technology and mounting pressure from animal rights groups and lawmakers, animal labs for medical training have become less common.

Just last month, the Physicians Committee for Responsible Medicine, a nonprofit group with a decades-long stance against the use of animals in medical education and research, placed billboards around the Portland, Ore., area demanding that Oregon Health and Science University stop using pigs to teach surgical residents.

Undergraduate medical programs no longer use live animals. But a small number of graduate medical education programs still use animals, predominantly pigs, to train physicians in subspecialties like internal medicine, emergency medicine, surgery, and anesthesiology, John Pippin, MD, FACC, director of academic affairs at PCRM, told this news organization.

Dr. Pippin says residents practice establishing emergency airways, inserting chest tubes, and accessing blood vessels on anesthetized pigs before euthanizing them.

Swine lab advocates say pigs make ideal training subjects because of their similarities to humans, including comparably sized organs like the heart, lungs, and kidneys. Pigs share about 85% of their DNA with people. Where pig skin alternatives may suffice for less invasive procedures, supporters say residents’ experiences with live tissue are irreplaceable.

In a statement, Sara Hottman, associate director of media relations at Oregon Health and Science University, told this news organization the school “only uses animal models in its surgical training program when nonanimal methods are inadequate or too dangerous for human participants.”

“We believe that the education and experience surgical trainees gain through the use of relevant animal models are essential to ensuring future surgeons have the knowledge and skills necessary to provide safe, high-quality care.”

Ms. Hottman also noted that the university continues to evaluate alternatives and looks forward to when nonanimal “surgical training methods are capable of faithfully modeling the complexity of a living system,” such as in the management of critical internal complications.

But Dr. Pippin argues that residents can gain sufficient expertise through simulators and hands-on training in the operating room, and that the differences between humans and pigs are too vast to provide meaningful clinical data or skills.

“Pigs have different genetic influences and very thick, tough skin,” he said. If you use the same pressure on a human that you learned on a pig, he added, “you’d slice right through the trachea. Whatever you think you find out in animals, you have to learn all over again with humans.”

Undergraduate medical education programs in the United States and Canada abandoned the practice of using live animals, including pigs, by 2016, with Johns Hopkins University, Baltimore, and the University of Tennessee, Chattanooga, last to announce their shift away from the controversial teaching model following campaigns by PCRM.

Today, most residency training programs have followed suit. Pippin said that pediatric residencies no longer use animals, and all trauma and anesthesiology programs have ceased such practices except two. Just 3% of emergency medicine programs continue to use animals, as do about 21% of surgical residencies, he said, based on PCRM’s latest surveys.
 

A public debate

Occasionally, PCRM goes public with a campaign against a residency program “if that’s the only way to win,” Dr. Pippin said.

In addition to billboards, the group has held protests, circulated petitions, and filed complaints with the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service, the entity responsible for overseeing the health and welfare of animals used in medical training and research.

In 2021, spurred by a complaint from PCRM, APHIS launched an investigation into the University of Cincinnati’s surgical residency program. At the time, a university spokesperson acknowledged the school’s limited use of pigs to train “highly-skilled, well-prepared surgeons in the most advanced, complex, real-world needs, procedures, and techniques,” adding that the training methods were endorsed by the American College of Surgeons and in compliance with federal guidelines.

Residency programs have caught the attention of state lawmakers, too. In 2020, bills introduced in both the Rhode Island House and Senate sought to ban the use of live animals in medical training when “there is an alternate teaching method that teaches the medical procedure or lesson without the use of an animal.” Violators would incur misdemeanor charges and monetary fines of up to $1,000 per animal.

The bills – backed by PCRM – targeted Brown University’s emergency medicine residency program, Providence, R.I., which sponsoring legislators said was the last program in New England still using the “outdated” and “unnecessary” method.

In testimony before lawmakers, the school said fewer than 15 pigs participate in the annual training, and faculty spoke about the benefits of the experience.

“If it was your brother or sister, or your mother or father who had to come in and get this procedure done, would you want the physician who’s doing it to be the one who does it for the very first time on a human being, on live tissue? Or do you want that provider to have only practiced on plastic and rubber?” said Nicholas Musisca, MD, an assistant program director with Brown University’s emergency medicine residency, NBC affiliate WJAR reported.

The bills have since stalled, and PCRM held a protest at Brown University in October 2022. In response, a university spokesperson told the Brown Daily Herald, “effective synthetic model alternatives simply do not exist for every complex medical procedure that an emergency physician must be prepared to perform,” including establishing an airway in adults and pediatric patients with severe facial trauma.
 

By the numbers

Annual reports from APHIS do not show the number of pigs dedicated solely to residency training. Instead, reporting indicates the number of animals “upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.”

For fiscal year 2021 – the most recent data available – Oregon Health and Science University had 154 pigs under its control, while the University of Cincinnati and Brown University had 118 and 71 pigs, respectively, according to APHIS. Primates were more commonly used at Oregon Health and Science University and guinea pigs at the University of Cincinnati.

Similarly, the Association of American Medical Colleges supports the “use of animals to meet essential educational objectives [across] the medical education continuum. ... Further restrictions on the use of animals in biomedical and behavioral research and education threatens progress in health care and disease prevention.”

The debate will likely rage on. “The one thing we don’t do is give up,” Dr. Pippin said.

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

Pigs have been long used in medical schools to teach surgical techniques and, more recently, in research trials and experimental xenotransplantation procedures. But given the rise of alternative simulation technology and mounting pressure from animal rights groups and lawmakers, animal labs for medical training have become less common.

Just last month, the Physicians Committee for Responsible Medicine, a nonprofit group with a decades-long stance against the use of animals in medical education and research, placed billboards around the Portland, Ore., area demanding that Oregon Health and Science University stop using pigs to teach surgical residents.

Undergraduate medical programs no longer use live animals. But a small number of graduate medical education programs still use animals, predominantly pigs, to train physicians in subspecialties like internal medicine, emergency medicine, surgery, and anesthesiology, John Pippin, MD, FACC, director of academic affairs at PCRM, told this news organization.

Dr. Pippin says residents practice establishing emergency airways, inserting chest tubes, and accessing blood vessels on anesthetized pigs before euthanizing them.

Swine lab advocates say pigs make ideal training subjects because of their similarities to humans, including comparably sized organs like the heart, lungs, and kidneys. Pigs share about 85% of their DNA with people. Where pig skin alternatives may suffice for less invasive procedures, supporters say residents’ experiences with live tissue are irreplaceable.

In a statement, Sara Hottman, associate director of media relations at Oregon Health and Science University, told this news organization the school “only uses animal models in its surgical training program when nonanimal methods are inadequate or too dangerous for human participants.”

“We believe that the education and experience surgical trainees gain through the use of relevant animal models are essential to ensuring future surgeons have the knowledge and skills necessary to provide safe, high-quality care.”

Ms. Hottman also noted that the university continues to evaluate alternatives and looks forward to when nonanimal “surgical training methods are capable of faithfully modeling the complexity of a living system,” such as in the management of critical internal complications.

But Dr. Pippin argues that residents can gain sufficient expertise through simulators and hands-on training in the operating room, and that the differences between humans and pigs are too vast to provide meaningful clinical data or skills.

“Pigs have different genetic influences and very thick, tough skin,” he said. If you use the same pressure on a human that you learned on a pig, he added, “you’d slice right through the trachea. Whatever you think you find out in animals, you have to learn all over again with humans.”

Undergraduate medical education programs in the United States and Canada abandoned the practice of using live animals, including pigs, by 2016, with Johns Hopkins University, Baltimore, and the University of Tennessee, Chattanooga, last to announce their shift away from the controversial teaching model following campaigns by PCRM.

Today, most residency training programs have followed suit. Pippin said that pediatric residencies no longer use animals, and all trauma and anesthesiology programs have ceased such practices except two. Just 3% of emergency medicine programs continue to use animals, as do about 21% of surgical residencies, he said, based on PCRM’s latest surveys.
 

A public debate

Occasionally, PCRM goes public with a campaign against a residency program “if that’s the only way to win,” Dr. Pippin said.

In addition to billboards, the group has held protests, circulated petitions, and filed complaints with the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service, the entity responsible for overseeing the health and welfare of animals used in medical training and research.

In 2021, spurred by a complaint from PCRM, APHIS launched an investigation into the University of Cincinnati’s surgical residency program. At the time, a university spokesperson acknowledged the school’s limited use of pigs to train “highly-skilled, well-prepared surgeons in the most advanced, complex, real-world needs, procedures, and techniques,” adding that the training methods were endorsed by the American College of Surgeons and in compliance with federal guidelines.

Residency programs have caught the attention of state lawmakers, too. In 2020, bills introduced in both the Rhode Island House and Senate sought to ban the use of live animals in medical training when “there is an alternate teaching method that teaches the medical procedure or lesson without the use of an animal.” Violators would incur misdemeanor charges and monetary fines of up to $1,000 per animal.

The bills – backed by PCRM – targeted Brown University’s emergency medicine residency program, Providence, R.I., which sponsoring legislators said was the last program in New England still using the “outdated” and “unnecessary” method.

In testimony before lawmakers, the school said fewer than 15 pigs participate in the annual training, and faculty spoke about the benefits of the experience.

“If it was your brother or sister, or your mother or father who had to come in and get this procedure done, would you want the physician who’s doing it to be the one who does it for the very first time on a human being, on live tissue? Or do you want that provider to have only practiced on plastic and rubber?” said Nicholas Musisca, MD, an assistant program director with Brown University’s emergency medicine residency, NBC affiliate WJAR reported.

The bills have since stalled, and PCRM held a protest at Brown University in October 2022. In response, a university spokesperson told the Brown Daily Herald, “effective synthetic model alternatives simply do not exist for every complex medical procedure that an emergency physician must be prepared to perform,” including establishing an airway in adults and pediatric patients with severe facial trauma.
 

By the numbers

Annual reports from APHIS do not show the number of pigs dedicated solely to residency training. Instead, reporting indicates the number of animals “upon which experiments, teaching, research, surgery, or tests were conducted involving accompanying pain or distress to the animals and for which appropriate anesthetic, analgesic, or tranquilizing drugs were used.”

For fiscal year 2021 – the most recent data available – Oregon Health and Science University had 154 pigs under its control, while the University of Cincinnati and Brown University had 118 and 71 pigs, respectively, according to APHIS. Primates were more commonly used at Oregon Health and Science University and guinea pigs at the University of Cincinnati.

Similarly, the Association of American Medical Colleges supports the “use of animals to meet essential educational objectives [across] the medical education continuum. ... Further restrictions on the use of animals in biomedical and behavioral research and education threatens progress in health care and disease prevention.”

The debate will likely rage on. “The one thing we don’t do is give up,” Dr. Pippin said.

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

It’s the end of an era. The Biden administration announced Jan. 30 that it will be ending the twin COVID-19 emergency declarations, marking a major change in the 3-year-old pandemic.

The orders spanned two presidencies. The Trump administration’s Health and Human Services Secretary Alex Azar issued a public health emergency in January 2020. Then-President Donald Trump declared the COVID-19 pandemic a national emergency 2 months later. Both emergency declarations – which remained in effect under President Joe Biden – are set to expire May 11. 

Read on for an overview of how the end of the public health emergency will trigger multiple federal policy changes. 
 

Changes that affect everyone

• There will be cost-sharing changes for COVID-19 vaccines, testing, and certain treatments. One hundred–percent coverage for COVID testing, including free at-home tests, will expire May 11. 
• Telemedicine cannot be used to prescribe controlled substances after May 11, 2023.
• Enhanced federal funding will be phased down through Dec. 31, 2023. This extends the time states must receive federally matched funds for COVID-related services and products, through the Consolidated Appropriations Act of 2023. Otherwise, this would have expired June 30, 2023.
• Emergency use authorizations for COVID-19 treatments and vaccinations will not be affected and/or end on May 11.

Changes that affect people with private health insurance

• Many will likely see higher costs for COVID-19 tests, as free testing expires and cost-sharing begins in the coming months.
• COVID-19 vaccinations and boosters will continue to be covered until the federal government’s vaccination supply is depleted. If that happens, you will need an in-network provider.
• You will still have access to COVID-19 treatments – but that could change when the federal supply dwindles.

Changes that affect Medicare recipients

• Medicare telehealth flexibilities will be extended through Dec. 31, 2024, regardless of public health emergency status. This means people can access telehealth services from anywhere, not just rural areas; can use a smartphone for telehealth; and can access telehealth in their homes. 
• Medicare cost-sharing for testing and treatments will expire May 11, except for oral antivirals. 

Changes that affect Medicaid/CHIP recipients

• Medicaid and Children’s Health Insurance Program (CHIP) recipients will continue to receive approved vaccinations free of charge, but testing and treatment without cost-sharing will expire during the third quarter of 2024.
• The Medicaid continuous enrollment provision will be separated from the public health emergency, and continuous enrollment will end March 31, 2023.

Changes that affect uninsured people

• The uninsured will no longer have access to 100% coverage for these products and services (free COVID-19 treatments, vaccines, and testing). 

Changes that affect health care providers

• There will be changes to how much providers get paid for diagnosing people with COVID-19, ending the enhanced Inpatient Prospective Payment System reimbursement rate, as of May 11, 2023.
• Health Insurance Portability and Accountability Act (HIPAA) potential penalty waivers will end. This allows providers to communicate with patients through telehealth on a smartphone, for example, without violating privacy laws and incurring penalties.

What the experts are saying 

This news organization asked several health experts for their thoughts on ending the emergency health declarations for COVID, and what effects this could have. Many expressed concerns about the timing of the ending, saying that the move could limit access to COVID-related treatments. Others said the move was inevitable but raised concerns about federal guidance related to the decision. 

Question: Do you agree with the timing of the end to the emergency order?

Answer: Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston: “A lead time to prepare and anticipate these consequences may ease the transition, compared to an abrupt declaration that ends the declaration.” 

Answer: Georges C. Benjamin, MD, executive director of the American Public Health Association: “I think it’s time to do so. It has to be done in a great, thoughtful, and organized way because we’ve attached so many different things to this public health emergency. It’s going to take time for the system to adapt. [Centers for Disease Control and Prevention] data collection most likely will continue. People are used to reporting now. The CDC needs to give guidance to the states so that we’re clear about what we’re reporting, what we’re not. If we did that abruptly, it would just be a mess.”

Answer: Bruce Farber, MD, chief public health and epidemiology officer at Northwell Health in Manhasset, N.Y.: “I would have hoped to see it delayed.”

Answer: Steven Newmark, JD, chief legal officer and director of policy at the Global Healthy Living Foundation: “While we understand that an emergency cannot last forever, we hope that expanded services such as free vaccination, promotion of widespread vaccination, increased use of pharmacists to administer vaccines, telehealth availability and reimbursement, flexibility in work-from-home opportunities, and more continues. Access to equitable health care should never backtrack or be reduced.”

Q: What will the end of free COVID vaccinations and free testing mean? 

A: Dr. Farber: “There will likely be a decrease in vaccinations and testing. The vaccination rates are very low to begin with, and this will likely lower it further.”

A: Dr. Atmar: “I think it will mean that fewer people will get tested and vaccinated,” which “could lead to increased transmission, although wastewater testing suggests that there is a lot of unrecognized infection already occurring.” 

A: Dr. Benjamin: “That is a big concern. It means that for people, particularly for people who are uninsured and underinsured, we’ve got to make sure they have access to those. There’s a lot of discussion and debate about what the cost of those tests and vaccines will be, and it looks like the companies are going to impose very steep, increasing costs.”

Q: How will this affect higher-risk populations, like people with weakened immune systems? 

A: Dr. Farber: “Without monoclonals [drugs to treat COVID] and free Paxlovid,” people with weakened immune systems “may be undertreated.”

A: Dr. Atmar: “The implications of ongoing widespread virus transmission are that immunocompromised individuals may be more likely to be exposed and infected and to suffer the consequences of such infection, including severe illness. However, to a certain degree, this may already be happening. We are still seeing about 500 deaths/day, primarily in persons at highest risk of severe disease.”

A: Dr. Benjamin:  “People who have good insurance, can afford to get immunized, and have good relations with practitioners probably will continue to be covered. But lower-income individuals and people who really can’t afford to get tested or get immunized would likely become underimmunized and more infected. 

“So even though the federal emergency declaration will go away, I’m hoping that the federal government will continue to encourage all of us to emphasize those populations at the highest risk – those with chronic disease and those who are immunocompromised.”

A: Mr. Newmark: “People who are immunocompromised by their chronic illness or the medicines they take to treat acute or chronic conditions remain at higher risk for COVID-19 and its serious complications. The administration needs to support continued development of effective treatments and updated vaccines to protect the individual and public health. We’re also concerned that increased health care services - such as vaccination or telehealth – may fall back to prepandemic levels while the burden of protection, such as masking, may fall to chronic disease patients alone, which adds to the burden of living with disease.”

Q: What effect will ending Medicaid expansion money have? 

A: Dr. Benjamin: Anywhere from 16 to 20 million people are going to lose in coverage. I’m hoping that states will look at their experience over these last 2 years or so and come to the decision that there were improvements in healthier populations.

Q: Will this have any effect on how the public perceives the pandemic? 

A: Dr. Farber: “It is likely to give the impression that COVID is gone, which clearly is not the case.”

A: Dr. Benjamin: “It’ll be another argument by some that the pandemic is over. People should think about this as kind of like a hurricane. A hurricane comes through and tragically tears up communities, and we have an emergency during that time. But then we have to go through a period of recovery. I’m hoping people will realize that even though the public health emergencies have gone away, that we still need to go through a period of transition ... and that means that they still need to protect themselves, get vaccinated, and wear a mask when appropriate.”

A: Dr. Atmar: “There needs to be messaging that while we are transitioning away from emergency management of COVID-19, it is still a significant public health concern.”

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

It’s the end of an era. The Biden administration announced Jan. 30 that it will be ending the twin COVID-19 emergency declarations, marking a major change in the 3-year-old pandemic.

The orders spanned two presidencies. The Trump administration’s Health and Human Services Secretary Alex Azar issued a public health emergency in January 2020. Then-President Donald Trump declared the COVID-19 pandemic a national emergency 2 months later. Both emergency declarations – which remained in effect under President Joe Biden – are set to expire May 11. 

Read on for an overview of how the end of the public health emergency will trigger multiple federal policy changes. 
 

Changes that affect everyone

• There will be cost-sharing changes for COVID-19 vaccines, testing, and certain treatments. One hundred–percent coverage for COVID testing, including free at-home tests, will expire May 11. 
• Telemedicine cannot be used to prescribe controlled substances after May 11, 2023.
• Enhanced federal funding will be phased down through Dec. 31, 2023. This extends the time states must receive federally matched funds for COVID-related services and products, through the Consolidated Appropriations Act of 2023. Otherwise, this would have expired June 30, 2023.
• Emergency use authorizations for COVID-19 treatments and vaccinations will not be affected and/or end on May 11.

Changes that affect people with private health insurance

• Many will likely see higher costs for COVID-19 tests, as free testing expires and cost-sharing begins in the coming months.
• COVID-19 vaccinations and boosters will continue to be covered until the federal government’s vaccination supply is depleted. If that happens, you will need an in-network provider.
• You will still have access to COVID-19 treatments – but that could change when the federal supply dwindles.

Changes that affect Medicare recipients

• Medicare telehealth flexibilities will be extended through Dec. 31, 2024, regardless of public health emergency status. This means people can access telehealth services from anywhere, not just rural areas; can use a smartphone for telehealth; and can access telehealth in their homes. 
• Medicare cost-sharing for testing and treatments will expire May 11, except for oral antivirals. 

Changes that affect Medicaid/CHIP recipients

• Medicaid and Children’s Health Insurance Program (CHIP) recipients will continue to receive approved vaccinations free of charge, but testing and treatment without cost-sharing will expire during the third quarter of 2024.
• The Medicaid continuous enrollment provision will be separated from the public health emergency, and continuous enrollment will end March 31, 2023.

Changes that affect uninsured people

• The uninsured will no longer have access to 100% coverage for these products and services (free COVID-19 treatments, vaccines, and testing). 

Changes that affect health care providers

• There will be changes to how much providers get paid for diagnosing people with COVID-19, ending the enhanced Inpatient Prospective Payment System reimbursement rate, as of May 11, 2023.
• Health Insurance Portability and Accountability Act (HIPAA) potential penalty waivers will end. This allows providers to communicate with patients through telehealth on a smartphone, for example, without violating privacy laws and incurring penalties.

What the experts are saying 

This news organization asked several health experts for their thoughts on ending the emergency health declarations for COVID, and what effects this could have. Many expressed concerns about the timing of the ending, saying that the move could limit access to COVID-related treatments. Others said the move was inevitable but raised concerns about federal guidance related to the decision. 

Question: Do you agree with the timing of the end to the emergency order?

Answer: Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston: “A lead time to prepare and anticipate these consequences may ease the transition, compared to an abrupt declaration that ends the declaration.” 

Answer: Georges C. Benjamin, MD, executive director of the American Public Health Association: “I think it’s time to do so. It has to be done in a great, thoughtful, and organized way because we’ve attached so many different things to this public health emergency. It’s going to take time for the system to adapt. [Centers for Disease Control and Prevention] data collection most likely will continue. People are used to reporting now. The CDC needs to give guidance to the states so that we’re clear about what we’re reporting, what we’re not. If we did that abruptly, it would just be a mess.”

Answer: Bruce Farber, MD, chief public health and epidemiology officer at Northwell Health in Manhasset, N.Y.: “I would have hoped to see it delayed.”

Answer: Steven Newmark, JD, chief legal officer and director of policy at the Global Healthy Living Foundation: “While we understand that an emergency cannot last forever, we hope that expanded services such as free vaccination, promotion of widespread vaccination, increased use of pharmacists to administer vaccines, telehealth availability and reimbursement, flexibility in work-from-home opportunities, and more continues. Access to equitable health care should never backtrack or be reduced.”

Q: What will the end of free COVID vaccinations and free testing mean? 

A: Dr. Farber: “There will likely be a decrease in vaccinations and testing. The vaccination rates are very low to begin with, and this will likely lower it further.”

A: Dr. Atmar: “I think it will mean that fewer people will get tested and vaccinated,” which “could lead to increased transmission, although wastewater testing suggests that there is a lot of unrecognized infection already occurring.” 

A: Dr. Benjamin: “That is a big concern. It means that for people, particularly for people who are uninsured and underinsured, we’ve got to make sure they have access to those. There’s a lot of discussion and debate about what the cost of those tests and vaccines will be, and it looks like the companies are going to impose very steep, increasing costs.”

Q: How will this affect higher-risk populations, like people with weakened immune systems? 

A: Dr. Farber: “Without monoclonals [drugs to treat COVID] and free Paxlovid,” people with weakened immune systems “may be undertreated.”

A: Dr. Atmar: “The implications of ongoing widespread virus transmission are that immunocompromised individuals may be more likely to be exposed and infected and to suffer the consequences of such infection, including severe illness. However, to a certain degree, this may already be happening. We are still seeing about 500 deaths/day, primarily in persons at highest risk of severe disease.”

A: Dr. Benjamin:  “People who have good insurance, can afford to get immunized, and have good relations with practitioners probably will continue to be covered. But lower-income individuals and people who really can’t afford to get tested or get immunized would likely become underimmunized and more infected. 

“So even though the federal emergency declaration will go away, I’m hoping that the federal government will continue to encourage all of us to emphasize those populations at the highest risk – those with chronic disease and those who are immunocompromised.”

A: Mr. Newmark: “People who are immunocompromised by their chronic illness or the medicines they take to treat acute or chronic conditions remain at higher risk for COVID-19 and its serious complications. The administration needs to support continued development of effective treatments and updated vaccines to protect the individual and public health. We’re also concerned that increased health care services - such as vaccination or telehealth – may fall back to prepandemic levels while the burden of protection, such as masking, may fall to chronic disease patients alone, which adds to the burden of living with disease.”

Q: What effect will ending Medicaid expansion money have? 

A: Dr. Benjamin: Anywhere from 16 to 20 million people are going to lose in coverage. I’m hoping that states will look at their experience over these last 2 years or so and come to the decision that there were improvements in healthier populations.

Q: Will this have any effect on how the public perceives the pandemic? 

A: Dr. Farber: “It is likely to give the impression that COVID is gone, which clearly is not the case.”

A: Dr. Benjamin: “It’ll be another argument by some that the pandemic is over. People should think about this as kind of like a hurricane. A hurricane comes through and tragically tears up communities, and we have an emergency during that time. But then we have to go through a period of recovery. I’m hoping people will realize that even though the public health emergencies have gone away, that we still need to go through a period of transition ... and that means that they still need to protect themselves, get vaccinated, and wear a mask when appropriate.”

A: Dr. Atmar: “There needs to be messaging that while we are transitioning away from emergency management of COVID-19, it is still a significant public health concern.”

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

It’s the end of an era. The Biden administration announced Jan. 30 that it will be ending the twin COVID-19 emergency declarations, marking a major change in the 3-year-old pandemic.

The orders spanned two presidencies. The Trump administration’s Health and Human Services Secretary Alex Azar issued a public health emergency in January 2020. Then-President Donald Trump declared the COVID-19 pandemic a national emergency 2 months later. Both emergency declarations – which remained in effect under President Joe Biden – are set to expire May 11. 

Read on for an overview of how the end of the public health emergency will trigger multiple federal policy changes. 
 

Changes that affect everyone

• There will be cost-sharing changes for COVID-19 vaccines, testing, and certain treatments. One hundred–percent coverage for COVID testing, including free at-home tests, will expire May 11. 
• Telemedicine cannot be used to prescribe controlled substances after May 11, 2023.
• Enhanced federal funding will be phased down through Dec. 31, 2023. This extends the time states must receive federally matched funds for COVID-related services and products, through the Consolidated Appropriations Act of 2023. Otherwise, this would have expired June 30, 2023.
• Emergency use authorizations for COVID-19 treatments and vaccinations will not be affected and/or end on May 11.

Changes that affect people with private health insurance

• Many will likely see higher costs for COVID-19 tests, as free testing expires and cost-sharing begins in the coming months.
• COVID-19 vaccinations and boosters will continue to be covered until the federal government’s vaccination supply is depleted. If that happens, you will need an in-network provider.
• You will still have access to COVID-19 treatments – but that could change when the federal supply dwindles.

Changes that affect Medicare recipients

• Medicare telehealth flexibilities will be extended through Dec. 31, 2024, regardless of public health emergency status. This means people can access telehealth services from anywhere, not just rural areas; can use a smartphone for telehealth; and can access telehealth in their homes. 
• Medicare cost-sharing for testing and treatments will expire May 11, except for oral antivirals. 

Changes that affect Medicaid/CHIP recipients

• Medicaid and Children’s Health Insurance Program (CHIP) recipients will continue to receive approved vaccinations free of charge, but testing and treatment without cost-sharing will expire during the third quarter of 2024.
• The Medicaid continuous enrollment provision will be separated from the public health emergency, and continuous enrollment will end March 31, 2023.

Changes that affect uninsured people

• The uninsured will no longer have access to 100% coverage for these products and services (free COVID-19 treatments, vaccines, and testing). 

Changes that affect health care providers

• There will be changes to how much providers get paid for diagnosing people with COVID-19, ending the enhanced Inpatient Prospective Payment System reimbursement rate, as of May 11, 2023.
• Health Insurance Portability and Accountability Act (HIPAA) potential penalty waivers will end. This allows providers to communicate with patients through telehealth on a smartphone, for example, without violating privacy laws and incurring penalties.

What the experts are saying 

This news organization asked several health experts for their thoughts on ending the emergency health declarations for COVID, and what effects this could have. Many expressed concerns about the timing of the ending, saying that the move could limit access to COVID-related treatments. Others said the move was inevitable but raised concerns about federal guidance related to the decision. 

Question: Do you agree with the timing of the end to the emergency order?

Answer: Robert Atmar, MD, professor of infectious diseases at Baylor College of Medicine in Houston: “A lead time to prepare and anticipate these consequences may ease the transition, compared to an abrupt declaration that ends the declaration.” 

Answer: Georges C. Benjamin, MD, executive director of the American Public Health Association: “I think it’s time to do so. It has to be done in a great, thoughtful, and organized way because we’ve attached so many different things to this public health emergency. It’s going to take time for the system to adapt. [Centers for Disease Control and Prevention] data collection most likely will continue. People are used to reporting now. The CDC needs to give guidance to the states so that we’re clear about what we’re reporting, what we’re not. If we did that abruptly, it would just be a mess.”

Answer: Bruce Farber, MD, chief public health and epidemiology officer at Northwell Health in Manhasset, N.Y.: “I would have hoped to see it delayed.”

Answer: Steven Newmark, JD, chief legal officer and director of policy at the Global Healthy Living Foundation: “While we understand that an emergency cannot last forever, we hope that expanded services such as free vaccination, promotion of widespread vaccination, increased use of pharmacists to administer vaccines, telehealth availability and reimbursement, flexibility in work-from-home opportunities, and more continues. Access to equitable health care should never backtrack or be reduced.”

Q: What will the end of free COVID vaccinations and free testing mean? 

A: Dr. Farber: “There will likely be a decrease in vaccinations and testing. The vaccination rates are very low to begin with, and this will likely lower it further.”

A: Dr. Atmar: “I think it will mean that fewer people will get tested and vaccinated,” which “could lead to increased transmission, although wastewater testing suggests that there is a lot of unrecognized infection already occurring.” 

A: Dr. Benjamin: “That is a big concern. It means that for people, particularly for people who are uninsured and underinsured, we’ve got to make sure they have access to those. There’s a lot of discussion and debate about what the cost of those tests and vaccines will be, and it looks like the companies are going to impose very steep, increasing costs.”

Q: How will this affect higher-risk populations, like people with weakened immune systems? 

A: Dr. Farber: “Without monoclonals [drugs to treat COVID] and free Paxlovid,” people with weakened immune systems “may be undertreated.”

A: Dr. Atmar: “The implications of ongoing widespread virus transmission are that immunocompromised individuals may be more likely to be exposed and infected and to suffer the consequences of such infection, including severe illness. However, to a certain degree, this may already be happening. We are still seeing about 500 deaths/day, primarily in persons at highest risk of severe disease.”

A: Dr. Benjamin:  “People who have good insurance, can afford to get immunized, and have good relations with practitioners probably will continue to be covered. But lower-income individuals and people who really can’t afford to get tested or get immunized would likely become underimmunized and more infected. 

“So even though the federal emergency declaration will go away, I’m hoping that the federal government will continue to encourage all of us to emphasize those populations at the highest risk – those with chronic disease and those who are immunocompromised.”

A: Mr. Newmark: “People who are immunocompromised by their chronic illness or the medicines they take to treat acute or chronic conditions remain at higher risk for COVID-19 and its serious complications. The administration needs to support continued development of effective treatments and updated vaccines to protect the individual and public health. We’re also concerned that increased health care services - such as vaccination or telehealth – may fall back to prepandemic levels while the burden of protection, such as masking, may fall to chronic disease patients alone, which adds to the burden of living with disease.”

Q: What effect will ending Medicaid expansion money have? 

A: Dr. Benjamin: Anywhere from 16 to 20 million people are going to lose in coverage. I’m hoping that states will look at their experience over these last 2 years or so and come to the decision that there were improvements in healthier populations.

Q: Will this have any effect on how the public perceives the pandemic? 

A: Dr. Farber: “It is likely to give the impression that COVID is gone, which clearly is not the case.”

A: Dr. Benjamin: “It’ll be another argument by some that the pandemic is over. People should think about this as kind of like a hurricane. A hurricane comes through and tragically tears up communities, and we have an emergency during that time. But then we have to go through a period of recovery. I’m hoping people will realize that even though the public health emergencies have gone away, that we still need to go through a period of transition ... and that means that they still need to protect themselves, get vaccinated, and wear a mask when appropriate.”

A: Dr. Atmar: “There needs to be messaging that while we are transitioning away from emergency management of COVID-19, it is still a significant public health concern.”

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

A mandatory cognitive screening policy targeting older drivers appeared to lower car crashes involving people over 70, according to results from a large population-based study using data from Japan.

But the same study, published in the Journal of the American Geriatrics Society, also reported a concurrent increase in pedestrian and cycling injuries, possibly because more older former drivers were getting around by alternative means. That finding echoed a 2012 study from Denmark, which also looked at the effects of an age-based cognitive screening policy for older drivers, and saw more fatal road injuries among older people who were not driving.

While some governments, including those of Denmark, Taiwan, and Japan, have implemented age-based cognitive screening for older drivers, there has been little evidence to date that such policies improve road safety. Guidelines issued in 2010 by the American Academy of Neurology discourage age-based screening, advising instead that people diagnosed with cognitive disorders be carefully evaluated for driving fitness and recommending one widely used scale, the Clinical Dementia Rating, as useful in identifying potentially unsafe drivers.
 

Japan’s national screening policy: Did it work?

The new study, led by Haruhiko Inada, MD, PhD, an epidemiologist at Johns Hopkins University in Baltimore, used national crash data from Japan, where since 2017 all drivers 75 and older not only must take cognitive tests measuring temporal orientation and memory at license renewal, but are also referred for medical evaluation if they fail them. People receiving a subsequent dementia diagnosis can have their licenses suspended or revoked.

Dr. Inada and his colleagues looked at national data from nearly 603,000 police-reported vehicle collisions and nearly 197,000 pedestrian or cyclist road injuries between March 2012 and December 2019, all involving people aged 70 and older. To assess the screening policy’s impact, the researchers calculated estimated monthly collision or injury incidence rates per 100,000 person-years. This way, they could “control for secular trends that were unaffected by the policy, such as the decreasing incidence of motor vehicle collisions year by year,” the researchers explained.

After the screening was implemented, cumulative estimated collisions among drivers 75 or older decreased by 3,670 (95% confidence interval, 5,125-2,104), while reported pedestrian or cyclist injuries increased by an estimated 959 (95% CI, 24-1,834). Dr. Inada and colleagues found that crashes declined among men but not women, noting also that more older men than women are licensed to drive in Japan. Pedestrian and cyclist injuries were highest among men aged 80-84, and women aged 80 and older.

“Cognitively screening older drivers at license renewal and promoting voluntary surrender of licenses may prevent motor vehicle collisions,” Dr. Inada and his colleagues concluded. “However, they are associated with an increase in road injuries for older pedestrians and cyclists. Future studies should examine the effectiveness of mitigation measures, such as alternative, safe transportation, and accommodations for pedestrians and cyclists.”
 

No definitive answers

Two investigators who have studied cognitive screening related to road safety were contacted for commentary on the study findings.

Anu Siren, PhD, professor of gerontology at Tampere (Finland) University, who in 2012 reported higher injuries after implementation of older-driver cognitive screening in Denmark, commented that the new study, while benefiting from a much larger data set than earlier studies, still “fails to show that decrease in collisions is because ‘unfit’ drivers were removed from the road. But it does confirm previous findings about how strict screening policies make people shift from cars to unprotected modes of transportation,” which are riskier.

In studies measuring driving safety, the usual definition of risk is incidents per exposure, Dr. Siren noted. In Dr. Inada and colleagues’ study, “the incident measure, or numerator, is the number of collisions. The exposure measure or denominator is population. Because the study uses population and not driver licenses (or distance traveled) as an exposure measure, the observed decrease in collisions does not say much about how the collision risk develops after the implementation of screening.”

Older driver screening “is likely to cause some older persons to cease from driving and probably continue to travel as unprotected road users,” Dr. Siren continued. “Similar to what we found [in 2012], the injury rates for pedestrians and cyclists went up after the introduction of screening, which suggests that screening indirectly causes increasing number of injuries among older unprotected road users.”

Matthew Rizzo, MD, professor and chair of the department of neurological sciences at the University of Nebraska Medical Center and codirector of the Nebraska Neuroscience Alliance in Omaha, Neb., and the lead author of the 2010 AAN guidelines on cognitive impairment and driving risk, cautioned against ageism in designing policies meant to protect motorists.

“We find some erratic/weak effects of age here and there, but the big effects we consistently find are from cognitive and visual decline – which is somewhat correlated with age, but with huge variance,” Dr. Rizzo said. “It is hard to say what an optimal age threshold for risk would be, and if 75 is it.”

U.S. crash data from the last decade points to drivers 80 and older as significantly more accident-prone than those in their 70s, or even late 70s, Dr. Rizzo noted. Moreover, “willingness to get on the road, number of miles driven, type of road (urban, rural, highway, commercial, residential), type of vehicle driven, traffic, and environment (day, night, weather), et cetera, are all factors to consider in driving risk and restriction,” he said.

Dr. Rizzo added that the 2010 AAN guidelines might need to be revisited in light of newer vehicle safety systems and automation.

Dr. Inada and colleagues’ study was funded by Japanese government grants, and Dr. Inada and his coauthors reported no financial conflicts of interest. Dr. Siren and Dr. Rizzo reported no financial conflicts of interest.
 

A mandatory cognitive screening policy targeting older drivers appeared to lower car crashes involving people over 70, according to results from a large population-based study using data from Japan.

But the same study, published in the Journal of the American Geriatrics Society, also reported a concurrent increase in pedestrian and cycling injuries, possibly because more older former drivers were getting around by alternative means. That finding echoed a 2012 study from Denmark, which also looked at the effects of an age-based cognitive screening policy for older drivers, and saw more fatal road injuries among older people who were not driving.

While some governments, including those of Denmark, Taiwan, and Japan, have implemented age-based cognitive screening for older drivers, there has been little evidence to date that such policies improve road safety. Guidelines issued in 2010 by the American Academy of Neurology discourage age-based screening, advising instead that people diagnosed with cognitive disorders be carefully evaluated for driving fitness and recommending one widely used scale, the Clinical Dementia Rating, as useful in identifying potentially unsafe drivers.
 

Japan’s national screening policy: Did it work?

The new study, led by Haruhiko Inada, MD, PhD, an epidemiologist at Johns Hopkins University in Baltimore, used national crash data from Japan, where since 2017 all drivers 75 and older not only must take cognitive tests measuring temporal orientation and memory at license renewal, but are also referred for medical evaluation if they fail them. People receiving a subsequent dementia diagnosis can have their licenses suspended or revoked.

Dr. Inada and his colleagues looked at national data from nearly 603,000 police-reported vehicle collisions and nearly 197,000 pedestrian or cyclist road injuries between March 2012 and December 2019, all involving people aged 70 and older. To assess the screening policy’s impact, the researchers calculated estimated monthly collision or injury incidence rates per 100,000 person-years. This way, they could “control for secular trends that were unaffected by the policy, such as the decreasing incidence of motor vehicle collisions year by year,” the researchers explained.

After the screening was implemented, cumulative estimated collisions among drivers 75 or older decreased by 3,670 (95% confidence interval, 5,125-2,104), while reported pedestrian or cyclist injuries increased by an estimated 959 (95% CI, 24-1,834). Dr. Inada and colleagues found that crashes declined among men but not women, noting also that more older men than women are licensed to drive in Japan. Pedestrian and cyclist injuries were highest among men aged 80-84, and women aged 80 and older.

“Cognitively screening older drivers at license renewal and promoting voluntary surrender of licenses may prevent motor vehicle collisions,” Dr. Inada and his colleagues concluded. “However, they are associated with an increase in road injuries for older pedestrians and cyclists. Future studies should examine the effectiveness of mitigation measures, such as alternative, safe transportation, and accommodations for pedestrians and cyclists.”
 

No definitive answers

Two investigators who have studied cognitive screening related to road safety were contacted for commentary on the study findings.

Anu Siren, PhD, professor of gerontology at Tampere (Finland) University, who in 2012 reported higher injuries after implementation of older-driver cognitive screening in Denmark, commented that the new study, while benefiting from a much larger data set than earlier studies, still “fails to show that decrease in collisions is because ‘unfit’ drivers were removed from the road. But it does confirm previous findings about how strict screening policies make people shift from cars to unprotected modes of transportation,” which are riskier.

In studies measuring driving safety, the usual definition of risk is incidents per exposure, Dr. Siren noted. In Dr. Inada and colleagues’ study, “the incident measure, or numerator, is the number of collisions. The exposure measure or denominator is population. Because the study uses population and not driver licenses (or distance traveled) as an exposure measure, the observed decrease in collisions does not say much about how the collision risk develops after the implementation of screening.”

Older driver screening “is likely to cause some older persons to cease from driving and probably continue to travel as unprotected road users,” Dr. Siren continued. “Similar to what we found [in 2012], the injury rates for pedestrians and cyclists went up after the introduction of screening, which suggests that screening indirectly causes increasing number of injuries among older unprotected road users.”

Matthew Rizzo, MD, professor and chair of the department of neurological sciences at the University of Nebraska Medical Center and codirector of the Nebraska Neuroscience Alliance in Omaha, Neb., and the lead author of the 2010 AAN guidelines on cognitive impairment and driving risk, cautioned against ageism in designing policies meant to protect motorists.

“We find some erratic/weak effects of age here and there, but the big effects we consistently find are from cognitive and visual decline – which is somewhat correlated with age, but with huge variance,” Dr. Rizzo said. “It is hard to say what an optimal age threshold for risk would be, and if 75 is it.”

U.S. crash data from the last decade points to drivers 80 and older as significantly more accident-prone than those in their 70s, or even late 70s, Dr. Rizzo noted. Moreover, “willingness to get on the road, number of miles driven, type of road (urban, rural, highway, commercial, residential), type of vehicle driven, traffic, and environment (day, night, weather), et cetera, are all factors to consider in driving risk and restriction,” he said.

Dr. Rizzo added that the 2010 AAN guidelines might need to be revisited in light of newer vehicle safety systems and automation.

Dr. Inada and colleagues’ study was funded by Japanese government grants, and Dr. Inada and his coauthors reported no financial conflicts of interest. Dr. Siren and Dr. Rizzo reported no financial conflicts of interest.
 

A mandatory cognitive screening policy targeting older drivers appeared to lower car crashes involving people over 70, according to results from a large population-based study using data from Japan.

But the same study, published in the Journal of the American Geriatrics Society, also reported a concurrent increase in pedestrian and cycling injuries, possibly because more older former drivers were getting around by alternative means. That finding echoed a 2012 study from Denmark, which also looked at the effects of an age-based cognitive screening policy for older drivers, and saw more fatal road injuries among older people who were not driving.

While some governments, including those of Denmark, Taiwan, and Japan, have implemented age-based cognitive screening for older drivers, there has been little evidence to date that such policies improve road safety. Guidelines issued in 2010 by the American Academy of Neurology discourage age-based screening, advising instead that people diagnosed with cognitive disorders be carefully evaluated for driving fitness and recommending one widely used scale, the Clinical Dementia Rating, as useful in identifying potentially unsafe drivers.
 

Japan’s national screening policy: Did it work?

The new study, led by Haruhiko Inada, MD, PhD, an epidemiologist at Johns Hopkins University in Baltimore, used national crash data from Japan, where since 2017 all drivers 75 and older not only must take cognitive tests measuring temporal orientation and memory at license renewal, but are also referred for medical evaluation if they fail them. People receiving a subsequent dementia diagnosis can have their licenses suspended or revoked.

Dr. Inada and his colleagues looked at national data from nearly 603,000 police-reported vehicle collisions and nearly 197,000 pedestrian or cyclist road injuries between March 2012 and December 2019, all involving people aged 70 and older. To assess the screening policy’s impact, the researchers calculated estimated monthly collision or injury incidence rates per 100,000 person-years. This way, they could “control for secular trends that were unaffected by the policy, such as the decreasing incidence of motor vehicle collisions year by year,” the researchers explained.

After the screening was implemented, cumulative estimated collisions among drivers 75 or older decreased by 3,670 (95% confidence interval, 5,125-2,104), while reported pedestrian or cyclist injuries increased by an estimated 959 (95% CI, 24-1,834). Dr. Inada and colleagues found that crashes declined among men but not women, noting also that more older men than women are licensed to drive in Japan. Pedestrian and cyclist injuries were highest among men aged 80-84, and women aged 80 and older.

“Cognitively screening older drivers at license renewal and promoting voluntary surrender of licenses may prevent motor vehicle collisions,” Dr. Inada and his colleagues concluded. “However, they are associated with an increase in road injuries for older pedestrians and cyclists. Future studies should examine the effectiveness of mitigation measures, such as alternative, safe transportation, and accommodations for pedestrians and cyclists.”
 

No definitive answers

Two investigators who have studied cognitive screening related to road safety were contacted for commentary on the study findings.

Anu Siren, PhD, professor of gerontology at Tampere (Finland) University, who in 2012 reported higher injuries after implementation of older-driver cognitive screening in Denmark, commented that the new study, while benefiting from a much larger data set than earlier studies, still “fails to show that decrease in collisions is because ‘unfit’ drivers were removed from the road. But it does confirm previous findings about how strict screening policies make people shift from cars to unprotected modes of transportation,” which are riskier.

In studies measuring driving safety, the usual definition of risk is incidents per exposure, Dr. Siren noted. In Dr. Inada and colleagues’ study, “the incident measure, or numerator, is the number of collisions. The exposure measure or denominator is population. Because the study uses population and not driver licenses (or distance traveled) as an exposure measure, the observed decrease in collisions does not say much about how the collision risk develops after the implementation of screening.”

Older driver screening “is likely to cause some older persons to cease from driving and probably continue to travel as unprotected road users,” Dr. Siren continued. “Similar to what we found [in 2012], the injury rates for pedestrians and cyclists went up after the introduction of screening, which suggests that screening indirectly causes increasing number of injuries among older unprotected road users.”

Matthew Rizzo, MD, professor and chair of the department of neurological sciences at the University of Nebraska Medical Center and codirector of the Nebraska Neuroscience Alliance in Omaha, Neb., and the lead author of the 2010 AAN guidelines on cognitive impairment and driving risk, cautioned against ageism in designing policies meant to protect motorists.

“We find some erratic/weak effects of age here and there, but the big effects we consistently find are from cognitive and visual decline – which is somewhat correlated with age, but with huge variance,” Dr. Rizzo said. “It is hard to say what an optimal age threshold for risk would be, and if 75 is it.”

U.S. crash data from the last decade points to drivers 80 and older as significantly more accident-prone than those in their 70s, or even late 70s, Dr. Rizzo noted. Moreover, “willingness to get on the road, number of miles driven, type of road (urban, rural, highway, commercial, residential), type of vehicle driven, traffic, and environment (day, night, weather), et cetera, are all factors to consider in driving risk and restriction,” he said.

Dr. Rizzo added that the 2010 AAN guidelines might need to be revisited in light of newer vehicle safety systems and automation.

Dr. Inada and colleagues’ study was funded by Japanese government grants, and Dr. Inada and his coauthors reported no financial conflicts of interest. Dr. Siren and Dr. Rizzo reported no financial conflicts of interest.
 

Sticks and stones may break my bones, but clots will never hurt me

You’ve probably seen “Ghostbusters” or at least heard the theme song. Maybe you even know about the Discovery Channel’s “Mythbusters.” But now there’s a new buster in town, and it eats platitudes for breakfast: Meet Cliche-busters, LOTME’s new recurring feature.

This week, Cliche-busters takes on “Two wrongs don’t make a right.” Yum.

We start with blood clots, which are bad. Doctors go to a lot of trouble to get rid of the things because they are dangerous. A blood clot, then, is a bodily function gone wrong.

Tornadoes are also bad. Out there in the world, these violently rotating columns of air can destroy buildings, toss large objects long distances, and inspire mediocre action movies. They are examples of nature gone wrong.

Seemingly, these two wrongs – blood clots and tornadoes – are not about to make a right. Has Cliche-busters bitten off more than it can chew?

Not according to Xiaoning Jiang of North Carolina State University, Raleigh, and his team of researchers. They’ve figured out a way to use a tiny ultrasonic tornado to break down clots in the brain. “Our new work uses vortex ultrasound, where the ultrasound waves have a helical wavefront. In other words, the ultrasound is swirling as it moves forward,” he said in a statement from the university.

Xiaoning Jiang and Chengzhi Shi

Their new tool’s single transducer is small enough to fit in a catheter, and its “vortex ultrasound-induced shear force has the potential to break down clots safely and improve the efficacy of thrombolysis,” they explained in the open-access journal Research.

The investigators used cow blood in a 3D-printed model of the cerebral venous sinus for the proof-of-concept study and were able to dissolve an acute blood clot in less than 30 minutes, compared with the 15-30 hours needed with a pharmaceutical intervention, according to the written statement.

Can you hear the sound of two wrongs making a right? We can, and that closes the curtain on this cliche.
 

With age does not come wisdom

We’ve all met this person before. The sort of person who takes a 10-minute IQ test on a shifty-looking website and then proceeds to brag about a 180 IQ until the heat death of the universe. The one who worships at the altar of Mensa. Yeah, that guy. They’re never as smart as they think they are, but they’ll never, ever admit it.

It’s not exactly a secret that IQ as a measurement of intelligence is highly overrated. A lot of scientists doubt we should bother measuring it at all. That said, a higher IQ is associated with greater success in academic and financial endeavors, so it’s not absolutely worthless. And if we’re stuck with it, we may as well study it.

That brings us neatly to new research published in Brain and Behavior. Most studies into IQ and self-estimated intelligence have focused on younger adults, and the author of this study was curious if the stereotype of young men inflating their IQ, a stereotype backed up by research, persisted into older adulthood. So she conducted a survey of 159 younger adults and 152 older adults to find out.

Wavebreakmedia Ltd/Thinkstock

The results in younger adults were not surprising: Younger men overestimated their actual IQ by 5-15 points, which tracks with previous research. We’re in for a bit of a surprise with the older adults, though, because the older men were more humble about their intelligence, with their estimation falling in line with their actual IQ. Older women, however, not so much. In fact, they overestimated their intelligence just as much as the younger men.

In addition, older women who perceived themselves as more attractive reported the highest self-estimated intelligence of all. That isn’t how intelligence works, but honestly, if Grandma’s out and about thinking she looks good and has the brains to go and win “Jeopardy!” do you really have the heart to tell her otherwise?
 

Fight temptation with empathy … and shoes

Relationships are tough. They all go through their respective ups and downs, but what happens when one person is feeling so down in the partnership that cheating comes to mind? Is there any way to stop it from happening?

Rawpixel

Well, a recent study suggests that there is, and it’s as simple as putting yourself in the other person’s shoes. By observing 408 heterosexual, monogamous participants in a series of experiments, psychologists in Israel and New York found that practicing empathy and “perspective taking” doesn’t necessarily stop people from cheating but it does reduces the desire.

People cheat on their significant others for many different reasons – men for a lack of sexual needs being met and women for shortfalls regarding emotional needs – but prioritizing the other person’s perspective gives the idea of being unfaithful a different view and could make one act differently, the investigators said.

Perspective taking also promotes other positive attributes to the relationship, such as the promotion of compassion and the feeling of being understood, lead author Gurit Birnbaum of Reichman University in Herzliya, Israel, said in a written statement. These things ultimately help couples navigate the rough patches and strengthen bonds, making them even less likely to cheat.

The researchers noted that even people in satisfying relationships do cheat, but this approach does encourage people to stop and think before they act. It could ultimately prevent what might be a huge mistake.

Think before they act. Hmm, that’s kind of like look before they leap, right? Sounds like a job for the Cliche-busters.

Sticks and stones may break my bones, but clots will never hurt me

You’ve probably seen “Ghostbusters” or at least heard the theme song. Maybe you even know about the Discovery Channel’s “Mythbusters.” But now there’s a new buster in town, and it eats platitudes for breakfast: Meet Cliche-busters, LOTME’s new recurring feature.

This week, Cliche-busters takes on “Two wrongs don’t make a right.” Yum.

We start with blood clots, which are bad. Doctors go to a lot of trouble to get rid of the things because they are dangerous. A blood clot, then, is a bodily function gone wrong.

Tornadoes are also bad. Out there in the world, these violently rotating columns of air can destroy buildings, toss large objects long distances, and inspire mediocre action movies. They are examples of nature gone wrong.

Seemingly, these two wrongs – blood clots and tornadoes – are not about to make a right. Has Cliche-busters bitten off more than it can chew?

Not according to Xiaoning Jiang of North Carolina State University, Raleigh, and his team of researchers. They’ve figured out a way to use a tiny ultrasonic tornado to break down clots in the brain. “Our new work uses vortex ultrasound, where the ultrasound waves have a helical wavefront. In other words, the ultrasound is swirling as it moves forward,” he said in a statement from the university.

Xiaoning Jiang and Chengzhi Shi

Their new tool’s single transducer is small enough to fit in a catheter, and its “vortex ultrasound-induced shear force has the potential to break down clots safely and improve the efficacy of thrombolysis,” they explained in the open-access journal Research.

The investigators used cow blood in a 3D-printed model of the cerebral venous sinus for the proof-of-concept study and were able to dissolve an acute blood clot in less than 30 minutes, compared with the 15-30 hours needed with a pharmaceutical intervention, according to the written statement.

Can you hear the sound of two wrongs making a right? We can, and that closes the curtain on this cliche.
 

With age does not come wisdom

We’ve all met this person before. The sort of person who takes a 10-minute IQ test on a shifty-looking website and then proceeds to brag about a 180 IQ until the heat death of the universe. The one who worships at the altar of Mensa. Yeah, that guy. They’re never as smart as they think they are, but they’ll never, ever admit it.

It’s not exactly a secret that IQ as a measurement of intelligence is highly overrated. A lot of scientists doubt we should bother measuring it at all. That said, a higher IQ is associated with greater success in academic and financial endeavors, so it’s not absolutely worthless. And if we’re stuck with it, we may as well study it.

That brings us neatly to new research published in Brain and Behavior. Most studies into IQ and self-estimated intelligence have focused on younger adults, and the author of this study was curious if the stereotype of young men inflating their IQ, a stereotype backed up by research, persisted into older adulthood. So she conducted a survey of 159 younger adults and 152 older adults to find out.

Wavebreakmedia Ltd/Thinkstock

The results in younger adults were not surprising: Younger men overestimated their actual IQ by 5-15 points, which tracks with previous research. We’re in for a bit of a surprise with the older adults, though, because the older men were more humble about their intelligence, with their estimation falling in line with their actual IQ. Older women, however, not so much. In fact, they overestimated their intelligence just as much as the younger men.

In addition, older women who perceived themselves as more attractive reported the highest self-estimated intelligence of all. That isn’t how intelligence works, but honestly, if Grandma’s out and about thinking she looks good and has the brains to go and win “Jeopardy!” do you really have the heart to tell her otherwise?
 

Fight temptation with empathy … and shoes

Relationships are tough. They all go through their respective ups and downs, but what happens when one person is feeling so down in the partnership that cheating comes to mind? Is there any way to stop it from happening?

Rawpixel

Well, a recent study suggests that there is, and it’s as simple as putting yourself in the other person’s shoes. By observing 408 heterosexual, monogamous participants in a series of experiments, psychologists in Israel and New York found that practicing empathy and “perspective taking” doesn’t necessarily stop people from cheating but it does reduces the desire.

People cheat on their significant others for many different reasons – men for a lack of sexual needs being met and women for shortfalls regarding emotional needs – but prioritizing the other person’s perspective gives the idea of being unfaithful a different view and could make one act differently, the investigators said.

Perspective taking also promotes other positive attributes to the relationship, such as the promotion of compassion and the feeling of being understood, lead author Gurit Birnbaum of Reichman University in Herzliya, Israel, said in a written statement. These things ultimately help couples navigate the rough patches and strengthen bonds, making them even less likely to cheat.

The researchers noted that even people in satisfying relationships do cheat, but this approach does encourage people to stop and think before they act. It could ultimately prevent what might be a huge mistake.

Think before they act. Hmm, that’s kind of like look before they leap, right? Sounds like a job for the Cliche-busters.

Sticks and stones may break my bones, but clots will never hurt me

You’ve probably seen “Ghostbusters” or at least heard the theme song. Maybe you even know about the Discovery Channel’s “Mythbusters.” But now there’s a new buster in town, and it eats platitudes for breakfast: Meet Cliche-busters, LOTME’s new recurring feature.

This week, Cliche-busters takes on “Two wrongs don’t make a right.” Yum.

We start with blood clots, which are bad. Doctors go to a lot of trouble to get rid of the things because they are dangerous. A blood clot, then, is a bodily function gone wrong.

Tornadoes are also bad. Out there in the world, these violently rotating columns of air can destroy buildings, toss large objects long distances, and inspire mediocre action movies. They are examples of nature gone wrong.

Seemingly, these two wrongs – blood clots and tornadoes – are not about to make a right. Has Cliche-busters bitten off more than it can chew?

Not according to Xiaoning Jiang of North Carolina State University, Raleigh, and his team of researchers. They’ve figured out a way to use a tiny ultrasonic tornado to break down clots in the brain. “Our new work uses vortex ultrasound, where the ultrasound waves have a helical wavefront. In other words, the ultrasound is swirling as it moves forward,” he said in a statement from the university.

Xiaoning Jiang and Chengzhi Shi

Their new tool’s single transducer is small enough to fit in a catheter, and its “vortex ultrasound-induced shear force has the potential to break down clots safely and improve the efficacy of thrombolysis,” they explained in the open-access journal Research.

The investigators used cow blood in a 3D-printed model of the cerebral venous sinus for the proof-of-concept study and were able to dissolve an acute blood clot in less than 30 minutes, compared with the 15-30 hours needed with a pharmaceutical intervention, according to the written statement.

Can you hear the sound of two wrongs making a right? We can, and that closes the curtain on this cliche.
 

With age does not come wisdom

We’ve all met this person before. The sort of person who takes a 10-minute IQ test on a shifty-looking website and then proceeds to brag about a 180 IQ until the heat death of the universe. The one who worships at the altar of Mensa. Yeah, that guy. They’re never as smart as they think they are, but they’ll never, ever admit it.

It’s not exactly a secret that IQ as a measurement of intelligence is highly overrated. A lot of scientists doubt we should bother measuring it at all. That said, a higher IQ is associated with greater success in academic and financial endeavors, so it’s not absolutely worthless. And if we’re stuck with it, we may as well study it.

That brings us neatly to new research published in Brain and Behavior. Most studies into IQ and self-estimated intelligence have focused on younger adults, and the author of this study was curious if the stereotype of young men inflating their IQ, a stereotype backed up by research, persisted into older adulthood. So she conducted a survey of 159 younger adults and 152 older adults to find out.

Wavebreakmedia Ltd/Thinkstock

The results in younger adults were not surprising: Younger men overestimated their actual IQ by 5-15 points, which tracks with previous research. We’re in for a bit of a surprise with the older adults, though, because the older men were more humble about their intelligence, with their estimation falling in line with their actual IQ. Older women, however, not so much. In fact, they overestimated their intelligence just as much as the younger men.

In addition, older women who perceived themselves as more attractive reported the highest self-estimated intelligence of all. That isn’t how intelligence works, but honestly, if Grandma’s out and about thinking she looks good and has the brains to go and win “Jeopardy!” do you really have the heart to tell her otherwise?
 

Fight temptation with empathy … and shoes

Relationships are tough. They all go through their respective ups and downs, but what happens when one person is feeling so down in the partnership that cheating comes to mind? Is there any way to stop it from happening?

Rawpixel

Well, a recent study suggests that there is, and it’s as simple as putting yourself in the other person’s shoes. By observing 408 heterosexual, monogamous participants in a series of experiments, psychologists in Israel and New York found that practicing empathy and “perspective taking” doesn’t necessarily stop people from cheating but it does reduces the desire.

People cheat on their significant others for many different reasons – men for a lack of sexual needs being met and women for shortfalls regarding emotional needs – but prioritizing the other person’s perspective gives the idea of being unfaithful a different view and could make one act differently, the investigators said.

Perspective taking also promotes other positive attributes to the relationship, such as the promotion of compassion and the feeling of being understood, lead author Gurit Birnbaum of Reichman University in Herzliya, Israel, said in a written statement. These things ultimately help couples navigate the rough patches and strengthen bonds, making them even less likely to cheat.

The researchers noted that even people in satisfying relationships do cheat, but this approach does encourage people to stop and think before they act. It could ultimately prevent what might be a huge mistake.

Think before they act. Hmm, that’s kind of like look before they leap, right? Sounds like a job for the Cliche-busters.

People with autism are more likely to face diabetes, high cholesterol, and heart disease than those without the neurologic condition, according to a study published in JAMA Pediatrics. Researchers also found that children with autism are especially likely to develop diabetes compared with their peers, and are at greater risk of hypertension, too.

While the link between autism and risk for obesity and gastrointestinal ailments is well-established, the new findings suggest that clinicians who care for these patients – particularly children – should focus on cardiometabolic health more broadly.

“Clinicians who are treating kids with autism need to pay more attention to this,” said Chanaka N. Kahathuduwa, MD, PhD, MPhil, of the department of neurology at Texas Tech University Health Sciences Center, in Lubbock, and a coauthor of the new study.

A pediatrician may prescribe an atypical antipsychotic medication such as risperidone to regulate the behavior of an autistic child, Dr. Kahathuduwa said, which may increase their cholesterol levels. Although this or similar drugs may be necessary in some cases, Dr. Kahathuduwa advised that clinicians explore other treatment options first.
 

Mining data from previously published studies

For the new analysis, Dr. Kahathuduwa and his colleagues pooled the results of 34 previously published studies, which included medical records of more than 276,000 people with autism and close to 8 million people without the condition.

Study participants were an average age of 31 years, and 47% were female. Some studies reported age ranges that enabled the researchers to differentiate between children and adults.

People with autism were 64% more likely to develop type 1 diabetes, 146% more likely to experience type 2 diabetes, and 46% more likely to have heart disease, overall, the study found. Children with autism were almost twice as likely as their peers to develop diabetes (184%) and high blood pressure (154%).

The study found associations, not causation, and does not include detailed data about medication prescribing patterns. While it would be ideal to understand why autism is linked to cardiometabolic risk, to address the link most effectively, Dr. Kahathuduwa said the causes likely are multifactorial. Medication history and genetics each play a role in a way that is hard to untangle. Even so, Dr. Kahathuduwa said he hoped the findings prompt clinicians to reevaluate how they treat their patients with autism.

“This may be an eye opener,” he said.

An editorial accompanying the study noted that people with autism may die up to 30 years earlier than people without autism, in part because of the physical health problems surfaced in the new research. They also are more likely than others to attempt suicide.

Elizabeth M. Weir, PhD, of the Autism Research Centre at the University of Cambridge (England) and author of the editorial, argued that current health delivery models often fail autistic people by not taking their needs into account.

Dr. Weir told this news organization that making adjustments such as dimming the lights for a light-sensitive patient or allowing people with autism to bring an advocate to appointments could build rapport.

“I diagnose autism pretty much every day and I know families get so overwhelmed with all the recommendations that we give,” said Sonia Monteiro, MD, a developmental and behavioral pediatrician at Texas Children’s Hospital in Houston. Still, Dr. Monteiro said clinicians should help parents of children with autism address the potential long-term cardiovascular risks – but to do so by layering in the information rather than merely adding more bullet points to an already long presentation.

“We know this information now, but finding a way to share that with families without overwhelming them even more, I think is challenging,” Dr. Monteiro said. “But it’s not something we can ignore.”

Dr. Kahathuduwa, Dr. Weir, and Dr. Monteiro report no relevant financial relationships.

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

People with autism are more likely to face diabetes, high cholesterol, and heart disease than those without the neurologic condition, according to a study published in JAMA Pediatrics. Researchers also found that children with autism are especially likely to develop diabetes compared with their peers, and are at greater risk of hypertension, too.

While the link between autism and risk for obesity and gastrointestinal ailments is well-established, the new findings suggest that clinicians who care for these patients – particularly children – should focus on cardiometabolic health more broadly.

“Clinicians who are treating kids with autism need to pay more attention to this,” said Chanaka N. Kahathuduwa, MD, PhD, MPhil, of the department of neurology at Texas Tech University Health Sciences Center, in Lubbock, and a coauthor of the new study.

A pediatrician may prescribe an atypical antipsychotic medication such as risperidone to regulate the behavior of an autistic child, Dr. Kahathuduwa said, which may increase their cholesterol levels. Although this or similar drugs may be necessary in some cases, Dr. Kahathuduwa advised that clinicians explore other treatment options first.
 

Mining data from previously published studies

For the new analysis, Dr. Kahathuduwa and his colleagues pooled the results of 34 previously published studies, which included medical records of more than 276,000 people with autism and close to 8 million people without the condition.

Study participants were an average age of 31 years, and 47% were female. Some studies reported age ranges that enabled the researchers to differentiate between children and adults.

People with autism were 64% more likely to develop type 1 diabetes, 146% more likely to experience type 2 diabetes, and 46% more likely to have heart disease, overall, the study found. Children with autism were almost twice as likely as their peers to develop diabetes (184%) and high blood pressure (154%).

The study found associations, not causation, and does not include detailed data about medication prescribing patterns. While it would be ideal to understand why autism is linked to cardiometabolic risk, to address the link most effectively, Dr. Kahathuduwa said the causes likely are multifactorial. Medication history and genetics each play a role in a way that is hard to untangle. Even so, Dr. Kahathuduwa said he hoped the findings prompt clinicians to reevaluate how they treat their patients with autism.

“This may be an eye opener,” he said.

An editorial accompanying the study noted that people with autism may die up to 30 years earlier than people without autism, in part because of the physical health problems surfaced in the new research. They also are more likely than others to attempt suicide.

Elizabeth M. Weir, PhD, of the Autism Research Centre at the University of Cambridge (England) and author of the editorial, argued that current health delivery models often fail autistic people by not taking their needs into account.

Dr. Weir told this news organization that making adjustments such as dimming the lights for a light-sensitive patient or allowing people with autism to bring an advocate to appointments could build rapport.

“I diagnose autism pretty much every day and I know families get so overwhelmed with all the recommendations that we give,” said Sonia Monteiro, MD, a developmental and behavioral pediatrician at Texas Children’s Hospital in Houston. Still, Dr. Monteiro said clinicians should help parents of children with autism address the potential long-term cardiovascular risks – but to do so by layering in the information rather than merely adding more bullet points to an already long presentation.

“We know this information now, but finding a way to share that with families without overwhelming them even more, I think is challenging,” Dr. Monteiro said. “But it’s not something we can ignore.”

Dr. Kahathuduwa, Dr. Weir, and Dr. Monteiro report no relevant financial relationships.

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

People with autism are more likely to face diabetes, high cholesterol, and heart disease than those without the neurologic condition, according to a study published in JAMA Pediatrics. Researchers also found that children with autism are especially likely to develop diabetes compared with their peers, and are at greater risk of hypertension, too.

While the link between autism and risk for obesity and gastrointestinal ailments is well-established, the new findings suggest that clinicians who care for these patients – particularly children – should focus on cardiometabolic health more broadly.

“Clinicians who are treating kids with autism need to pay more attention to this,” said Chanaka N. Kahathuduwa, MD, PhD, MPhil, of the department of neurology at Texas Tech University Health Sciences Center, in Lubbock, and a coauthor of the new study.

A pediatrician may prescribe an atypical antipsychotic medication such as risperidone to regulate the behavior of an autistic child, Dr. Kahathuduwa said, which may increase their cholesterol levels. Although this or similar drugs may be necessary in some cases, Dr. Kahathuduwa advised that clinicians explore other treatment options first.
 

Mining data from previously published studies

For the new analysis, Dr. Kahathuduwa and his colleagues pooled the results of 34 previously published studies, which included medical records of more than 276,000 people with autism and close to 8 million people without the condition.

Study participants were an average age of 31 years, and 47% were female. Some studies reported age ranges that enabled the researchers to differentiate between children and adults.

People with autism were 64% more likely to develop type 1 diabetes, 146% more likely to experience type 2 diabetes, and 46% more likely to have heart disease, overall, the study found. Children with autism were almost twice as likely as their peers to develop diabetes (184%) and high blood pressure (154%).

The study found associations, not causation, and does not include detailed data about medication prescribing patterns. While it would be ideal to understand why autism is linked to cardiometabolic risk, to address the link most effectively, Dr. Kahathuduwa said the causes likely are multifactorial. Medication history and genetics each play a role in a way that is hard to untangle. Even so, Dr. Kahathuduwa said he hoped the findings prompt clinicians to reevaluate how they treat their patients with autism.

“This may be an eye opener,” he said.

An editorial accompanying the study noted that people with autism may die up to 30 years earlier than people without autism, in part because of the physical health problems surfaced in the new research. They also are more likely than others to attempt suicide.

Elizabeth M. Weir, PhD, of the Autism Research Centre at the University of Cambridge (England) and author of the editorial, argued that current health delivery models often fail autistic people by not taking their needs into account.

Dr. Weir told this news organization that making adjustments such as dimming the lights for a light-sensitive patient or allowing people with autism to bring an advocate to appointments could build rapport.

“I diagnose autism pretty much every day and I know families get so overwhelmed with all the recommendations that we give,” said Sonia Monteiro, MD, a developmental and behavioral pediatrician at Texas Children’s Hospital in Houston. Still, Dr. Monteiro said clinicians should help parents of children with autism address the potential long-term cardiovascular risks – but to do so by layering in the information rather than merely adding more bullet points to an already long presentation.

“We know this information now, but finding a way to share that with families without overwhelming them even more, I think is challenging,” Dr. Monteiro said. “But it’s not something we can ignore.”

Dr. Kahathuduwa, Dr. Weir, and Dr. Monteiro report no relevant financial relationships.

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

Misinformation regarding COVID-19 has been cited as a public health threat since the beginning of the worldwide pandemic. Doctors and professional organizations are standing guard, hoping to protect patients from any harm that results from mistruths spread by colleagues.

Case in point: Several physicians and the American Board of Pathology filed complaints with Washington and Idaho medical boards alleging that Ryan Cole, MD, a board-certified pathologist who practices in Boise, Idaho, but who also holds a license in Washington, has spread antivaccine and pro-ivermectin statements on social media. Dr. Cole is one of the founders of America’s Frontline Doctors, a right-wing political organization. Dr. Cole did not respond to a request for comment.

Gary W. Procop, MD, CEO, American Board of Pathology, told this news organization that “as physicians and board-certified pathologists, we have a public trust, and we must be accountable to patients, society, and the profession. Misinformation can cause real harm to patients, which may include death. Misinformation diverts patients away from lifesaving vaccination and other preventive measures, promotes viral transmission, and recommends ineffective therapies that may be toxic instead of evidence-based medical care.”
 

Cavalcade of complaints

Several doctors also chimed in with formal complaints alleging that Cole is spreading unreliable information, according to a report from KTVB News. For example, a Boise doctor wrote in his complaint that Dr. Cole is “a major purveyor of misinformation” and called it “amazing” that the physician was continuing to publicly support debunked information about COVID-19 more than a year into the pandemic. The doctor also stated, “Cole is a health menace, abusing his status as a physician to mislead the public.”

As a result of such complaints, the Washington medical board has charged Cole with COVID-19–related violations. It is unclear whether or not the Idaho medical board will sanction the doctor. At least 12 medical boards have sanctioned doctors for similar violations since the start of the pandemic.

The statement of charges from the Washington medical board contends that since March 2021, Dr. Cole has made numerous misleading statements regarding the COVID-19 pandemic, vaccines, the use of ivermectin to treat COVID-19, and the effectiveness of masks.

In addition, the statement alleges that Dr. Cole treated several COVID-19 patients via telemedicine. During these sessions, he prescribed ivermectin, an antiparasite drug that has not been found to have any effectiveness in treating, curing, or preventing COVID-19. One of the patients died after receiving this treatment, according to the complaint.

Citing a study published in the New England Journal of Medicine, Dr. Procop pointed out that use of ivermectin, which is not approved by the U.S. Food and Drug Administration to treat COVID-19, is particularly troubling.

“There is a concern whenever an ineffective treatment is prescribed when more effective and scientifically proven therapies are available. Therapeutics have potential side effects, and toxicities have been associated with the use of ivermectin,” Dr. Procop said. “The benefits of therapy should always outweigh the risks of treatment.”

If the Washington medical board finds that Dr. Cole has engaged in unprofessional conduct, possible sanctions include revocation or suspension of his license. Washington state law also provides for a range of other possible sanctions, including restriction or limitation of his practice, requiring that he complete a specific program of remedial education or treatment, monitoring of his practice, censure or reprimand, probation, a fine of up to $5,000 for each violation, or refunding fees that his practice has billed to and collected from patients. Dr. Cole had until January 30 to respond to the medical board’s statement.

“The American Board of Pathology supports the actions of the Washington State Medical Board regarding their inquiries into any physician that holds license in their state who makes false and misleading medical claims, or provides medical care beyond their scope of practice, as indicated by their training,” Dr. Procop said.
 

Law in limbo

While medical boards are seeking to sanction professionals who spread falsehoods, the pause button has been hit on the California law that allows regulators to punish doctors for spreading false information about COVID-19 vaccinations and treatments.

The law went into effect Jan. 1 but was temporarily halted when U.S. District Judge William B. Shubb of the Eastern District of California granted a preliminary injunction against the law on Jan. 25, according to a report in the Sacramento Bee.

Mr. Shubb said the measure’s definition of “misinformation” was “unconstitutionally vague” under the due process clause of the 14th Amendment. He also criticized the law’s definition of “misinformation” as being “grammatically incoherent.”

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

Misinformation regarding COVID-19 has been cited as a public health threat since the beginning of the worldwide pandemic. Doctors and professional organizations are standing guard, hoping to protect patients from any harm that results from mistruths spread by colleagues.

Case in point: Several physicians and the American Board of Pathology filed complaints with Washington and Idaho medical boards alleging that Ryan Cole, MD, a board-certified pathologist who practices in Boise, Idaho, but who also holds a license in Washington, has spread antivaccine and pro-ivermectin statements on social media. Dr. Cole is one of the founders of America’s Frontline Doctors, a right-wing political organization. Dr. Cole did not respond to a request for comment.

Gary W. Procop, MD, CEO, American Board of Pathology, told this news organization that “as physicians and board-certified pathologists, we have a public trust, and we must be accountable to patients, society, and the profession. Misinformation can cause real harm to patients, which may include death. Misinformation diverts patients away from lifesaving vaccination and other preventive measures, promotes viral transmission, and recommends ineffective therapies that may be toxic instead of evidence-based medical care.”
 

Cavalcade of complaints

Several doctors also chimed in with formal complaints alleging that Cole is spreading unreliable information, according to a report from KTVB News. For example, a Boise doctor wrote in his complaint that Dr. Cole is “a major purveyor of misinformation” and called it “amazing” that the physician was continuing to publicly support debunked information about COVID-19 more than a year into the pandemic. The doctor also stated, “Cole is a health menace, abusing his status as a physician to mislead the public.”

As a result of such complaints, the Washington medical board has charged Cole with COVID-19–related violations. It is unclear whether or not the Idaho medical board will sanction the doctor. At least 12 medical boards have sanctioned doctors for similar violations since the start of the pandemic.

The statement of charges from the Washington medical board contends that since March 2021, Dr. Cole has made numerous misleading statements regarding the COVID-19 pandemic, vaccines, the use of ivermectin to treat COVID-19, and the effectiveness of masks.

In addition, the statement alleges that Dr. Cole treated several COVID-19 patients via telemedicine. During these sessions, he prescribed ivermectin, an antiparasite drug that has not been found to have any effectiveness in treating, curing, or preventing COVID-19. One of the patients died after receiving this treatment, according to the complaint.

Citing a study published in the New England Journal of Medicine, Dr. Procop pointed out that use of ivermectin, which is not approved by the U.S. Food and Drug Administration to treat COVID-19, is particularly troubling.

“There is a concern whenever an ineffective treatment is prescribed when more effective and scientifically proven therapies are available. Therapeutics have potential side effects, and toxicities have been associated with the use of ivermectin,” Dr. Procop said. “The benefits of therapy should always outweigh the risks of treatment.”

If the Washington medical board finds that Dr. Cole has engaged in unprofessional conduct, possible sanctions include revocation or suspension of his license. Washington state law also provides for a range of other possible sanctions, including restriction or limitation of his practice, requiring that he complete a specific program of remedial education or treatment, monitoring of his practice, censure or reprimand, probation, a fine of up to $5,000 for each violation, or refunding fees that his practice has billed to and collected from patients. Dr. Cole had until January 30 to respond to the medical board’s statement.

“The American Board of Pathology supports the actions of the Washington State Medical Board regarding their inquiries into any physician that holds license in their state who makes false and misleading medical claims, or provides medical care beyond their scope of practice, as indicated by their training,” Dr. Procop said.
 

Law in limbo

While medical boards are seeking to sanction professionals who spread falsehoods, the pause button has been hit on the California law that allows regulators to punish doctors for spreading false information about COVID-19 vaccinations and treatments.

The law went into effect Jan. 1 but was temporarily halted when U.S. District Judge William B. Shubb of the Eastern District of California granted a preliminary injunction against the law on Jan. 25, according to a report in the Sacramento Bee.

Mr. Shubb said the measure’s definition of “misinformation” was “unconstitutionally vague” under the due process clause of the 14th Amendment. He also criticized the law’s definition of “misinformation” as being “grammatically incoherent.”

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

Misinformation regarding COVID-19 has been cited as a public health threat since the beginning of the worldwide pandemic. Doctors and professional organizations are standing guard, hoping to protect patients from any harm that results from mistruths spread by colleagues.

Case in point: Several physicians and the American Board of Pathology filed complaints with Washington and Idaho medical boards alleging that Ryan Cole, MD, a board-certified pathologist who practices in Boise, Idaho, but who also holds a license in Washington, has spread antivaccine and pro-ivermectin statements on social media. Dr. Cole is one of the founders of America’s Frontline Doctors, a right-wing political organization. Dr. Cole did not respond to a request for comment.

Gary W. Procop, MD, CEO, American Board of Pathology, told this news organization that “as physicians and board-certified pathologists, we have a public trust, and we must be accountable to patients, society, and the profession. Misinformation can cause real harm to patients, which may include death. Misinformation diverts patients away from lifesaving vaccination and other preventive measures, promotes viral transmission, and recommends ineffective therapies that may be toxic instead of evidence-based medical care.”
 

Cavalcade of complaints

Several doctors also chimed in with formal complaints alleging that Cole is spreading unreliable information, according to a report from KTVB News. For example, a Boise doctor wrote in his complaint that Dr. Cole is “a major purveyor of misinformation” and called it “amazing” that the physician was continuing to publicly support debunked information about COVID-19 more than a year into the pandemic. The doctor also stated, “Cole is a health menace, abusing his status as a physician to mislead the public.”

As a result of such complaints, the Washington medical board has charged Cole with COVID-19–related violations. It is unclear whether or not the Idaho medical board will sanction the doctor. At least 12 medical boards have sanctioned doctors for similar violations since the start of the pandemic.

The statement of charges from the Washington medical board contends that since March 2021, Dr. Cole has made numerous misleading statements regarding the COVID-19 pandemic, vaccines, the use of ivermectin to treat COVID-19, and the effectiveness of masks.

In addition, the statement alleges that Dr. Cole treated several COVID-19 patients via telemedicine. During these sessions, he prescribed ivermectin, an antiparasite drug that has not been found to have any effectiveness in treating, curing, or preventing COVID-19. One of the patients died after receiving this treatment, according to the complaint.

Citing a study published in the New England Journal of Medicine, Dr. Procop pointed out that use of ivermectin, which is not approved by the U.S. Food and Drug Administration to treat COVID-19, is particularly troubling.

“There is a concern whenever an ineffective treatment is prescribed when more effective and scientifically proven therapies are available. Therapeutics have potential side effects, and toxicities have been associated with the use of ivermectin,” Dr. Procop said. “The benefits of therapy should always outweigh the risks of treatment.”

If the Washington medical board finds that Dr. Cole has engaged in unprofessional conduct, possible sanctions include revocation or suspension of his license. Washington state law also provides for a range of other possible sanctions, including restriction or limitation of his practice, requiring that he complete a specific program of remedial education or treatment, monitoring of his practice, censure or reprimand, probation, a fine of up to $5,000 for each violation, or refunding fees that his practice has billed to and collected from patients. Dr. Cole had until January 30 to respond to the medical board’s statement.

“The American Board of Pathology supports the actions of the Washington State Medical Board regarding their inquiries into any physician that holds license in their state who makes false and misleading medical claims, or provides medical care beyond their scope of practice, as indicated by their training,” Dr. Procop said.
 

Law in limbo

While medical boards are seeking to sanction professionals who spread falsehoods, the pause button has been hit on the California law that allows regulators to punish doctors for spreading false information about COVID-19 vaccinations and treatments.

The law went into effect Jan. 1 but was temporarily halted when U.S. District Judge William B. Shubb of the Eastern District of California granted a preliminary injunction against the law on Jan. 25, according to a report in the Sacramento Bee.

Mr. Shubb said the measure’s definition of “misinformation” was “unconstitutionally vague” under the due process clause of the 14th Amendment. He also criticized the law’s definition of “misinformation” as being “grammatically incoherent.”

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

Brain atrophy patterns are similar in individuals with obesity and those with Alzheimer’s disease (AD), a new study shows.

Comparisons of MRI scans for more than 1,000 participants indicate correlations between the two conditions, especially in areas of gray matter thinning, suggesting that managing excess weight might slow cognitive decline and lower the risk for AD, according to the researchers.

However, brain maps of obesity did not correlate with maps of amyloid or tau protein accumulation.

“The fact that obesity-related brain atrophy did not correlate with the distribution of amyloid and tau proteins in AD was not what we expected,” study author Filip Morys, PhD, a postdoctoral researcher at McGill University, Montreal, said in an interview. “But it might just show that the specific mechanisms underpinning obesity- and Alzheimer’s disease–related neurodegeneration are different. This remains to be confirmed.”

The study was published in the Journal of Alzheimer’s Disease.
 

Cortical Thinning

The current study was prompted by the team’s earlier study, which showed that obesity-related neurodegeneration patterns were visually similar to those of AD, said Dr. Morys. “It was known previously that obesity is a risk factor for AD, but we wanted to directly compare brain atrophy patterns in both, which is what we did in this new study.”

The researchers analyzed data from a pooled sample of more than 1,300 participants. From the ADNI database, the researchers selected participants with AD and age- and sex-matched cognitively healthy controls. From the UK Biobank, the researchers drew a sample of lean, overweight, and obese participants without neurologic disease.

To determine how the weight status of patients with AD affects the correspondence between AD and obesity maps, they categorized participants with AD and healthy controls from the ADNI database into lean, overweight, and obese subgroups.

Then, to investigate mechanisms that might drive the similarities between obesity-related brain atrophy and AD-related amyloid-beta accumulation, they looked for overlapping areas in PET brain maps between patients with these outcomes.

The investigations showed that obesity maps were highly correlated with AD maps, but not with amyloid-beta or tau protein maps. The researchers also found significant correlations between obesity and the lean individuals with AD.

Brain regions with the highest similarities between obesity and AD were located mainly in the left temporal and bilateral prefrontal cortices.

“Our research confirms that obesity-related gray matter atrophy resembles that of AD,” the authors concluded. “Excess weight management could lead to improved health outcomes, slow down cognitive decline in aging, and lower the risk for AD.”

Upcoming research “will focus on investigating how weight loss can affect the risk for AD, other dementias, and cognitive decline in general,” said Dr. Morys. “At this point, our study suggests that obesity prevention, weight loss, but also decreasing other metabolic risk factors related to obesity, such as type-2 diabetes or hypertension, might reduce the risk for AD and have beneficial effects on cognition.”
 

Lifestyle habits

Commenting on the findings, Claire Sexton, DPhil, vice president of scientific programs and outreach at the Alzheimer’s Association, cautioned that a single cross-sectional study isn’t conclusive. “Previous studies have illustrated that the relationship between obesity and dementia is complex. Growing evidence indicates that people can reduce their risk of cognitive decline by adopting key lifestyle habits, like regular exercise, a heart-healthy diet and staying socially and cognitively engaged.”

The Alzheimer’s Association is leading a 2-year clinical trial, U.S. Pointer, to study how targeting these risk factors in combination may reduce risk for cognitive decline in older adults.

The work was supported by a Foundation Scheme award from the Canadian Institutes of Health Research. Dr. Morys received a postdoctoral fellowship from Fonds de Recherche du Quebec – Santé. Data collection and sharing were funded by the Alzheimer’s Disease Neuroimaging Initiative, the National Institute on Aging, the National Institute of Biomedical Imaging and Bioengineering, and multiple pharmaceutical companies and other private sector organizations. Dr. Morys and Dr. Sexton reported no relevant financial relationships.

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

Brain atrophy patterns are similar in individuals with obesity and those with Alzheimer’s disease (AD), a new study shows.

Comparisons of MRI scans for more than 1,000 participants indicate correlations between the two conditions, especially in areas of gray matter thinning, suggesting that managing excess weight might slow cognitive decline and lower the risk for AD, according to the researchers.

However, brain maps of obesity did not correlate with maps of amyloid or tau protein accumulation.

“The fact that obesity-related brain atrophy did not correlate with the distribution of amyloid and tau proteins in AD was not what we expected,” study author Filip Morys, PhD, a postdoctoral researcher at McGill University, Montreal, said in an interview. “But it might just show that the specific mechanisms underpinning obesity- and Alzheimer’s disease–related neurodegeneration are different. This remains to be confirmed.”

The study was published in the Journal of Alzheimer’s Disease.
 

Cortical Thinning

The current study was prompted by the team’s earlier study, which showed that obesity-related neurodegeneration patterns were visually similar to those of AD, said Dr. Morys. “It was known previously that obesity is a risk factor for AD, but we wanted to directly compare brain atrophy patterns in both, which is what we did in this new study.”

The researchers analyzed data from a pooled sample of more than 1,300 participants. From the ADNI database, the researchers selected participants with AD and age- and sex-matched cognitively healthy controls. From the UK Biobank, the researchers drew a sample of lean, overweight, and obese participants without neurologic disease.

To determine how the weight status of patients with AD affects the correspondence between AD and obesity maps, they categorized participants with AD and healthy controls from the ADNI database into lean, overweight, and obese subgroups.

Then, to investigate mechanisms that might drive the similarities between obesity-related brain atrophy and AD-related amyloid-beta accumulation, they looked for overlapping areas in PET brain maps between patients with these outcomes.

The investigations showed that obesity maps were highly correlated with AD maps, but not with amyloid-beta or tau protein maps. The researchers also found significant correlations between obesity and the lean individuals with AD.

Brain regions with the highest similarities between obesity and AD were located mainly in the left temporal and bilateral prefrontal cortices.

“Our research confirms that obesity-related gray matter atrophy resembles that of AD,” the authors concluded. “Excess weight management could lead to improved health outcomes, slow down cognitive decline in aging, and lower the risk for AD.”

Upcoming research “will focus on investigating how weight loss can affect the risk for AD, other dementias, and cognitive decline in general,” said Dr. Morys. “At this point, our study suggests that obesity prevention, weight loss, but also decreasing other metabolic risk factors related to obesity, such as type-2 diabetes or hypertension, might reduce the risk for AD and have beneficial effects on cognition.”
 

Lifestyle habits

Commenting on the findings, Claire Sexton, DPhil, vice president of scientific programs and outreach at the Alzheimer’s Association, cautioned that a single cross-sectional study isn’t conclusive. “Previous studies have illustrated that the relationship between obesity and dementia is complex. Growing evidence indicates that people can reduce their risk of cognitive decline by adopting key lifestyle habits, like regular exercise, a heart-healthy diet and staying socially and cognitively engaged.”

The Alzheimer’s Association is leading a 2-year clinical trial, U.S. Pointer, to study how targeting these risk factors in combination may reduce risk for cognitive decline in older adults.

The work was supported by a Foundation Scheme award from the Canadian Institutes of Health Research. Dr. Morys received a postdoctoral fellowship from Fonds de Recherche du Quebec – Santé. Data collection and sharing were funded by the Alzheimer’s Disease Neuroimaging Initiative, the National Institute on Aging, the National Institute of Biomedical Imaging and Bioengineering, and multiple pharmaceutical companies and other private sector organizations. Dr. Morys and Dr. Sexton reported no relevant financial relationships.

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

Brain atrophy patterns are similar in individuals with obesity and those with Alzheimer’s disease (AD), a new study shows.

Comparisons of MRI scans for more than 1,000 participants indicate correlations between the two conditions, especially in areas of gray matter thinning, suggesting that managing excess weight might slow cognitive decline and lower the risk for AD, according to the researchers.

However, brain maps of obesity did not correlate with maps of amyloid or tau protein accumulation.

“The fact that obesity-related brain atrophy did not correlate with the distribution of amyloid and tau proteins in AD was not what we expected,” study author Filip Morys, PhD, a postdoctoral researcher at McGill University, Montreal, said in an interview. “But it might just show that the specific mechanisms underpinning obesity- and Alzheimer’s disease–related neurodegeneration are different. This remains to be confirmed.”

The study was published in the Journal of Alzheimer’s Disease.
 

Cortical Thinning

The current study was prompted by the team’s earlier study, which showed that obesity-related neurodegeneration patterns were visually similar to those of AD, said Dr. Morys. “It was known previously that obesity is a risk factor for AD, but we wanted to directly compare brain atrophy patterns in both, which is what we did in this new study.”

The researchers analyzed data from a pooled sample of more than 1,300 participants. From the ADNI database, the researchers selected participants with AD and age- and sex-matched cognitively healthy controls. From the UK Biobank, the researchers drew a sample of lean, overweight, and obese participants without neurologic disease.

To determine how the weight status of patients with AD affects the correspondence between AD and obesity maps, they categorized participants with AD and healthy controls from the ADNI database into lean, overweight, and obese subgroups.

Then, to investigate mechanisms that might drive the similarities between obesity-related brain atrophy and AD-related amyloid-beta accumulation, they looked for overlapping areas in PET brain maps between patients with these outcomes.

The investigations showed that obesity maps were highly correlated with AD maps, but not with amyloid-beta or tau protein maps. The researchers also found significant correlations between obesity and the lean individuals with AD.

Brain regions with the highest similarities between obesity and AD were located mainly in the left temporal and bilateral prefrontal cortices.

“Our research confirms that obesity-related gray matter atrophy resembles that of AD,” the authors concluded. “Excess weight management could lead to improved health outcomes, slow down cognitive decline in aging, and lower the risk for AD.”

Upcoming research “will focus on investigating how weight loss can affect the risk for AD, other dementias, and cognitive decline in general,” said Dr. Morys. “At this point, our study suggests that obesity prevention, weight loss, but also decreasing other metabolic risk factors related to obesity, such as type-2 diabetes or hypertension, might reduce the risk for AD and have beneficial effects on cognition.”
 

Lifestyle habits

Commenting on the findings, Claire Sexton, DPhil, vice president of scientific programs and outreach at the Alzheimer’s Association, cautioned that a single cross-sectional study isn’t conclusive. “Previous studies have illustrated that the relationship between obesity and dementia is complex. Growing evidence indicates that people can reduce their risk of cognitive decline by adopting key lifestyle habits, like regular exercise, a heart-healthy diet and staying socially and cognitively engaged.”

The Alzheimer’s Association is leading a 2-year clinical trial, U.S. Pointer, to study how targeting these risk factors in combination may reduce risk for cognitive decline in older adults.

The work was supported by a Foundation Scheme award from the Canadian Institutes of Health Research. Dr. Morys received a postdoctoral fellowship from Fonds de Recherche du Quebec – Santé. Data collection and sharing were funded by the Alzheimer’s Disease Neuroimaging Initiative, the National Institute on Aging, the National Institute of Biomedical Imaging and Bioengineering, and multiple pharmaceutical companies and other private sector organizations. Dr. Morys and Dr. Sexton reported no relevant financial relationships.

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

A network of neural connections is linked to six psychiatric disorders: schizophrenia, bipolar disorder (BD), depression, addiction, obsessive-compulsive disorder (OCD), and anxiety, new research shows.

Investigators used coordinate and lesion network mapping to assess whether there was a shared brain network common to multiple psychiatric disorders. In a meta-analysis of almost 200 studies encompassing more than 15,000 individuals, they found that atrophy coordinates across these six psychiatric conditions all mapped to a common brain network.

Moreover, lesion damage to this network in patients with penetrating head trauma correlated with the number of psychiatric illnesses that the patients were diagnosed with post trauma.

The findings have “bigger-picture potential implications,” lead author Joseph Taylor, MD, PhD, medical director of transcranial magnetic stimulation at Brigham and Women’s Hospital’s Center for Brain Circuit Therapeutics, Boston, told this news organization.

“In psychiatry, we talk about symptoms and define our disorders based on symptom checklists, which are fairly reliable but don’t have neurobiological underpinnings,” said Dr. Taylor, who is also an associate psychiatrist in Brigham’s department of psychiatry.

By contrast, “in neurology, we ask: ‘Where is the lesion?’ Studying brain networks could potentially help us diagnose and treat people with psychiatric illness more effectively, just as we treat neurological disorders,” he added.

The findings were published online in Nature Human Behavior.
 

Beyond symptom checklists

Dr. Taylor noted that, in the field of psychiatry, “we often study disorders in isolation,” such as generalized anxiety disorder and major depressive disorder.

“But what see clinically is that half of patients meet the criteria for more than one psychiatric disorder,” he said. “It can be difficult to diagnose and treat these patients, and there are worse treatment outcomes.”

There is also a “discrepancy” between how these disorders are studied (one at a time) and how patients are treated in clinic, Dr. Taylor noted. And there is increasing evidence that psychiatric disorders may share a common neurobiology.

This “highlights the possibility of potentially developing transdiagnostic treatments based on common neurobiology, not just symptom checklists,” Dr. Taylor said.

Prior work “has attempted to map abnormalities to common brain regions rather than to a common brain network,” the investigators wrote. Moreover, “prior studies have rarely tested specificity by comparing psychiatric disorders to other brain disorders.”

In the current study, the researchers used “morphometric brain lesion datasets coupled with a wiring diagram of the human brain to derive a convergent brain network for psychiatric illness.”

They analyzed four large published datasets. Dataset 1 was sourced from an activation likelihood estimation meta-analysis (ALE) of whole-brain voxel-based studies that compared patients with psychiatric disorders such as schizophrenia, BD, depression, addiction, OCD, and anxiety to healthy controls (n = 193 studies; 15,892 individuals in total).

Dataset 2 was drawn from published neuroimaging studies involving patients with Alzheimer’s disease (AD) and other neurodegenerative conditions (n = 72 studies). They reported coordinates regarding which patients with these disorders had more atrophy compared with control persons.

Dataset 3 was sourced from the Vietnam Head Injury study, which followed veterans with and those without penetrating head injuries (n = 194 veterans with injuries). Dataset 4 was sourced from published neurosurgical ablation coordinates for depression.
 

Shared neurobiology

Upon analyzing dataset 1, the researchers found decreased gray matter in the bilateral anterior insula, dorsal anterior cingulate cortex, dorsomedial prefrontal cortex, thalamus, amygdala, hippocampus, and parietal operculum – findings that are “consistent with prior work.”

However, fewer than 35% of the studies contributed to any single cluster; and no cluster was specific to psychiatric versus neurodegenerative coordinates (drawn from dataset 2).

On the other hand, coordinate network mapping yielded “more statistically robust” (P < .001) results, which were found in 85% of the studies. “Psychiatric atrophy coordinates were functionally connected to the same network of brain regions,” the researchers reported.

This network was defined by two types of connectivity, positive and negative.

“The topography of this transdiagnostic network was independent of the statistical threshold and specific to psychiatric (vs. neurodegenerative) disorders, with the strongest peak occurring in the posterior parietal cortex (Brodmann Area 7) near the intraparietal sulcus,” the investigators wrote.

When lesions from dataset 3 were overlaid onto the ALE map and the transdiagnostic network in order to evaluate whether damage to either map correlated with number of post-lesion psychiatric diagnosis, results showed no evidence of a correlation between psychiatric comorbidity and damage on the ALE map (Pearson r, 0.02; P = .766).

However, when the same approach was applied to the transdiagnostic network, a statistically significant correlation was found between psychiatric comorbidity and lesion damage (Pearson r, –0.21; P = .01). A multiple regression model showed that the transdiagnostic, but not the ALE, network “independently predicted the number of post-lesion psychiatric diagnoses” (P = .003 vs. P = .1), the investigators reported.

All four neurosurgical ablative targets for psychiatric disorders found on analysis of dataset 4 “intersected” and aligned with the transdiagnostic network.

“The study does not immediately impact clinical practice, but it would be helpful for practicing clinicians to know that psychiatric disorders commonly co-occur and might share common neurobiology and a convergent brain network,” Dr. Taylor said.

“Future work based on our findings could potentially influence clinical trials and clinical practice, especially in the area of brain stimulation,” he added.
 

‘Exciting new targets’

In a comment, Desmond Oathes, PhD, associate director, Center for Neuromodulation and Stress, University of Pennsylvania, Philadelphia, said the “next step in the science is to combine individual brain imaging, aka, ‘individualized connectomes,’ with these promising group maps to determine something meaningful at the individual patient level.”

Dr. Oathes, who is also a faculty clinician at the Center for the Treatment and Study of Anxiety and was not involved with the study, noted that an open question is whether the brain volume abnormalities/atrophy “can be changed with treatment and in what direction.”

A “strong take-home message from this paper is that brain volume measures from single coordinates are noisy as measures of psychiatric abnormality, whereas network effects seem to be especially sensitive for capturing these effects,” Dr. Oathes said.

The “abnormal networks across these disorders do not fit easily into well-known networks from healthy participants. However, they map well onto other databases relevant to psychiatric disorders and offer exciting new potential targets for prospective treatment studies,” he added.

The investigators received no specific funding for this work. Dr. Taylor reported no relevant financial relationships. Dr. Oathes reported no relevant financial relationships.

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

A network of neural connections is linked to six psychiatric disorders: schizophrenia, bipolar disorder (BD), depression, addiction, obsessive-compulsive disorder (OCD), and anxiety, new research shows.

Investigators used coordinate and lesion network mapping to assess whether there was a shared brain network common to multiple psychiatric disorders. In a meta-analysis of almost 200 studies encompassing more than 15,000 individuals, they found that atrophy coordinates across these six psychiatric conditions all mapped to a common brain network.

Moreover, lesion damage to this network in patients with penetrating head trauma correlated with the number of psychiatric illnesses that the patients were diagnosed with post trauma.

The findings have “bigger-picture potential implications,” lead author Joseph Taylor, MD, PhD, medical director of transcranial magnetic stimulation at Brigham and Women’s Hospital’s Center for Brain Circuit Therapeutics, Boston, told this news organization.

“In psychiatry, we talk about symptoms and define our disorders based on symptom checklists, which are fairly reliable but don’t have neurobiological underpinnings,” said Dr. Taylor, who is also an associate psychiatrist in Brigham’s department of psychiatry.

By contrast, “in neurology, we ask: ‘Where is the lesion?’ Studying brain networks could potentially help us diagnose and treat people with psychiatric illness more effectively, just as we treat neurological disorders,” he added.

The findings were published online in Nature Human Behavior.
 

Beyond symptom checklists

Dr. Taylor noted that, in the field of psychiatry, “we often study disorders in isolation,” such as generalized anxiety disorder and major depressive disorder.

“But what see clinically is that half of patients meet the criteria for more than one psychiatric disorder,” he said. “It can be difficult to diagnose and treat these patients, and there are worse treatment outcomes.”

There is also a “discrepancy” between how these disorders are studied (one at a time) and how patients are treated in clinic, Dr. Taylor noted. And there is increasing evidence that psychiatric disorders may share a common neurobiology.

This “highlights the possibility of potentially developing transdiagnostic treatments based on common neurobiology, not just symptom checklists,” Dr. Taylor said.

Prior work “has attempted to map abnormalities to common brain regions rather than to a common brain network,” the investigators wrote. Moreover, “prior studies have rarely tested specificity by comparing psychiatric disorders to other brain disorders.”

In the current study, the researchers used “morphometric brain lesion datasets coupled with a wiring diagram of the human brain to derive a convergent brain network for psychiatric illness.”

They analyzed four large published datasets. Dataset 1 was sourced from an activation likelihood estimation meta-analysis (ALE) of whole-brain voxel-based studies that compared patients with psychiatric disorders such as schizophrenia, BD, depression, addiction, OCD, and anxiety to healthy controls (n = 193 studies; 15,892 individuals in total).

Dataset 2 was drawn from published neuroimaging studies involving patients with Alzheimer’s disease (AD) and other neurodegenerative conditions (n = 72 studies). They reported coordinates regarding which patients with these disorders had more atrophy compared with control persons.

Dataset 3 was sourced from the Vietnam Head Injury study, which followed veterans with and those without penetrating head injuries (n = 194 veterans with injuries). Dataset 4 was sourced from published neurosurgical ablation coordinates for depression.
 

Shared neurobiology

Upon analyzing dataset 1, the researchers found decreased gray matter in the bilateral anterior insula, dorsal anterior cingulate cortex, dorsomedial prefrontal cortex, thalamus, amygdala, hippocampus, and parietal operculum – findings that are “consistent with prior work.”

However, fewer than 35% of the studies contributed to any single cluster; and no cluster was specific to psychiatric versus neurodegenerative coordinates (drawn from dataset 2).

On the other hand, coordinate network mapping yielded “more statistically robust” (P < .001) results, which were found in 85% of the studies. “Psychiatric atrophy coordinates were functionally connected to the same network of brain regions,” the researchers reported.

This network was defined by two types of connectivity, positive and negative.

“The topography of this transdiagnostic network was independent of the statistical threshold and specific to psychiatric (vs. neurodegenerative) disorders, with the strongest peak occurring in the posterior parietal cortex (Brodmann Area 7) near the intraparietal sulcus,” the investigators wrote.

When lesions from dataset 3 were overlaid onto the ALE map and the transdiagnostic network in order to evaluate whether damage to either map correlated with number of post-lesion psychiatric diagnosis, results showed no evidence of a correlation between psychiatric comorbidity and damage on the ALE map (Pearson r, 0.02; P = .766).

However, when the same approach was applied to the transdiagnostic network, a statistically significant correlation was found between psychiatric comorbidity and lesion damage (Pearson r, –0.21; P = .01). A multiple regression model showed that the transdiagnostic, but not the ALE, network “independently predicted the number of post-lesion psychiatric diagnoses” (P = .003 vs. P = .1), the investigators reported.

All four neurosurgical ablative targets for psychiatric disorders found on analysis of dataset 4 “intersected” and aligned with the transdiagnostic network.

“The study does not immediately impact clinical practice, but it would be helpful for practicing clinicians to know that psychiatric disorders commonly co-occur and might share common neurobiology and a convergent brain network,” Dr. Taylor said.

“Future work based on our findings could potentially influence clinical trials and clinical practice, especially in the area of brain stimulation,” he added.
 

‘Exciting new targets’

In a comment, Desmond Oathes, PhD, associate director, Center for Neuromodulation and Stress, University of Pennsylvania, Philadelphia, said the “next step in the science is to combine individual brain imaging, aka, ‘individualized connectomes,’ with these promising group maps to determine something meaningful at the individual patient level.”

Dr. Oathes, who is also a faculty clinician at the Center for the Treatment and Study of Anxiety and was not involved with the study, noted that an open question is whether the brain volume abnormalities/atrophy “can be changed with treatment and in what direction.”

A “strong take-home message from this paper is that brain volume measures from single coordinates are noisy as measures of psychiatric abnormality, whereas network effects seem to be especially sensitive for capturing these effects,” Dr. Oathes said.

The “abnormal networks across these disorders do not fit easily into well-known networks from healthy participants. However, they map well onto other databases relevant to psychiatric disorders and offer exciting new potential targets for prospective treatment studies,” he added.

The investigators received no specific funding for this work. Dr. Taylor reported no relevant financial relationships. Dr. Oathes reported no relevant financial relationships.

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

A network of neural connections is linked to six psychiatric disorders: schizophrenia, bipolar disorder (BD), depression, addiction, obsessive-compulsive disorder (OCD), and anxiety, new research shows.

Investigators used coordinate and lesion network mapping to assess whether there was a shared brain network common to multiple psychiatric disorders. In a meta-analysis of almost 200 studies encompassing more than 15,000 individuals, they found that atrophy coordinates across these six psychiatric conditions all mapped to a common brain network.

Moreover, lesion damage to this network in patients with penetrating head trauma correlated with the number of psychiatric illnesses that the patients were diagnosed with post trauma.

The findings have “bigger-picture potential implications,” lead author Joseph Taylor, MD, PhD, medical director of transcranial magnetic stimulation at Brigham and Women’s Hospital’s Center for Brain Circuit Therapeutics, Boston, told this news organization.

“In psychiatry, we talk about symptoms and define our disorders based on symptom checklists, which are fairly reliable but don’t have neurobiological underpinnings,” said Dr. Taylor, who is also an associate psychiatrist in Brigham’s department of psychiatry.

By contrast, “in neurology, we ask: ‘Where is the lesion?’ Studying brain networks could potentially help us diagnose and treat people with psychiatric illness more effectively, just as we treat neurological disorders,” he added.

The findings were published online in Nature Human Behavior.
 

Beyond symptom checklists

Dr. Taylor noted that, in the field of psychiatry, “we often study disorders in isolation,” such as generalized anxiety disorder and major depressive disorder.

“But what see clinically is that half of patients meet the criteria for more than one psychiatric disorder,” he said. “It can be difficult to diagnose and treat these patients, and there are worse treatment outcomes.”

There is also a “discrepancy” between how these disorders are studied (one at a time) and how patients are treated in clinic, Dr. Taylor noted. And there is increasing evidence that psychiatric disorders may share a common neurobiology.

This “highlights the possibility of potentially developing transdiagnostic treatments based on common neurobiology, not just symptom checklists,” Dr. Taylor said.

Prior work “has attempted to map abnormalities to common brain regions rather than to a common brain network,” the investigators wrote. Moreover, “prior studies have rarely tested specificity by comparing psychiatric disorders to other brain disorders.”

In the current study, the researchers used “morphometric brain lesion datasets coupled with a wiring diagram of the human brain to derive a convergent brain network for psychiatric illness.”

They analyzed four large published datasets. Dataset 1 was sourced from an activation likelihood estimation meta-analysis (ALE) of whole-brain voxel-based studies that compared patients with psychiatric disorders such as schizophrenia, BD, depression, addiction, OCD, and anxiety to healthy controls (n = 193 studies; 15,892 individuals in total).

Dataset 2 was drawn from published neuroimaging studies involving patients with Alzheimer’s disease (AD) and other neurodegenerative conditions (n = 72 studies). They reported coordinates regarding which patients with these disorders had more atrophy compared with control persons.

Dataset 3 was sourced from the Vietnam Head Injury study, which followed veterans with and those without penetrating head injuries (n = 194 veterans with injuries). Dataset 4 was sourced from published neurosurgical ablation coordinates for depression.
 

Shared neurobiology

Upon analyzing dataset 1, the researchers found decreased gray matter in the bilateral anterior insula, dorsal anterior cingulate cortex, dorsomedial prefrontal cortex, thalamus, amygdala, hippocampus, and parietal operculum – findings that are “consistent with prior work.”

However, fewer than 35% of the studies contributed to any single cluster; and no cluster was specific to psychiatric versus neurodegenerative coordinates (drawn from dataset 2).

On the other hand, coordinate network mapping yielded “more statistically robust” (P < .001) results, which were found in 85% of the studies. “Psychiatric atrophy coordinates were functionally connected to the same network of brain regions,” the researchers reported.

This network was defined by two types of connectivity, positive and negative.

“The topography of this transdiagnostic network was independent of the statistical threshold and specific to psychiatric (vs. neurodegenerative) disorders, with the strongest peak occurring in the posterior parietal cortex (Brodmann Area 7) near the intraparietal sulcus,” the investigators wrote.

When lesions from dataset 3 were overlaid onto the ALE map and the transdiagnostic network in order to evaluate whether damage to either map correlated with number of post-lesion psychiatric diagnosis, results showed no evidence of a correlation between psychiatric comorbidity and damage on the ALE map (Pearson r, 0.02; P = .766).

However, when the same approach was applied to the transdiagnostic network, a statistically significant correlation was found between psychiatric comorbidity and lesion damage (Pearson r, –0.21; P = .01). A multiple regression model showed that the transdiagnostic, but not the ALE, network “independently predicted the number of post-lesion psychiatric diagnoses” (P = .003 vs. P = .1), the investigators reported.

All four neurosurgical ablative targets for psychiatric disorders found on analysis of dataset 4 “intersected” and aligned with the transdiagnostic network.

“The study does not immediately impact clinical practice, but it would be helpful for practicing clinicians to know that psychiatric disorders commonly co-occur and might share common neurobiology and a convergent brain network,” Dr. Taylor said.

“Future work based on our findings could potentially influence clinical trials and clinical practice, especially in the area of brain stimulation,” he added.
 

‘Exciting new targets’

In a comment, Desmond Oathes, PhD, associate director, Center for Neuromodulation and Stress, University of Pennsylvania, Philadelphia, said the “next step in the science is to combine individual brain imaging, aka, ‘individualized connectomes,’ with these promising group maps to determine something meaningful at the individual patient level.”

Dr. Oathes, who is also a faculty clinician at the Center for the Treatment and Study of Anxiety and was not involved with the study, noted that an open question is whether the brain volume abnormalities/atrophy “can be changed with treatment and in what direction.”

A “strong take-home message from this paper is that brain volume measures from single coordinates are noisy as measures of psychiatric abnormality, whereas network effects seem to be especially sensitive for capturing these effects,” Dr. Oathes said.

The “abnormal networks across these disorders do not fit easily into well-known networks from healthy participants. However, they map well onto other databases relevant to psychiatric disorders and offer exciting new potential targets for prospective treatment studies,” he added.

The investigators received no specific funding for this work. Dr. Taylor reported no relevant financial relationships. Dr. Oathes reported no relevant financial relationships.

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

A new “smart patch” composed of microneedles that can detect proinflammatory markers via simulated skin interstitial fluid (ISF) may help diagnose neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease very early on.

Originally developed to deliver medications and vaccines via the skin in a minimally invasive manner, the microneedle arrays were fitted with molecular sensors that, when placed on the skin, detect neuroinflammatory biomarkers such as interleukin-6 in as little as 6 minutes.

The literature suggests that these biomarkers of neurodegenerative disease are present years before patients become symptomatic, said study investigator Sanjiv Sharma, PhD.

“Neurodegenerative disorders such as Parkinson’s disease and Alzheimer’s disease are [characterized by] progressive loss in nerve cell and brain cells, which leads to memory problems and a loss of mental ability. That is why early diagnosis is key to preventing the loss of brain tissue in dementia, which can go undetected for years,” added Dr. Sharma, who is a lecturer in medical engineering at Swansea (Wales) University.

Dr. Sharma developed the patch with scientists at the Polytechnic of Porto (Portugal) School of Engineering in Portugal. In 2022, they designed, and are currently testing, a microneedle patch that will deliver the COVID vaccine.

The investigators describe their research on the patch’s ability to detect IL-6 in an article published in ACS Omega.
 

At-home diagnosis?

“The skin is the largest organ in the body – it contains more skin interstitial fluid than the total blood volume,” Dr. Sharma noted. “This fluid is an ultrafiltrate of blood and holds biomarkers that complement other biofluids, such as sweat, saliva, and urine. It can be sampled in a minimally invasive manner and used either for point-of-care testing or real-time using microneedle devices.”

Dr. Sharma and associates tested the microneedle patch in artificial ISF that contained the inflammatory cytokine IL-6. They found that the patch accurately detected IL-6 concentrations as low as 1 pg/mL in the fabricated ISF solution.

“In general, the transdermal sensor presented here showed simplicity in designing, short measuring time, high accuracy, and low detection limit. This approach seems a successful tool for the screening of inflammatory biomarkers in point of care testing wherein the skin acts as a window to the body,” the investigators reported.

Dr. Sharma noted that early detection of neurodegenerative diseases is crucial, as once symptoms appear, the disease may have already progressed significantly, and meaningful intervention is challenging.

The device has yet to be tested in humans, which is the next step, said Dr. Sharma.

“We will have to test the hypothesis through extensive preclinical and clinical studies to determine if bloodless, transdermal (skin) diagnostics can offer a cost-effective device that could allow testing in simpler settings such as a clinician’s practice or even home settings,” he noted.
 

Early days

Commenting on the research, David K. Simon, MD, PhD, professor of neurology at Harvard Medical School, Boston, said it is “a promising step regarding validation of a potentially beneficial method for rapidly and accurately measuring IL-6.”

However, he added, “many additional steps are needed to validate the method in actual human skin and to determine whether or not measuring these biomarkers in skin will be useful in studies of neurodegenerative diseases.”

He noted that one study limitation is that inflammatory cytokines such as IL-6 are highly nonspecific, and levels are elevated in various diseases associated with inflammation.

“It is highly unlikely that measuring IL-6 will be useful as a diagnostic tool. However, it does have potential as a biomarker for measuring the impact of treatments aimed at reducing inflammation. As the authors point out, it’s more likely that clinicians will require a panel of biomarkers rather than only measuring IL-6,” he said.

The study was funded by Fundação para a Ciência e Tecnologia. The investigators disclosed no relevant financial relationships.

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

A new “smart patch” composed of microneedles that can detect proinflammatory markers via simulated skin interstitial fluid (ISF) may help diagnose neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease very early on.

Originally developed to deliver medications and vaccines via the skin in a minimally invasive manner, the microneedle arrays were fitted with molecular sensors that, when placed on the skin, detect neuroinflammatory biomarkers such as interleukin-6 in as little as 6 minutes.

The literature suggests that these biomarkers of neurodegenerative disease are present years before patients become symptomatic, said study investigator Sanjiv Sharma, PhD.

“Neurodegenerative disorders such as Parkinson’s disease and Alzheimer’s disease are [characterized by] progressive loss in nerve cell and brain cells, which leads to memory problems and a loss of mental ability. That is why early diagnosis is key to preventing the loss of brain tissue in dementia, which can go undetected for years,” added Dr. Sharma, who is a lecturer in medical engineering at Swansea (Wales) University.

Dr. Sharma developed the patch with scientists at the Polytechnic of Porto (Portugal) School of Engineering in Portugal. In 2022, they designed, and are currently testing, a microneedle patch that will deliver the COVID vaccine.

The investigators describe their research on the patch’s ability to detect IL-6 in an article published in ACS Omega.
 

At-home diagnosis?

“The skin is the largest organ in the body – it contains more skin interstitial fluid than the total blood volume,” Dr. Sharma noted. “This fluid is an ultrafiltrate of blood and holds biomarkers that complement other biofluids, such as sweat, saliva, and urine. It can be sampled in a minimally invasive manner and used either for point-of-care testing or real-time using microneedle devices.”

Dr. Sharma and associates tested the microneedle patch in artificial ISF that contained the inflammatory cytokine IL-6. They found that the patch accurately detected IL-6 concentrations as low as 1 pg/mL in the fabricated ISF solution.

“In general, the transdermal sensor presented here showed simplicity in designing, short measuring time, high accuracy, and low detection limit. This approach seems a successful tool for the screening of inflammatory biomarkers in point of care testing wherein the skin acts as a window to the body,” the investigators reported.

Dr. Sharma noted that early detection of neurodegenerative diseases is crucial, as once symptoms appear, the disease may have already progressed significantly, and meaningful intervention is challenging.

The device has yet to be tested in humans, which is the next step, said Dr. Sharma.

“We will have to test the hypothesis through extensive preclinical and clinical studies to determine if bloodless, transdermal (skin) diagnostics can offer a cost-effective device that could allow testing in simpler settings such as a clinician’s practice or even home settings,” he noted.
 

Early days

Commenting on the research, David K. Simon, MD, PhD, professor of neurology at Harvard Medical School, Boston, said it is “a promising step regarding validation of a potentially beneficial method for rapidly and accurately measuring IL-6.”

However, he added, “many additional steps are needed to validate the method in actual human skin and to determine whether or not measuring these biomarkers in skin will be useful in studies of neurodegenerative diseases.”

He noted that one study limitation is that inflammatory cytokines such as IL-6 are highly nonspecific, and levels are elevated in various diseases associated with inflammation.

“It is highly unlikely that measuring IL-6 will be useful as a diagnostic tool. However, it does have potential as a biomarker for measuring the impact of treatments aimed at reducing inflammation. As the authors point out, it’s more likely that clinicians will require a panel of biomarkers rather than only measuring IL-6,” he said.

The study was funded by Fundação para a Ciência e Tecnologia. The investigators disclosed no relevant financial relationships.

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

A new “smart patch” composed of microneedles that can detect proinflammatory markers via simulated skin interstitial fluid (ISF) may help diagnose neurodegenerative disorders such as Alzheimer’s disease and Parkinson’s disease very early on.

Originally developed to deliver medications and vaccines via the skin in a minimally invasive manner, the microneedle arrays were fitted with molecular sensors that, when placed on the skin, detect neuroinflammatory biomarkers such as interleukin-6 in as little as 6 minutes.

The literature suggests that these biomarkers of neurodegenerative disease are present years before patients become symptomatic, said study investigator Sanjiv Sharma, PhD.

“Neurodegenerative disorders such as Parkinson’s disease and Alzheimer’s disease are [characterized by] progressive loss in nerve cell and brain cells, which leads to memory problems and a loss of mental ability. That is why early diagnosis is key to preventing the loss of brain tissue in dementia, which can go undetected for years,” added Dr. Sharma, who is a lecturer in medical engineering at Swansea (Wales) University.

Dr. Sharma developed the patch with scientists at the Polytechnic of Porto (Portugal) School of Engineering in Portugal. In 2022, they designed, and are currently testing, a microneedle patch that will deliver the COVID vaccine.

The investigators describe their research on the patch’s ability to detect IL-6 in an article published in ACS Omega.
 

At-home diagnosis?

“The skin is the largest organ in the body – it contains more skin interstitial fluid than the total blood volume,” Dr. Sharma noted. “This fluid is an ultrafiltrate of blood and holds biomarkers that complement other biofluids, such as sweat, saliva, and urine. It can be sampled in a minimally invasive manner and used either for point-of-care testing or real-time using microneedle devices.”

Dr. Sharma and associates tested the microneedle patch in artificial ISF that contained the inflammatory cytokine IL-6. They found that the patch accurately detected IL-6 concentrations as low as 1 pg/mL in the fabricated ISF solution.

“In general, the transdermal sensor presented here showed simplicity in designing, short measuring time, high accuracy, and low detection limit. This approach seems a successful tool for the screening of inflammatory biomarkers in point of care testing wherein the skin acts as a window to the body,” the investigators reported.

Dr. Sharma noted that early detection of neurodegenerative diseases is crucial, as once symptoms appear, the disease may have already progressed significantly, and meaningful intervention is challenging.

The device has yet to be tested in humans, which is the next step, said Dr. Sharma.

“We will have to test the hypothesis through extensive preclinical and clinical studies to determine if bloodless, transdermal (skin) diagnostics can offer a cost-effective device that could allow testing in simpler settings such as a clinician’s practice or even home settings,” he noted.
 

Early days

Commenting on the research, David K. Simon, MD, PhD, professor of neurology at Harvard Medical School, Boston, said it is “a promising step regarding validation of a potentially beneficial method for rapidly and accurately measuring IL-6.”

However, he added, “many additional steps are needed to validate the method in actual human skin and to determine whether or not measuring these biomarkers in skin will be useful in studies of neurodegenerative diseases.”

He noted that one study limitation is that inflammatory cytokines such as IL-6 are highly nonspecific, and levels are elevated in various diseases associated with inflammation.

“It is highly unlikely that measuring IL-6 will be useful as a diagnostic tool. However, it does have potential as a biomarker for measuring the impact of treatments aimed at reducing inflammation. As the authors point out, it’s more likely that clinicians will require a panel of biomarkers rather than only measuring IL-6,” he said.

The study was funded by Fundação para a Ciência e Tecnologia. The investigators disclosed no relevant financial relationships.

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

An agent biologically similar to the humanized monoclonal antibody natalizumab is as effective and safe as the original reference drug for relapsing remitting multiple sclerosis (RRMS) – and has a similar level of immunogenicity, new research shows.

The investigators noted that these phase 3 trial findings are the final stage in the regulatory approval process.

“There will be a biosimilar that with respect to all parameters – efficacy, side effects, immunogenicity – doesn’t differ from the original drug and will probably be an option to consider to reduce treatment costs in MS,” said lead investigator Bernhard Hemmer, MD, a professor in the department of neurology, Technical University of Munich (Germany).

The findings were published online in JAMA Neurology.
 

Potential cost savings

Disease-modifying therapies (DMTs), particularly targeted biologics, have revolutionized the treatment of MS, including RRMS. Natalizumab, which was the first targeted biologic therapy approved for RRMS, is very effective and widely used, Dr. Hemmer said.

However, this and other DMTs are costly. Biosimilars, which are medicines clinically similar to an already marketed reference biologic medicine, can address this issue. In the areas of rheumatology and oncology, biosimilars have already demonstrated significant cost savings and improved treatment access.

The biosimilar natalizumab (biosim-NTZ), developed by Polpharma Biologics, is the first biosimilar monoclonal antibody therapy to be developed for MS.

Health authorities such as the Food and Drug Administration require comparative phase 3 studies to confirm there are no clinically relevant differences between a proposed biosimilar and its reference medicine.

The new multicenter, phase 3, double-blind, randomized trial – known as Antelope – included 264 adult patients with RRMS at 48 centers in seven Eastern European countries. Most study participants were women (61.4%), and their mean age was 36.7 years.

All study participants were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of biosim-NTZ or reference natalizumab (ref-NTZ) for a total of 12 infusions.

At week 24, 30 patients were switched from ref-NTZ to biosim-NTZ for the remainder of their infusions. Including such a population is required by regulatory agencies to ensure switching patients from a drug they’ve been taking to a new biosimilar does not introduce any concerns, said Dr. Hemmer.
 

Comparable efficacy, safety profile

The primary efficacy endpoint was the cumulative number of new active brain lesions on MRI.

At baseline, 48.1% of the biosimilar group and 45.9% of the reference drug group had at least one gadolinium-enhancing lesion. In addition, 96.9% of the biosimilar group had more than 15 T2 lesions, compared with 96.2% of the reference group.

At week 24, the mean difference between biosim-NTZ and ref-NTZ in the cumulative number of new active lesions was 0.17 (least square means, 0.34 vs. 0.45), with a 95% confidence interval of –0.61 to 0.94 and a point estimate within the prespecified margins of ± 2.1.

The annualized relapse rate for biosim-NTZ and ref-NTZ was similar at 24 weeks (0.21 vs. 0.15), as well as at 48 weeks (0.17 vs. 0.13). For Expanded Disability Status Scale scores, which were similar between treatment groups at baseline (mean, 3.4 vs. 3.2), change at 24 and 48 weeks was minimal and similar in both groups.

The safety profile was as expected for patients with RRMS receiving natalizumab. There were few adverse events of special interest, with similar proportions across all treatment groups.

The overall adverse-event profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching.

Rates of treatment-emergent adverse events (TEAEs) were similar, at 64.9% for biosim-NTZ, 68.9% for ref-NTZ, and 73.3% for the switch group. The most-reported TEAEs among all treatment groups were nervous system disorders and infections and infestations.

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, is associated with some DMTs – notably ref-NTZ. It is caused by infection with the John Cunningham virus (JCV) (also referred to as human polyomavirus), the researchers noted.

As per the study protocol, no participant had a JCV-positive index of more than 1.5 at baseline. Proportions of patients positive for anti-JCV antibodies were similarly distributed between treatment groups throughout the study.
 

Similar immunogenicity

There was strong concordance regarding positivity for treatment-emergent antidrug antibodies between the biosim-NTZ and ref-NTZ groups (79.4% and 74.0%). This was also the case for antinatalizumab-neutralizing antibodies (69.0% and 66.2%).

“There was nothing that indicated immunogenicity is different” between the two agents, said Dr. Hemmer.

While this might change “when you look at longer time periods,” antibodies to natalizumab usually develop “very early on,” he added.

Dr. Hemmer noted that this comparison of the proposed biosimilar with the reference drug had no real surprises.

“If the immunogenicity is the same, the mode of action is the same, and the dose is the same, you would expect to have a similar clinical effect and also a similar side-effect profile, which is indeed the case,” he said.

Dr. Hemmer added that he has no insight as to when the drug might be approved but believes developers expect that to occur sometime this year.
 

Welcome results

Commenting on the study results, Torge Rempe, MD, assistant professor in the department of neurology, University of Florida, Gainesville, and the William T. And Janice M. Neely professor for research in MS, said he welcomes these new results showing the biosimilar matched the reference medication.

“The authors report no significant difference in their primary endpoint of cumulative number of active lesions as well as their secondary clinical endpoints of annualized relapse rate and changes from baseline Expanded Disability Status Scale scores,” said Dr. Rempe, who was not involved with the research.

The study also showed the reported adverse events were similar between the biosimilar and reference natalizumab, he noted.

However, although no cases of PML were uncovered during the study period, further research is needed to determine long-term safety in this area, Dr. Rempe said.

Finally, he agreed that the development of biosimilars such as this one addresses the issue of high annual costs for DMTs, an area of concern in the field of MS.

The study was funded by Polpharma Biologics. Dr. Hemmer has reported receiving personal fees from Polpharma and Sandoz during the conduct of the study and personal fees from Novartis, Biocom, and TG Therapeutics outside the submitted work. He has also received a patent for genetic determinants of antibodies against interferon-beta and a patent for KIR4.1 antibodies in MS; served on scientific advisory boards for Novartis; served as a data monitoring and safety committee member for AllergyCare, Polpharma Biologics, Sandoz, and TG Therapeutics; and received speaker honoraria from Desitin, grants from Regeneron for MS research, and funding from the Multiple MS EU consortium, the CLINSPECT-M consortium, and the German Research Foundation. Dr. Rempe has reported no relevant financial relationships.

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

An agent biologically similar to the humanized monoclonal antibody natalizumab is as effective and safe as the original reference drug for relapsing remitting multiple sclerosis (RRMS) – and has a similar level of immunogenicity, new research shows.

The investigators noted that these phase 3 trial findings are the final stage in the regulatory approval process.

“There will be a biosimilar that with respect to all parameters – efficacy, side effects, immunogenicity – doesn’t differ from the original drug and will probably be an option to consider to reduce treatment costs in MS,” said lead investigator Bernhard Hemmer, MD, a professor in the department of neurology, Technical University of Munich (Germany).

The findings were published online in JAMA Neurology.
 

Potential cost savings

Disease-modifying therapies (DMTs), particularly targeted biologics, have revolutionized the treatment of MS, including RRMS. Natalizumab, which was the first targeted biologic therapy approved for RRMS, is very effective and widely used, Dr. Hemmer said.

However, this and other DMTs are costly. Biosimilars, which are medicines clinically similar to an already marketed reference biologic medicine, can address this issue. In the areas of rheumatology and oncology, biosimilars have already demonstrated significant cost savings and improved treatment access.

The biosimilar natalizumab (biosim-NTZ), developed by Polpharma Biologics, is the first biosimilar monoclonal antibody therapy to be developed for MS.

Health authorities such as the Food and Drug Administration require comparative phase 3 studies to confirm there are no clinically relevant differences between a proposed biosimilar and its reference medicine.

The new multicenter, phase 3, double-blind, randomized trial – known as Antelope – included 264 adult patients with RRMS at 48 centers in seven Eastern European countries. Most study participants were women (61.4%), and their mean age was 36.7 years.

All study participants were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of biosim-NTZ or reference natalizumab (ref-NTZ) for a total of 12 infusions.

At week 24, 30 patients were switched from ref-NTZ to biosim-NTZ for the remainder of their infusions. Including such a population is required by regulatory agencies to ensure switching patients from a drug they’ve been taking to a new biosimilar does not introduce any concerns, said Dr. Hemmer.
 

Comparable efficacy, safety profile

The primary efficacy endpoint was the cumulative number of new active brain lesions on MRI.

At baseline, 48.1% of the biosimilar group and 45.9% of the reference drug group had at least one gadolinium-enhancing lesion. In addition, 96.9% of the biosimilar group had more than 15 T2 lesions, compared with 96.2% of the reference group.

At week 24, the mean difference between biosim-NTZ and ref-NTZ in the cumulative number of new active lesions was 0.17 (least square means, 0.34 vs. 0.45), with a 95% confidence interval of –0.61 to 0.94 and a point estimate within the prespecified margins of ± 2.1.

The annualized relapse rate for biosim-NTZ and ref-NTZ was similar at 24 weeks (0.21 vs. 0.15), as well as at 48 weeks (0.17 vs. 0.13). For Expanded Disability Status Scale scores, which were similar between treatment groups at baseline (mean, 3.4 vs. 3.2), change at 24 and 48 weeks was minimal and similar in both groups.

The safety profile was as expected for patients with RRMS receiving natalizumab. There were few adverse events of special interest, with similar proportions across all treatment groups.

The overall adverse-event profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching.

Rates of treatment-emergent adverse events (TEAEs) were similar, at 64.9% for biosim-NTZ, 68.9% for ref-NTZ, and 73.3% for the switch group. The most-reported TEAEs among all treatment groups were nervous system disorders and infections and infestations.

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, is associated with some DMTs – notably ref-NTZ. It is caused by infection with the John Cunningham virus (JCV) (also referred to as human polyomavirus), the researchers noted.

As per the study protocol, no participant had a JCV-positive index of more than 1.5 at baseline. Proportions of patients positive for anti-JCV antibodies were similarly distributed between treatment groups throughout the study.
 

Similar immunogenicity

There was strong concordance regarding positivity for treatment-emergent antidrug antibodies between the biosim-NTZ and ref-NTZ groups (79.4% and 74.0%). This was also the case for antinatalizumab-neutralizing antibodies (69.0% and 66.2%).

“There was nothing that indicated immunogenicity is different” between the two agents, said Dr. Hemmer.

While this might change “when you look at longer time periods,” antibodies to natalizumab usually develop “very early on,” he added.

Dr. Hemmer noted that this comparison of the proposed biosimilar with the reference drug had no real surprises.

“If the immunogenicity is the same, the mode of action is the same, and the dose is the same, you would expect to have a similar clinical effect and also a similar side-effect profile, which is indeed the case,” he said.

Dr. Hemmer added that he has no insight as to when the drug might be approved but believes developers expect that to occur sometime this year.
 

Welcome results

Commenting on the study results, Torge Rempe, MD, assistant professor in the department of neurology, University of Florida, Gainesville, and the William T. And Janice M. Neely professor for research in MS, said he welcomes these new results showing the biosimilar matched the reference medication.

“The authors report no significant difference in their primary endpoint of cumulative number of active lesions as well as their secondary clinical endpoints of annualized relapse rate and changes from baseline Expanded Disability Status Scale scores,” said Dr. Rempe, who was not involved with the research.

The study also showed the reported adverse events were similar between the biosimilar and reference natalizumab, he noted.

However, although no cases of PML were uncovered during the study period, further research is needed to determine long-term safety in this area, Dr. Rempe said.

Finally, he agreed that the development of biosimilars such as this one addresses the issue of high annual costs for DMTs, an area of concern in the field of MS.

The study was funded by Polpharma Biologics. Dr. Hemmer has reported receiving personal fees from Polpharma and Sandoz during the conduct of the study and personal fees from Novartis, Biocom, and TG Therapeutics outside the submitted work. He has also received a patent for genetic determinants of antibodies against interferon-beta and a patent for KIR4.1 antibodies in MS; served on scientific advisory boards for Novartis; served as a data monitoring and safety committee member for AllergyCare, Polpharma Biologics, Sandoz, and TG Therapeutics; and received speaker honoraria from Desitin, grants from Regeneron for MS research, and funding from the Multiple MS EU consortium, the CLINSPECT-M consortium, and the German Research Foundation. Dr. Rempe has reported no relevant financial relationships.

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

An agent biologically similar to the humanized monoclonal antibody natalizumab is as effective and safe as the original reference drug for relapsing remitting multiple sclerosis (RRMS) – and has a similar level of immunogenicity, new research shows.

The investigators noted that these phase 3 trial findings are the final stage in the regulatory approval process.

“There will be a biosimilar that with respect to all parameters – efficacy, side effects, immunogenicity – doesn’t differ from the original drug and will probably be an option to consider to reduce treatment costs in MS,” said lead investigator Bernhard Hemmer, MD, a professor in the department of neurology, Technical University of Munich (Germany).

The findings were published online in JAMA Neurology.
 

Potential cost savings

Disease-modifying therapies (DMTs), particularly targeted biologics, have revolutionized the treatment of MS, including RRMS. Natalizumab, which was the first targeted biologic therapy approved for RRMS, is very effective and widely used, Dr. Hemmer said.

However, this and other DMTs are costly. Biosimilars, which are medicines clinically similar to an already marketed reference biologic medicine, can address this issue. In the areas of rheumatology and oncology, biosimilars have already demonstrated significant cost savings and improved treatment access.

The biosimilar natalizumab (biosim-NTZ), developed by Polpharma Biologics, is the first biosimilar monoclonal antibody therapy to be developed for MS.

Health authorities such as the Food and Drug Administration require comparative phase 3 studies to confirm there are no clinically relevant differences between a proposed biosimilar and its reference medicine.

The new multicenter, phase 3, double-blind, randomized trial – known as Antelope – included 264 adult patients with RRMS at 48 centers in seven Eastern European countries. Most study participants were women (61.4%), and their mean age was 36.7 years.

All study participants were randomly assigned to receive intravenous infusions every 4 weeks of 300 mg of biosim-NTZ or reference natalizumab (ref-NTZ) for a total of 12 infusions.

At week 24, 30 patients were switched from ref-NTZ to biosim-NTZ for the remainder of their infusions. Including such a population is required by regulatory agencies to ensure switching patients from a drug they’ve been taking to a new biosimilar does not introduce any concerns, said Dr. Hemmer.
 

Comparable efficacy, safety profile

The primary efficacy endpoint was the cumulative number of new active brain lesions on MRI.

At baseline, 48.1% of the biosimilar group and 45.9% of the reference drug group had at least one gadolinium-enhancing lesion. In addition, 96.9% of the biosimilar group had more than 15 T2 lesions, compared with 96.2% of the reference group.

At week 24, the mean difference between biosim-NTZ and ref-NTZ in the cumulative number of new active lesions was 0.17 (least square means, 0.34 vs. 0.45), with a 95% confidence interval of –0.61 to 0.94 and a point estimate within the prespecified margins of ± 2.1.

The annualized relapse rate for biosim-NTZ and ref-NTZ was similar at 24 weeks (0.21 vs. 0.15), as well as at 48 weeks (0.17 vs. 0.13). For Expanded Disability Status Scale scores, which were similar between treatment groups at baseline (mean, 3.4 vs. 3.2), change at 24 and 48 weeks was minimal and similar in both groups.

The safety profile was as expected for patients with RRMS receiving natalizumab. There were few adverse events of special interest, with similar proportions across all treatment groups.

The overall adverse-event profile for patients who switched from ref-NTZ to biosim-NTZ was similar to patients continuing ref-NTZ treatment and did not indicate any new or increased risks associated with switching.

Rates of treatment-emergent adverse events (TEAEs) were similar, at 64.9% for biosim-NTZ, 68.9% for ref-NTZ, and 73.3% for the switch group. The most-reported TEAEs among all treatment groups were nervous system disorders and infections and infestations.

Progressive multifocal leukoencephalopathy (PML), a rare and potentially fatal demyelinating disease of the central nervous system, is associated with some DMTs – notably ref-NTZ. It is caused by infection with the John Cunningham virus (JCV) (also referred to as human polyomavirus), the researchers noted.

As per the study protocol, no participant had a JCV-positive index of more than 1.5 at baseline. Proportions of patients positive for anti-JCV antibodies were similarly distributed between treatment groups throughout the study.
 

Similar immunogenicity

There was strong concordance regarding positivity for treatment-emergent antidrug antibodies between the biosim-NTZ and ref-NTZ groups (79.4% and 74.0%). This was also the case for antinatalizumab-neutralizing antibodies (69.0% and 66.2%).

“There was nothing that indicated immunogenicity is different” between the two agents, said Dr. Hemmer.

While this might change “when you look at longer time periods,” antibodies to natalizumab usually develop “very early on,” he added.

Dr. Hemmer noted that this comparison of the proposed biosimilar with the reference drug had no real surprises.

“If the immunogenicity is the same, the mode of action is the same, and the dose is the same, you would expect to have a similar clinical effect and also a similar side-effect profile, which is indeed the case,” he said.

Dr. Hemmer added that he has no insight as to when the drug might be approved but believes developers expect that to occur sometime this year.
 

Welcome results

Commenting on the study results, Torge Rempe, MD, assistant professor in the department of neurology, University of Florida, Gainesville, and the William T. And Janice M. Neely professor for research in MS, said he welcomes these new results showing the biosimilar matched the reference medication.

“The authors report no significant difference in their primary endpoint of cumulative number of active lesions as well as their secondary clinical endpoints of annualized relapse rate and changes from baseline Expanded Disability Status Scale scores,” said Dr. Rempe, who was not involved with the research.

The study also showed the reported adverse events were similar between the biosimilar and reference natalizumab, he noted.

However, although no cases of PML were uncovered during the study period, further research is needed to determine long-term safety in this area, Dr. Rempe said.

Finally, he agreed that the development of biosimilars such as this one addresses the issue of high annual costs for DMTs, an area of concern in the field of MS.

The study was funded by Polpharma Biologics. Dr. Hemmer has reported receiving personal fees from Polpharma and Sandoz during the conduct of the study and personal fees from Novartis, Biocom, and TG Therapeutics outside the submitted work. He has also received a patent for genetic determinants of antibodies against interferon-beta and a patent for KIR4.1 antibodies in MS; served on scientific advisory boards for Novartis; served as a data monitoring and safety committee member for AllergyCare, Polpharma Biologics, Sandoz, and TG Therapeutics; and received speaker honoraria from Desitin, grants from Regeneron for MS research, and funding from the Multiple MS EU consortium, the CLINSPECT-M consortium, and the German Research Foundation. Dr. Rempe has reported no relevant financial relationships.

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